Bausch & lomb tobramycin ophthalmic solution usp 0.3% & Tulsa, ok
 

Pills
 

ED Pills

ED Drugs
 

Tobramycin eent


Class: Antibacterials
CAS Number: 32986-56-4
Brands: AK-Tob, TobraDex, Tobrex, Zylet

Introduction

Antibacterial; aminoglycoside antibiotic produced by Streptomyces tenebrarius.1 2 a d e

Uses for Tobramycin Bacterial Ophthalmic Infections

Treatment of superficial infections of the eye caused by susceptible bacteria.1 2 d e

Used alone or in fixed combination with topical corticosteroids (e.g., dexamethasone, loteprednol etabonate) when such combination therapy is indicated.3 4 5 (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Tobramycin Dosage and Administration General

Monitor for bacterial response during therapy.d e

A 5- to 7-day course of anti-infective therapy usually is adequate for the treatment of mild bacterial conjunctivitis.6

Administration Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment, solution, or suspension.1 2 3 4 5 e For ophthalmic use only.b e

Not for injection;1 2 3 4 5 e do not inject subconjunctivally or directly into the anterior chamber of the eye.1 2 5 b c

Shake suspension vigorously prior to use.3 5

Do not administer suspensions containing benzalkonium chloride while wearing soft contact lenses.5 b (See Advice to Patients.)

Avoid contamination of preparation container.1 2 3 4 5 e

Dosage Pediatric Patients Bacterial Ophthalmic Infections Tobramycin 0.3% Ophthalmic Ointment

Children ?2 months of age, mild-to-moderate infections: Apply a 1.25-cm ribbon to the affected eye(s) 2–3 times daily.d

Children ?2 months of age, severe infections: Apply a 1.25-cm ribbon to the affected eye(s) every 3–4 hours.d Decrease dosing frequency when improvement occurs.d

Ophthalmic Solution

Children ?2 months of age, mild-to-moderate infections: 1 or 2 drops into the affected eye(s) every 4 hours.e

Children ?2 months of age, severe infections: 2 drops into the affected eye(s) every hour.e Decrease dosing frequency when improvement occurs.e

Tobramycin 0.3% and Dexamethasone 0.1% Ophthalmic Ointment

Children ?2 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of affected eye(s) up to 3 or 4 times daily.c

Ophthalmic Suspension

Children ?2 years of age: Initial 24–48 hours, 1 or 2 drops into the affected eye(s) every 2 hours.b Thereafter, 1 or 2 drops every 4–6 hours.b Decrease dosing frequency when improvement occurs.b Do not discontinue prematurely.b

Adults Bacterial Ophthalmic Infections Tobramycin 0.3% Ophthalmic Ointment

Mild-to-moderate infections: Apply a 1.25-cm ribbon to the affected eye(s) 2–3 times daily.d

Severe infections: Apply a 1.25-cm ribbon to the affected eye(s) every 3–4 hours.d Decrease dosing frequency when improvement occurs.d

Ophthalmic Solution

Mild-to-moderate infections: 1 or 2 drops into the affected eye(s) every 4 hours.e

Severe infections: 2 drops into the affected eye(s) every hour.e Decrease dosing frequency when improvement occurs.e

Tobramycin 0.3% and Dexamethasone 0.1% Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of affected eye(s) up to 3 or 4 times daily.c

Ophthalmic Suspension

Initial 24–48 hours: 1 or 2 drops into the conjunctival sac of the affected eye(s) every 2 hours.b Thereafter, 1 or 2 drops every 4–6 hours.b Decrease dosing frequency when improvement occurs.b Do not discontinue prematurely.b

Tobramycin 0.3% and Loteprednol Etabonate 0.5% Ophthalmic Suspension

Initial 24–48 hours: 1 or 2 drops into the conjunctival sac of affected eye(s) every 1–2 hours.5 Thereafter, 1 or 2 drops every 4–6 hours.5 Decrease dosing frequency when improvement occurs.5 Do not discontinue prematurely.5

Cautions for Tobramycin Contraindications

Known hypersensitivity to tobramycin or any ingredient in the formulation.1 2 5 b c e

Warnings/Precautions Sensitivity Reactions

Hypersensitivity reported.1 2 5 b c If hypersensitivity occurs, discontinue the drug.1 2 5 b c e

Cross-allergenicity occurs among the aminoglycosides.1 2 5 b c e

General Precautions Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.1 2 5 b c e If superinfection occurs, discontinue the drug and institute appropriate therapy.1 2 5 c e

Infection Complications

Ophthalmic ointments may delay corneal healing.c d

Use of Fixed Combinations Containing Corticosteroids

Concomitant topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections, prevent recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to ingredients in the formulation.3 4 5

When tobramycin is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with EENT corticosteroids.3 4 5

Specific Populations Pregnancy

Category B.1 2 e

In fixed combination with dexamethasone or loteprednol etabonate: Category C.5 b c

Lactation

Discontinue nursing or the drug.1 2 e

Pediatric Use

Safety and efficacy of tobramycin ophthalmic ointment or ophthalmic solution not established in children <2 months of age.1 d e

Safety and efficacy of tobramycin in fixed combination with dexamethasone (ophthalmic ointment or ophthalmic suspension) not established in children <2 years of age.3 4 b c

Safety and efficacy of loteprednol etabonate in fixed combination with tobramycin ophthalmic suspension not established.5

Geriatric Use

No overall differences in safety and efficacy observed between geriatric and younger adults.1 5 b c d e

Common Adverse Effects

Itching and edema of the eyelid, conjunctival erythema.1 2 5 b

Tobramycin Pharmacokinetics Absorption Bioavailability

Not known if absorbed into the vitreous humor following topical instillation; absorption greatest when the cornea is abraded.a

Stability Storage Ophthalmic Ointment

Tobramycin alone and tobramycin in fixed combination with dexamethasone: 8–27°C.2 c

Solution

Tobramycin: 8–27°C.e

Suspension

Tobramycin in fixed combination with dexamethasone: Upright container at 8–27°C.b

Loteprednol etabonate in fixed combination with tobramycin: Upright container at 15–25°C; do not freeze.5

Actions and SpectrumActions

Usually bactericidal.a

Exact mechanism of action not fully elucidated; appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.a

Spectrum of activity of tobramycin includes many aerobic gram-negative bacteria and some aerobic gram-positive bacteria.1 2

Inactive against Chlamydia, fungi, viruses, and most anaerobic bacteria.a

Gram-positive aerobes: Active against Staphylococcus aureus, S. epidermidis, and some streptococci.1 2 3 4 5 e

Gram-negative aerobes: Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, some Neisseria, Moraxella lacunata, Proteus, and Pseudomonas aeruginosa.1 2 3 4 5 e

Partial cross-resistance occurs between tobramycin and other aminoglycosides.a

Advice to Patients

Importance of discontinuing therapy and consulting clinician if condition persists or deteriorates or signs of sensitivity occur.1 2 3 4 5

Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1 2 3 4 5 e

Importance of not wearing contact lenses if signs and symptoms of bacterial ocular infection occur.1 b c e When using an ophthalmic preparation that contains benzalkonium chloride, importance of not wearing soft contact lenses.5

Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 2 3 4 5

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2 3 4 5

Importance of informing patients of other important precautionary information.1 2 3 4 5 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Tobramycin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.3%

Tobrex (with chlorobutanol)

Alcon

Solution

0.3%*

AK-Tob (with benzalkonium chloride)

Akorn

Tobramycin

Bausch & Lomb, Falcon

Tobrex (with benzalkonium chloride)

Alcon

Tobramycin and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.3% Tobramycin and Dexamethasone 0.1%

TobraDex (with chlorobutanol)

Alcon

Suspension

0.3% Tobramycin and Dexamethasone 0.1%

TobraDex (with benzalkonium chloride)

Alcon

Other Tobramycin Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.3% with Loteprednol Etabonate 0.5%

Zylet (with benzalkonium chloride and povidone)

Bausch & Lomb

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

TobraDex 0.3-0.1% Ointment (ALCON VISION): 3/$139.99 or 10/$400.95

TobraDex 0.3-0.1% Suspension (ALCON VISION): 2/$61.99 or 7/$159.97

TobraDex 0.3-0.1% Suspension (ALCON VISION): 5/$112.99 or 15/$320.96

Tobramycin Sulfate 0.3% Solution (BAUSCH &amp; LOMB): 5/$15.99 or 10/$22.98

Tobramycin-Dexamethasone 0.3-0.1% Suspension (FALCON PHARMACEUTICALS): 10/$129.98 or 30/$359.96

Tobramycin-Dexamethasone 0.3-0.1% Suspension (FALCON PHARMACEUTICALS): 5/$69.99 or 15/$179.98

Tobrex 0.3% Ointment (ALCON VISION): 3/$84.99 or 10/$227.98

Tobrex 0.3% Solution (ALCON VISION): 5/$66.56 or 15/$185.2

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Falcon Pharmaceuticals. Tobramycin ophthalmic solution USP, 0.3% prescribing information. Ft. Worth, TX; 2003 Nov.

2. Alcon. Tobrex (tobramycin 0.3%) Ophthalmic ointment prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 30th ed. Montevale, NJ; Medical Economics Company. 2002:220-1.

3. Alcon. Tobradex (tobramycin and dexamethasone) ophthalmic suspension information. In: Physicians’ desk reference for ophthalmic medicines. 32nd ed. Montevale, NJ; Thompson Healthcare Inc; 2004:209-10.

4. Alcon. Tobradex (tobramycin and dexamethasone) Ophthalmic ointment sterile prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 32nd ed. Montevale, NJ; Thompson Healthcare Inc; 2004:210-11.

5. Bausch & Lomb Pharmaceuticals, Inc. Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%) ophthalmic suspension prescribing information. Tampa, FL; 2004 Dec.

6. American Academy of Ophthalmology. Preferred Practice Pattern: Conjunctivitis. 2003. From the American Academy of Ophthalmology website () Accessed 11 May 2006.

a. AHFS drug information 2008. McEvoy GK, ed. Tobramycin. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2756-7.

b. Alcon Laboratories, Inc. Tobradex (tobramycin and dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2006 May.

c. Alcon Laboratories, Inc. Tobradex (tobramycin and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2003 Oct.

d. Alcon Laboratories, Inc. Tobrex (tobramycin ophthalmic ointment) 0.3% prescribing information. Fort Worth, TX; 2003 Oct.

e. Alcon Laboratories, Inc. Tobrex (tobramycin ophthalmic solution) 0.3% prescribing information. Fort Worth, TX; 2003 Sept.

More Tobramycin eent resources Tobramycin eent Use in Pregnancy & Breastfeeding Tobramycin eent Support Group 3 Reviews for Tobramycin eent - Add your own review/rating Compare Tobramycin eent with other medications Conjunctivitis, Bacterial
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Tobralcon


Generic Name: tobramycin ophthalmic (TOE bra MYE sin off THAL mik)
Brand Names: Aktob, Tobralcon, Tobrasol, Tobrex

What is Tobralcon (tobramycin ophthalmic)?

Tobramycin ophthalmic is an antibiotic.

Tobramycin ophthalmic is used to treat bacterial infections of the eyes.

Tobramycin ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Tobralcon (tobramycin ophthalmic)? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down the tear ducts.

What should I discuss with my healthcare provider before using Tobralcon (tobramycin ophthalmic)? Do not use tobramycin ophthalmic if you have a viral or fungal infection in the eye. It is used to treat infections caused by bacteria only. Tobramycin ophthalmic is in the FDA pregnancy category B. This means that it is unlikely to be harmful to an unborn baby. Do not use tobramycin ophthalmic without first talking to your doctor if you are pregnant. It is not known whether tobramycin ophthalmic passes into breast milk. Do not use tobramycin ophthalmic without first talking to your doctor if you are breast-feeding a baby. How should I use Tobralcon (tobramycin ophthalmic)?

Use tobramycin ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eyedrops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye, repeat the process with about 5 minutes between drops. If you are using drops in both eyes, repeat the process in the other eye.

To apply the ointment:

Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before applying the other medication.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye. Do not use any eyedrop that is discolored or has particles in it. Store tobramycin ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose or if the medication has been ingested, call an emergency room or poison control center for advice.

What should I avoid while using Tobralcon (tobramycin ophthalmic)? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye. Use caution when driving, operating machinery, or performing other hazardous activities. Tobramycin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with tobramycin ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with tobramycin ophthalmic unless otherwise directed by your doctor. Tobralcon (tobramycin ophthalmic) side effects

Serious side effects are not expected with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tobralcon (tobramycin ophthalmic)? Do not use other eye drops or medications during treatment with tobramycin ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with tobramycin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Tobralcon resources Tobralcon Side Effects (in more detail) Tobralcon Use in Pregnancy & Breastfeeding Tobralcon Support Group 0 Reviews for Tobralcon - Add your own review/rating AKTob Advanced Consumer (Micromedex) - Includes Dosage Information Tobrex Prescribing Information (FDA) Tobrex Drops MedFacts Consumer Leaflet (Wolters Kluwer) Compare Tobralcon with other medications Conjunctivitis, Bacterial Where can I get more information? Your pharmacist has additional information about tobramycin ophthalmic written for health professionals that you may read.

See also: Tobralcon side effects (in more detail)


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Erythromycin Ophthalmic Ointment


Dosage Form: ophthalmic ointment
Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)

Rx only

DESCRIPTION:

Erythromycin Ophthalmic Ointment USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin is an antibiotic produced from a strain of Streptomyces erythraeus. It is basic and readily forms a salt when combined with an acid. It has the following structural formula:

C37H67NO13

Mol. Wt. 733.94

Chemical Name: (3R•, 4S•, 5S•, 6R•, 7R•, 9R•, 11R•, 12R•, 13S•, 14R•)-4-[(2,6-Dideoxy-3-C-methyl-3-0-methyl-?-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13 - hexamethyl - 6 - [[3,4,6 - trideoxy - 3 - (dimethylamino) - ? - D - xylo - hexopyranosyl]oxy]oxacyclotetradecane - 2, 10-dione

Each Gram Contains: ACTIVE: Erythromycin, USP 5 mg (0.5%); INACTIVES: White Petrolatum, Mineral Oil.

CLINICAL PHARMACOLOGY: Microbiology

Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections: Streptococcus pyogenes (group A ?-hemolytic), Alpha-hemolytic streptococci (viridans group); Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin); Streptococcus pneumoniae; Mycoplasma pneumoniae (Eaton Agent, PPLO); Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved); Treponema pallidum; Corynebacterium diphtheriae; Neisseria gonorrhoeae; Chlamydia trachomatis.

INDICATIONS AND USAGE:

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.

For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis.

The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established.

For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

CONTRAINDICATIONS:

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

PRECAUTIONS: General

The use of antimicrobial agents may be associated with the overgrowth of non-susceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.

Information for Patients:

Avoid contaminating the tip of container with material from the eye, fingers or other source.

Carcinogenesis, mutagenesis, impairment of fertility:

Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. No evidence of impaired fertility or harm to the fetus that appeared related to erythromycin was reported in these studies.

Pregnancy:

Pregnancy Category B.

Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.

Nursing Mothers:

Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use:

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS:

The most frequently reported adverse reactions are minor ocular irritations, redness and hypersensitivity reactions.

DOSAGE AND ADMINISTRATION:

In the treatment of superficial ocular infections, Erythromycin Ophthalmic Ointment approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.

HOW SUPPLIED:

Erythromycin Ophthalmic Ointment USP, 0.5% is available in the following sizes:

1/8 oz. (3.5 g) tamper-resistant tube – 09234

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

1 g tin container (in cartons of 50)

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

Storage:

Store between 15°-30°C (59°-86°F).

KEEP OUT OF REACH OF CHILDREN.

Revised February 2007

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

9043401 (Folded)
9043501 (Flat)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-910-55

Bausch & Lomb

Erythromycin Ophthalmic Ointment USP,
0.5% (Sterile)

Rx only

[icon- eye] [icon- 0.5%] [icon- ointment] [icon- 3.5gm]

Net wt. 1/8 oz
(3.5g)


ERYTHROMYCIN 
erythromycin  ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-910 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERYTHROMYCIN (ERYTHROMYCIN) ERYTHROMYCIN 5 mg  in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM   MINERAL OIL   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 24208-910-19 50 TUBE In 1 BOX contains a TUBE 1 1 g In 1 TUBE This package is contained within the BOX (24208-910-19) 2 24208-910-55 1 TUBE In 1 CARTON contains a TUBE 2 3.5 g In 1 TUBE This package is contained within the CARTON (24208-910-55)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064067 07/29/1994
Labeler - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Operations Bausch & Lomb Incorporated 807927397 MANUFACTURE Revised: 09/2010Bausch & Lomb Incorporated
More Erythromycin Ophthalmic Ointment resources Erythromycin Ophthalmic Ointment Use in Pregnancy & Breastfeeding Erythromycin Ophthalmic Ointment Support Group 0 Reviews for Erythromycin Ophthalmic - Add your own review/rating Compare Erythromycin Ophthalmic Ointment with other medications Conjunctivitis, Bacterial
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Tobradex


Generic Name: tobramycin and dexamethasone ophthalmic (TOE bra MYE sin and DEX a METH a sone off THAL mik)
Brand Names: Tobradex

What is tobramycin and dexamethasone ophthalmic?

Tobramycin is an antibiotic. It is used to treat bacterial infections.

Dexamethasone is a steroid. Dexamethasone ophthalmic is used to treat the swelling associated with bacterial infections of the eye.

Tobramycin and dexamethasone ophthalmic is used to treat bacterial infections of the eyes.

Tobramycin and dexamethasone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about tobramycin and dexamethasone ophthalmic?

Contact your doctor if the symptoms begin to get worse or if you do not see any improvement in the condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

What should I discuss with my doctor before using tobramycin and dexamethasone ophthalmic? Do not use tobramycin and dexamethasone ophthalmic if you have a viral or fungal infection in the eye. It is used to treat infections caused by bacteria only. It is not known whether tobramycin and dexamethasone ophthalmic will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether tobramycin and dexamethasone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby. How should I use tobramycin and dexamethasone ophthalmic?

Use tobramycin and dexamethasone ophthalmic eye drops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using the eye drops or ointment.

To apply the eye drops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye, repeat the process with about 5 minutes between drops. If you are using drops in both eyes, repeat the process in the other eye.

To apply the ointment:

Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before application of the other medication.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye. Do not use any eyedrop that is discolored or has particles in it. Store tobramycin and dexamethasone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose or if the medication has been ingested, contact an emergency room or poison control center for advice.

What should I avoid while using tobramycin and dexamethasone ophthalmic? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye. Use caution when driving, operating machinery, or performing other hazardous activities. Tobramycin and dexamethasone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with tobramycin and dexamethasone ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with tobramycin and dexamethasone ophthalmic unless otherwise directed by your doctor. Tobramycin and dexamethasone ophthalmic side effects

Serious side effects are not expected to occur with the use of this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tobramycin and dexamethasone ophthalmic? Do not use other eye drops or medications during treatment with tobramycin and dexamethasone ophthalmic unless otherwise directed by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with tobramycin and dexamethasone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Tobradex resources Tobradex Side Effects (in more detail) Tobradex Use in Pregnancy & Breastfeeding Tobradex Drug Interactions Tobradex Support Group 3 Reviews for Tobradex - Add your own review/rating Tobradex Advanced Consumer (Micromedex) - Includes Dosage Information Tobradex Consumer Overview TobraDex Prescribing Information (FDA) TobraDex Drops MedFacts Consumer Leaflet (Wolters Kluwer) TobraDex ST Prescribing Information (FDA) TobraDex ST Drops MedFacts Consumer Leaflet (Wolters Kluwer) Compare Tobradex with other medications Conjunctivitis, Bacterial Keratitis Uveitis Where can I get more information? Your pharmacist has additional information about tobramycin and dexamethasone ophthalmic written for health professionals that you may read.

See also: Tobradex side effects (in more detail)


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Tobramycin Ophthalmic Solution


Dosage Form: ophthalmic solution
Tobramycin Ophthalmic Solution USP, 0.3% DESCRIPTION

Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin Ophthalmic Solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water.

Tobramycin Ophthalmic Solution USP, 0.3% has a pH range between 7.0 and 8.0.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

The chemical structure of tobramycin is:

MW=467.2

Molecular Formula

C18H37N5O9

Chemical name: 0-{3-amino-3-deoxy-?-D-gluco-pyranosyl-(1?4)} -0- {2,6-diamino-2,3,6-trideoxy-?-D-ribohexopyranosyl-(1?6) }-2-deoxystreptamine.

CLINICAL PHARMACOLOGY

In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

INDICATIONS AND USAGE

Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDICATIONS

Tobramycin Ophthalmic Solution USP, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to Tobramycin Ophthalmic Solution USP, 0.3% occurs, discontinue use.

PRECAUTIONS General

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Information For Patients

Do not touch dropper tip to any surface, as this may contaminate the solution.

Pregnancy Category B

Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for adverse reactions in nursing infants from Tobramycin Ophthalmic Solution USP, 0.3%, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

ADVERSE REACTIONS

The most frequent adverse reactions to Tobramycin Ophthalmic Solution USP, 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with Tobramycin Ophthalmic Solution USP, 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from Tobramycin Ophthalmic Solution USP, 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of Tobramycin Ophthalmic Solution USP, 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.

HOW SUPPLIED

5 mL sterile solution is packaged in a 5 mL white plastic DROP-TAINER* bottle with a plastic dispensing plug and white plastic closure (NDC 61314-643-05) containing tobramycin 0.3% (3 mg/mL).

Storage: Store at 2° - 25°C (36° - 77°F).

Rx Only

*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.

9000857-0605

Dist. by:

FALCON Pharmaceuticals, Ltd

Fort Worth, TX 76134

Mfd. by:

ALCON LABORATORIES, INC.

Fort Worth, TX 76134 USA

Revised: June 2005

Printed in USA

PRINCIPAL DISPLAY PANEL

NDC 61314-643-05       Rx Only

FALCON PHARMACEUTICALS®

Tobramycin

Ophthalmic

Solution USP

0.3%

5 mL STERILE

AFFILIATE OF

ALCON LABORATORIES, INC.

QUALITY RX


TOBRAMYCIN 
tobramycin  solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61314-643 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   BORIC ACID   SODIUM SULFATE   SODIUM CHLORIDE   TYLOXAPOL   SODIUM HYDROXIDE   SULFURIC ACID   WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 61314-643-05 5 mL In 1 BOTTLE, PLASTIC None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062535 01/09/1995
Labeler - Falcon Pharmaceuticals, Ltd. (874345820) Registrant - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Operations Alcon Laboratories, Inc. 008018525 MANUFACTURE Revised: 08/2011Falcon Pharmaceuticals, Ltd. More Tobramycin Ophthalmic Solution resources Tobramycin Ophthalmic Solution Use in Pregnancy & Breastfeeding Tobramycin Ophthalmic Solution Support Group 3 Reviews for Tobramycin Ophthalmic - Add your own review/rating Compare Tobramycin Ophthalmic Solution with other medications Conjunctivitis, Bacterial
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Eye Allergy Relief


pheniramine maleate and naphazoline hydrochloride
Dosage Form: ophthalmic solution
Drug Facts Active ingredients

*Naphazoline HCl (0.02675%)

**Pheniramine Maleate (0.315%)

Purpose

*Redness Reliever

**Antihistamine

Uses Temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander. Warnings Do not use if you are sensitive to any ingredient in this product if solution changes color or becomes cloudy Ask a doctor before use if you have heart disease high blood pressure trouble urinating due to an enlarged prostate gland narrow angle glaucoma When using this product overuse may cause more eye redness pupils may become enlarged temporarily do not touch tip of container to any surface to avoid contamination you may feel a brief tingling after putting drops in eye replace cap after use remove contact lenses before using Stop use and ask a doctor if you experience eye pain changes in vision redness or irritation of the eye that worsens or lasts more than 72 hours Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Directions Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily. Children under 6 years: Ask a doctor Other information Store at 20°-25° C (68°-77° F). Protect from light. Use before expiration date marked on the carton or bottle. Inactive ingredients

Benzalkonium Chloride, Boric Acid, Edetate Disodium, Hypromellose, Purified Water, Sodium Borate and Sodium Chloride.

Questions?

Call 1-800-910-6874

Package/Label Principal Display Panel

NDC 11673-430-15

eye drops allergy relief

itching and redness reliever

eye drops

pheniramine maleate 0.315% and naphazoline hydrochloride 0.02675% ophthalmic solution

[icon- arrow- up&up] sterile

0.5 FL OZ (15 mL)


Eye Allergy Relief 
pheniramine maleate and naphazoline hydrochloride  solution/ drops Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-430 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.2675 mg  in 1 mL PHENIRAMINE MALEATE (PHENIRAMINE) PHENIRAMINE MALEATE 3.15 mg  in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   BORIC ACID   EDETATE SODIUM   HYPROMELLOSE   WATER   SODIUM BORATE   SODIUM CHLORIDE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 11673-430-15 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 15 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (11673-430-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020065 08/31/2010
Labeler - Target Corporation (006961700) Registrant - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Operations Bausch & Lomb Incorporated 114406598 MANUFACTURE Establishment Name Address ID/FEI Operations Loba Feinchemie AG 300137478 API MANUFACTURE Revised: 08/2010Target Corporation
More Eye Allergy Relief resources Eye Allergy Relief Dosage Eye Allergy Relief Use in Pregnancy & Breastfeeding Eye Allergy Relief Drug Interactions 0 Reviews for Eye Allergy Relief - Add your own review/rating Naphcon-A MedFacts Consumer Leaflet (Wolters Kluwer) Compare Eye Allergy Relief with other medications Eye Redness/Itching
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Crolom


cromolyn sodium
Dosage Form: ophthalmic solution
Crolom®
cromolyn sodium
ophthalmic solution USP, 4%
STERILE OPHTHALMIC SOLUTION

Rx only

DESCRIPTION:

Crolom® (cromolyn sodium ophthalmic solution USP, 4%) is a clear, colorless, sterile solution for topical ophthalmic use.

Cromolyn sodium is represented by the following structural formula:

C23H14Na2O11                                                                                                           Mol. Wt. 512.34

Chemical Name: Disodium 5,5'- [(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]

Pharmacologic Category: Mast cell stabilizer.

EACH mL CONTAINS: ACTIVE: Cromolyn Sodium 40 mg (4%); INACTIVES: Edetate Disodium 0.1% and Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 - 7.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

CLINICAL PHARMACOLOGY:

In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium acts by inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the mast cell.

Another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the degranulation of nonsensitized rat mast cells by phospholipase A and the subsequent release of chemical mediators. Another study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.

Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or anti-inflammatory activity.

Cromolyn sodium is poorly absorbed. When multiple doses of cromolyn sodium ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.

In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to the eye.

INDICATIONS AND USAGE:

Cromolyn sodium ophthalmic solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

CONTRAINDICATIONS:

Cromolyn sodium ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.

PRECAUTIONS: General:

Patients may experience a transient stinging or burning sensation following application of cromolyn sodium ophthalmic solution.

The recommended frequency of administration should not be exceeded (see DOSAGE AND ADMINISTRATION).

Information for Patients:

Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.

Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. Do not wear contact lenses during treatment with cromolyn sodium ophthalmic solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects. The average daily maximum dose levels administered in these studies were 192.9 mg/m2 for mice, 47.2 mg/m2 for hamsters and 385.8 mg/m2 for rats. These doses correspond to approximately 6.8, 1.7, and 14 times the maximum daily human dose of 28 mg/m2.

Cromolyn sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes.

No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m2) in males and 100 mg/kg/day (600 mg/m2) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m2.

Pregnancy: Teratogenic effects:

Pregnancy Category B. Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m2) and 164 mg/kg (984 mg/m2), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m2) produced no evidence of fetal malformation. These doses represent approximately 57, 35, and 205 times the maximum daily human dose, respectively, on a mg/m2 basis. Adverse fetal effects (increased resorption and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cromolyn sodium ophthalmic solution is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients below the age of 4 years have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS:

The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation.

The following adverse reactions have been reported as infrequent events. It is unclear whether they are attributed to the drug:

Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes.

Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema, and rash.

DOSAGE AND ADMINISTRATION:

The dose is 1 – 2 drops in each eye 4 – 6 times a day at regular intervals.

One drop contains approximately 1.6 mg cromolyn sodium.

Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.

Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution.

FOR OPHTHALMIC USE ONLY

HOW SUPPLIED:

Crolom® (cromolyn sodium ophthalmic solution USP, 4%) is supplied in a plastic bottle individually cartoned with a controlled drop tip in the following sizes:

10 mL bottle (NDC 24208-300-10) - AB30709

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

Storage:

Store between 15°-30°C (59°-86°F). Protect from light – store in original carton. Keep tightly closed. Replace cap immediately after use.

KEEP OUT OF REACH OF CHILDREN.

Rx only

Bausch & Lomb Incorporated
Tampa, Florida 33637
©Bausch & Lomb Incorporated

XO50206 (Folded)
XM10005 (Flat)
R.1/04-83

Patient Instructions

PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

Information for the Patient

Crolom®

(cromolyn sodium ophthalmic solution USP, 4%) Sterile

It is important to use Crolom® regularly, as directed by your physician.

1. Thoroughly wash your hands.

2. Remove safety seal (Figure 1).

3. Remove cap (Figure 2).

4. Sit or stand comfortably, with your head tilted back (Figure 3).

5. Open eyes, look up, and draw the lower lid of your eye down gently with your index finger (Figure 4).

6. Hold the Crolom® bottle upside down. Place dropper tip as close as possible to the lower eyelid and gently squeeze out the prescribed number of drops (Figure 5).

7. Do not touch the eye or eyelid with the dropper tip.

8. Blink a few times to make sure the eye is covered with the solution.

9. Close your eye and remove any excess solution with a clean tissue.

10. Repeat process in the other eye.

 

SPECIAL TIPS

1. Avoid placing Crolom® solution directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of eye drops more comfortable if you place the drops just inside the lower eyelid as shown in Figure 5 on the previous page.

2. To avoid contamination of the solution, do not touch dropper tip to the eye, fingers or any other surface. Replace cap after use. It is recommended that any remaining contents be discarded after the treatment period prescribed by your physician.

3. Store between 15°-30°C (59°-86°F). Protect from light – store in original carton. Keep tightly closed. Replace cap immediately after use.

4. Keep out of the reach of children.

5. Do not use with any other ocular medication unless directed by your physician. Do not wear contact lenses during treatment with Crolom®.

Bausch & Lomb Incorporated
Tampa, Florida 33637
©Bausch & Lomb Incorporated

XO50206 (Folded)
XM10005 (Flat)
R.1/04-83

Principal Display Panel

NDC 24208-300-10

Bausch & Lomb

Crolom

Cromolyn Sodium Ophthalmic Solution USP, 4%

[icon- eye]

STERILE

Rx only

10 mL


Crolom 
cromolyn sodium  solution/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-300 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CROMOLYN SODIUM (CROMOLYN) CROMOLYN SODIUM 40 mg  in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   EDETATE DISODIUM   HYDROCHLORIC ACID   WATER   SODIUM HYDROXIDE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 24208-300-10 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-300-10)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074443 01/30/1995
Labeler - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Operations Bausch & Lomb Incorporated 807927397 MANUFACTURE Revised: 03/2011Bausch & Lomb Incorporated
More Crolom resources Crolom Side Effects (in more detail) Crolom Dosage Crolom Use in Pregnancy & Breastfeeding Crolom Support Group 0 Reviews for Crolom - Add your own review/rating Crolom Advanced Consumer (Micromedex) - Includes Dosage Information Crolom ophthalmic Concise Consumer Information (Cerner Multum) cromolyn ophthalmic Concise Consumer Information (Cerner Multum) Compare Crolom with other medications Conjunctivitis, Allergic Keratitis Keratoconjunctivitis
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Tobrex Ophthalmic Ointment


Generic Name: tobramycin
Dosage Form: ophthalmic ointment
Tobrex® (tobramycin ophthalmic ointment) 0.3% DESCRIPTION

TOBREX® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each gram of TOBREX® (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil, white petrolatum.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

The chemical structure of tobramycin is :

Molecular formula:

C18H37N5O9

Molecular weight:

467.52

Chemical name:

0-{3-amino-3-deoxy-?-D-gluco-pyranosyl-(1?4) }-0-{2,6-diamino-2,3,6-trideoxy-?-D-ribohexo-pyranosyl-(1?6) }-2-deoxystreptamine.

CLINICAL PHARMACOLOGY

In Vitro Data : In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

INDICATIONS AND USAGE

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX® (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDICATIONS

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to TOBREX® (tobramycin ophthalmic ointment) 0.3% occurs, discontinue use.

PRECAUTIONS

General. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Ophthalmic ointments may retard corneal wound healing.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular infections.

Information For Patients

Do not touch tube tip to any surface, as this may contaminate the ointment.

Do not use the product if the imprinted carton seals have been damaged, or removed.

Pregnancy Category B

Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for adverse reactions in nursing infants from TOBREX® (tobramycin ophthalmic ointment) 0.3%, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

ADVERSE REACTIONS

The most frequent adverse reactions to TOBREX® (tobramycin ophthalmic ointment) 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with TOBREX® (tobramycin ophthalmic ointment) 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from TOBREX® (tobramycin ophthalmic ointment) 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. In clinical trials, TOBREX® (tobramycin ophthalmic ointment) 0.3 % produced significantly fewer adverse reactions (3.7%) than did GARAMYCIN® Ophthalmic Ointment (10.6%).

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of TOBREX® (tobramycin ophthalmic ointment) 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

In mild to moderate disease, apply a half-inch ribbon into the affected eye(s) two or three times per day. In severe infections, instill a half-inch ribbon into the affected eye(s) every three to four hours until improvement, following which treatment should be reduced prior to discontinuation.

How to Apply TOBREX® (tobramycin ophthalmic ointment) 0.3%:

1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a ''V'' pocket is formed between your eyeball and your lower lid.

3. Place a small amount (about 1/2 inch) of TOBREX® (tobramycin ophthalmic ointment) 0.3% in the ''V'' pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

HOW SUPPLIED

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap (NDC 0065-0644-35), containing tobramycin 0.3% (3 mg/g).

Storage: Store at 2°- 25°C (36°- 77°F).

Rx Only

© 2002, 2008 Alcon, Inc.

Revised: July 2008

Manufactured for:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Puurs, Belgium

44280-1

PRINCIPAL DISPLAY PANEL

NDC 0065-0644-35  Alcon®

Tobrex®

(tobramycin ophthalmic

ointment) 0.3%

Sterile 3.5 g Net Wt.

  

  


TOBREX 
tobramycin  ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0644 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 g Inactive Ingredients Ingredient Name Strength CHLOROBUTANOL   MINERAL OIL   PETROLATUM   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0065-0644-35 3.5 g In 1 TUBE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050555 06/28/1981
Labeler - Alcon Laboratories, Inc. (008018525) Registrant - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Operations S.A. ALCON-COUVREUR N.V. 370205429 MANUFACTURE Revised: 07/2011Alcon Laboratories, Inc. More Tobrex Ophthalmic Ointment resources Tobrex Ophthalmic Ointment Use in Pregnancy & BreastfeedingTobrex Ophthalmic Ointment Support Group3 Reviews for Tobrex Ophthalmic - Add your own review/rating Compare Tobrex Ophthalmic Ointment with other medications Conjunctivitis, Bacterial
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Ophthalmic diagnostic agents


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Ophthalmic diagnostic agents are given intravenously to perform diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. A few preparations also contain a local anesthetic to reduce pain in the nerves of the eyes.

See also

Medical conditions associated with ophthalmic diagnostic agents:

Diagnosis and Investigation Ophthalmic Surgical Staining Drug List: Ak-Fluor Flucaine-Drops Fluoracaine-Drops Flurox-Ophthalmic-Solution Ic-Green Membraneblue Visionblue
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Maxidex eent


Generic Name: Dexamethasone eent
Class: Corticosteroids
ATC Class: S01CA01
VA Class: OP350
CAS Number: 50-02-2

Introduction

A synthetic fluorinated corticosteroid.a b d

Uses for Maxidex Ophthalmic Inflammation

Symptomatic relief of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (e.g., allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides).a c d e f g h

Treatment of chronic anterior uveitis.e g h

Treatment of corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.a c d e f g h

Bacterial Ophthalmic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye;e f g h used in fixed combination with neomycin and polymyxin B sulfates or tobramycin when such combination therapy is indicated.e f g h If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.d (See Infections under Cautions.)

Otic Inflammation

Symptomatic relief of corticosteroid-responsive inflammatory conditions of the ear canal (e.g., allergic otitis externa).b c i

Bacterial Otic Infections

Used for anti-inflammatory properties in conjunction with ciprofloxacin for treatment of acute otitis externa and in pediatric patients with tympanostomy tubes for acute otitis media.i

Used to reduce edema and inflammation in select cases of purulent and nonpurulent infective otitis externa.c

If a corticosteroid is used alone or in combination with an otic anti-infective, weigh benefits against risks.d (See Infections under Cautions.)

Maxidex Dosage and Administration Administration

Apply topically to the eye or ear.a b c e f g h i

Ophthalmic Administration

Apply topically to the eye as an ophthalmic ointment, solution, or suspension.a b c e f g h

Not for injection.e f g h

Shake suspension well prior to each use.a g

Avoid contamination of preparation container.a b e f

Do not administer solutions or suspensions containing benzalkonium chloride while wearing soft contact lenses.a c g Wait ?15 minutes after instilling drops before inserting contact lenses.c (See Advice to Patients.)

Otic Administration

Apply topically to the ear as an otic suspension or an ophthalmic solution.b c i

Not for injection.i Do not instill otic preparations into the eye.i

May use dexamethasone sodium phosphate ophthalmic solution in the ear.b c

Shake suspension well prior to each use.i

To avoid dizziness that may result from instilling a cold preparation into the ear, warm the preparation by holding the bottle in the hands for 1–2 minutes prior to administration.i

Clean and dry ear canal prior to administration;b c d pH of otic preparations should be neutral or acidic.b

Lie with the affected ear upward and instill drops.i For pediatric patients with otitis media and tympanostomy tubes, pump the tragus 5 times to ease penetration of drops into the middle ear.i For acute otitis externa, pull outer ear lobe upward and backward to facilitate entry of drug into ear canal.i

Keep affected ear upward for ?60 seconds following drug administration.i If necessary, repeat procedure for the opposite ear.i

Use otic corticosteroids sparingly to prevent an accumulation of excess debris in the ear canal.b d

Dosage

Commercially available alone or in fixed combination with anti-infectives; available as dexamethasone or dexamethasone sodium phosphate.a c d e f g h i Solution available as dexamethasone sodium phosphate; dosage expressed in terms of dexamethasone phosphate.c

Pediatric Patients Bacterial Ophthalmic Infections

Duration of therapy depends on the type and severity of the disease and response to therapy.g Do not discontinue prematurely.g

When discontinuing therapy, gradually taper dosing frequency to avoid exacerbation of the disease.b

Dexamethasone 0.1% and Tobramycin 0.3% Ophthalmic Suspension

Children ?2 years of age: Initial 24–48 hours, 1 or 2 drop(s) into the conjunctival sac of the affected eye(s) every 2 hours.g Thereafter, 1 or 2 drops every 4–6 hours.g Gradually reduce dosing frequency as infection improves.g

Ophthalmic Ointment

Children ?2 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.h

Bacterial Otic Infections Acute Otitis Externa Otic Suspension (Dexamethasone 0.1% and Ciprofloxacin 0.3%)

Children ?6 months of age: 4 drops into the affected ear(s) twice daily for 7 days.i

Acute Otitis Media Otic Suspension (Dexamethasone 0.1% and Ciprofloxacin 0.3%)

Children ?6 months of age with tympanostomy tubes: 4 drops into the affected ear(s) twice daily for 7 days.i

Adults Ophthalmic Inflammation and Bacterial Infections

Duration of therapy depends on the type and severity of the disease and response to therapy.g Do not discontinue prematurely.g

When discontinuing therapy, gradually taper dosing frequency to avoid exacerbation of the disease.b

Dexamethasone 0.1% Ophthalmic Suspension

For mild inflammation: 1 or 2 drops into the conjunctival sac of the affected eye(s) up to 4–6 times daily.a

For severe inflammation: 1 or 2 drops into the conjunctival sac of the affected eye(s) every hour.a Taper dosing frequency as inflammation subsides.a

Dexamethasone Sodium Phosphate 0.1% Ophthalmic Solution

Initially, 1 or 2 drops into the conjunctival sac of the affected eye(s) every hour during the day and every 2 hours during the night.c When a favorable response is attained, decrease to 1 drop every 4 hours.c May decrease to 1 drop 3 or 4 times daily to control symptoms.c

Dexamethasone 0.1%, Neomycin 0.35%, and Polymyxin B Sulfates 10,000 units Ophthalmic Suspension

For mild inflammation: 1 or 2 drop(s) into the conjunctival sac of the affected eye(s) up to 4–6 times daily.f

For severe inflammation: 1 or 2 drops into the conjunctival sac of the affected eye(s) hourly.f As inflammation subsides, gradually reduce dosing frequency to discontinue.f

Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.e

Dexamethasone 0.1% and Tobramycin 0.3% Ophthalmic Suspension

Initial 24–48 hours, 1 or 2 drops into the conjunctival sac of the affected eye(s) every 2 hours; thereafter, 1 or 2 drops every 4 to 6 hours.g Gradually reduce dosing frequency as infection improves.g

Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.h

Otic Inflammation Dexamethasone Sodium Phosphate 0.1% Ophthalmic Solution Otic

Initially, 3 or 4 drops of the ophthalmic solution into the ear canal 2 or 3 times daily.b c May reduce dosing frequency as symptoms improve.b c Gradually taper the drug when it is discontinued.c

Alternatively, a cotton wick saturated with the ophthalmic solution may be packed into the ear canal; keep the wick moist with the ophthalmic solution; remove saturated wick from ear after 12 to 24 hours.b c Repeat as necessary.b c

Duration of treatment may range from a few days to several weeks.b

Bacterial Otic Infections: Acute Otitis Externa Dexamethasone 0.1% and Ciprofloxacin 0.3% Otic

4 drops into the affected ear(s) twice daily for 7 days.i

Special Populations

No special population dosage recommendations at this time.a c e f g h i

Cautions for Maxidex Contraindications

Known hypersensitivity to dexamethasone or any ingredient in the formulation.a c e f g h i

Ophthalmic Preparations

Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).a c e f g h

Mycobacterial infection (e.g., ocular tuberculosis) of the eye.a c e f g h

Fungal disease of ocular structures.a c e f g h

Otic Preparations

Viral infections of the external ear canal (e.g., herpes simplex).i

Perforation of the ear drum.c

Fungal diseases of auricular structures.c

Warnings/Precautions Warnings Ocular Effects

Risk of glaucoma with possible damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.a c d e f g h Use with caution in patients with glaucoma because IOP may increase.a c d e f g h

If used for ?10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.a c d e f g h

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.a c d e f g h

Use of high-dose corticosteroids may delay healing.c h Use after cataract surgery may delay healing and increase incidence of bleb formation.c

Infections

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.a c e f g

In acute purulent conditions of the eye or ear, corticosteroids may mask infection or enhance existing infection.a c d e f g h (See Contraindications under Cautions.)

Herpes Simplex

Use of corticosteroids in the treatment of herpes simplex infections other than epithelial herpes simplex keratitis, in which corticosteroids are contraindicated, requires great caution; periodic slit-lamp microscopy is essential.a c e f

General Precautions Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 8 g of 0.1% ointment or 20 mL of 0.1% suspension should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).e f g h

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea.a d e f g h Consider possibility of fungal infection in patients with persistent corneal ulceration who have been or are receiving corticosteroid therapy.a c d e f h

Corneal Reepithelialization

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.h

Use of Fixed Combination

When used in fixed combination with ciprofloxacin, neomycin and polymyxin B sulfates, or tobramycin, consider the cautions, precautions, and contraindications associated with the concomitant agents.e f g h i

Specific Populations Pregnancy

Category C.a c e f g h i

Lactation

Not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.a e f g h i

Caution if used in nursing women.a e f g h

Dexamethasone sodium phosphate ophthalmic solution and dexamethasone in fixed combination with ciprofloxacin otic suspension: Manufacturers recommend discontinuing nursing or the drug.c i

Pediatric Use

Safety and efficacy of ophthalmic dexamethasone suspension or dexamethasone sodium phosphate solution not established.a c

Safety and efficacy of ophthalmic dexamethasone in fixed combination with neomycin and polymyxin B sulfates not established.e f

Safety and efficacy of ophthalmic dexamethasone in fixed combination with tobramycin not established in children <2 years of age.g h

Safety and efficacy of otic dexamethasone suspension in fixed combination with ciprofloxacin not established in infants <6 months of age.i

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients.a e h

Common Adverse Effects

Ophthalmic administration: Elevated IOP,a c e f g h posterior subcapsular cataract formation,a c e g h optic nerve damage,a c e f g h delayed wound healing.e f h

Otic administration: Ear discomfort, ear pain, ear pruritus.i

Maxidex Pharmacokinetics Absorption Bioavailability

Corticosteroids are absorbed through the aqueous humor; because only low doses are given, little if any systemic absorption occurs after ophthalmic administration.d

Distribution Extent

Systemically absorbed corticosteroids are distributed into milk; not known whether topical corticosteroids could produce detectable levels in human milk.a e f g h i

Stability Storage Ophthalmic Ointment

Neomycin and polymyxin B sulfates and dexamethasone: 2–25°C.e

Tobramycin and dexamethasone: 8–27°C.h

Solution

Dexamethasone sodium phosphate: 15–30°C.c

Suspension

Dexamethasone: Tight, light-resistant containersb at 8–27°C;a store upright.a

Neomycin and polymyxin B sulfates and dexamethasone: 8–27°C.f

Tobramycin and dexamethasone: Upright containers at 8–27°C.g

Otic Suspension

Ciprofloxacin and dexamethasone: 15–30°C; protect from light.i Do not freeze.i

ActionsActions

Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.a c d e f g h

Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte and phagocyte migration; in addition, the drugs reduce capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.d

Advice to Patients

Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloridea g h and of delaying reinsertion of the lenses for ?15 minutes after administration.c Importance of not wearing contact lenses if signs or symptoms of an eye infection occur.e

Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the container.a e f i

Importance of advising patients not to touch tip of dropper to eye or surrounding tissue.a c f g h i

Importance of informing a clinician if another eye condition (e.g., trauma, surgery, infection) develops during ophthalmic therapy.c

Advise patients to warm the ear suspension by holding the bottle in the hands for 1–2 minutes prior to administration.i

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.a c e g h i

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a c e g h i

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.1%

Maxidex (with benzalkonium chloride; viscous)

Alcon

Ciprofloxacin and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Otic

Suspension

Ciprofloxacin 0.3% and Dexamethasone 0.1% per mL

Ciprodex (with benzalkonium chloride)

Alcon

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin and Polymyxin B Sulfates and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) and Dexamethasone 0.1% per g*

Maxitrol

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone

Bausch & Lomb, Falcon, Fougera

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) and Dexamethasone 0.1% per mL*

Maxitrol (with benzalkonium chloride; viscous)

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone

Bausch & Lomb, Falcon

Tobramycin and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.3% Tobramycin and Dexamethasone 0.1% per g

TobraDex (with chlorobutanol)

Alcon

Suspension

0.3% Tobramycin and Dexamethasone 0.1% per mL

TobraDex (with benzalkonium chloride)

Alcon

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dexamethasone Sodium Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.1% (of dexamethasone phosphate)*

Dexamethasone Sodium Phosphate (with benzalkonium chloride)

Falcon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ciprodex 0.3-0.1% Suspension (ALCON VISION): 7/$142.98 or 22/$407.95

Dexamethasone Sodium Phosphate 0.1% Solution (FALCON PHARMACEUTICALS): 5/$19.99 or 10/$30.97

Maxidex 0.1% Suspension (ALCON VISION): 5/$56.27 or 15/$154.48

TobraDex 0.3-0.1% Ointment (ALCON VISION): 3/$139.99 or 10/$400.95

TobraDex 0.3-0.1% Suspension (ALCON VISION): 5/$112.99 or 15/$320.96

TobraDex 0.3-0.1% Suspension (ALCON VISION): 2/$61.99 or 7/$159.97

Tobramycin-Dexamethasone 0.3-0.1% Suspension (FALCON PHARMACEUTICALS): 10/$129.98 or 30/$359.96

Tobramycin-Dexamethasone 0.3-0.1% Suspension (FALCON PHARMACEUTICALS): 5/$69.99 or 15/$179.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Alcon Laboratories, Inc. Maxidex 0.1% (dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2007 May.

b. AHFS drug information 2008. McEvoy GK, ed. Dexamethasone. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2874-5.

c. Falcon Pharmaceuticals. Dexamethasone sodium phosphate ophthalmic solution, USP prescribing information. Fort Worth, TX; 2007 Jul.

d. AHFS drug information 2008. McEvoy GK, ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2867-9.

e. Alcon Laboratories, Inc. Maxitrol(neomycin and polymyxin B sulfates, and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2003 Oct.

f. Alcon Laboratories, Inc. Maxitrol (neomycin and polymyxin B sulfates, and dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2003 Aug.

g. Alcon Laboratories, Inc. TobraDex (tobramycin and dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2006 May.

h. Alcon Laboratories, Inc. TobraDex (tobramycin and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2003 Oct.

i. Alcon Laboratories, Inc. Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension) prescribing information. Fort Worth, TX; 2003 Jul.


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Zylet


loteprednol etabonate and tobramycin
Dosage Form: ophthalmic suspension
Zylet®
loteprednol etabonate 0.5%
and tobramycin 0.3%
ophthalmic suspension

STERILE

DESCRIPTION:

Zylet (loteprednol etabonate and tobramycin ophthalmic suspension), is a sterile, multiple dose topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below.

Loteprednol etabonate:

C24H31ClO7                         Mol. Wt. 466.96

Chemical name: chloromethyl 17?-[(ethoxycarbonyl)oxy]-11?-hydroxy-3-oxoandrosta-1,4-diene-17?-carboxylate

Tobramycin:

C18H37N5O9                           Mol. Wt. 467.52

Chemical Name:

O-3-Amino-3-deoxy-?-D-glucopyranosyl-(1? 4)-O- [2,6-diamino-2,3,6-trideoxy-?-D-ribo-hexopyranosyl- (1? 6)] -2-deoxystreptamine

Each mL contains:

Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.7-5.9. The suspension is essentially isotonic with a tonicity of 260 to 320 mOsmol/kg.

CLINICAL PHARMACOLOGY:

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteroids are capable of producing a rise in intraocular pressure.

Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent. It is highly lipid soluble which enhances its penetration into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites.

The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis,Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Pharmacokinetics:

In a controlled clinical study of ocular penetration, the levels of loteprednol etabonate in the aqueous humor were found to be comparable between Lotemax and Zylet treatment groups.

Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and ?1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate ophthalmic suspension 8 times daily for 2 days or 4 times daily for 42 days. This study suggests that limited (<1 ng/mL) systemic absorption occurs with 0.5% loteprednol etabonate.

INDICATIONS AND USAGE:

Zylet is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

CONTRAINDICATIONS:

Zylet, as with other steroid anti-infective ophthalmic combination drugs, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Zylet is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS:

NOT FOR INJECTION INTO THE EYE.

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Sensitivity to topically applied aminoglycosides may occur in some patients. If sensitivity reaction does occur, discontinue use.

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

PRECAUTIONS: General:

For ophthalmic use only. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

If this product is used for 10 days or longer, intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients (See WARNINGS:).

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Information for Patients:

This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses when using Zylet.

Carcinogenesis, mutagenesis, impairment of fertility:

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate or tobramycin.

Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma TK assay, a chromosome aberration test in human lymphocytes, or in an in vivo mouse micronucleus assay.

Oral treatment of male and female rats at 50 mg/kg/day and 25mg/kg/day of loteprednol etabonate, respectively, (500 and 250 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at 100 mg/kg/day (1700 times the maximum daily clinical dose).

Pregnancy: Teratogenic effects

Pregnancy Category C.

Loteprednol etabonate was shown to be teratogenic when administered orally to rats and rabbits during organogenesis at 5 and 3 mg/kg/day, respectively (50 and 30 times the maximum daily clinical dose in rats and rabbits, respectively). An oral dose of loteprednol etabonate in rats at 50 mg/kg/day (500 times the maximum daily clinical dose) during late pregnancy through the weaning period showed a decrease in the growth and survival of pups without dystocia. However, no adverse effect in the pups was observed at 5 mg/kg/day (50 times the maximum daily clinical dose).

Parenteral doses of tobramycin did not show any harm to fetuses up to 100 mg/kg/day (1700 times the maximum daily clinical dose) in rats and rabbits.

There are no adequate and well controlled studies in pregnant women. Zylet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Zylet is administered to a nursing woman.

Pediatric Use:

In a trial to evaluate the safety and efficacy of Zylet in pediatric subjects age zero to six years with lid inflammation, Zylet with warm compresses did not demonstrate efficacy compared to vehicle with warm compresses. Patients received warm compress lid treatment plus Zylet or vehicle for 14 days. The majority of patients in both treatment groups showed reduced lid inflammation. There were no differences in safety assessments between the treatment groups.

Geriatric Use:

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS:

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.

Zylet:

In a 42 day safety study comparing Zylet to placebo, the incidence of ocular adverse events reported in greater than 10% of subjects included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Zylet) and 4% (placebo) of subjects. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation. Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders.

The incidence of non-ocular adverse events reported in approximately 14% of subjects was headache; all other non-ocular events had an incidence of less than 5%.

Loteprednol etabonate ophthalmic suspension 0.2% - 0.5%:

Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (? 10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.

Tobramycin ophthalmic solution 0.3%:

The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

DOSAGE AND ADMINISTRATION:

SHAKE VIGOROUSLY BEFORE USING.

Apply one or two drops of Zylet into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

HOW SUPPLIED:

Zylet (loteprednol etabonate and tobramycin ophthalmic suspension) is supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a white polypropylene cap in the following sizes:

2.5 mL (NDC 24208-358-25) in a 7.5 mL bottle

5 mL (NDC 24208-358-05) in a 7.5 mL bottle

10 mL (NDC 24208-358-10) in a 10 mL bottle

USE ONLY IF IMPRINTED NECKBAND IS INTACT.

Storage: Store upright at 15°-25°C (59°-77°F). PROTECT FROM FREEZING.

KEEP OUT OF REACH OF CHILDREN.

Rx only

Revised November 2009

Manufactured by:
Bausch & Lomb Incorporated
Tampa, Florida 33637
©Bausch & Lomb Incorporated

U.S. Patent Numbers: 4,996,335; 5,540,930; 5,747,061

Zylet is a registered trademark of Bausch & Lomb Incorporated

9007702 (FOLDED)
9004402 (FLAT)

Principle Display Panel

NDC 24208-358-10

Bausch & Lomb

Zylet®

loteprednol etabonate 0.5% and tobramycin 0.3%
ophthalmic suspension

Rx only

10 mL

Sterile Ophthalmic Suspension


Zylet 
loteprednol etabonate and tobramycin  suspension/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-358 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOTEPREDNOL ETABONATE (LOTEPREDNOL) LOTEPREDNOL ETABONATE 5 mg  in 1 mL TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 24208-358-10 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-10) 2 24208-358-25 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 2 2.5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-25) 3 24208-358-05 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 3 5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-05)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050804 12/14/2004
Labeler - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Operations Bausch & Lomb Incorporated 807927397 MANUFACTURE Revised: 01/2011Bausch & Lomb Incorporated
More Zylet resources Zylet Side Effects (in more detail)Zylet DosageZylet Use in Pregnancy & BreastfeedingZylet Drug InteractionsZylet Support Group4 Reviews for Zylet - Add your own review/rating Zylet Advanced Consumer (Micromedex) - Includes Dosage Information Zylet Drops MedFacts Consumer Leaflet (Wolters Kluwer) Zylet Consumer Overview Compare Zylet with other medications Conjunctivitis, BacterialCyclitisIritisKeratitisUveitis
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Neomycin, Polymyxin B, Bacitracin Ophthalmic Ointment



Dosage Form: ophthalmic ointment
Neomycin and Polymyxin B Sulfates and
Bacitracin Zinc Ophthalmic Ointment USP (Sterile)

Rx only

DESCRIPTION:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is a sterile antimicrobial ointment for ophthalmic use.

Each Gram Contains:

ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, and Bacitracin Zinc equivalent to 400 bacitracin units; INACTIVES: White Petrolatum, Mineral Oil.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin standard per milligram, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis.

The structural formulae are:

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per milligram.

The structural formula for bacitracin A is:

CLINICAL PHARMACOLOGY:

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin.

Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.

Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.

Microbiology: Neomycin sulfate, polymyxin B sulfate and bacitracin zinc together are considered active against the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

INDICATIONS AND USAGE:

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

CONTRAINDICATIONS:

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in those individuals who have shown hypersensitivity to any of its components.

WARNINGS:

NOT FOR INJECTION INTO THE EYE.

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

PRECAUTIONS: General

As with other antibiotic preparations, prolonged use of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.

Bacterial resistance to neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients:

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface.

The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

Pregnancy; Teratogenic Effects:

Pregnancy Category C. Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate, or bacitracin. It is also not known whether neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

DOSAGE AND ADMINISTRATION:

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

HOW SUPPLIED:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip.

Prod. No. 03534

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

FOR OPHTHALMIC USE ONLY

Storage:

Store between 15° - 30°C (59°- 86°F).

KEEP OUT OF REACH OF CHILDREN.

Revised November 2007

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

9113600 (Folded)
9113700 (Flat)

Principal Display Panel

RXV

RXV Products

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP

STERILE OPHTHALMIC OINTMENT

Rx only

Net wt. 3.5 g


NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 
neomycin sulfate, polymyxin b sulfate and bacitracin zinc  ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 14049-464 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 3.5 mg  in 1 g POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 10000 [USP'U]  in 1 g BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 400 [USP'U]  in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL   PETROLATUM   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 14049-464-34 1 TUBE In 1 CARTON contains a TUBE 1 3.5 g In 1 TUBE This package is contained within the CARTON (14049-464-34)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064064 10/30/1995
Labeler - RXV (059580480) Registrant - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Operations Bausch & Lomb Incorporated 807927397 MANUFACTURE Revised: 11/2010RXV
More Neomycin, Polymyxin B, Bacitracin Ophthalmic Ointment resources Neomycin, Polymyxin B, Bacitracin Ophthalmic Ointment Use in Pregnancy & Breastfeeding Neomycin, Polymyxin B, Bacitracin Ophthalmic Ointment Support Group 1 Review for Neomycin, Polymyxin B, Bacitracin Ophthalmic - Add your own review/rating Compare Neomycin, Polymyxin B, Bacitracin Ophthalmic Ointment with other medications Blepharitis Blepharoconjunctivitis Conjunctivitis, Bacterial Keratitis Keratoconjunctivitis
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Polymyxin B Sulfate eent


Class: Antibacterials
VA Class: OT101
CAS Number: 1405-20-5
Brands: AK-Poly-Bac, Cortisporin, Maxitrol, Neosporin, Pediotic, Poly-Pred, Polytrim

Introduction

Antibacterial; polymyxin antibiotic produced by Bacillus polymyxa.a b c d f g h k l

Uses for Polymyxin B Sulfate Bacterial Ophthalmic Infections

Used in fixed combination with other anti-infectives (e.g., bacitracin, neomycin, gramicidin, trimethoprim) for treatment of superficial infections of the eye caused by susceptible bacteria.b e k l

Used in fixed combination with corticosteroids and other anti-infectives in certain bacterial ocular infections.a d h i j

Not indicated for treatment or prophylaxis of ophthalmic neonatorum.e

Bacterial Otic Infections

Used in fixed combination with corticosteroids (with or without other anti-infectives) for treatment of otitis externa caused by susceptible bacteria.c f g

Polymyxin B Sulfate Dosage and Administration Administration

Apply topically to the eye or ear.a b c d e f g h i j k l

Ophthalmic Administration

In fixed combination with other anti-infectives and corticosteroids, apply topically to the eye as an ophthalmic ointment, solution, or suspension.a b e d h i j k l

Not for injection; do not inject subconjunctivally or directly into the anterior chamber of the eye.a b d h j l

Avoid contamination of the preparation container.a b h l

Shake suspension well prior to each use.a h

To treat eyelids, instill into the eye, then close the eye and rub the excess onto the lids and lid margins.h

Otic Administration

In fixed combination with corticosteroids (with or without other anti-infectives), instill into the external ear as an otic solution or suspension.c f g

Otic preparations are not for use in the eye.c g

Clean and dry ear canal prior to administration.c g Lie with the affected ear upward and instill the otic preparation into the ear canal; maintain this position for 5 minutes.c g Repeat procedure if necessary for the opposite ear.c g

Shake suspension well prior to each use.g

Use sparingly to prevent an accumulation of excess debris in the ear canal.f

Dosage

Potency and dosage of polymyxin B sulfate are expressed in terms of polymyxin B activity.f

Pediatric Patients Bacterial Ophthalmic Infections Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution

Infants and children ?2 months of age, mild-to-moderate infections: 1 drop into the affected eye(s) every 3 hours, up to 6 doses daily, for 7–10 days.e

Bacterial Otic Infections Polymyxin B and Neomycin Sulfates and Hydrocortisone Otic Solution or Suspension

Children ?2 years of age: 3 drops into the affected ear(s) 3 or 4 times daily for up to 10 days.c g

Alternatively, insert a cotton wick that has been saturated with the otic preparation into the ear canal; keep the wick moist by adding additional drug every 4 hours.c g Replace the wick at least once every 24 hours.c g

Adults Bacterial Ophthalmic Infections Polymyxin B and Neomycin Sulfates and Bacitracin Zinc Ophthalmic Ointment

Apply to the affected eye(s) every 3 or 4 hours for 7–10 days, depending on the severity of the infection.l

Polymyxin B and Neomycin Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment

Apply to the affected eye(s) every 3 or 4 hours, depending on the severity of the infection.d

Polymyxin B and Neomycin Sulfates and Dexamethasone Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.i

Ophthalmic Suspension

Mild infections: 1 or 2 drops into the conjunctival sac of the affected eye(s) up to 4–6 times daily.j

Severe infections: 1 or 2 drops into the conjunctival sac of the affected eye(s) hourly.j Reduce dosing frequency as infection improves.j

Polymyxin B and Neomycin Sulfates and Gramicidin Ophthalmic Solution

1 or 2 drops into the affected eye(s) every 4 hours for 7–10 days.b

Severe infections: Up to 2 drops into the affected eye(s) every hour.b

Polymyxin B and Neomycin Sulfates and Hydrocortisone Ophthalmic Suspension

1 or 2 drops into the affected eye(s) every 3 or 4 hours, or more frequently as necessary.a

Polymyxin B and Neomycin Sulfates and Prednisolone Acetate Ophthalmic Suspension

1 or 2 drops into the affected eye(s) every 3–4 hours, or more frequently, as required.h For acute infection, may administer every 30 minutes.h Reduce dosing frequency as infection improves.h

To treat eyelids: 1 or 2 drops into the affected eye(s) every 3 or 4 hours.h (See Administration under Dosage and Administration.)

Polymyxin B Sulfate and Bacitracin Zinc Ophthalmic Ointment

Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on the severity of the infection.k

Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution

1 drop into the affected eye(s) every 3 hours, up to 6 doses daily, for 7–10 days.e

Bacterial Otic Infections Polymyxin B and Neomycin Sulfates and Hydrocortisone Otic Solution or Suspension

4 drops into the affected ear(s) 3 or 4 times daily for up to 10 days.c g

Alternatively, insert a cotton wick that has been saturated with the otic preparation into the ear canal; keep the wick moist by adding additional drug every 4 hours.c g Replace the wick at least once every 24 hours.c g

Prescribing Limits Pediatric Patients Bacterial Ophthalmic Infections Polymyxin B Sulfate and Trimethoprim Sulfate: Ophthalmic Solution

Infants and children ?2 months of age: Maximum 6 doses in 24 hours.e

Bacterial Otic Infections Polymyxin B and Neomycin Sulfates and Hydrocortisone Otic Solution or Suspension

Children ?2 years of age: Maximum 10 consecutive days of therapy.c g

Adults Bacterial Ophthalmic Infections Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution

Maximum 6 doses in 24 hours.e

Bacterial Otic Infections Polymyxin B and Neomycin Sulfates and Hydrocortisone Otic Solution or Suspension

Maximum 10 consecutive days of therapy.c g

Special Populations

No special population dosage recommendations at this time.a b c d e g h i j k l

Cautions for Polymyxin B Sulfate Contraindications

Known hypersensitivity to polymyxin B or any ingredient in the formulation.a b c d e f g h i j k l

Warnings/Precautions Warnings Administration

Do not use otic preparations in any patient with a perforated tympanic membrane.c g

Ophthalmic Ointments

Ophthalmic ointments may delay corneal healing.f k l

Sensitivity Reactions Hypersensitivity Reactions

Hypersensitivity reactions possible (e.g., rash, itching, reddening, conjunctival and eyelid edema);b c d anaphylaxis reported rarely.a b d h If hypersensitivity occurs, discontinue the drug.a b c d g

Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.111 112 113 114 115 116 117 118 c

General Precautions Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.b c e f g h k If superinfection occurs, discontinue the drug and institute appropriate therapy.b e f g h

Use of Fixed Combinations

Concomitant topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the antibiotic; or suppress hypersensitivity reactions to ingredients in the formulation.d h

When polymyxin B is used in fixed combination with other agents (corticosteroids, other anti-infectives), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).a b c d e h l

Specific Populations Pregnancy

In fixed combination with other agents (corticosteroids, other anti-infectives): Category C.a b c d e g h l

Lactation

Ophthalmic preparations in fixed combination with other anti-infectives: Caution advised.b e h l

Ophthalmic preparations in fixed combination with other anti-infectives and hydrocortisone: Discontinue nursing or the drug.a d

Ophthalmic preparations in fixed combination with other anti-infectives and dexamethasone: Caution advised.i

Otic preparations in fixed combination with other anti-infectives and corticosteroids: Caution advised.c g

Pediatric Use

Safety and efficacy of trimethoprim sulfate and polymyxin B ophthalmic solution not established in infants <2 months of age.e

Safety and efficacy of neomycin and polymyxin B sulfates and hydrocortisone otic solution and suspension not established in children <2 years of age.c g

Safety and efficacy of other polymyxin B fixed-combination preparations (e.g., with corticosteroids and/or anti-infectives) not established.a b d h i j l

Geriatric Use

Ophthalmic preparations in fixed combination with other anti-infectives and hydrocortisone or prednisolone: No overall differences in safety or efficacy relative to younger patients.a d h

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment: No overall differences in safety or efficacy relative to younger patients.i

Otic preparations: Insufficient experience in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults.c g

Common Adverse Effects

Local irritation.a b c d e g

Polymyxin B Sulfate Pharmacokinetics Absorption Bioavailability

Minimal or no absorption from intact or denuded skin or from mucous membranes.e f

Distribution Extent

Not known whether topical polymyxin B is distributed into human milk.b e (See Bioavailability under Pharmacokinetics.)

Stability Storage Ophthalmic Ointment

Polymyxin B and bacitracin zinc: 20–25°C.k

Polymyxin B and neomycin sulfates and bacitracin zinc: Tightly closed containers at 15–25°C.l

Polymyxin B and neomycin sulfates, bacitracin zinc, and hydrocortisone acetate: 15–25°C.d

Polymyxin B and neomycin sulfates and dexamethasone: 2–25°C.i

Solution

Polymyxin B and neomycin sulfates and gramicidin: Tightly closed containers at 15–25°C; protect from light.b

Polymyxin B sulfate and trimethoprim sulfate: 20–25°C; protect from light.e

Suspension

Polymyxin B sulfate and neomycin sulfates and dexamethasone: 8–27°C.j

Polymyxin B and neomycin sulfates and hydrocortisone: 20–25°C.a

Polymyxin B and neomycin sulfates and prednisolone acetate: Tightly closed containers at 15–25°C.h Store in upright position; protect from freezing.h

Otic Solution or Suspension

15–25°C.c g

Actions and SpectrumActions

Usually bactericidal.b e f l

Polymyxin B increases permeability of the bacterial cell wall membrane by interacting with the phospholipid components of the cell membrane.b e f l

Spectrum of activity of polymyxin B includes many aerobic gram-negative bacteria.e f k l Inactive against gram-positive bacteria and fungi.f

Gram-negative aerobes: Active against Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.e f

Neisseria and Proteus usually are resistant.f Complete cross-resistance between colistin derivatives and polymyxin B.f

Advice to Patients

Importance of discontinuing therapy and contacting clinician if condition worsens or does not improve or if signs of sensitivity (e.g., rash, itching, swelling, redness) occur.a b c d e g h l

Advise patients to immediately consult clinician regarding continued use of ophthalmic preparations if another eye condition (e.g., trauma, infection) occurs.f

Importance of not touching tip of container to the eye, eyelid, fingers, or any other surface to avoid contamination.a b c d e g h l Advise patient to keep container tightly closed when not in use.b h l

Importance of not wearing contact lenses if signs and symptoms of eye infection occur.h

Advise patient not to share the drug with any other person.a b d e h

Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a b c d e g

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b c d e g h

Importance of informing patients of other important precautionary information.a b c d e g h (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Bacitracin Zinc and Polymyxin B Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Bacitracin Zinc 500 units (of bacitracin) per g and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g

AK-Poly-Bac

Akorn

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment

Bausch & Lomb, Fougera

Neomycin and Polymyxin B Sulfate and Bacitracin Zinc

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment

Akorn, Fougera

Neosporin Ophthalmic Ointment

Monarch

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1%*

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment

Bausch & Lomb, Fougera

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone Acetate 1%

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate Ophthalmic Ointment

Fougera

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin and Polymyxin B Sulfates and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Dexamethasone 0.1%*

Maxitrol (with parabens)

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment

Bausch & Lomb, Falcon, Fougera

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Dexamethasone 0.1%*

Maxitrol (with benzalkonium chloride; viscous)

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension

Bausch & Lomb, Falcon

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin and Polymyxin B Sulfates and Gramicidin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Gramicidin 0.0025%*

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution

Bausch & Lomb

Neosporin Ophthalmic Solution (with alcohol 0.5%, propylene glycol, and thimerosal)

Monarch

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension (with propylene glycol and thimerosal)

Falcon

Otic

Solution

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%*

Cortisporin (with potassium metabisulfite and propylene glycol)

Monarch

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution

Falcon

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%*

Neosporin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension (with propylene glycol and thimerosal)

Falcon

Pediotic Suspension (with propylene glycol and thimerosal)

Monarch

Neomycin and Polymyxin B Sulfates and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Prednisolone Acetate 0.5%

Poly-Pred (with propylene glycol and thimerosal; viscous)

Allergan

Polymyxin B Sulfate and Trimethoprim Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL and Trimethoprim Sulfate 0.1% (of trimethoprim)

Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution (with benzalkonium chloride)

Akorn

Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution

Bausch & Lomb

Polytrim (with benzalkonium chloride)

Allergan

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

101. Monarch Pharmaceuticals, Inc. Cortisporin Ophthalmic Suspension Sterile (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension, USP) prescribing information. Bristol, TN; 2003 Jul.

102. Monarch. Neosporin Ophthalmic Solution Sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) prescribing information. Bristol, TN; 2003 Apr.

103. Monarch. Cortisporin Otic Solution Sterile (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP) prescribing information. Bristol, TN; 2003 Apr.

104. Bedford. Polymyxin B for injection 500,000 units prescribing information. Bedford, OH; 2004 Feb.

105. Akorn. Trimethoprim sulfate and polymyxin B sulfates ophthalmic solution prescribing information. Buffalo Grove, IL; 1998 Aug.

111. Food and Drug Administration. Sulfites in foods and drugs. FDA Drug Bull. 1983; 13:12. [PubMed 6604672]

112. Sogn D. The ubiquitous sulfites. JAMA. 1984; 251:2986 7. Editorial. [IDIS 185969] [PubMed 6716628]

113. Koepke JW, Christopher KL, Chai H et al. Dose dependent bronchospasm from sulfites in isoetharine. JAMA. 1984; 251:2982 3. [IDIS 185966] [PubMed 6716626]

114. Twarog FJ, Leung DYM. Anaphylaxis to a component of isoetharine (sodium bisulfite). JAMA. 1982; 248:2030 1. [IDIS 158261] [PubMed 7120631]

115. Baker GJ, Collett P, Allen DH. Bronchospasm induced by metabisulphite containing foods and drugs. Med J Aust. 1981; 2:614 7. [IDIS 146240] [PubMed 7334982]

116. Koepke JW, Selner JC, Dunhill AL. Presence of sulfur dioxide in commonly used bronchodilator solutions. J Allergy Clin Immunol. 1983; 72:504 8. [IDIS 178793] [PubMed 6630799]

117. Food and Drug Administration. Sulfiting agents; labeling in drugs for human use: warning statement. [Docket No. 84N 0113] Fed Regist. 1985; 50:47558 63.

118. Food and Drug Administration Center for Food Safety and Applied Nutrition. The reexamination of the GRAS status of sulfiting agents, January 1985. (Doc. No. 223-83-2020.) Bethesda, MD: FASEB Life Sciences Research Office.

a. Falcon Pharmaceuticals. Neomycin and polymyxin B sulfates, and hydrocortisone ophthalmic suspension prescribing information. Fort Worth, TX; 2006 Mar.

b. Monarch Pharmaceuticals, Inc. Neosporin (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) prescribing information. Bristol, TN; 2003 Apr.

c. Monarch Pharmaceuticals, Inc. Cortisporin (neomycin and polymyxin B sulfates and hydrocortisone) otic solution prescribing information. Bristol, TN; 2003 Apr.

d. E. Fougera & Co. Neomycin and polymyxin B sulfates, and bacitracin zinc, with hydrocortisone acetate ophthalmic ointment prescribing information. Melville, NY; 2004 Aug.

e. Akorn, Inc. Trimethoprim sulfate and polymyxin B sulfate ophthalmic solution prescribing information. Buffalo Grove, IL; 2006 Mar.

f. AHFS drug information 2008. McEvoy GK, ed. Polymyxin B sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2853-5.

g. Monarch Pharmaceuticals, Inc. Pediotic (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) prescribing information. Bristol, TN; 2003 Apr.

h. Allergan, Inc. Poly-Pred (prednisolone acetate, neomycin sulfate, polymyxin B sulfate ophthalmic suspension, USP) prescribing information. Irvine, CA; 2004 Dec.

i. Alcon Laboratories, Inc. Maxitrol (neomycin and polymyxin b sulfates and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2003 Oct.

j. Alcon Laboratories, Inc. Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2003 Aug.

k. Akorn Pharmaceuticals, Inc. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP prescribing information. Buffalo Grove, IL. 2007 Aug.

l. E. Fougera & Co. Neomycin and polymyxin B sulfates, and bacitracin zinc ophthalmic ointment, USP prescribing information. Melville, NY; 2004 Jul.


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Apo-Tobramycin


Generic Name: tobramycin (Ophthalmic route)

toe-bra-MYE-sin

Commonly used brand name(s)

In the U.S.

AKTob Tobrasol Tobrex

In Canada

Apo-Tobramycin Sab-Tobramycin Tomycine

Available Dosage Forms:

Ointment Solution

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For Apo-Tobramycin

Ophthalmic tobramycin is used in the eye to treat bacterial infections of the eye. Tobramycin works by killing bacteria.

Ophthalmic tobramycin may be used alone or with other medicines for eye infections. Either the drops or the ointment form of this medicine may be used alone during the day. In addition, both forms may be used together, with the drops being used during the day and the ointment at night.

Tobramycin ophthalmic preparations are available only with your doctor's prescription.

Before Using Apo-Tobramycin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic tobramycin in the elderly with use in other age groups.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alcuronium Atracurium Cidofovir Cisatracurium Colistimethate Sodium Decamethonium Doxacurium Ethacrynic Acid Fazadinium Furosemide Gallamine Hexafluorenium Lysine Metocurine Mivacurium Pancuronium Pipecuronium Rapacuronium Rocuronium Succinylcholine Tacrolimus Tubocurarine Vancomycin Vecuronium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cisplatin Cyclosporine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of tobramycin

This section provides information on the proper use of a number of products that contain tobramycin. It may not be specific to Apo-Tobramycin. Please read with care.

For patients using tobramycin ophthalmic solution (eye drops):

The bottle is only partially full to provide proper drop control. To use: First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection. If you think you did not get the drop of medicine into your eye properly, use another drop. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. If your doctor ordered two different ophthalmic solutions to be used together, wait at least 5 minutes between the times you apply the medicines. This will help to keep the second medicine from ``washing out'' the first one.

For patients using tobramycin ophthalmic ointment (eye ointment):

To use: First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1.25-cm (approximately ?-inch) strip of ointment usually is enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes and keep them closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using tobramycin eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your eye infection completely, keep using tobramycin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ophthalmic ointment dosage forms: For mild to moderate infections: Adults and children—Use every eight to twelve hours. For severe infections: Adults and children—Use every three to four hours until improvement occurs. For ophthalmic solution (eye drops) dosage forms: For mild to moderate infections: Adults and children—One drop every four hours. For severe infections: Adults and children—One drop every hour until improvement occurs. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Apo-Tobramycin

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

Apo-Tobramycin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common Itching, redness, swelling, or other sign of eye or eyelid irritation not present before use of this medicine Symptoms of overdose Increased watering of the eyes itching, redness, or swelling of the eyes or eyelids painful irritation of the clear front part of the eye

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Burning or stinging of the eyes

Eye ointments usually cause your vision to blur for a few minutes after application.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Apo-Tobramycin resources Apo-Tobramycin Use in Pregnancy & Breastfeeding Apo-Tobramycin Support Group 3 Reviews for Apo-Tobramycin - Add your own review/rating Compare Apo-Tobramycin with other medications Conjunctivitis, Bacterial
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Sab-Tobramycin


Generic Name: tobramycin (Ophthalmic route)

toe-bra-MYE-sin

Commonly used brand name(s)

In the U.S.

AKTob Tobrasol Tobrex

In Canada

Apo-Tobramycin Sab-Tobramycin Tomycine

Available Dosage Forms:

Ointment Solution

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For Sab-Tobramycin

Ophthalmic tobramycin is used in the eye to treat bacterial infections of the eye. Tobramycin works by killing bacteria.

Ophthalmic tobramycin may be used alone or with other medicines for eye infections. Either the drops or the ointment form of this medicine may be used alone during the day. In addition, both forms may be used together, with the drops being used during the day and the ointment at night.

Tobramycin ophthalmic preparations are available only with your doctor's prescription.

Before Using Sab-Tobramycin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic tobramycin in the elderly with use in other age groups.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alcuronium Atracurium Cidofovir Cisatracurium Colistimethate Sodium Decamethonium Doxacurium Ethacrynic Acid Fazadinium Furosemide Gallamine Hexafluorenium Lysine Metocurine Mivacurium Pancuronium Pipecuronium Rapacuronium Rocuronium Succinylcholine Tacrolimus Tubocurarine Vancomycin Vecuronium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cisplatin Cyclosporine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of tobramycin

This section provides information on the proper use of a number of products that contain tobramycin. It may not be specific to Sab-Tobramycin. Please read with care.

For patients using tobramycin ophthalmic solution (eye drops):

The bottle is only partially full to provide proper drop control. To use: First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection. If you think you did not get the drop of medicine into your eye properly, use another drop. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. If your doctor ordered two different ophthalmic solutions to be used together, wait at least 5 minutes between the times you apply the medicines. This will help to keep the second medicine from ``washing out'' the first one.

For patients using tobramycin ophthalmic ointment (eye ointment):

To use: First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1.25-cm (approximately ?-inch) strip of ointment usually is enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes and keep them closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using tobramycin eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your eye infection completely, keep using tobramycin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ophthalmic ointment dosage forms: For mild to moderate infections: Adults and children—Use every eight to twelve hours. For severe infections: Adults and children—Use every three to four hours until improvement occurs. For ophthalmic solution (eye drops) dosage forms: For mild to moderate infections: Adults and children—One drop every four hours. For severe infections: Adults and children—One drop every hour until improvement occurs. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Sab-Tobramycin

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

Sab-Tobramycin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common Itching, redness, swelling, or other sign of eye or eyelid irritation not present before use of this medicine Symptoms of overdose Increased watering of the eyes itching, redness, or swelling of the eyes or eyelids painful irritation of the clear front part of the eye

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Burning or stinging of the eyes

Eye ointments usually cause your vision to blur for a few minutes after application.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Prednisolone Acetate eent


Class: Corticosteroids
Note: This monograph also contains information on Prednisolone Sodium Phosphate
ATC Class: S02BA03
VA Class: OP300
Chemical Name: 11?,17,21-trihydroxypregna-1,4-diene-3,20-dione
Molecular Formula: C21H28O5
CAS Number: 52-21-1
Brands: AK-Pred, Blephamide, Econopred, Inflamase, Poly-Pred, Pred, Pred-G, Vasocidin

Introduction

A synthetic nonfluorinated corticosteroid.a b

Uses for Prednisolone Acetate Ophthalmic Inflammation

Symptomatic relief of corticosteroid-responsive allergic and inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (e.g., allergic or vernal conjunctivitis, acne rosacea keratitis, superficial punctate keratitis, herpes zoster keratitis, uveitis, iritis, cyclitis).b g h i

Treatment of corneal, conjunctival, and scleral injuries from chemical, radiation, or thermal burns or penetration of foreign bodies.b g h

Bacterial Ophthalmic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye;c d e f g j k used in fixed combination with gentamicin sulfate, sulfacetamide sodium, or the combination of neomycin sulfate and polymyxin b sulfate when such combination therapy is indicated.c d e f j k If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.g (See Infections under Cautions.)

Prednisolone Acetate Dosage and Administration Administration Ophthalmic Administration

Apply topically to the eyes as an ophthalmic ointment, solution, or suspension.a b c d e f h i j k

Not for injection.c d e f h j

Shake suspension well prior to each use.b c e i j

Avoid contamination of the preparation container.a b c d e f h i j k

May use ointment at night in conjunction with daytime use of a suspension or solution to reduce the frequency of applications required with the liquid dosage forms.a

To treat eyelids, instill into the eye, then close the eye and rub the excess onto the lids and lid margins.c

Dosage

Available as prednisolone acetate or prednisolone sodium phosphate, alone or in fixed combination with anti-infectives.b c d e f h i j k Potency of prednisolone acetate preparations expressed in terms of the salt.b c e f i j k Potency of sodium phosphate preparations expressed in terms of prednisolone phosphate or prednisolone sodium phosphate.a d h

Pediatric Patients

If improvement does not occur after 2 days, reevaluate the patient.d f j

Duration of therapy ranges from a few days to several weeks; depending on the type and severity of the disease and response to therapy.a Avoid long-term therapy.a Do not discontinue prematurely.d f j

When discontinuing therapy in chronic conditions, gradually taper dosing frequency to avoid exacerbation of the disease.a d f j

Bacterial Ophthalmic Infections Prednisolone Acetate 0.2% and Sulfacetamide Sodium 10% Ophthalmic Ointment

Children ?6 years of age: Apply 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3–4 times during the day and once or twice during the night.f Reduce dosing frequency as infection improves.f

Ophthalmic Suspension

Children ?6 years of age: 2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.j Reduce dosing frequency as infection improves.j

Prednisolone Sodium Phosphate 0.25% and Sulfacetamide Sodium 10% Ophthalmic Solution

Children ?6 years of age: 2 drops into the conjunctival sac of the affected eye(s) every 4 hours.d Reduce dosing frequency as infection improves.d

Adults

If improvement does not occur after 2 days, reevaluate the patient.b f i j k

Duration of therapy ranges from a few days to a few weeks; depending on the type and severity of the disease and response to therapy.a h Avoid long-term therapy.a Do not discontinue prematurely.b f j k

When discontinuing therapy in chronic conditions, gradually taper dosing frequency to avoid exacerbation of the disease.a f j

Ophthalmic Inflammation Prednisolone Acetate 0.12% or 1% Ophthalmic Suspension

1 or 2 drops into the conjunctival sac of the affected eye(s) 2–4 times daily.b i During initial 24–48 hours, may increase dosing frequency if necessary.b i

Prednisolone Sodium Phosphate 0.125% or 1% Ophthalmic Solution

Initially, depending on severity of inflammation, 1 or 2 drops into the conjunctival sac of the affected eye(s) up to every hour during the day and every 2 hours during the night as necessary.h When a favorable response is attained, reduce dosing frequency to 1 drop every 4 hours and subsequently to 1 drop 3 or 4 times daily.h

Bacterial Ophthalmic Infections Prednisolone Acetate 0.5%, Neomycin Sulfate 0.35%, and Polymyxin B Sulfate 10,000 units Ophthalmic Suspension

1 or 2 drops into the conjunctival sac of the affected eye(s) every 3 or 4 hours, or more frequently as required.c For acute infection, may administer every 30 minutes.c Reduce dosing frequency as infection improves.c

To treat eyelids: 1 or 2 drops into the affected eye(s) every 3 to 4 hours.c (See Administration under Dosage and Administration.)

Prednisolone Acetate 0.6% and Gentamicin Sulfate 0.3% Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 1–3 times daily.k

Ophthalmic Suspension

Initial 24–48 hours, up to 1 drop into the conjunctival sac of the affected eye(s) every hour; thereafter, 1 drop 2–4 times daily.e

Prednisolone Acetate 0.2% and Sulfacetamide Sodium 10% Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3–4 times during the day and once or twice during the night.f Reduce dosing frequency as infection improves.f

Ophthalmic Suspension

2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.j Reduce dosing frequency as infection improves.j

Prednisolone Sodium Phosphate 0.25% and Sulfacetamide Sodium 10%. Ophthalmic Solution

2 drops into the conjunctival sac of the affected eye(s) every 4 hours.d Reduce dosing frequency as infection improves.d

Special Populations

No special population dosage recommendations at this time.b c d e f h i j k

Cautions for Prednisolone Acetate Contraindications

Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).b c d e f g h i j k

Mycobacterial infection of the eye.b c d e f g h i j k

Fungal disease of ocular structures.b c d e f g h i j k

Acute, purulent, untreated infections of the eye.b

After uncomplicated removal of a corneal foreign body.c h

Known hypersensitivity to prednisolone, other corticosteroids, or any ingredient in the formulation.b c d e f g h i j k

Warnings/Precautions Warnings Ocular Effects

Risk of glaucoma (with damage to optic nerve), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.b c d e f g h i j k Use with caution in glaucoma because IOP may increase.b c d e f i j k

If used for ?10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.b c d e f g h i j k

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.b c d e f g h i j k

Use of high-dose corticosteroids may delay healing.b c d e f g i j k Use after cataract surgery may delay healing and increase incidence of bleb formation.b d e f g i j k

Infections

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.b c d e f g h i j k

In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.b c d e f h i j k (See Contraindications under Cautions.)

Herpes Simplex

Use of corticosteroids in the treatment of herpes simplex infections other than epithelial herpes simplex keratitis, in which corticosteroids are contraindicated, requires great caution; periodic slit-lamp microscopy is essential.b c d e f g h i j k

Sensitivity Reactions Sulfite Sensitivity

Some formulations of prednisolone contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.b g i

General Precautions Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 8 g of ointment or 20 mL of suspension or solution should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).b c d e f i j k

Reevaluate patient if improvement does not occur after 2 days.b d e f i j k

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea.b c d e f i j k Consider possibility of fungal infection in patients with persistent corneal ulceration who have been or who are receiving corticosteroid therapy.b c d e f h i j k

Use of Fixed Combinations

When prednisolone acetate or prednisolone sodium phosphate is used in fixed combination with gentamicin sulfate, sulfacetamide sodium, or the combination of neomycin sulfate and polymyxin B sulfate, consider the cautions, precautions, and contraindications associated with the concomitant agent(s).d f

Corneal Reepithelialization

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.f g

Specific Populations Pregnancy

Category C.b c d e f h i j k

Lactation

Not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.b d e f h i j k

Caution if used in nursing women.c h Some manufacturers recommend that women discontinue nursing or the drug.b i

Pediatric Use

Safety and efficacy of ophthalmic preparations containing prednisolone acetate or prednisolone sodium phosphate in fixed combination with sulfacetamide sodium not established in children <6 years of age.d f j

Safety and efficacy of other ophthalmic prednisolone preparations (prednisolone sodium phosphate alone, prednisolone acetate alone or in fixed combination with gentamicin or with neomycin sulfate and polymyxin B sulfate) not established in children of any age.b c e h i k

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients.b c e i k

Common Adverse Effects

Elevated IOP,b c d e f h i j k transient stinging or burning,b e h i blurred vision,g i ocular irritation,b e k foreign body sensation.i

Prednisolone Acetate Pharmacokinetics Absorption Bioavailability

Corticosteroids are absorbed through the aqueous humor; because only low doses are given, little if any systemic absorption occurs.g

Distribution Extent

Systemically absorbed corticosteroids are distributed into milk; not known whether topical corticosteroids could produce detectable levels in human milk.b d e f h i j k

Stability Storage Ophthalmic

Sulfacetamide-containing solutions darken on prolonged standing and exposure to heat and light.d j Discard preparations that have darkened; yellow discoloration does not affect activity.d j

Ointment

Gentamicin and prednisolone acetate: 15–25°C.k

Sulfacetamide sodium and prednisolone acetate: 15–25°C.f

Solution

Prednisolone sodium phosphate: 15–25°C; protect from light.h

Sulfacetamide sodium and prednisolone acetate: 15–25°C; protect from heat and light.d Do not freeze.d

Suspension

Gentamicin and prednisolone acetate: 15–25°C; do not freeze.e Do not expose to ?40°C.e

Prednisolone acetate (Pred Forte): ?25°C; do not freeze.i

Prednisolone acetate (Pred-Mild): 15–30°C; do not freeze.b

Prednisolone acetate, neomycin sulfate, polymyxin B sulfate: 15–25°C; do not freeze.c

Sulfacetamide sodium and prednisolone acetate: 8–24°C; protect from light and freezing.j

Compatibility Ophthalmic Solutions and Suspensions

Sulfacetamide sodium and prednisolone acetate or prednisolone sodium phosphate preparations: Incompatible with preparations containing silver.d f j

ActionsActions

Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.c d e f g h j k

Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.b g i

Advice to Patients

Importance of discontinuing therapy and consulting a clinician if inflammation or pain persists for >48 hours or worsens.b c d e f i j k

Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the container.b c d e f g h i j k

Advise patient not to share the drug with any other person.b c d e f i j k

Importance of not wearing contact lenses if signs or symptoms of eye infections occur.c j

Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloride and of delaying reinsertion of the lenses for ?5 minutes after administration.l

Importance of informing a clinician if another eye condition (e.g., trauma, surgery, infection) develops during ophthalmic therapy.g

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b c d e f g h i j k

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c d e f g h i j k

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder

Ophthalmic

Suspension

0.12%

Pred Mild (with benzalkonium chloride and sodium bisulfite)

Allergan

1%

Econopred Plus (with benzalkonium chloride)

Alcon

Pred Forte (with benzalkonium chloride and sodium bisulfite)

Allergan

Prednisolone Acetate

Falcon

Gentamicin Sulfate and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Gentamicin Sulfate 0.3% (of gentamicin) and Prednisolone Acetate 0.6%

Pred-G (with chlorobutanol)

Allergan

Suspension

Gentamicin Sulfate 0.3% (of gentamicin) and Prednisolone Acetate 1%

Pred-G (with benzalkonium chloride; viscous)

Allergan

Neomycin and Polymyxin B Sulfates and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Prednisolone Acetate 0.5%

Poly-Pred (with propylene glycol and thimerosal; viscous)

Allergan

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sulfacetamide Sodium and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

10% Sulfacetamide Sodium and Prednisolone Acetate 0.2%

Blephamide (with phenylmercuric acetate)

Allergan

Suspension

10% Sulfacetamide Sodium and Prednisolone Acetate 0.2%*

Blephamide (with benzalkonium chloride; viscous)

Allergan

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Prednisolone Sodium Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.125% (0.11% of prednisolone phosphate)*

Inflamase Mild (with benzalkonium chloride)

Novartis

1% (0.9% of prednisolone phosphate)

AK-Pred (with benzalkonium chloride and sodium bisulfite)

Akorn

Inflamase Forte (with benzalkonium chloride)

Novartis

Prednisolone Sodium Phosphate

Bausch & Lomb

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Prednisolone Sodium Phosphate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.25% (0.23% of prednisolone phosphate) with Sulfacetamide Sodium 10%*

Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Bausch & Lomb, Falcon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Blephamide 10-0.2% Suspension (ALLERGAN): 10/$95.99 or 30/$275.97

Blephamide 10-0.2% Suspension (ALLERGAN): 5/$67.99 or 15/$189.98

Blephamide S.O.P. 10-0.2% Ointment (ALLERGAN): 3/$68.99 or 10/$185.96

Econopred Plus 1% Suspension (ALCON VISION): 10/$57.99 or 30/$165.98

Econopred Plus 1% Suspension (ALCON VISION): 5/$40.99 or 15/$155.97

Omnipred 1% Suspension (ALCON VISION): 10/$85.99 or 30/$239.97

Pred Forte 1% Suspension (ALLERGAN): 10/$69.99 or 30/$199.97

Pred Forte 1% Suspension (ALLERGAN): 15/$99.99 or 45/$279.98

Pred Forte 1% Suspension (ALLERGAN): 5/$39.99 or 15/$105.97

Pred Mild 0.12% Suspension (ALLERGAN): 10/$47.83 or 30/$124.76

Pred Mild 0.12% Suspension (ALLERGAN): 5/$37.43 or 15/$89.41

Pred-G 0.3-1% Suspension (ALLERGAN): 5/$39.35 or 15/$101.19

PrednisoLONE Acetate 1% Suspension (FALCON PHARMACEUTICALS): 5/$19.99 or 15/$45.97

PrednisoLONE Acetate 1% Suspension (FALCON PHARMACEUTICALS): 15/$33.99 or 45/$95.98

PrednisoLONE Acetate 1% Suspension (FALCON PHARMACEUTICALS): 10/$25.99 or 30/$59.97

PrednisoLONE Sodium Phosphate 1% Solution (BAUSCH &amp; LOMB): 10/$72.99 or 30/$210.97

Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH &amp; LOMB): 10/$30.99 or 20/$53.97

Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH &amp; LOMB): 5/$21.99 or 15/$53.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2008. McEvoy GK, ed. Prednisolone. Bethesda, MD: American Society of Health-Systems Pharmacists; 2008: 2887-8.

b. Allergan, Inc. Pred-Mild (prednisolone acetate ophthalmic suspension) prescribing information. Irvine, CA; 2004 Jun.

c. Allergan, Inc. Poly-Pred (prednisolone acetate, neomycin sulfate, polymyxin B sulfate ophthalmic suspension) prescribing information. Irvine, CA; 2004 Dec.

d. Falcon Pharmaceuticals, Ltd. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution prescribing information. Ft Worth, TX; 2007 Jul.

e. Allergan, Inc. Pred G (gentamicin sulfate 0.3% and prednisolone acetate 0.1% ophthalmic suspension) prescribing information. Irvine, CA; 2005 Dec .

f. Allergan, Inc. Blephamide (sulfacetamide sodium 10% and prednisolone acetate 0.2% ophthalmic ointment) prescribing information. Irvine, CA; 2004 Sep.

g. AHFS drug information 2008. McEvoy GK, ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health Systems Pharmacists; 2008: 2867-9.

h. Novartis Ophthalmics. Inflamase Mild 1/8% and Inflamase Forte 1% (prednisolone sodium phosphate) ophthalmic solution prescribing information. Duluth, GA; 2001 Jul.

i. Allergan, Inc. Pred-Forte (prednisolone acetate ophthalmic suspension) prescribing information. Irvine, CA; 2004 Mar.

j. Allergan, Inc. Blephamide (sulfacetamide sodium 10% and prednisolone acetate 0.2% ophthalmic suspension) prescribing information. Irvine, CA; 2004 Jun.

k. Allergan, Inc. Pred-G (gentamicin sulfate 0.3% and prednisolone acetate 0.6% ophthalmic ointment) prescribing information. Irvine, CA; 2004 Jan.

l. Christensen MT, Barry JR, Twiner FD. Five-minute removal of soft lenses prevents most absorption of a topical ophthalmic solution. CLAO J. 1998; 24:227-31. [PubMed 9800062]

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Tobramycin/Dexamethasone Ointment


Pronunciation: toe-bra-MYE-sin/dex-a-METH-a-sone
Generic Name: Tobramycin/Dexamethasone
Brand Name: TobraDex
Tobramycin/Dexamethasone Ointment is used for:

Treating eye inflammation and bacterial infection.

Tobramycin/Dexamethasone Ointment is an antibiotic (tobramycin) and steroid (dexamethasone) combination eye ointment. The antibiotic works by killing bacteria and the steroid reduces redness, irritation, and swelling.

Do NOT use Tobramycin/Dexamethasone Ointment if: you are allergic to any ingredient in Tobramycin/Dexamethasone Ointment you have herpes simplex, vaccinia, varicella, or any other viral, mycobacterial, or fungal eye infection

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tobramycin/Dexamethasone Ointment:

Some medical conditions may interact with Tobramycin/Dexamethasone Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have thinning of the cornea or the white part of the eye if you have diabetes

Some MEDICINES MAY INTERACT with Tobramycin/Dexamethasone Ointment. Because little, if any, of Tobramycin/Dexamethasone Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Tobramycin/Dexamethasone Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tobramycin/Dexamethasone Ointment:

Use Tobramycin/Dexamethasone Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tobramycin/Dexamethasone Ointment is only for the eye. Do not get it in your nose or mouth. To use Tobramycin/Dexamethasone Ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Tobramycin/Dexamethasone Ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed. Do not wear contact lenses while you are using Tobramycin/Dexamethasone Ointment. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them. Using Tobramycin/Dexamethasone Ointment at the same time each day will help you to remember to use it. To clear up your infection completely, use Tobramycin/Dexamethasone Ointment for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Tobramycin/Dexamethasone Ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tobramycin/Dexamethasone Ointment.

Important safety information: Tobramycin/Dexamethasone Ointment may cause blurred vision. Use Tobramycin/Dexamethasone Ointment with caution. Do not drive or perform other possibly unsafe tasks if you cannot see clearly. If your symptoms do not improve within a few days or if they get worse, check with your doctor. Be sure to use Tobramycin/Dexamethasone Ointment for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Tobramycin/Dexamethasone Ointment may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Do not use Tobramycin/Dexamethasone Ointment for future eye problems unless directed by your doctor. Lab tests, including eye exams, may be performed while you use Tobramycin/Dexamethasone Ointment. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Tobramycin/Dexamethasone Ointment should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tobramycin/Dexamethasone Ointment while you are pregnant. It is not known if Tobramycin/Dexamethasone Ointment is found in breast milk. Do not breast-feed while taking Tobramycin/Dexamethasone Ointment. Possible side effects of Tobramycin/Dexamethasone Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning or stinging when you first put the medicine in your eye; delayed wound healing.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; itching and swelling of the eyelid; redness or swelling of the eye; second infection; severe eye pain; vision loss.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include flushing; increased tearing; lid itching; redness; swelling; spots or lesions on the surface of the cornea.

Proper storage of Tobramycin/Dexamethasone Ointment:

Store Tobramycin/Dexamethasone Ointment between 46 and 80 degrees F (8 and 27 degrees C). Store upright in the original container and away from heat, moisture, and light. Do not store in the bathroom. Keep Tobramycin/Dexamethasone Ointment out of the reach of children and away from pets.

General information: If you have any questions about Tobramycin/Dexamethasone Ointment, please talk with your doctor, pharmacist, or other health care provider. Tobramycin/Dexamethasone Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tobramycin/Dexamethasone Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tobramycin/Dexamethasone resources Tobramycin/Dexamethasone DosageTobramycin/Dexamethasone Use in Pregnancy & BreastfeedingTobramycin/Dexamethasone Drug InteractionsTobramycin/Dexamethasone Support Group3 Reviews for Tobramycin/Dexamethasone - Add your own review/rating Compare Tobramycin/Dexamethasone with other medications Conjunctivitis, BacterialKeratitisUveitis
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Fluorometholone


Class: Corticosteroids
ATC Class: S01CA07
VA Class: OP300
Chemical Name: 9-fluoro-11?,17-dihydroxy-6?-methylpregna-1,4-diene-3,20-dione
Molecular Formula: C24H31FO5
CAS Number: 426-13-1
Brands: Flarex, Fluor-Op, FML, FML-S, Tobraflex

Introduction

A synthetic fluorinated corticosteroid; structurally related to progesterone.a

Uses for Fluorometholone Ophthalmic Inflammation

Symptomatic relief of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. b c e g

Treatment of chronic anterior uveitisd f and corneal injury from burns or penetration of foreign bodies.d f g

Bacterial Ophthalmic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye;d f g used in fixed combination with sulfacetamide sodium or tobramycin when such combination therapy is indicated.d f If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.g (See Infections under Cautions.)

Fluorometholone Dosage and Administration Administration Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment or suspension.b c d e f g

Not for injection.b d f

Shake suspension vigorously prior to use.b d e f

Avoid contamination of the preparation container.a b c d e f

Do not administer suspensions containing benzalkonium chloride while wearing soft contact lenses.b e (See Advice to Patients.)

Dosage

Available as fluorometholone and fluorometholone acetate, alone or in fixed combination with anti-infectives; dosage of fluorometholone acetate expressed in terms of the salt.b c d e f

Pediatric Patients Ophthalmic Inflammation Ophthalmic

Fluorometholone 0.1% suspension: In children ?2 years of age, instill 1 drop into the conjunctival sac of the affected eye(s) 2–4 times daily.e During initial 24–48 hours, dosage may be increased to 1 drop every 4 hours.e

Fluorometholone 0.25% suspension: In children ?2 years of age, instill 1 drop into the conjunctival sac of the affected eye(s) 2–4 times daily.h

Fluorometholone 0.1% ointment: In children ?2 years of age, apply ribbon of ointment (approximately 1.3 cm in length) into the conjunctival sac of the affected eye(s) 1–3 times daily.c May be applied every 4 hours during initial 24–48 hours of therapy.c

If improvement does not occur after 2 days, reevaluate the patient.c e h

Duration of therapy depends on the type and severity of the disease and response to therapy.a Do not discontinue prematurely.a c e h

In chronic conditions, gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a c e h

Bacterial Ophthalmic Infections Ophthalmic

Fluorometholone and sulfacetamide sodium ophthalmic suspension: In children ?2 years of age, instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily.d

Fluorometholone acetate and tobramycin ophthalmic suspension: In children ?2 years of age, instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4–6 hours.f During initial 24–48 hours, dosage may be increased to 1 or 2 drops every 2 hours.f

If improvement does not occur after 2 days, reevaluate the patient.d

Duration of therapy depends on the type and severity of the disease and response to therapy.a Do not discontinue prematurely.a d f

In chronic conditions, gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a d

Adults Ophthalmic Inflammation Ophthalmic

Fluorometholone 0.1% suspension: Instill 1 drop into the conjunctival sac of the affected eye(s) 2–4 times daily.e During initial 24–48 hours, dosage may be increased to 1 drop every 4 hours.e

Fluorometholone 0.25% suspension: Instill 1 drop into the conjunctival sac of the affected eye(s) 2–4 times daily.h

Fluorometholone 0.1% ointment: Apply ribbon of ointment (approximately 1.3 cm in length) into the conjunctival sac of the affected eye(s) 1–3 times daily.c May be applied every 4 hours during initial 24–48 hours of therapy.c

Fluorometholone acetate 0.1% suspension: Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) 4 times daily.b During initial 24–48 hours, dosage may be increased to 2 drops every 2 hours.b

If improvement does not occur after 2 days, reevaluate the patient.c e h

Duration of therapy depends on the type and severity of the disease and response to therapy.a Do not discontinue prematurely.a c e h

In chronic conditions, gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a c e h

Bacterial Ophthalmic Infections Ophthalmic

Fluorometholone and sulfacetamide sodium ophthalmic suspension: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily.d

Fluorometholone acetate and tobramycin ophthalmic suspension: Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4–6 hours.f During initial 24–48 hours, dosage may be increased to 1 or 2 drops every 2 hours.f

If improvement does not occur after 2 days, reevaluate the patient.d

Duration of therapy depends on the type and severity of the disease and response to therapy.a Do not discontinue prematurely.a d f

In chronic conditions, gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a d

Special Populations

No special population dosage recommendations at this time.a b c d e f h

Cautions for Fluorometholone Contraindications

Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).b c d e f g h

Mycobacterial infection of the eye.b c d e f g h

Fungal disease of ocular structures.b c d e f g h

Acute, purulent, untreated infections of the eye.b g

Known hypersensitivity to fluorometholone, other corticosteroids, or any ingredient in the formulation.b c d e f g h

Warnings/Precautions Warnings Ocular Effects

Risk of glaucoma (with damage to optic nerve), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.b c d e f g h Use with caution in glaucoma because IOP may increase.b c d e f g h

Average time until IOP increase occurs is longer with fluorometholone than with ophthalmic dexamethasone.b c d e f h

If used for ?10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.c d e f g h

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.b c d e f g h

Use of high-dose corticosteroids may delay healing.b c e g Use after cataract surgery may delay healing and increase incidence of bleb formation.c d e g h

Infections

See Contraindications under Cautions.

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.b c d e f g h

In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.b c d e f g h

Herpes Simplex

Use of corticosteroids in the treatment of herpes simplex infections other than epithelial herpes simplex keratitis, in which corticosteroids are contraindicated, requires great caution; periodic slit-lamp microscopy is essential.b d c g h

General Precautions Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 8 g of 0.1% ointment or 20 mL of 0.1 or 0.25% suspension should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).c d e h

Reevaluate patient if improvement does not occur after 2 days.c d e h

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea.b c d e f g Consider possibility of fungal infection in patients with persistent corneal ulceration who have been or are receiving corticosteroid therapy.b c d e f g

Use of Fixed Combinations

When fluorometholone or fluorometholone acetate is used in fixed combination with sulfacetamide sodium or tobramycin, consider the cautions, precautions, and contraindications associated with the concomitant agent.d f

Ophthalmic Ointments

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.c g

Specific Populations Pregnancy

Category C.b c d e f h

Lactation

Not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.b c d e f h

Caution if used in nursing women.b f Most manufacturers recommend that women discontinue nursing or the drug.c d e h

Pediatric Use

Safety and efficacy of fluorometholone alone or in fixed combination with sulfacetamide sodium or fluorometholone acetate in fixed combination with tobramycin not established in children <2 years of age.a c d e f h

Manufacturer states that safety and efficacy of fluorometholone acetate alone have not been established in children of any age.a b

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients.c d e f h

Common Adverse Effects

Elevated IOP,c d e h transient stinging or burning,e g h blurred vision,e g h ocular irritation,e g h taste perversion.e h

Fluorometholone Pharmacokinetics Absorption Bioavailability

Corticosteroids are absorbed through the aqueous humor; because only low doses are given, little if any systemic absorption occurs.g

Stability Storage Ophthalmic Ointment

<25°C. c Avoid exposure to temperatures >40°C. c

Suspension

Fluorometholone or fluorometholone acetate suspension: 2–27°C.a b Do not freeze. a b

Fluorometholone and sulfacetamide sodium suspension: Light-protected container at 15–30°C.d Do not freeze.d Do not use suspension if dark brown. d

Fluorometholone acetate and tobramycin suspension: Upright at 2–25°C.f

Compatibility Ophthalmic Suspension

Fluorometholone and sulfacetamide sodium suspension: Incompatible with preparations containing silver.d

ActionsActions

Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.b c d e f g h

Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.c d e g h

Advice to Patients

Importance of discontinuing therapy and consulting a clinician if inflammation or pain persists for >48 hours or worsens.c d e h

Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chlorideb e and of delaying reinsertion of the lenses for ?15 minutes after administration.e

Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the container.b c d e f h

Importance of warning the patient not to share the drug.c d e h

Importance of informing a clinician if an intercurrent ocular condition (e.g., trauma, surgery, infection) develops during ophthalmic therapy.g

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.c d e f h

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c d e f h

Importance of informing patients of other important precautionary information.b c d e f g h (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Fluorometholone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.1%

FML (with phenylmercuric acetate)

Allergan

Suspension

0.1%

Fluor-Op (with benzalkonium chloride)

Novartis

Fluorometholone Ophthalmic Suspension

Bausch & Lomb, Falcon

FML (with benzalkonium chloride)

Allergan

0.25%

FML Forte (with benzalkonium chloride)

Allergan

Fluorometholone Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.1% with Sulfacetamide Sodium 10%

FML-S Liquifilm (with benzalkonium chloride and povidone)

Allergan

Fluorometholone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.1%

Flarex (with benzalkonium chloride)

Alcon

Fluorometholone Acetate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.1% with Tobramycin 0.3%

Tobraflex (with benzalkonium chloride)

Alcon

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2007. McEvoy GK, ed. Fluorometholone. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007: 2825.

b. Alcon Laboratories, Inc. Flarex (fluorometholone acetate) suspension prescribing information. Fort Worth , TX; 1999 Jun.

c. Allergan, Inc. FML (fluorometholone) ointment prescribing information. Irvine, CA; 2001 Nov.

d. Allergan, Inc. FML-S (fluorometholone and sulfacetamide sodium) suspension prescribing information. Irvine, CA; 2005 Feb.

e. Allergan, Inc. FML (fluorometholone) ophthalmic suspension, 0.1% prescribing information. Irvine, CA; 2003 Jun.

f. Alcon Pharmaceuticals. Tobraflex (tobramycin and fluorometholone acetate) suspension prescribing information. Fort Worth, TX; 2001 May.

g. AHFS drug information 2007. McEvoy GK,ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health Systems Pharmacists; 2007: 2813-5.

h. Allergan, Inc. FMLForte (fluorometholone) suspension prescribing information. Irvine, CA; 2004 Jun.

More Fluorometholone resources Fluorometholone Side Effects (in more detail) Fluorometholone Use in Pregnancy & Breastfeeding Fluorometholone Drug Interactions Fluorometholone Support Group 1 Review for Fluorometholone - Add your own review/rating Flarex Prescribing Information (FDA) Flarex Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Flarex Concise Consumer Information (Cerner Multum) Fluor-Op Prescribing Information (FDA) Fluor-Op MedFacts Consumer Leaflet (Wolters Kluwer) Compare Fluorometholone with other medications Eye Dryness/Redness Eye Redness/Itching Eyelash Hypotrichosis
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Tobramycin Drops


Pronunciation: toe-bra-MYE-sin
Generic Name: Tobramycin
Brand Name: Examples include AK-Tob and Tobrex
Tobramycin Drops are used for:

Treating eye infections.

Tobramycin Drops are an antibiotic. It works by killing or slowing the growth of certain types of bacteria.

Do NOT use Tobramycin Drops if: you are allergic to any ingredient in Tobramycin Drops or to similar medicines

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tobramycin Drops:

Some medical conditions may interact with Tobramycin Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Tobramycin Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cephalosporins by injection (eg, ceftazidime) because they may decrease Tobramycin Drops's effectiveness Cyclosporine, fludarabine, loop diuretics (eg, furosemide), methoxyflurane, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin), nitrosoureas (eg, streptozocin), polypeptide antibiotics (eg, polymyxin B), or vancomycin injection because they may increase the risk of Tobramycin Drops's side effects, including increased risk of kidney or hearing problems Cephalosporins by injection (eg, ceftazidime), nondepolarizing muscle relaxants (eg, pancuronium), or succinylcholine because their side effects may be increased by Tobramycin Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tobramycin Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tobramycin Drops:

Use Tobramycin Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Remove contact lenses before you use Tobramycin Drops. Do not wear contact lenses while you are using Tobramycin Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them. To use Tobramycin Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed. To clear up your infection completely, take/use Tobramycin Drops for the full course of treatment. Keep taking/using it even if you feel better in a few days. Tobramycin Drops works best if it is used at the same time each day. Do not miss any doses. If you miss a dose of Tobramycin Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Tobramycin Drops.

Important safety information: Tobramycin Drops may cause blurred vision. Use Tobramycin Drops with caution. Do not drive or perform other possibly unsafe tasks if you cannot see clearly. If your symptoms do not get better within a few days or if they get worse, check with your doctor. Be sure to use Tobramycin Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Tobramycin Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Tobramycin Drops should not be used in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tobramycin Drops while you are pregnant. It is not known if Tobramycin Drops are found in breast milk. Do not breast-feed while using Tobramycin Drops. Possible side effects of Tobramycin Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning or stinging in the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye or eyelid swelling, itching, or redness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; eye pain; eye watering; swelling and itching of the eyelid.

Proper storage of Tobramycin Drops:

Store Tobramycin Drops at room temperature, between 46 and 80 degrees F (8 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tobramycin Drops out of the reach of children and away from pets.

General information: If you have any questions about Tobramycin Drops, please talk with your doctor, pharmacist, or other health care provider. Tobramycin Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tobramycin Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tobramycin resources Tobramycin Use in Pregnancy & BreastfeedingTobramycin Support Group3 Reviews for Tobramycin - Add your own review/rating Compare Tobramycin with other medications Conjunctivitis, Bacterial
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tobramycin and dexamethasone Ophthalmic


toe-bra-MYE-sin, dex-a-METH-a-sone

Commonly used brand name(s)

In the U.S.

Tobradex Tobradex ST

In Canada

Tobradex Ointment Tobradex Suspension

Available Dosage Forms:

Ointment Suspension

Therapeutic Class: Aminoglycoside/Corticosteroid Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Aminoglycoside

Uses For tobramycin and dexamethasone

Tobramycin and dexamethasone is a combination of an antibiotic and a corticosteroid. It is used in the eye to prevent permanent damage, which may occur with certain eye problems.

tobramycin and dexamethasone is available only with your doctor's prescription.

Before Using tobramycin and dexamethasone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tobramycin and dexamethasone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tobramycin and dexamethasone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on tobramycin and dexamethasone have been done only in adult patients, and there is no specific information comparing use of ophthalmic tobramycin and dexamethasone in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic tobramycin and dexamethasone in the elderly with use in other age groups.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tobramycin and dexamethasone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tobramycin and dexamethasone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Praziquantel Rilpivirine Rotavirus Vaccine, Live

Using tobramycin and dexamethasone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alcuronium Aldesleukin Atracurium Boceprevir Bupropion Cidofovir Cisatracurium Colistimethate Sodium Darunavir Dasatinib Decamethonium Doxacurium Efavirenz Ethacrynic Acid Etravirine Fazadinium Fosamprenavir Furosemide Gallamine Hexafluorenium Imatinib Ixabepilone Lapatinib Lysine Metocurine Mivacurium Nevirapine Nilotinib Pancuronium Pipecuronium Quetiapine Rapacuronium Rivaroxaban Rocuronium Romidepsin Succinylcholine Sunitinib Tacrolimus Telaprevir Temsirolimus Thalidomide Ticagrelor Tubocurarine Vancomycin Vandetanib Vecuronium

Using tobramycin and dexamethasone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alatrofloxacin Alcuronium Aminoglutethimide Aprepitant Aspirin Atracurium Balofloxacin Caspofungin Cinoxacin Ciprofloxacin Cisplatin Clinafloxacin Cyclosporine Enoxacin Fleroxacin Fluindione Flumequine Fosaprepitant Fosphenytoin Gallamine Gemifloxacin Grepafloxacin Hexafluorenium Itraconazole Levofloxacin Licorice Lomefloxacin Metocurine Moxifloxacin Norfloxacin Ofloxacin Pancuronium Pefloxacin Phenobarbital Phenytoin Primidone Prulifloxacin Rifampin Rifapentine Ritonavir Rosoxacin Rufloxacin Saiboku-To Sparfloxacin Temafloxacin Tosufloxacin Trovafloxacin Mesylate Vecuronium Warfarin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of tobramycin and dexamethasone. Make sure you tell your doctor if you have any other medical problems, especially:

Glaucoma—The dexamethasone in the eyedrops may cause glaucoma or make it worse if the eyedrops are used for a long time Herpes infection of the eye or Any other eye infection, including bacterial and fungal—The dexamethasone in the eyedrops may make existing infections worse or cause new infections Proper Use of tobramycin and dexamethasone

For patients using the ophthalmic suspension (eye drops) form of tobramycin and dexamethasone:

Always shake the container very well just before applying the eye drops. To use: First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye. If you think you did not get the drop of medicine into your eye properly, use another drop. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Always keep the container tightly closed.

For patients using the ophthalmic ointment form of tobramycin and dexamethasone:

To use: First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1/2-inch strip of ointment is usually enough. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the irritation. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye ointment, wipe the tip of the ointment tube with a clean tissue. Do not wash the tip with water. Always keep the tube tightly closed. Dosing

The dose of tobramycin and dexamethasone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tobramycin and dexamethasone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ophthalmic ointment dosage form: For eye disorders: Adults—Use about a 1/2-inch strip of ointment in the eye up to three or four times a day. Children—Use and dose must be determined by your doctor. For ophthalmic suspension (eye drops) dosage form: For eye disorders: Adults—Use 1 or 2 drops in the eye every four to six hours. Your doctor may have you use the drops more frequently during the first day or two and will probably have you space the doses farther apart as the eye gets better. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of tobramycin and dexamethasone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using tobramycin and dexamethasone

If you will be using tobramycin and dexamethasone for more than a few weeks, an ophthalmologist (eye doctor) should examine your eyes at regular visits to make sure it does not cause unwanted effects.

tobramycin and dexamethasone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common Itching and swelling of eyelid redness of eye Rare Delayed wound healing eye pain gradual blurring or loss of vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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