neo/poly/hc 1% otic solution
 

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Otic anesthetics


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.

Otic anesthetics are agents that act locally to relieve pain in the ears. Some of these agents are available with other medicines such as analgesics, decongestants, etc. They are generally available as ear drops.

See also

Medical conditions associated with otic anesthetics:

Acute Otitis ExternaEar ConditionsEar Wax ImpactionOtitis ExternaOtitis Media Drug List:/tags/a-b-otic/
/tags/auralgan/
/tags/auroto/
/tags/chlorphenylcaine-ear-drops/
/tags/neotic-drops/
/tags/otic-edge/
/tags/otilam/
/tags/otogesic/
/tags/pr-otic/
/tags/treagan/
Uni-Otic-Drops
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Keratoconjunctivitis Medications


Definition of Keratoconjunctivitis: Inflammation of the cornea and conjunctiva.

Drugs associated with Keratoconjunctivitis

The following drugs and medications are in some way related to, or used in the treatment of Keratoconjunctivitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Ak-Cide Ak-Neo-Dex Ak-Poly-Bac Ak-Trol Alomide Blephamide-Suspension Blephamide-S-O-P-Ointment Cetapred Cortisporin-Ophthalmic-Suspension-Drops-Suspension Cortomycin-Suspension Crolom-Ophthalmic Dexacidin Dexacine Dexasporin Fml-S-Suspension Fml-S-Liquifilm Isopto-Cetapred Maxitrol-Drops Methadex Metimyd Neo-Decadron Neo-Decadron-Ocumeter Neo-Dex Neo-Dexair Neo-Poly-Dex Neocidin-Ophthalmic-Ointment Neocin-Ointment Neosporin-Ophthalmic-Ointment Npd-Ophthalmic-Ointment Ocu-Lone-C Ocu-Spore-B Ocu-Trol Ocutricin Opticrom-Ophthalmic Poly-Pred-Drops Poly-Dex-Drops Polycin-B-Ointment Polysporin-Ophthalmic Polytracin-Ophthalmic Pred-G Pred-G-S-O-P Vasocidin-Drops Voltaren-Drops
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Milbemite



Dosage Form: FOR ANIMAL USE ONLY
Milbemite Otic Solution

Milbemite™ OTIC Solution

(0.1% milbemycin oxime)

Caution:

U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

Milbemite OTIC Solution is available in plastic dispensing tubes with break-off tips. Each plastic tube contains 0.25 mL of Milbemite OTIC Solution as a 0.1% solution of milbemycin oxime. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32H45NO7, MW 555.71) and 20% A3 (C31H43NO7, MW 541.68).

Indications:

Milbemite OTIC Solution is indicated for treatment of ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.

Human Warnings:

Not for human use. Keep this and all drugs out of the reach of children.

Precautions:

The safe use of Milbemite OTIC Solution in cats used for breeding purposes, during pregnancy, or in lactating queens, has not been evaluated.

Adverse Reactions:

No adverse reactions caused by Milbemite OTIC Solution have been reported in controlled effectiveness studies in adult cats and kittens (4 weeks of age).

Dosage:

 Milbemite OTIC Solution should be administered topically into the external ear canal as the entire contents of a single-dose tube per ear. The volume delivered will be approximately 0.2 mL, with 0.05 mL residual volume remaining in dispensing tube. Repeat the treatment one time if necessary, based upon the ear mite life cycle and the response to treatment.

Administration:

Milbemite OTIC Solution should be administered as one tube per ear as a single treatment. Each foil pouch contains two tubes of solution, one for each ear. Open the tube by snapping off the cap. Squeeze the tube to administer the contents of one tube into each external ear canal. Massage the base of the ear for optimal distribution. In clinical field trials, ears were not cleaned and many animals still had debris in their ears at the end of the study. Cleaning of the external ear canal prior to treatment may be performed, but is not necessary to provide effectiveness.

Effectiveness:

The clinical effectiveness of milbemycin oxime 0.1% solution was evaluated in a placebo-controlled clinical field trial of client-owned cats. Otodectes cynotis infestation was diagnosed by direct microscopic visualization of ear swab debris. Test or placebo treatment was administered to both ears of the cat following the pre-treatment examination. Cats’ ears were examined by ear swab microscopy at multiple intervals throughout the life cycle of the mite (up to day 30). Ninety-nine percent (99%) of the milbemycin oxime-treated group were ear mite negative at the microscopic exams.

Safety:

A study was conducted using otic doses of 0.1, 0.3 or 0.5% milbemycin oxime solutions administered once weekly for six applications in kittens that were 4 weeks of age at the initiation of the study. Otic doses of 0.1 and 0.3% did not produce adverse systemic or local effects. One kitten treated with 0.5% was lethargic 8 hours after the second treatment. The kitten was offered milk replacer and by 10 hours post-treatment it appeared normal. In this kitten, lethargy was not observed after subsequent treatments. A study was conducted to evaluate the safety of a 0.1% milbemycin oxime solution in adult cats. Topical doses at 1X, 3X or 5X the recommended dose applied in one ear did not produce adverse effects.

Storage Conditions:

 Milbemite OTIC Solution should be stored at room temperature, between 59° and 77° F (15-25° C).

How Supplied:

Milbemite OTIC Solution is supplied in individual white polypropylene tubes, paired in a foil overlay pouch. The product is packaged in a box of 10 pouches of 2 tubes of 0.25 mL each.

U.S. Patent No. 4,547,520

Manufactured for: Novartis Animal Health US, Inc.

Greensboro, NC 27408 USA

NADA #141-163, Approved by FDA.

©2002 Novartis

NAH/MIL-LE/VI/3

PRINCIPAL DISPLAY PANEL

MilbemiteTM 

OTIC Solution (0.1% milbemycin oxime)

FOR USE IN

CATS & KITTENS

FOUR WEEKS

OF AGE

AND OLDER

Net contents:

10 pouches of

2 tubes of

0.25 mL each

NADA # 141-163, Approved by the FDA.


Milbemite 
milbemycin oxime  solution Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 58198-8602 Route of Administration AURICULAR (OTIC) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MILBEMYCIN OXIME (MILBEMYCIN OXIME) MILBEMYCIN OXIME 1 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 58198-8602-5 10 POUCH In 1 BOX contains a POUCH 1 2 TUBE In 1 POUCH This package is contained within the BOX (58198-8602-5) and contains a TUBE 1 0.25 mL In 1 TUBE This package is contained within a POUCH and a BOX (58198-8602-5)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141163 02/02/2000
Labeler - Novartis Animal Health US, Inc. (966985624) Revised: 03/2010Novartis Animal Health US, Inc.

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Otitis Media Medications


Definition of Otitis Media:

Infection and inflammation of the middle ear space and ear drum.

Symptoms include earache, fever and in some cases, diminished hearing.

Drugs associated with Otitis Media

The following drugs and medications are in some way related to, or used in the treatment of Otitis Media. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Otitis MediaChronic Otitis Media (2 drugs in 2 topics) Otitis Media with Perforation of Ear Drum (0 drugs) Perforated Tympanic Membrane (0 drugs)
Drug List:/tags/a-b-otic/
/tags/amoclan-suspension/
/tags/augmentin/
/tags/augmentin-xr-extended-release-tablets/
/tags/auroto/
/tags/bactrim/
/tags/beepen-vk/
/tags/biaxin-xl-extended-release-tablets/
/tags/bicillin-c-r-900-300/
/tags/bio-cef/
/tags/ceftin/
/tags/ceptaz/
/tags/ciprodex/
/tags/coly-mycin-s-drops/
/tags/cortatrigen/
/tags/cortisporin-solution/
/tags/cortomycin-solution/
/tags/dispermox/
/tags/drotic/
/tags/dynabac-d5-pak/
/tags/e-e-s-200/
/tags/e-e-s-400-filmtab/
/tags/eryc-delayed-release-particles-capsules/
/tags/erythrocin/
/tags/erythrocin-stearate-filmtab/
/tags/floxin-otic/
/tags/gantrisin-suspension/
/tags/ilosone/
/tags/keflex/
/tags/levaquin-leva-pak/
/tags/lorabid-pulvules/
/tags/omnicef/
/tags/oti-sone/
/tags/otocort-sterile-solution/
/tags/otogesic/
/tags/pc-pen-vk/
/tags/pediazole/
/tags/pen-v/
/tags/penicillin-vk/
/tags/primsol-solution/
/tags/proloprim/
/tags/rocephin/
/tags/septra/
/tags/smz-tmp-ds/
/tags/sulfatrim-suspension/
/tags/sulfimycin/
/tags/tazicef/
/tags/tequin-teqpaq/
/tags/trimpex/
/tags/tympagesic/
/tags/vantin/
/tags/velosef/
/tags/zithromax/

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Ophthalmic steroids with anti-infectives


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 steroids with anti-infectives are preparations designed to be applied into the eyes. They contain steroids and anti-infectives. Steroids are effective anti-inflammatory agents and are used to treat pain and inflammation. The anti-infectives commonly present in eye drops are antibiotics that either kill or inhibit the growth of bacteria.

Steroids and antibiotics in combination are used to treat eye infections, which have pain and inflammation component or they can be used post surgery to prevent infections and to treat the inflammation.

See also

Medical conditions associated with ophthalmic steroids with anti-infectives:

Blepharitis Conjunctivitis, Bacterial Cyclitis Iritis Keratitis Keratoconjunctivitis Uveitis Drug List: Fml-S-Liquifilm Neo-Decadron Tobradex Zylet Blephamide-Suspension Ak-Cide Ak-Neo-Dex Ak-Trol Blephamide-S-O-P-Ointment Cetapred Cortisporin-Ophthalmic Cortisporin-Ophthalmic-Suspension-Drops-Suspension Cortomycin-Eye-Ointment Cortomycin-Suspension Dexacidin Dexacine Dexasporin Fml-S-Suspension Isopto-Cetapred Maxitrol-Drops Methadex Metimyd Neo-Decadron-Ocumeter Neo-Dex Neo-Dexair Neo-Poly-Bac Neo-Poly-Dex Neotricin-Hc Npd-Ophthalmic-Ointment Ocu-Cort Ocu-Lone-C Ocu-Trol Ophthocort Poly-Dex-Drops Poly-Pred-Drops Pred-G Pred-G-S-O-P Tobradex-St-Drops Triple-Antibiotic-Hc-Ophthalmic-Ointment Vasocidin-Drops
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Coly-Mycin S Otic


Generic Name: Colistin/Hydrocortisone/Neomycin (koe-LIS-tin/hye-droe-KOR-ti-sone/nee-oh-MYE-sin)
Brand Name: Coly-Mycin S Otic
Coly-Mycin S Otic is used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Coly-Mycin S Otic is a combination of 2 antibiotics and a corticosteroid. The antibiotics work by killing sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Coly-Mycin S Otic if: you are allergic to any ingredient in Coly-Mycin S Otic, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone) you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles) you have a perforated ear drum

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

Before using Coly-Mycin S Otic:

Some medical conditions may interact with Coly-Mycin S Otic. 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 if you have the blood disease porphyria

Some MEDICINES MAY INTERACT with Coly-Mycin S Otic. Because little, if any, of Coly-Mycin S Otic is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Coly-Mycin S Otic 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 Coly-Mycin S Otic:

Use Coly-Mycin S Otic as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Coly-Mycin S Otic is only for the ear. Do not it in your eyes, nose, or mouth. If you get Coly-Mycin S Otic in your eyes, rinse immediately with cool tap water. Wash your hands before and after using Coly-Mycin S Otic. Wash and dry the outer ear with a sterile cotton applicator. Shake well before each use. Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. Do not heat Coly-Mycin S Otic by any other method because it could decrease its effectiveness. Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from contaminating your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed. To clear up your infection completely, use Coly-Mycin S Otic for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Coly-Mycin S Otic, 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 Coly-Mycin S Otic.

Important safety information: Coly-Mycin S Otic only works against bacteria; it does not treat viral infections (eg, the common cold). Be sure to use Coly-Mycin S Otic 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 Coly-Mycin S Otic 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 take more than the recommended dose or use for longer than 10 days without checking with your doctor. Do not use Coly-Mycin S Otic for other ear conditions at a later time. Tell your doctor or dentist that you take Coly-Mycin S Otic before you receive any medical or dental care, emergency care, or surgery. PREGNANCY and BREAST-FEEDING: It is not known if Coly-Mycin S Otic can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Coly-Mycin S Otic while you are pregnant. It is not known if Coly-Mycin S Otic is found in breast milk. If you are or will be breast-feeding while you are using Coly-Mycin S Otic, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Coly-Mycin S Otic:

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:

Mild, temporary burning or stinging.

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); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; pain, redness, itching, irritation, or swelling not present when you began using Coly-Mycin S Otic; thinning, softening, or discoloration of the skin.

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.

See also: Coly-Mycin S Otic side effects (in more detail)

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.

Proper storage of Coly-Mycin S Otic:

Store Coly-Mycin S Otic between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Coly-Mycin S Otic out of the reach of children and away from pets.

General information: If you have any questions about Coly-Mycin S Otic, please talk with your doctor, pharmacist, or other health care provider. Coly-Mycin S Otic 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.

This information is a summary only. It does not contain all information about Coly-Mycin S Otic. 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 Coly-Mycin S Otic resources Coly-Mycin S Otic Side Effects (in more detail)Coly-Mycin S Otic Use in Pregnancy & BreastfeedingColy-Mycin S Otic Drug InteractionsColy-Mycin S Otic Support Group0 Reviews for Coly-Mycin S Otic - Add your own review/rating Compare Coly-Mycin S Otic with other medications Acute Otitis ExternaChronic Otitis MediaOtitis ExternaOtitis Media
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Poly-Pred Drops


Pronunciation: NEE-oh-MYE-sin/POL-ee-MIX-in/pred-NIS-oh-lone
Generic Name: Neomycin/Polymyxin B/Prednisolone
Brand Name: Poly-Pred
Poly-Pred Drops are used for:

Treating infections and relieving the redness, irritation, and discomfort associated with certain eye problems.

Poly-Pred Drops are an antibiotic and steroid combination. It works by inhibiting the growth of bacteria and decreasing inflammation.

Do NOT use Poly-Pred Drops if: you are allergic to any ingredient in Poly-Pred Drops you have certain eye infections (eg, herpes simplex, tuberculosis, fungal, mycobacterial, or viral infections), chickenpox, or an infection due to smallpox vaccination (vaccinia)

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

Before using Poly-Pred Drops:

Some medical conditions may interact with Poly-Pred 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 if you have diabetes, glaucoma, optic nerve damage, or thinning of the cornea or other eye tissues

Some MEDICINES MAY INTERACT with Poly-Pred Drops. Because little, if any, of Poly-Pred Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Poly-Pred 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 Poly-Pred Drops:

Use Poly-Pred Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Shake well before each use. To use Poly-Pred 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 eye 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. If your doctor prescribed more than 1 eye medicine, ask the best order for using each medicine. Do not wear contact lenses while you are using Poly-Pred Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them. If you miss a dose of Poly-Pred 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. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Poly-Pred Drops.

Important safety information: Poly-Pred Drops may cause blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Poly-Pred Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do NOT use more than the recommended dose or use for longer than 10 days or for future eye problems without checking with your doctor. LAB TESTS, such as eye exams, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Poly-Pred Drops while you are pregnant. It is not known if Poly-Pred Drops are found in breast milk. If you are or will be breast-feeding while you use Poly-Pred Drops, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Poly-Pred 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:

Blurred vision; temporary burning or stinging.

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; continued or worsening itching, swelling, or irritation; continuing blurred vision; discharge from eyes; eye pain.

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.

See also: Poly-Pred side effects (in more detail)

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.

Proper storage of Poly-Pred Drops:

Store Poly-Pred Drops at room temperature, below 77 degrees F (25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Poly-Pred Drops out of the reach of children and away from pets.

General information: If you have any questions about Poly-Pred Drops, please talk with your doctor, pharmacist, or other health care provider. Poly-Pred 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 Poly-Pred 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 Poly-Pred resources Poly-Pred Side Effects (in more detail)Poly-Pred Use in Pregnancy & BreastfeedingPoly-Pred Drug InteractionsPoly-Pred Support Group0 Reviews for Poly-Pred - Add your own review/rating Compare Poly-Pred with other medications BlepharitisConjunctivitis, BacterialKeratitisKeratoconjunctivitisUveitis
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Cortic-ND otic


Generic Name: chloroxylenol, hydrocortisone, and pramoxine (otic) (KLOR oh ZYE nol, HYE droe KOR ti sone, pra MOX een)
Brand Names: Aero Otic HC, Cortamox, Cortane-B, Cortane-B Aqueous, Cortane-B Otic, Cortic-ND, Cyotic, Exotic-HC, Hydro Ear, IvDerm, Otirx, Oto-End, Otomar HC, Tri-Otic, Zolene HC, Zoto-HC Drops

What is Cortic-ND (chloroxylenol, hydrocortisone, and pramoxine (otic))?

Chloroxylenol is an antibiotic that fights bacteria.

Pramoxine is a topical anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

The combination of chloroxylenol, hydrocortisone, and pramoxine otic (for the ear) are used to treat pain, and swelling caused by ear infections.

Chloroxylenol, hydrocortisone, and pramoxine otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cortic-ND (chloroxylenol, hydrocortisone, and pramoxine (otic))? Do not use this medication if you have a ruptured (torn) ear drum, or the medication could leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your doctor will use a special scope to see any tear in your ear drum.

Before using chloroxylenol, hydrocortisone, and pramoxine, tell your doctor if you are allergic to any drugs, or if you have any type of illness or infection (other than an ear infection).

Chloroxylenol, hydrocortisone, and pramoxine otic is for use only in your ear. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Stop using this medication and call your doctor at once if you have ear drainage or discharge, severe burning or itching in your ear, or worsening pain, irritation, or rash.

Less serious side effects are more likely, and you may have none at all.

What should I discuss with my healthcare provider before using Cortic-ND (chloroxylenol, hydrocortisone, and pramoxine (otic))?

You should not use this medication if you are allergic to chloroxylenol, hydrocortisone, or pramoxine.

Do not use this medication if you have a ruptured (torn) ear drum, or the medication could leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your doctor will use a special scope to see any tear in your ear drum.

Before using chloroxylenol, hydrocortisone, and pramoxine, tell your doctor if you are allergic to any drugs, or if you have any type of illness or infection (other than an ear infection).

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether chloroxylenol, hydrocortisone, and pramoxine otic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use my Cortic-ND (chloroxylenol, hydrocortisone, and pramoxine (otic))?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Do not use the medication in your eyes or take it by mouth. Chloroxylenol, hydrocortisone, and pramoxine otic is for use in the ears only.

For best results, remove any ear wax or other debris before using the ear drops. Ask your doctor about safe methods of ear wax removal.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and place enough drops of the medicine in your ear to fill the ear canal.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, keep the ear tilted upward for about 5 minutes. You may also be able to soak a small cotton wick with the medication and leave it in place. Ask your doctor of pharmacist for instructions on using a cotton wick.

Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after using this medication.

Store the ear drops at room temperature away from moisture and heat. Keep the bottle properly capped. What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of chloroxylenol, hydrocortisone, and pramoxine applied into the ear is not likely to cause life-threatening symptoms.

What should I avoid while using this medication? Do not use other ear drops during treatment with chloroxylenol, hydrocortisone, and pramoxine otic without first talking to your doctor. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Chloroxylenol, hydrocortisone, and pramoxine otic is for use only in your ear. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Cortic-ND (chloroxylenol, hydrocortisone, and pramoxine (otic)) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

ear drainage or discharge;

severe burning or itching in your ear; or

worsening pain, irritation, or rash.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect my Cortic-ND (chloroxylenol, hydrocortisone, and pramoxine (otic))?

It is not likely that other drugs you take orally or inject will have an effect on chloroxylenol, hydrocortisone, and hydrocortisone otic. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Cortic-ND resources Cortic-ND Use in Pregnancy & Breastfeeding Cortic-ND Support Group 0 Reviews for Cortic-ND - Add your own review/rating Compare Cortic-ND with other medications Acute Otitis Externa Ear Conditions Otitis Externa Where can I get more information? Your pharmacist can provide more information about chloroxylenol, hydrocortisone, and pramoxine otic.
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Tri-Adcortyl Otic Ointment


The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

TRI-ADCORTYL OTIC OINTMENT

Your doctor has prescribed Tri-Adcortyl Otic Ointment for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

What Is In Tri-Adcortyl Otic Ointment?

This ointment contains four active ingredients: triamcinolone acetonide which belongs to a group of medicines called steroids which are used to reduce inflammation, nystatin which is a member of a group of medicines called anti-fungal agents, neomycin and gramicidin which are antibiotics.

Each gram of Tri-Adcortyl Otic contains 0.1% of triamcinolone acetonide, nystatin 100,000 units, Neomycin 1625 units (0.25%) and Gramicidin 0.025% and is supplied in tubes of 10g. The other ingredients are: liquid paraffin and polyethylene resin.

Product Licence Holder: E. R. Squibb & Sons Ltd. Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH England Tel:0800 7311736 Manufacturer: Bristol-Myers Squibb SpA Contrada Fontana del Ceraso 03012 Anagni (Fr) Italy What Is This Medicine For ?

Tri-Adcortyl Otic ointment is prescribed to treat infection and inflammation of the external ear.

Before Using Your Medicine Should you be using Tri-Adcortyl Otic ointment?

This ointment has been prescribed to treat the skin problem that you showed your doctor. DO NOT use it on any other skin problems as it may make them worse.

This ointment is NOT for Use in the Eyes

DO NOT use Tri-Adcortyl Otic ointment if you have any of the following skin conditions:

Tuberculosis (TB) of the skin; viral infections e.g. cold sores, herpes, chickenpox fungal skin conditions unless a suitable antifungal preparation has also been given acne inflammation around the mouth (perioral dermatitis) a condition called rosacea (flushed, red face)

Tri-Adcortyl Otic ointment should not be used

inside the ears of patients with perforated eardrums (holes in eardrums) for long periods of time over large areas of the body in the eyes.

This ointment should not be used if you have had an allergic reaction to any product containing the same ingredients as Tri-Adcortyl Otic ointment.

If Tri-Adcortyl Otic ointment is to be used on the face, or on children, treatment should not be longer than 5 days and the treated area should not be covered with any airtight or waterproof plasters/dressings.

This medicine should not be used in children under one year of age.

What if I am pregnant or breast feeding ?

You should always tell your doctor if you are pregnant, planning to become pregnant or breast feeding and let him decide if it is wise for you to use this medicine.

Do you have problems with your ears or hearing?

Make sure that your doctor knows about any problems you have with your ears before you start using Tri-Adcortyl Otic ointment. Neomycin, which is one of the active ingredients, may be harmful to the ears, particularly if used in large amounts and for long periods of time.

Using Your Medicine How should I apply Tri-Adcortyl Otic ointment?

This ointment should be applied to the affected area two or occasionally three times daily. In the elderly this ointment should be used sparingly and for short periods of time. If after 7 days little or no improvement occurs then tell your doctor.

If you are using this ointment on burnt skin that has become infected or ulcerated skin, make sure you use a small amount of ointment, as these skin conditions may make it easier for the active ingredient in the ointment to pass through the skin into the blood stream and may increase the possibility of side-effects.

Are there special directions for children?.

As children are more likely to get side effects, they should not normally be treated for longer than 5 days, unless your doctor has told you to to do so.

What if Tri-Adcortyl Otic ointment is swallowed?

If this ointment is swallowed tell your doctor immediately or go to your nearest hospital casualty department.

What happens if you miss an application?

If you forget to use your ointment, apply it as soon as possible. However, if it is nearly time for your next application skip the missed dose and continue as before.

What should you do if you put Tri-Adcortyl Otic ointment on areas of normal or healthy skin?

Remove the ointment with a clean tissue and wash the area with plenty of water.

Undesirable Effects Are there any unwanted effects of Tri-Adcortyl Otic ointment?

If absorbed into the bloodstream, the active ingredient neomycin can damage the ears or the kidneys.

Check with your doctor if you notice any of the following side effects: blistering, burning, itching, peeling, dryness or other signs of skin irritation not present before using this ointment.

If the ointment is used for a long time additional side effects may occur. Check with your doctor as soon as possible if you notice any of these: acne or oily skin, increased facial hair growth, increased sweating, lightheadedness on standing, reddish purple lines on arms, face, legs, trunk or groin; thinning of skin with easy bruising or wounds that are slow to heal, rashes consisting of slightly raised rounded red patches. It may also cause changes in your body's sugar levels. If you have skin reaction tests, eg. for allergies, the steroid contained in this ointment may affect the result by reducing the reaction. If you notice any other unwanted effect tell your doctor or pharmacist.

Looking After Your Medicine

Do not use your medicine after the expiry date which you will find on both the Ointment tube and box.

Keep all your medicines where children cannot reach them, preferably in a locked cupboard or medicine cabinet. Do not store Tri-Adcortyl Otic ointment above 25°C.

If your doctor decides to stop the ointment, ask your pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION June 2005


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Ciprodex


Generic Name: ciprofloxacin and dexamethasone otic (sih pro FLOCK sah sin and dex ah MEH thah sone)
Brand Names: Ciprodex

What is ciprofloxacin and dexamethasone otic?

Ciprofloxacin is a fluoroquinolone antibiotic. Ciprofloxacin fights bacteria in the body.

Dexamethasone is a steroid. It is used with ciprofloxacin to reduce inflammation caused by an infection.

Together, ciprofloxacin and dexamethasone are used to treat ear infections.

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

What is the most important information I should know about ciprofloxacin and dexamethasone otic? Do not use this medication in the eyes or take it by mouth. Ciprofloxacin and dexamethasone otic is intended for use in the ears only. Do not touch the dropper opening to any surface, including the ears or hands. The dropper opening is sterile. If it becomes contaminated, it could cause another infection in the ear.

Notify your doctor if the condition does not improve or appears to worsen.

What should I discuss with my healthcare provider before using ciprofloxacin and dexamethasone otic? Do not use ciprofloxacin and dexamethasone otic without first talking to your doctor if you have had a previous allergic reaction to it or to another similar oral or topical medication such as:

a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), sparfloxacin (Zagam), or trovafloxacin (Trovan);

an oral or injectable steroid such as cortisone (Cortef, Cortone), dexamethasone (Decadron), dexamethasone (Hydrocortone), methylprednisolone (Medrol), prednisolone (Prelone, Pediapred), prednisone (Orasone, Deltasone), and others; or

a topical steroid such as betamethasone (Diprosone, Diprolene), clobetasol (Temovate, Olux), fluocinolone (Synalar, Synemol, Fluonid), fluocinonide (Lidex), fluticasone (Cutivate), halobetasol (Ultravate), mometasone (Elocon), triamcinolone (Aristocort), and others.

You may not be able to use ciprofloxacin and dexamethasone otic, or you may require a dosage adjustment or special monitoring during treatment.

Ciprofloxacin and dexamethasone otic is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use ciprofloxacin and dexamethasone otic without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether ciprofloxacin and dexamethasone otic passes into breast milk. Do not use ciprofloxacin and dexamethasone otic without first talking to your doctor if you are breast-feeding a baby. How should I use ciprofloxacin and dexamethasone otic? Use ciprofloxacin and dexamethasone otic exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you. Do not use this medication in the eyes or take it by mouth. Ciprofloxacin and dexamethasone otic is intended for use in the ears only.

In general, ciprofloxacin and dexamethasone otic should be used as follows:

Warm the drops slightly by holding them in the hands for 1 or 2 minutes. Administration of cold drops into the ear may cause dizziness.

Have another person administer the drops whenever possible. Have the affected person lie on their side or tilt the ear up to make administering a drop easier.

Gently shake the drops just before administration.

For adults, gently hold the earlobe up and back. For children, gently hold the earlobe down and back. This will allow the drops to run into the ear canal. Carefully instill the prescribed number of drops in the first ear.

Keep the ear tilted for at least 60 seconds to allow the medication to penetrate the ear.

If the patient being treated has ear tubes, the doctor may recommend gently pressing the tragus (part of the ear in front of the opening of the ear canal) five times in a pumping motion after administration of the drops. This may allow the drops to pass through the tubes into the middle ear. Follow the doctor's instructions.

Repeat the process in the other ear if prescribed.

Ciprofloxacin and dexamethasone ear drops are usually used twice a day, about 12 hours apart. Follow your doctor's instructions.

Use all of the medication that has been prescribed. Symptoms may begin to improve before the condition is completely treated. If you do not use all of the medication prescribed, the condition could return or worsen.

It is important to use ciprofloxacin and dexamethasone otic regularly to get the most benefit.

Notify your doctor if the condition does not improve or appears to worsen.

Avoid getting water inside of the affected ear(s) during treatment with ciprofloxacin and dexamethasone. Care should be used while bathing and swimming may not be recommended. Talk to your healthcare provider.

Store ciprofloxacin and dexamethasone otic at room temperature, away from moisture, heat, and direct light. Keep the bottle properly capped.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of ciprofloxacin and dexamethasone otic unless otherwise directed by your doctor.

What happens if I overdose? Seek emergency medical attention if an overdose is suspected or if the medication has been ingested.

Symptoms of a ciprofloxacin and dexamethasone otic overdose are not known.

What should I avoid while using ciprofloxacin and dexamethasone? Ear infections may sometimes cause dizziness or a loss of balance. Use caution when driving, operating machinery, or performing other hazardous activities if you experience dizziness or a loss of balance. Avoid getting water inside of the affected ear(s) during treatment with ciprofloxacin and dexamethasone. Care should be used while bathing and swimming may not be recommended. Talk to your healthcare provider. Ciprofloxacin and dexamethasone otic side effects Stop using ciprofloxacin and dexamethasone otic and seek emergency medical attention or notify your doctor if you experience:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

skin rash; or

ear drainage, discharge, or worsening pain.

Other less serious side effects may also occur such as ear discomfort or itching or an unusual taste in the mouth. Continue to use the medication and talk to your doctor if these side effects seem excessive or unusual.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect my ciprofloxacin and dexamethasone otic? Do not use other ear drops during treatment with ciprofloxacin and dexamethasone otic without first talking to your doctor.

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

More Ciprodex resources Ciprodex Side Effects (in more detail) Ciprodex Dosage Ciprodex Use in Pregnancy & Breastfeeding Ciprodex Support Group 11 Reviews for Ciprodex - Add your own review/rating Ciprodex Prescribing Information (FDA) Ciprodex Advanced Consumer (Micromedex) - Includes Dosage Information Ciprodex MedFacts Consumer Leaflet (Wolters Kluwer) Ciprodex Consumer Overview Compare Ciprodex with other medications Otitis Externa Otitis Media Where can I get more information? Your pharmacist has more information about ciprofloxacin and dexamethasone otic written for health professionals that you may read.

See also: Ciprodex side effects (in more detail)


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Uveitis Medications


Definition of Uveitis: Uveitis is an inflammation of the the uvea, the layer between the sclera and the retina, which includes the iris, ciliary body, and the choroid.

Drugs associated with Uveitis

The following drugs and medications are in some way related to, or used in the treatment of Uveitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Uveitis Cyclitis (8 drugs) Panuveitis (0 drugs) Uveitis, Anterior (27 drugs in 4 topics) Uveitis, Posterior (17 drugs in 2 topics) Learn more about Uveitis

Medical Encyclopedia:

Uveitis

Harvard Health Guide:

Symptoms and treatment for Uveitis
Drug List: Ak-Cide Ak-Dex-Ophthalmic Ak-Neo-Dex Ak-Pentolate Ak-Trol Aristocort Aristocort-Forte Atropin-Care-Drops Atropisol Azasan Azulfidine Azulfidine-En-Tabs-Delayed-Release-Tablets Blephamide-Suspension Blephamide-S-O-P-Ointment Cetapred Clinacort-Injection Clinalog-Injection Cortisporin-Ophthalmic Cortisporin-Ophthalmic-Suspension-Drops-Suspension Cortomycin-Eye-Ointment Cortomycin-Suspension Cortone-Acetate Cyclogyl Cylate Decadron-Ocumeter Dexacidin Dexacine Dexasol-Drops Dexasporin Enbrel Fml-S-Suspension Fml-S-Liquifilm Homatropaire-Drops Imuran Isopto-Atropine-Drops Isopto-Cetapred Isopto-Homatropine-Drops Ken-Jec-40-Injection Kenalog-40-Suspension Maxidex-Suspension Maxitrol-Drops Methadex Metimyd Neo-Decadron Neo-Decadron-Ocumeter Neo-Dex Neo-Dexair Neo-Poly-Bac Neo-Poly-Dex Neotricin-Hc Npd-Ophthalmic-Ointment Ocu-Cort Ocu-Dex-Ophthalmic Ocu-Lone-C Ocu-Pentolate Ocu-Trol Ocu-Tropine Ozurdex Poly-Pred-Drops Poly-Dex-Drops Pred-G Pred-G-S-O-P Remicade Retisert Sulfazine Tac-3-Injection Tobradex Tobradex-St-Drops Trexall Triam-Forte Triamcot-Injection Triamonide-40-Injection Triesence Triple-Antibiotic-Hc-Ophthalmic-Ointment Trivaris U-Tri-Lone-Injection Vasocidin-Drops Vexol Zylet
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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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Poly Tan D Suspension


Pronunciation: DEX-brome-fen-IR-a-meen/FEN-il-EF-rin/pir-IL-a-meen
Generic Name: Dexbrompheniramine/Phenylephrine/Pyrilamine
Brand Name: Poly Tan D
Poly Tan D Suspension is used for:

Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Poly Tan D Suspension is an antihistamine and decongestant combination. The antihistamines work by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.

Do NOT use Poly Tan D Suspension if: you are allergic to any ingredient in Poly Tan D Suspension you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Poly Tan D Suspension:

Some medical conditions may interact with Poly Tan D Suspension. 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 if you have a fast, slow, or irregular heartbeat if you have a history of asthma; lung problems (eg, emphysema); sleep apnea; adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; blood vessel problems; stroke; glaucoma or increased pressure in the eye; a blockage of your bladder, stomach, or intestines; ulcers; trouble sleeping; trouble urinating; an enlarged prostate or other prostate problems; seizures; kidney problems; thyroid problems; or phenylketonuria

Some MEDICINES MAY INTERACT with Poly Tan D Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine ), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Poly Tan D Suspension's side effects Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Poly Tan D Suspension Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Poly Tan D Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Poly Tan D Suspension 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 Poly Tan D Suspension:

Use Poly Tan D Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Poly Tan D Suspension by mouth with or without food. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Poly Tan D Suspension, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Poly Tan D Suspension.

Important safety information: Poly Tan D Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Poly Tan D Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Poly Tan D Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Do not take diet or appetite control medicines while you are taking Poly Tan D Suspension without checking with your doctor. Poly Tan D Suspension has dexbrompheniramine, pyrilamine, and phenylephrine in it. Before you start any new medicine, check the label to see if it has an antihistamine or a decongestant in it too. If it does or if you are not sure, check with your doctor or pharmacist. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor. Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product. Poly Tan D Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Poly Tan D Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Poly Tan D Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Poly Tan D Suspension for a few days before the tests. Tell your doctor or dentist that you take Poly Tan D Suspension before you receive any medical or dental care, emergency care, or surgery. Use Poly Tan D Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating. Caution is advised when using Poly Tan D Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability. Poly Tan D Suspension 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 Poly Tan D Suspension while you are pregnant. Do not take Poly Tan D Suspension in the third trimester of pregnancy. Poly Tan D Suspension is found in breast milk. Do not breast-feed while taking Poly Tan D Suspension. Possible side effects of Poly Tan D Suspension:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); blurred vision or other vision changes; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; persistent trouble sleeping; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

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.

See also: Poly Tan D side effects (in more detail)

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; confusion; hallucinations; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat.

Proper storage of Poly Tan D Suspension:

Store Poly Tan D Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Poly Tan D Suspension out of the reach of children and away from pets.

General information: If you have any questions about Poly Tan D Suspension, please talk with your doctor, pharmacist, or other health care provider. Poly Tan D Suspension 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 Poly Tan D Suspension. 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 Poly Tan D resources Poly Tan D Side Effects (in more detail) Poly Tan D Use in Pregnancy & Breastfeeding Poly Tan D Drug Interactions Poly Tan D Support Group 0 Reviews for Poly Tan D - Add your own review/rating Compare Poly Tan D with other medications Nasal Congestion
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Rhinorrhea Medications


Drugs associated with Rhinorrhea

The following drugs and medications are in some way related to, or used in the treatment of Rhinorrhea. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List:/tags/aldex-an-suspension/
/tags/alka-seltzer-plus-sparkling-original-cold-formula-effervescent-tablets/
/tags/brovex-cb/
/tags/care-one-sleep-aid/
/tags/coricidin/
/tags/delhistine-d/
/tags/dimetapp-nighttime-flu-suspension/
/tags/endacof-ac/
/tags/equate-sleep-aid/
/tags/iohist-d/
/tags/liqui-histine-d/
/tags/metahistine-d/
/tags/nalex-ac-syrup/
/tags/nytol-maximum-strength/
/tags/pbz-sr/
/tags/poly-histine-d/
/tags/sleep-aid-tablets/
/tags/trihist-d/
/tags/tylenol-cold-multi-symptom-liquid/
/tags/unisom/
Zymine-Xr-Suspension
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TriOxin Ear Drops


chloroxylenol, benzocaine and hydrocortisone acetate
Dosage Form: otic suspension
TriOxin OTIC SUSPENSION

Rx Only

TriOxin Ear Drops Description

Each 1 mL for otic administration contains:

Chloroxylenol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg

Benzocaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 mg

Hydrocortisone Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . 10 mg

INACTIVE INGREDIENTS: PEG-12 Glyceryl Dimyristate, Sodium Hydroxide, PEG-40 HCO, Purified Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Potassium Sorbate, Isopropyl Alcohol.

CLINICAL PHARMACOLOGY1

TriOxin is effective both as an antibacterial and antifungal agent. The unique Hydrophilic Lipid based delivery system provides a suspension having an acid pH and a low surface tension, exerting a drying effect and allowing the medication to spread quickly to all contiguous surfaces, softening and reducing accumulated cerumen. Chloroxylenol is a halogenated phenol; non-toxic, non-corrosive, non-staining with high phenol coefficient. It may be applied directly to a wound and shows no chemical reactivity toward blood. TriOxin which contains hydrocortisone acetate is indicated when otitis is complicated by inflammation or to control itching. Benzocaine is a topical anesthetic with a low index of sensitization and toxicity.

1 van Asperen IA, de Rover CM, Schijven JF, et al. Risk of otitis externa after swimming in recreational fresh water lakes containing Pseudomonas aeruginosa. BMJ.1995;311:1407-1410.
Sander R. Otitis Externa: A Practical Guide to Treatment and Prevention. Available at http://www.aafp.org/afp/20010301/927.html. Accessed 4/9/09.
BioZone Laboratories, Inc. Qusomes™. Available at: http://www.biozonelabs.com/html/qusomes/qusomes.htm. Accessed 4/15/09. Indications and Usage for TriOxin Ear Drops

For the treatment of superficial infections of the external auditory canal complicated by inflammation caused by organisms susceptible to the action of the antimicrobial. May also be used to control itching in the auditory canal.

Contraindications

Topical steroids are contraindicated in varicella, vaccinia and in patients sensitive to any of the components of this preparation. The preparation is not to be used for ophthalmic use and should not be applied in the external auditory canal of patients with perforated eardrums.

Warnings

This preparation is not intended for ophthalmic or oral use. If accidental ingestion occurs, seek professional help. If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

Precautions General

If a favorable response does not occur promptly, discontinue the use of this preparation until the infection is controlled by other appropriate measures. Although systemic side effects are not common with topical corticosteroids, the possibility of occurrence must be kept in mind, particularly when used for an extended period of time.

USAGE IN PREGNANCY

The safety of topical steroid preparations during pregnancy has not been established. Therefore, they should not be used on pregnant patients.

Adverse Reactions

The following adverse reactions with topical corticosteroids have been observed: itching, burning, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentations, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

OVERDOSE

Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effects.

TriOxin Ear Drops Dosage and Administration

SHAKE WELL BEFORE USING. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 to 5 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward to instill the drops and this position maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

How is TriOxin Ear Drops Supplied

TriOxin Otic Suspension is supplied in 15mL amber glass bottles with dosage dropper and package insert. NDC 68025-041-15

Rx Only

Storage Conditions

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

05/09

Manufactured for
VERTICAL PHARMACEUTICALS, INC.
Sayreville, NJ 08872

Lipid Base Delivery System
QuSomes™
US Patent No. 6,610,322
US Patent No. 6,958,160
US Patent No. 7,150,883
Other patents may apply

PRINCIPAL DISPLAY PANEL-Sample Label

NDC 68025-041-02
TriOxin
Rx Only
Otic Suspension

(Chloroxylenol 1 mg, Benzocaine 15 mg,
Hydrocortisone Acetate10 mg)

2 mL

PRINCIPAL DISPLAY PANEL-Sample Carton

Physician Samples - not for resale

TriOxin
Rx Only
Otic Suspension

Each 1 mL for otic administration contains:

Chloroxylenol . . . . . . . . . . . . . . . 1 mg
Benzocaine . . . . . . . . . . . . . . . 15 mg
Hydrocortisone Acetate . . . . . 10 mg

Manufactured for:
VERTICAL
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL-15 mL Carton

NDC 68025-041-15
15 mL bottle

TriOxin
Rx Only
Otic Suspension

Each 1 mL for otic administration contains:

Chloroxylenol . . . . . . . . . . . . . . . 1 mg
Benzocaine . . . . . . . . . . . . . . . 15 mg
Hydrocortisone Acetate . . . . . 10 mg

• Antibacterial and antifungal penetration
   using the QuSomes™ delivery system*

• Local anesthetic agent for pain relief*

• Local anti-inflammatory agent to
   reduce ear canal swelling*

*Please see Package insert

SHAKE WELL BEFORE USING

Manufactured for:
VERTICAL
PHARMACEUTICALS, INC.

Lipid Base Delivery System
QuSomes™
US Patent No. 6,610,322
US Patent No. 6,958,160
US Patent No. 7,150,883
Other patents may apply


TRIOXIN 
chloroxylenol, benzocaine and hydrocortisone acetate  solution/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68025-041 Route of Administration AURICULAR (OTIC) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chloroxylenol (Chloroxylenol) Chloroxylenol 1 mg  in 1 mL BENZOCAINE (BENZOCAINE) BENZOCAINE 15 mg  in 1 mL Hydrocortisone Acetate (Hydrocortisone) Hydrocortisone 10 mg  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68025-041-02 12 BOTTLE In 1 BOX contains a BOTTLE 1 2 mL In 1 BOTTLE This package is contained within the BOX (68025-041-02) 2 68025-041-15 1 BOTTLE In 1 BOX contains a BOTTLE 2 15 mL In 1 BOTTLE This package is contained within the BOX (68025-041-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved other 07/02/2009
Labeler - Vertical Pharmaceuticals, Inc (173169017) Establishment Name Address ID/FEI Operations Sonar Products, Inc. 104283945 MANUFACTURE Revised: 06/2009Vertical Pharmaceuticals, Inc More TriOxin Ear Drops resources TriOxin Ear Drops Side Effects (in more detail) TriOxin Ear Drops Dosage TriOxin Ear Drops Use in Pregnancy & Breastfeeding TriOxin Ear Drops Support Group 0 Reviews for TriOxin Ear - Add your own review/rating Compare TriOxin Ear Drops with other medications Otitis Externa
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hydrocortisone and acetic acid Otic


hye-droe-KOR-ti-sone, a-SEE-tik AS-id

Commonly used brand name(s)

In the U.S.

Acetasol HC Vosol HC

Available Dosage Forms:

Solution

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Acetic Acid (class)

Uses For hydrocortisone and acetic acid

Corticosteroid and acetic acid combinations are used to treat certain problems of the ear canal. They also help relieve the redness, itching, and swelling that may accompany these conditions.

These medicines may also be used for other conditions as determined by your doctor.

Corticosteroid and acetic acid combinations are available only with your doctor's prescription.

Before Using hydrocortisone and acetic acid

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 hydrocortisone and acetic acid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hydrocortisone and acetic acid 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

There is no specific information comparing the use of otic corticosteroids in children under 3 years of age with use in other age groups.

Geriatric

Although there is no specific information comparing the use of otic corticosteroids in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 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 hydrocortisone and acetic acid, 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 hydrocortisone and acetic acid 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.

Rotavirus Vaccine, Live

Using hydrocortisone and acetic acid 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.

Aldesleukin Bupropion Quetiapine

Using hydrocortisone and acetic acid 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 Atracurium Balofloxacin Cinoxacin Ciprofloxacin Clinafloxacin Colestipol Enoxacin Fleroxacin Flumequine Gallamine Gemifloxacin Grepafloxacin Hexafluorenium Itraconazole Levofloxacin Licorice Lomefloxacin Metocurine Moxifloxacin Norfloxacin Ofloxacin Pefloxacin Primidone Prulifloxacin Rifapentine Rosoxacin Rufloxacin Saiboku-To Sparfloxacin Temafloxacin Tosufloxacin Trovafloxacin Mesylate 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 hydrocortisone and acetic acid. Make sure you tell your doctor if you have any other medical problems, especially:

Any other ear infection or condition—Otic corticosteroids may worsen existing infections or cause new infections Punctured ear drum—Using otic corticosteroids when you have a punctured ear drum may damage the ear Proper Use of hydrocortisone and acetic acid

To use:

Lie down or tilt the head so that the affected ear faces up. Gently pull the ear lobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several (about 5) minutes to allow the medicine to run to the bottom of the ear canal. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out. At first, your doctor may want you to put more medicine on the cotton plug during the day to keep it moist.

To keep the medicine as germ-free as possible, avoid touching the dropper or applicator tip to any surface as much as possible (including the ear). Also, always keep the container tightly closed.

For patients using hydrocortisone and acetic acid ear drops:

Do not wash the dropper or applicator tip, because water may get into the medicine and make it weaker. If necessary, you may wipe the dropper or applicator tip with a clean tissue.

Do not use corticosteroids more often or for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Do not use any leftover medicine for future ear problems without first checking with your doctor. hydrocortisone and acetic acid should not be used if certain kinds of infections are present. To do so may make the infection worse.

Dosing

The dose of hydrocortisone and acetic acid 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 hydrocortisone and acetic acid. 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 hydrocortisone and acetic acid For ear drops dosage form: For ear infections: Adults and children over 3 years of age—Use 3 to 5 drops in the affected ear every four to six hours for the first twenty-four hours, then 5 drops three to four times daily. Children under 3 years of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of hydrocortisone and acetic acid, apply 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 stop treatment abruptly.

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 hydrocortisone and acetic acid

If your condition does not improve within 5 to 7 days, or if it becomes worse, check with your doctor.

hydrocortisone and acetic acid 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.

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 Anorexia, weakness, weight loss (in children) stinging, itching, irritation, or burning of the ear

There have not been any other side effects reported with hydrocortisone and acetic acid. However, if you notice any other effects, check with your doctor.

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More hydrocortisone and acetic acid Otic resources Hydrocortisone and acetic acid Otic Side Effects (in more detail) Hydrocortisone and acetic acid Otic Use in Pregnancy & Breastfeeding Hydrocortisone and acetic acid Otic Support Group 1 Review for Hydrocortisone and acetic acid Otic - Add your own review/rating Compare hydrocortisone and acetic acid Otic with other medications Otitis Externa
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Poly Hist NC Liquid


Pronunciation: SOO-doe-e-FED-rin/trye-PROE-li-deen/KOE-deen
Generic Name: Pseudoephedrine/Triprolidine/Codeine
Brand Name: Poly Hist NC
Poly Hist NC Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory infections, or allergies. It may also be used for other conditions as determined by your doctor.

Poly Hist NC Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Poly Hist NC Liquid if: you are allergic to any ingredient in Poly Hist NC Liquid or any other codeine- or morphine-related medicine (eg, dihydrocodeine, oxycodone) you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, or slow or shallow breathing you are unable to urinate or are having an asthma attack you take droxidopa, sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Poly Hist NC Liquid:

Some medical conditions may interact with Poly Hist NC Liquid. 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 if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, angina; fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, liver or kidney problems, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, a curvature of the spine (kyphoscoliosis), pancreas problems (eg, pancreatitis), or thyroid problems if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing) if you have a persistent cough, a chronic cough, or a cough that occurs with large amounts of mucus if you have severe drowsiness, a recent head or brain injury, a brain tumor or lesion, increased pressure in the brain, an infection of the brain or nervous system, or a seizure disorder (eg, epilepsy) if you have a blockage of your stomach, bladder, or bowel; trouble urinating; prostate problems (eg, enlarged prostate); or if you have had recent stomach, bowel, or urinary surgery if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation, ulceration of the bowel, diarrhea due to antibiotic use), or gallbladder problems (eg, gallstones) if you have a history of alcohol or drug abuse, trouble sleeping, mental or mood problems (eg, depression), suicidal thoughts or behavior, are in alcohol withdrawal, or are in poor health or are very overweight if you take medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Poly Hist NC Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased Furazolidone, linezolid, or MAOIs (eg, phenelzine) because severe high blood pressure and fever may occur Barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), cimetidine, HIV protease inhibitors (eg, ritonavir), muscle relaxants (eg, cyclobenzaprine), opioid analgesics (eg, hydrocodone), phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Poly Hist NC Liquid's side effects Buprenorphine, quinidine, or rifamycins (eg, rifampin) because they may decrease Poly Hist NC Liquid's effectiveness Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Poly Hist NC Liquid Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Poly Hist NC Liquid Naltrexone because it may decrease Poly Hist NC Liquid's effectiveness. Withdrawal symptoms may also occur in patients who are physically dependent on opioids. Do not take naltrexone until you have stopped taking Poly Hist NC Liquid for 7 to 10 days and you have had a negative naloxone challenge test

This may not be a complete list of all interactions that may occur. Ask your health care provider if Poly Hist NC Liquid 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 Poly Hist NC Liquid:

Use Poly Hist NC Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Poly Hist NC Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Take Poly Hist NC Liquid with a full glass of water (8 oz/240 mL). Drink plenty of water while taking Poly Hist NC Liquid. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Poly Hist NC Liquid and you are taking it regularly, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Poly Hist NC Liquid.

Important safety information: Poly Hist NC Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Poly Hist NC Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Poly Hist NC Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Poly Hist NC Liquid may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Do not take diet or appetite control medicines while you take Poly Hist NC Liquid without checking with your doctor. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it. If it does or if you are not sure, check with your doctor or pharmacist. Do not use Poly Hist NC Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. If your symptoms do not get better within 7 days; if they get worse, come back, or occur along with a fever, rash, or persistent headache; or if new symptoms occur, check with your doctor. Poly Hist NC Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Poly Hist NC Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Poly Hist NC Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Poly Hist NC Liquid for a few days before the tests. Tell your doctor or dentist that you take Poly Hist NC Liquid before you receive any medical or dental care, emergency care, or surgery. Use Poly Hist NC Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating. Caution is advised when using Poly Hist NC Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability. Poly Hist NC Liquid should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed. They may be at greater risk of severe and possibly fatal breathing problems. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Poly Hist NC Liquid while you are pregnant. Some ingredients in Poly Hist NC Liquid may be found in breast milk. Do not breast-feed while taking Poly Hist NC Liquid.

When used for long periods of time or at high doses, Poly Hist NC Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Poly Hist NC Liquid stops working well. Do not take more than prescribed.

Some people who use Poly Hist NC Liquid for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Poly Hist NC Liquid suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Poly Hist NC Liquid:

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:

Constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, irritability); persistent trouble sleeping; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble urinating or inability to urinate; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or blurred vision.

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.

See also: Poly Hist NC side effects (in more detail)

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; cold and clammy skin; coma; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Poly Hist NC Liquid:

Store Poly Hist NC Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Poly Hist NC Liquid out of the reach of children and away from pets.

General information: If you have any questions about Poly Hist NC Liquid, please talk with your doctor, pharmacist, or other health care provider. Poly Hist NC Liquid 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 Poly Hist NC Liquid. 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 Poly Hist NC resources Poly Hist NC Side Effects (in more detail) Poly Hist NC Use in Pregnancy & Breastfeeding Poly Hist NC Drug Interactions 0 Reviews · Be the first to review/rate this drug
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Poly Hist DHC Liquid


Pronunciation: FEN-il-EF-rin/pir-IL-a-meen/dye-HYE-droe-KOE-deen
Generic Name: Phenylephrine/Pyrilamine/Dihydrocodeine
Brand Name: Poly Hist DHC
Poly Hist DHC Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory tract infections, or allergies. It may also be used for other conditions as determined by your doctor.

Poly Hist DHC Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Poly Hist DHC Liquid if: you are allergic to any ingredient in Poly Hist DHC Liquid or to codeine you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, narrow-angle glaucoma, known or suspected bowel blockage (paralytic ileus), a stomach ulcer, or you are unable to urinate you have very slow or shallow breathing, severe asthma, or you are having an asthma attack you take droxidopa, sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Poly Hist DHC Liquid:

Some medical conditions may interact with Poly Hist DHC Liquid. 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 if you are allergic to other narcotic pain medicines (eg, morphine) if you have a history of adrenal gland problems (eg, Addison disease, an adrenal gland tumor), heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, liver or kidney problems, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, slow or shallow breathing, curvature of the spine (scoliosis), or thyroid problems if you have a history of asthma, chronic obstructive pulmonary disease (COPD), other lung or breathing problems (eg, chronic bronchitis, emphysema, slow or irregular breathing), chronic cough, or breathing problems when you sleep (eg, sleep apnea), or if your cough occurs with large amounts of mucus if you have severe drowsiness, a recent head or brain injury, growths in the brain (eg, tumor, lesions), increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy) if you have a history of constipation, stomach or bowel problems (eg, chronic inflammation, ulceration of the bowel, or diarrhea due to antibiotic use); gallbladder problems (eg, gallstones); pancreatitis; a blockage of your stomach, bladder, or bowel; trouble urinating; an enlarged prostate or other prostate problems; or if you have had recent stomach, bowel, or urinary surgery if you have a history of alcohol or drug abuse, mental or mood problems (eg, depression), suicidal thoughts or behavior, you are in alcohol withdrawal, or if you are in poor health or are very overweight

Some MEDICINES MAY INTERACT with Poly Hist DHC Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin or droxidopa because the risk of irregular heartbeat or a heart attack may be increased Furazolidone, linezolid, or MAOIs (eg, phenelzine) because severe high blood pressure and fever may occur Anticholinergics (eg, scopolamine), barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, HIV protease inhibitors (eg, ritonavir), muscle relaxants (eg, cyclobenzaprine), opioid analgesics (eg, hydrocodone), phenothiazines (eg, chlorpromazine), sleep medicines (eg, zolpidem), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Poly Hist DHC Liquid's side effects Quinidine or rifamycins (eg, rifampin) because they may decrease Poly Hist DHC Liquid's effectiveness Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Poly Hist DHC Liquid Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Poly Hist DHC Liquid Naltrexone because it may decrease Poly Hist DHC Liquid's effectiveness. Withdrawal symptoms may also occur in patients who are physically dependent on opioids. Do not take naltrexone until you have stopped taking Poly Hist DHC Liquid for 7 to 10 days and you have had a negative naloxone challenge test

This may not be a complete list of all interactions that may occur. Ask your health care provider if Poly Hist DHC Liquid 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 Poly Hist DHC Liquid:

Use Poly Hist DHC Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Poly Hist DHC Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Take Poly Hist DHC Liquid with a full glass of water (8 oz/240 mL). Drink plenty of water while taking Poly Hist DHC Liquid. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Poly Hist DHC Liquid and you are taking it regularly, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Poly Hist DHC Liquid.

Important safety information: Poly Hist DHC Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Poly Hist DHC Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Poly Hist DHC Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Poly Hist DHC Liquid may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Do not take diet or appetite control medicines while you take Poly Hist DHC Liquid without checking with your doctor. Poly Hist DHC Liquid has a decongestant, antihistamine, and cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist. Do not use Poly Hist DHC Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. If your symptoms do not get better within 5 to 7 days, if they get worse, or if they occur along with a fever, check with your doctor. Poly Hist DHC Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Poly Hist DHC Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Poly Hist DHC Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Poly Hist DHC Liquid for a few days before the tests. Tell your doctor or dentist that you take Poly Hist DHC Liquid before you receive any medical or dental care, emergency care, or surgery. Use Poly Hist DHC Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, slow or shallow breathing, and trouble urinating. Caution is advised when using Poly Hist DHC Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability. Poly Hist DHC Liquid should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed. They may be at greater risk of severe and possibly fatal breathing problems. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Poly Hist DHC Liquid while you are pregnant. Some ingredients of Poly Hist DHC Liquid may be found in breast milk. Do not breast-feed while taking Poly Hist DHC Liquid.

When used for long periods of time or at high doses, Poly Hist DHC Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Poly Hist DHC Liquid stops working well. Do not take more than prescribed.

Some people who use Poly Hist DHC Liquid for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Poly Hist DHC Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Poly Hist DHC Liquid:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; lightheadedness; loss of appetite; nausea; nervousness or anxiety; sweating; trouble sleeping; upset stomach or mild stomach pain; vomiting; weakness.

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); confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); persistent trouble sleeping; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe or persistent stomach pain; slow or shallow breathing; tremor; trouble urinating or inability to urinate; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or blurred vision.

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.

See also: Poly Hist DHC side effects (in more detail)

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; cold and clammy skin; coma; confusion; hallucinations; limp muscles; seizures; severe dizziness, drowsiness, lightheadedness, or headache; slow or shallow breathing; small pupils; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Poly Hist DHC Liquid:

Store Poly Hist DHC Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Poly Hist DHC Liquid out of the reach of children and away from pets.

General information: If you have any questions about Poly Hist DHC Liquid, please talk with your doctor, pharmacist, or other health care provider. Poly Hist DHC Liquid 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 Poly Hist DHC Liquid. 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 Poly Hist DHC resources Poly Hist DHC Side Effects (in more detail) Poly Hist DHC Use in Pregnancy & Breastfeeding Poly Hist DHC Drug Interactions 0 Reviews · Be the first to review/rate this drug
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Surolan



Dosage Form: FOR ANIMAL USE ONLY
Surolan®

otic suspension
(miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

Rx

Antifungal, antibacterial and anti-inflammatory
For otic use in dogs only

CAUTION

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Surolan Description

Surolan contains 23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B sulfate and 5 mg/mL prednisolone acetate. Inactive ingredients are colloidal silicon dioxide and liquid paraffin.

INDICATIONS

Surolan is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Surolan Dosage and Administration

Shake well before use.

The external ear should be thoroughly cleaned and dried before the initiation of treatment. Verify that the eardrum is intact. Instill 5 drops of Surolan in the ear canal twice daily and massage the ear. Therapy should continue for 7 consecutive days.

Contraindications

Surolan is contraindicated in dogs with suspected or known hypersensitivity to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate.

Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity.

Warnings

Not for use in humans. Keep this and all drugs out of reach of children.

ANIMAL WARNINGS

Do not administer orally.

For otic use only.

Precautions

Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membranes are not ruptured.

If overgrowth of non-susceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

Long-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hypoadrenalcorticism in dogs.

The safe use of Surolan in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.

Adverse Reactions

In the field study, 161 dogs treated with Surolan were included in the safety database. Two dogs experienced reduced hearing at the end of treatment; on follow-up one dog had normal hearing capacity while the other case was lost for follow-up. The owner of another dog reported that on day 4 of treatment, build-up of the medication decreased the dog's hearing. At the end of treatment, this dog had normal hearing as assessed by the investigator. Residue build-up was reported in 1 dog and pain upon drug application in another dog.

A total of 161 dogs treated with the active control was included in the safety database and adverse reactions were reported in 8 dogs treated with the active control. One dog experienced reduced hearing at the end of treatment. Residue build-up was noted in 1 dog. Four dogs vomited during treatment, 1 dog showed red pustules on the pinna and head shaking was observed in another dog.

Foreign market experience: the following adverse events were reported voluntarily during post-approval use of the product in foreign markets: deafness, reduced hearing, topical hypersensitivity reactions and red blisters on pinna.

For a copy of the Material Safety Data Sheet (MSDS), for technical assistance or to report adverse reactions call V?toquinol USA Inc. at 1-800-835-9496.

PHARMACOLOGY

By virtue of its 3 active ingredients, Surolan has antibacterial, antifungal, and anti-inflammatory activity. Polymyxin B sulfate is a broad-spectrum polypeptide antibiotic with activity against both Gram-positive and Gram-negative species. Miconazole nitrate is a synthetic imidazole derivative with antifungal activity and antibacterial activity against Gram-positive bacteria. Moreover, synergistic effects between miconazole nitrate and polymyxin B sulfate have been demonstrated in an in vitro study(1). Prednisolone acetate is a glucocorticoid with anti-inflammatory activity. A study performed using an experimentally-induced model of ear inflammation in mice demonstrated the effectiveness of prednisolone acetate in treating ear inflammation either alone or in combination with the other active ingredients of Surolan(2).

MICROBIOLOGY

The compatibility and additive effect of each of the components in Surolan was demonstrated in a component effectiveness and non-interference study. An in vitro study of organisms collected from clinical cases of otitis externa at a veterinary teaching hospital and from dogs enrolled in the clinical effectiveness study for Surolan determined that polymyxin B sulfate and miconazole nitrate inhibit the growth of bacteria and yeast commonly associated with canine otitis externa. Furthermore, a synergistic effect of the two antimicrobials was demonstrated. The addition of prednisolone acetate to the combination did not impair antimicrobial activity to any clinically-significant extent.

ANIMAL SAFETY

The following adverse reactions were reported in a study when Surolan was administered at 1X, 3X and 5X for 42 consecutive days (6 times the recommended treatment duration) in laboratory Beagles: hypersensitivity reactions which included mild erythema and hyperemia, painful and sensitive ear canals on examination, changes in hematology, clinical chemistry and urinalysis values consistent with the systemic absorption of topical corticosteroids, and veterinary observations of pale ear canals.

EFFECTIVENESS

Of 337 dogs enrolled in the field study, 176 dogs were included in the effectiveness database; 91 were treated with Surolan and 85 were treated with an FDA-approved active control. Clinical evaluations of otitis externa included pain/discomfort, swelling, redness, and exudate. A non-inferiority evaluation was used to compare Surolan with the active control with respect to each clinical sign of otitis externa and overall clinical improvement. Surolan was determined to be non-inferior to treatment with the active control for otitis externa. Malassezia pachydermatis and Staphylococcus pseudintermedius were identified pre-treatment in at least 10 cases that were clinically responsive to Surolan.

Table 1. Mean Percentage of Improvement in Clinical Signs of Otitis Externa Clinical sign Surolan
N=91 Active control
N=85 Pain/discomfort 94.4% 91.7% Swelling 89.1% 90.5% Redness 91.2% 86.1% Exudate 83.1% 82.1% Overall 96.7% 95.2% How is Surolan Supplied

Surolan is available in 15 mL and 30 mL plastic dispensing bottles with applicator tip for otic use.

STORAGE AND HANDLING

Store at or below 25 °C (77 °F).

NADA 141-298, Approved by FDA.

Manufactured for V?toquinol USA Inc. by:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Copyright © 2009, Janssen Animal Health

Date of most recent labeling revision: 09/2009

US - 973772

REFERENCES Pietschmann S. et al. (2009)
Synergistic effects of miconazole and polymyxin B on microbial pathogens.
Veterinary Research Communications 33(6), 489-505 Bolinder A. et al. (2006)
In vivo efficacy study of the anti-inflammatory properties of Surolan
The Canadian Journal of Veterinary Research 70, 234-236 PRINCIPAL DISPLAY PANEL - 15 mL Box

NDC 17030-947-15

Surolan®

otic suspension
(miconazole nitrate,
polymyxin B sulfate,
prednisolone acetate)

15mL

For otic use in dogs only.

CAUTION:
Federal (USA) law
restricts this drug to use
by or on the order of a
licensed veterinarian.

NADA 141-298
Approved by FDA

V?toquinol


Surolan 
miconazole nitrate, polymyxin b sulfate, and prednisolone acetate  suspension/ drops Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 17030-947 Route of Administration AURICULAR (OTIC) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength miconazole nitrate (miconazole) miconazole nitrate 23 mg  in 1 mL polymyxin B sulfate (polymyxin B) polymyxin B sulfate 0.5293 mg  in 1 mL prednisolone acetate (prednisolone) prednisolone acetate 5 mg  in 1 mL Inactive Ingredients Ingredient Name Strength paraffin   Product Characteristics Color WHITE (opaque) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 17030-947-15 1 BOTTLE In 1 BOX contains a BOTTLE, WITH APPLICATOR 1 15 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the BOX (17030-947-15) 2 17030-947-30 1 BOTTLE In 1 BOX contains a BOTTLE, WITH APPLICATOR 2 30 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the BOX (17030-947-30)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141298 12/30/2009
Labeler - Vetoquinol USA Inc (106824209) Establishment Name Address ID/FEI Operations Jansen Pharmaceutica NV 370005019 MANUFACTURE Revised: 12/2009Vetoquinol USA Inc
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Vosol HC


Generic Name: hydrocortisone and acetic acid (Otic route)

hye-droe-KOR-ti-sone, a-SEE-tik AS-id

Commonly used brand name(s)

In the U.S.

Acetasol HC Vosol HC

Available Dosage Forms:

Solution

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Acetic Acid (class)

Uses For Vosol HC

Corticosteroid and acetic acid combinations are used to treat certain problems of the ear canal. They also help relieve the redness, itching, and swelling that may accompany these conditions.

These medicines may also be used for other conditions as determined by your doctor.

Corticosteroid and acetic acid combinations are available only with your doctor's prescription.

Before Using Vosol HC

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

There is no specific information comparing the use of otic corticosteroids in children under 3 years of age with use in other age groups.

Geriatric

Although there is no specific information comparing the use of otic corticosteroids in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rotavirus Vaccine, Live

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.

Aldesleukin Bupropion Quetiapine

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.

Alatrofloxacin Alcuronium Atracurium Balofloxacin Cinoxacin Ciprofloxacin Clinafloxacin Colestipol Enoxacin Fleroxacin Flumequine Gallamine Gemifloxacin Grepafloxacin Hexafluorenium Itraconazole Levofloxacin Licorice Lomefloxacin Metocurine Moxifloxacin Norfloxacin Ofloxacin Pefloxacin Primidone Prulifloxacin Rifapentine Rosoxacin Rufloxacin Saiboku-To Sparfloxacin Temafloxacin Tosufloxacin Trovafloxacin Mesylate 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Any other ear infection or condition—Otic corticosteroids may worsen existing infections or cause new infections Punctured ear drum—Using otic corticosteroids when you have a punctured ear drum may damage the ear Proper Use of hydrocortisone and acetic acid

This section provides information on the proper use of a number of products that contain hydrocortisone and acetic acid. It may not be specific to Vosol HC. Please read with care.

To use:

Lie down or tilt the head so that the affected ear faces up. Gently pull the ear lobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several (about 5) minutes to allow the medicine to run to the bottom of the ear canal. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out. At first, your doctor may want you to put more medicine on the cotton plug during the day to keep it moist.

To keep the medicine as germ-free as possible, avoid touching the dropper or applicator tip to any surface as much as possible (including the ear). Also, always keep the container tightly closed.

For patients using hydrocortisone and acetic acid ear drops:

Do not wash the dropper or applicator tip, because water may get into the medicine and make it weaker. If necessary, you may wipe the dropper or applicator tip with a clean tissue.

Do not use corticosteroids more often or for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Do not use any leftover medicine for future ear problems without first checking with your doctor. This medicine should not be used if certain kinds of infections are present. To do so may make the infection worse.

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 hydrocortisone and acetic acid For ear drops dosage form: For ear infections: Adults and children over 3 years of age—Use 3 to 5 drops in the affected ear every four to six hours for the first twenty-four hours, then 5 drops three to four times daily. Children under 3 years of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, apply 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 stop treatment abruptly.

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 Vosol HC

If your condition does not improve within 5 to 7 days, or if it becomes worse, check with your doctor.

Vosol HC 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.

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 Anorexia, weakness, weight loss (in children) stinging, itching, irritation, or burning of the ear

There have not been any other side effects reported with this medicine. However, if you notice any other effects, check with your doctor.

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 Vosol HC resources Vosol HC Use in Pregnancy & Breastfeeding Vosol HC Support Group 1 Review for Vosol HC - Add your own review/rating Acetasol HC Prescribing Information (FDA) Acetasol HC otic Concise Consumer Information (Cerner Multum) Acetasol HC Solution MedFacts Consumer Leaflet (Wolters Kluwer) Compare Vosol HC with other medications Otitis Externa
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