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Sulfacetamide Topical



Dosage Form: suspension
SULFACETAMIDE SODIUM
TOPICAL SUSPENSION USP, 10%

Rx only

Sulfacetamide Topical Description

Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically sulfacetamide sodium is N' -[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Sulfacetamide Topical - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

Indications and Usage for Sulfacetamide Topical

Sulfacetamide Sodium Topical Suspension USP, 10% is indicated in the topical treatment of acne vulgaris.

Contraindications

Sulfacetamide Sodium Topical Suspension USP, 10% is contraindicated for use by patients having a known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Warnings

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

Sulfacetamide Sodium Topical Suspension USP, 10% contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people (see CONTRAINDICATIONS section).

Precautions

General: For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Keep out of reach of children.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy- Category C: Animal reproduction studies have not been conducted with Sulfacetamide Sodium Topical Suspension USP, 10%. It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% should be given to a pregnant woman only if clearly needed.

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers: It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10%. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing mothers.

Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Adverse Reactions

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Sulfacetamide Sodium Topical Suspension USP, 10% was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sulfacetamide Sodium Topical Suspension USP, 10% had local adverse reactions of erythema, itching and edema. It has been reported that sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of the medication has to be discontinued.

Sulfacetamide Topical Dosage and Administration

Apply a thin film to affected areas twice daily.

How is Sulfacetamide Topical Supplied

Sulfacetamide Sodium Topical Suspension USP, 10%, is supplied in

    118 mL bottles    NDC 0168-0382-04

Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].

Shake well before using. Keep tightly closed.

E. FOUGERA & CO.
A division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

I2382A
R11/07
#280

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 118 mL (4 fl oz) CONTAINER LABEL

NDC 0168-0382-04

FOUGERA ®

SULFACETAMIDE

SODIUM TOPICAL

SUSPENSION USP, 10%

USUAL DOSAGE: Shake well before using. Apply a thin film to the affected areas twice daily. See package insert for full prescribing information.

WARNING: Keep away from eyes. For external use only. Keep out of reach of children.

Store at Controlled Room Temperature 20°-25°C (68°-77°F) [see USP]. Keep tightly closed.

Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 118 mL (4 fl oz) CARTON

NDC 0168-0382-04

FOUGERA ®

SULFACETAMIDE

SODIUM TOPICAL

SUSPENSION

USP, 10%

Rx only

118 mL (4 fl oz)

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747


SULFACETAMIDE SODIUM 
sulfacetamide sodium  suspension Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0168-0382 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 mL Inactive Ingredients Ingredient Name Strength water   sodium chloride   sodium metabisulfite   edetate disodium   xanthan gum   propylene glycol   methylparaben   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0168-0382-04 118 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077015 08/28/2008
Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424) Registrant - Nycomed US Inc. (043838424) Establishment Name Address ID/FEI Operations Nycomed US Inc. 174491316 MANUFACTURE Establishment Name Address ID/FEI Operations Nycomed US Inc. 043838424 ANALYSIS Revised: 09/2009E. FOUGERA & CO., A division of Nycomed US Inc. More Sulfacetamide Topical resources Sulfacetamide Topical Use in Pregnancy & Breastfeeding Sulfacetamide Topical Support Group 0 Reviews for Sulfacetamide Topical - Add your own review/rating Compare Sulfacetamide Topical with other medications Seborrheic Dermatitis Secondary Cutaneous Bacterial Infections
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Sulfacetamide/Sulfur Emulsion


Pronunciation: sul-fa-SEE-ta-mide/SULL-fer
Generic Name: Sulfacetamide/Sulfur
Brand Name: Examples include Plexion TS and Sumaxin TS
Sulfacetamide/Sulfur Emulsion is used for:

Treating acne, rosacea, and seborrhea. It may also be used for other conditions as determined by your doctor.

Sulfacetamide/Sulfur Emulsion is a sulfonamide antibiotic and keratolytic. It works by killing bacteria and shedding the top layer of skin to help treat acne.

Do NOT use Sulfacetamide/Sulfur Emulsion if: you are allergic to any ingredient in Sulfacetamide/Sulfur Emulsion you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide you have kidney disease

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

Before using Sulfacetamide/Sulfur Emulsion:

Some medical conditions may interact with Sulfacetamide/Sulfur Emulsion. 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 eczema or a history of lupus

Some MEDICINES MAY INTERACT with Sulfacetamide/Sulfur Emulsion. Tell your health care provider if you are taking any other medicines, especially any of the following:

Silver-containing products (eg, silver sulfadiazine) because they may decrease Sulfacetamide/Sulfur Emulsion's effectiveness Methenamine because it may increase the risk of Sulfacetamide/Sulfur Emulsion's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sulfacetamide/Sulfur Emulsion 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 Sulfacetamide/Sulfur Emulsion:

Use Sulfacetamide/Sulfur Emulsion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Sulfacetamide/Sulfur Emulsion is for use on the skin only. Sulfacetamide/Sulfur Emulsion may stain clothing and the skin if too much is used. Wash hands before and after using Sulfacetamide/Sulfur Emulsion. Gently wash and dry the affected area. Apply a small amount of Sulfacetamide/Sulfur Emulsion to the affected area. Rub in gently. To clear up your infection completely, continue using Sulfacetamide/Sulfur Emulsion for the full course of treatment even if you feel better in a few days. Sulfacetamide/Sulfur Emulsion works best if it is used at the same time each day. Continue to use Sulfacetamide/Sulfur Emulsion even if you feel well. Do not miss any doses. If you miss a dose of Sulfacetamide/Sulfur Emulsion, 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 Sulfacetamide/Sulfur Emulsion.

Important safety information: Avoid getting Sulfacetamide/Sulfur Emulsion in your eyes, nose, or mouth. If you get Sulfacetamide/Sulfur Emulsion in your eyes, rinse immediately with cool tap water. Talk with your doctor before you use any other medicines or cleansers on your skin. Do not apply Sulfacetamide/Sulfur Emulsion to open wounds or to damaged or burned skin without first checking with your doctor. If you use topical products too often, your condition may become worse. Sulfacetamide/Sulfur Emulsion only works against bacteria; it does not treat viral infections. Be sure to use Sulfacetamide/Sulfur Emulsion 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 Sulfacetamide/Sulfur Emulsion 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. Sulfacetamide/Sulfur Emulsion should be used with extreme caution in CHILDREN younger than 12 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 Sulfacetamide/Sulfur Emulsion while you are pregnant. It is not known if Sulfacetamide/Sulfur Emulsion is found in breast milk after topical use. If you are or will be breast-feeding while you use Sulfacetamide/Sulfur Emulsion, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Sulfacetamide/Sulfur Emulsion:

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 irritation, stinging, or burning of the skin.

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); cracked or extremely dry skin; fever; joint pain; red, swollen, scaling, or blistered skin; severe diarrhea; sores in the mouth; yellowing of the skin or eyes.

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: Sulfacetamide/Sulfur 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. Sulfacetamide/Sulfur Emulsion may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Sulfacetamide/Sulfur Emulsion:

Store Sulfacetamide/Sulfur Emulsion 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. Do not freeze. Keep Sulfacetamide/Sulfur Emulsion out of the reach of children and away from pets.

General information: If you have any questions about Sulfacetamide/Sulfur Emulsion, please talk with your doctor, pharmacist, or other health care provider. Sulfacetamide/Sulfur Emulsion 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 Sulfacetamide/Sulfur Emulsion. 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 Sulfacetamide/Sulfur resources Sulfacetamide/Sulfur Side Effects (in more detail) Sulfacetamide/Sulfur Use in Pregnancy & Breastfeeding Sulfacetamide/Sulfur Drug Interactions Sulfacetamide/Sulfur Support Group 18 Reviews for Sulfacetamide/Sulfur - Add your own review/rating Compare Sulfacetamide/Sulfur with other medications Acne Rosacea Seborrheic Dermatitis
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Sulfacetamide and Prednisolone



Dosage Form: ophthalmic solution
Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution DESCRIPTION

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is a sterile topical ophthalmic solution combining an antibacterial and a corticosteroid.

Each mL Contains: Actives: sulfacetamide sodium (as the monohydrate) 100 mg, prednisolone sodium phosphate 2.5 mg (equivalent to prednisolone phosphate 2.3 mg). Preservative: thimerosal 0.1 mg. Inactives: edetate disodium, poloxamer 407, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection. pH range is 6.5 to 7.5.

The chemical name for sulfacetamide sodium, is N-sulfanilylacetamide monosodium salt monohydrate.

The chemical name for prednisolone sodium phosphate is 11?,17,21-trihydroxypregna-1,4-diene-3,20-dione,21-(disodium phosphate).

They have the following chemical structures:

Sulfacetamide Sodium (as the monohydrate)

MW = 254.24

Prednisolone Sodium Phosphate

MW = 484.39

CLINICAL PHARMACOLOGY

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antibacterial drug may be used when this inhibition is considered to be clinically significant in a particular case.

When a decision to administer both a corticosteroid and an antibacterial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

Microbiology: Sulfacetamide exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-amino-benzoic acid.

Some strains of these bacteria may be resistant to sulfacetamide or resistant strains may emerge in vivo.

The anti-infective component in these products is included to provide action against specific organisms susceptible to it. Sulfacetamide sodium is active in vitro against susceptible strains of the following microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus pneumonia, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens (See INDICATIONS AND USAGE).

INDICATIONS AND USAGE

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.

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

The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens.

A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

CONTRAINDICATIONS

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. This product is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids. See WARNINGS. (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)

WARNINGS

NOT FOR INJECTION INTO THE EYE. Prolonged use of corticosteroids may result in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.

Prolonged use of sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

If the product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.

The use of steroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in treatment of herpes simplex requires great caution.

Topical steroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered, irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated (See ADVERSE REACTIONS).

PRECAUTIONS General

The initial prescription and renewal of the medication order beyond 20 mL of solution should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining: If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Use with caution in patients with severe dry eye. Fungal cultures should be taken when appropriate.

The p-aminobenzoic acid present in purulent exudates competes with sulfonamides and can reduce their effectiveness.

Information for Patients

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician (See WARNINGS).

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the dropper tip to eyelids or to any other surface. The use of this dropper bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Protect from light. Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity. Keep out of reach of children.

Laboratory Tests

Eyelid cultures and tests to determine the susceptibility of organisms to sulfacetamide may be indicated if signs and symptoms persist or recur in spite of the recommended course of treatment with sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution.

Drug Interactions

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Prednisolone has been reported to be noncarcinogenic. Long-term animal studies for carcinogenic potential have not been performed with sulfacetamide.

One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisia following application of sulfacetamide sodium. The significance of this finding to topical ophthalmic use of sulfacetamide sodium in the human is unknown.

Mutagenic studies with prednisolone have been negative. Studies on reproduction and fertility have not been performed with sulfacetamide. A long-term chronic toxicity study in dogs showed that high oral doses of prednisolone prevented estrus. A decrease in fertility was seen in male and female rats that were mated following oral dosing with another glucocorticosteroid.

Pregnancy Teratogenic Effects

Pregnancy Category C: Animal reproduction studies have not been conducted with sulfacetamide sodium. Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women dosed with corticosteroids.

Kernicterus may be precipitated in infants by sulfonamides being given systemically during the third trimester of pregnancy. It is not known whether sulfacetamide sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution, a decision should be made whether to discontinue nursing or to discontinue the medication.

Pediatric Use

Safety and effectiveness in children below the age of six have not been established.

ADVERSE REACTIONS

Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the antibacterial ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (See WARNINGS).

Sulfacetamide sodium may cause local irritation.

The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.

Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriasis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

Secondary Infection: The development of secondary infection has occurred after use of combinations containing corticosteroids and antibacterials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

DOSAGE AND ADMINISTRATION

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution: Instill two drops topically in the eye(s) every four hours.

Not more than 20 mL should be prescribed initially.

The dosing of sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (See PRECAUTIONS).

HOW SUPPLIED

Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution, 10%/0.25%, is available in 5 mL and 10 mL plastic DROP-TAINER* dispensers, individually packaged.

Dispense only in original, unopened container.

5mL NDC: 61314-297-05

10mL NDC: 61314-297-10

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

PROTECT FROM LIGHT: Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity.

KEEP OUT OF REACH OF CHILDREN.

Rx Only

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

Dist. By:

FALCON Pharmaceuticals, Ltd.

Fort Worth, Texas 76134 USA

Mfd. By:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

9002765-0707

Revised: July 2007

PRINCIPAL DISPLAY PANEL

NDC 61314-297-05          Rx Only

FALCON PHARMACEUTICALS®

Sulfacetamide Sodium

and Prednisolone

Sodium Phosphate

Ophthalmic Solution

10% / 0.25%

5 mL STERILE

AFFILIATE OF

ALCON LABORATORIES, INC.

QUALITY RX


SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE 
sulfacetamide sodium and prednisolone sodium phosphate  solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61314-297 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 mL PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE) PREDNISOLONE SODIUM PHOSPHATE 2.5 mg  in 1 mL Inactive Ingredients Ingredient Name Strength THIMEROSAL   EDETATE DISODIUM   POLOXAMER 407   BORIC ACID   SODIUM HYDROXIDE   HYDROCHLORIC ACID   WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 61314-297-05 5 mL In 1 BOTTLE None 2 61314-297-10 10 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073630 03/09/2004
Labeler - Falcon Pharmaceuticals, Ltd. (874345820) Registrant - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Operations Alcon Laboratories, Inc. 008018525 MANUFACTURE Revised: 08/2011Falcon Pharmaceuticals, Ltd. More Sulfacetamide and Prednisolone resources Sulfacetamide and Prednisolone Side Effects (in more detail) Sulfacetamide and Prednisolone Dosage Sulfacetamide and Prednisolone Use in Pregnancy & Breastfeeding Sulfacetamide and Prednisolone Drug Interactions Sulfacetamide and Prednisolone Support Group 1 Review for Sulfacetamide and Prednisolone - Add your own review/rating Compare Sulfacetamide and Prednisolone with other medications Blepharitis Conjunctivitis, Bacterial Keratitis Keratoconjunctivitis Uveitis
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sodium sulfacetamide and urea topical


Generic Name: sodium sulfacetamide and urea topical (SOW dee um sull fa SEH tah mide and yer EE ah)
Brand names: Carmol Scalp, Carmol Scalp Treatment Kit, Rosula NS

What is sodium sulfacetamide and urea topical?

Sodium sulfacetamide is an antibacterial agent. Sodium sulfacetamide interferes with the growth of bacteria on the skin.

Urea is an emollient (softening agent). It is used to moisturize the skin.

Sodium sulfacetamide and urea topical is used in the treatment of dandruff and seborrheic dermatitis (red, flaking skin rash).

Sodium sulfacetamide and urea topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about sodium sulfacetamide and urea topical? Stop using sodium sulfacetamide and urea topical and contact your healthcare provider if you develop new or worsening signs of skin irritation or a rash anywhere on the skin. Do not use other topical products on the scalp area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide and urea topical. Do not cover the area after applying sodium sulfacetamide and urea topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful. What should I discuss with my healthcare provider before using sodium sulfacetamide and urea topical? Do not use sodium sulfacetamide and urea topical without first talking to your doctor if you have an allergy to sulfa products. You may not be able to use sodium sulfacetamide and urea topical, or you may require special monitoring during treatment.

Do not apply sodium sulfacetamide and urea topical to large areas of open, broken, burned, or infected skin without first talking to your doctor. Large areas of damaged skin may allow more medicine to be absorbed by the body, possibly resulting in side effects.

Sodium sulfacetamide and urea topical is in the FDA pregnancy category C. This means that it is not known whether sodium sulfacetamide and urea topical will be harmful to an unborn baby. Do not use sodium sulfacetamide and urea topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether sodium sulfacetamide passes into breast milk. Do not use sodium sulfacetamide and urea topical without first talking to your doctor if you are breast-feeding a baby. How should I use sodium sulfacetamide and urea topical?

Use sodium sulfacetamide and urea topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash the hair before applying the medication, unless otherwise directed by your doctor. Part the hair one section at a time and apply a small quantity of lotion. Gently rub the lotion in with the fingertips to completely moisten the scalp. Brush the hair thoroughly for 2 to 3 minutes. For best results, the medication should be applied at bedtime and allowed to remain on the hair overnight unless otherwise directed by your doctor. The hair should be washed at least once a week. Rinsing with plain water or thorough brushing will remove any excess medication between washes.

Do not cover the affected area after applying sodium sulfacetamide and urea topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

It is important to use sodium sulfacetamide regularly to get the most benefit. It may take several weeks or more to see the effects of this drug.

Store sodium sulfacetamide and urea topical at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and apply only the next regularly scheduled dose.

What happens if I overdose?

An overdose of sodium sulfacetamide and urea topical is unlikely to threaten life. If an overdose is suspected or if the medication has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using sodium sulfacetamide and urea topical? Do not use other topical products on the scalp area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide and urea topical. Do not cover the area after applying sodium sulfacetamide and urea topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful. Sodium sulfacetamide and urea topical side effects Stop using sodium sulfacetamide and urea topical and contact your healthcare provider if you develop new or worsening signs of skin irritation or a rash anywhere on the skin. Serious side effects are not likely to occur with the use of sodium sulfacetamide and urea topical. If you experience a rare, but serious allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives), stop using sodium sulfacetamide and urea topical and seek emergency medical attention or contact your doctor immediately.

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.

Sodium sulfacetamide and urea topical Dosing Information

Usual Adult Dose for Secondary Cutaneous Bacterial Infections:

Sodium sulfacetamide-urea 10%-10% topical lotion:
Apply to affected areas 2 to 4 times daily until cleared.
Sodium sulfacetamide-urea 10%-10% topical pads:
Apply to affected areas 1 to 2 times daily until cleared.

Usual Adult Dose for Dandruff:

Sodium sulfacetamide-urea 10%-10% topical lotion:
Apply to scalp at bedtime and leave on overnight. In severe cases, use twice daily.
Sodium sulfacetamide-urea 10%-10% topical pads:
Apply to affected areas 1 to 2 times daily.

Usual Adult Dose for Seborrheic Dermatitis:

Sodium sulfacetamide-urea 10%-10% topical lotion:
Apply to scalp at bedtime and leave on overnight. In severe cases, use twice daily.
Sodium sulfacetamide-urea 10%-10% topical pads:
Apply to affected areas 1 to 2 times daily.

Usual Pediatric Dose for Secondary Cutaneous Bacterial Infections:

Sodium sulfacetamide-urea 10%-10% topical lotion:
>=12 years:
Apply to affected areas 2 to 4 times daily until cleared.
Sodium sulfacetamide-urea 10%-10% topical pads:
>=12 years:
Apply to affected areas 1 to 2 times daily until cleared.

Usual Pediatric Dose for Dandruff:

Sodium sulfacetamide-urea 10%-10% topical lotion:
>=12 years:
Apply to scalp at bedtime and leave on overnight. In severe cases, use twice daily.
Sodium sulfacetamide-urea 10%-10% topical pads:
>=12 years:
Apply to affected areas 1 to 2 times daily.

Usual Pediatric Dose for Seborrheic Dermatitis:

Sodium sulfacetamide-urea 10%-10% topical lotion:
>=12 years:
Apply to scalp at bedtime and leave on overnight. In severe cases, use twice daily.
Sodium sulfacetamide-urea 10%-10% topical pads:
>=12 years:
Apply to affected areas 1 to 2 times daily.

What other drugs will affect sodium sulfacetamide and urea topical? Do not use other topical products on the scalp area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide and urea topical.

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

More sodium sulfacetamide and urea topical resources Sodium sulfacetamide and urea topical Use in Pregnancy & Breastfeeding Sodium sulfacetamide and urea topical Support Group 0 Reviews for Sodium sulfacetamide and urea - Add your own review/rating Compare sodium sulfacetamide and urea topical with other medications Dandruff Seborrheic Dermatitis Secondary Cutaneous Bacterial Infections Where can I get more information? Your pharmacist has additional information about sodium sulfacetamide and urea topical written for health professionals that you may read.
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Sulfacetamide/Urea Medicated Pads


Pronunciation: sul-fa-SEE-ta-mide/yoor-EE-a
Generic Name: Sulfacetamide/Urea
Brand Name: Rosula NS
Sulfacetamide/Urea Medicated Pads are used for:

Treating certain skin conditions (eg, seborrheic dermatitis) and certain bacterial infections of the skin. It may also be used for other conditions as determined by your doctor.

Sulfacetamide/Urea Medicated Pads are a sulfonamide antibiotic. It works by killing bacteria.

Do NOT use Sulfacetamide/Urea Medicated Pads if: you are allergic to any ingredient in Sulfacetamide/Urea Medicated Pads you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide you are taking methenamine

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

Before using Sulfacetamide/Urea Medicated Pads:

Some medical conditions may interact with Sulfacetamide/Urea Medicated Pads. 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 lupus

Some MEDICINES MAY INTERACT with Sulfacetamide/Urea Medicated Pads. Tell your health care provider if you are taking any other medicines, especially any of the following:

Silver-containing products (eg, silver sulfadiazine) because they may decrease Sulfacetamide/Urea Medicated Pads's effectiveness Methenamine because it may increase the risk of Sulfacetamide/Urea Medicated Pads's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sulfacetamide/Urea Medicated Pads 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 Sulfacetamide/Urea Medicated Pads:

Use Sulfacetamide/Urea Medicated Pads as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Sulfacetamide/Urea Medicated Pads are for use on the skin only. Wash and completely dry the affected area. Gently apply the medicated pad to the affected area as directed by your doctor. Wash your hands immediately after using Sulfacetamide/Urea Medicated Pads unless your hands are part of the treated area. To clear up your infection completely, use Sulfacetamide/Urea Medicated Pads for the full course of treatment. Keep using it even if you feel better in a few days. Sulfacetamide/Urea Medicated Pads works best if it is used at the same time each day. Continue to use Sulfacetamide/Urea Medicated Pads even if you feel well. Do not miss any doses. If you miss a dose of Sulfacetamide/Urea Medicated Pads, 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 Sulfacetamide/Urea Medicated Pads.

Important safety information: It may take several days for Sulfacetamide/Urea Medicated Pads to work fully. Avoid getting Sulfacetamide/Urea Medicated Pads in your eyes, nose, or mouth. Talk with your doctor before you use any other medicines or cleansers on your skin. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor. Sulfacetamide/Urea Medicated Pads only works against bacteria; it does not treat viral infections. Be sure to use Sulfacetamide/Urea Medicated Pads 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 Sulfacetamide/Urea Medicated Pads 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. Sulfacetamide/Urea Medicated Pads should be used with extreme caution in CHILDREN younger than 12 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 Sulfacetamide/Urea Medicated Pads while you are pregnant. It is not known if Sulfacetamide/Urea Medicated Pads are found in breast milk after topical use. If you are or will be breast-feeding while you use Sulfacetamide/Urea Medicated Pads, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Sulfacetamide/Urea Medicated Pads:

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:

Irritation, stinging, or burning of the skin.

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); bloody diarrhea; fever; joint pain; red, swollen, or blistered skin; severe diarrhea; sores in the mouth; stomach cramps/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.

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. Sulfacetamide/Urea Medicated Pads may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Sulfacetamide/Urea Medicated Pads:

Store Sulfacetamide/Urea Medicated Pads 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. Do not freeze. Keep Sulfacetamide/Urea Medicated Pads out of the reach of children and away from pets.

General information: If you have any questions about Sulfacetamide/Urea Medicated Pads, please talk with your doctor, pharmacist, or other health care provider. Sulfacetamide/Urea Medicated Pads 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 Sulfacetamide/Urea Medicated Pads. 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 Sulfacetamide/Urea resources Sulfacetamide/Urea Use in Pregnancy & Breastfeeding Sulfacetamide/Urea Support Group 0 Reviews for Sulfacetamide/Urea - Add your own review/rating Compare Sulfacetamide/Urea with other medications Dandruff Seborrheic Dermatitis Secondary Cutaneous Bacterial Infections
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Prednisolone/Sulfacetamide Drops


Pronunciation: pred-NISS-oh-lone/sul-fa-SEE-ta-mide
Generic Name: Prednisolone/Sulfacetamide
Brand Name: Generic only. No brands available.
Prednisolone/Sulfacetamide Drops are used for:

Treating inflammation (swelling, warmth, redness, pain) of the eyes and eyelids when infection or risk of infection is present.

Prednisolone/Sulfacetamide Drops are an antibacterial and corticosteroid combination. It works by reducing the itching, redness, and swelling of the eye. It also works to stop the growth of certain bacteria that cause eye infections.

Do NOT use Prednisolone/Sulfacetamide Drops if: you are allergic to any ingredient in Prednisolone/Sulfacetamide Drops, to other corticosteroids (eg, dexamethasone), or to other sulfonamides (eg, acetazolamide, celecoxib, hydrochlorothiazide, glyburide, probenecid, sulfamethoxazole, valdecoxib, zonisamide) you have a viral eye infection (eg, herpes simplex, vaccinia, chickenpox), tuberculosis eye infection, or fungal infection of the eye or eye structures you have thinning of the cornea of the eye

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

Before using Prednisolone/Sulfacetamide Drops:

Some medical conditions may interact with Prednisolone/Sulfacetamide 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 thinning of the eye tissues (eg, cornea, sclera), other eye problems (eg, glaucoma, cataracts, nerve damage), severe dry eyes, or diabetes if you have recently had cataract surgery

Some MEDICINES MAY INTERACT with Prednisolone/Sulfacetamide Drops. Tell your health care provider if you are taking any other medicine, especially any of the following:

Silver-containing medicines (eg, silver nitrate) because the risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prednisolone/Sulfacetamide 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 Prednisolone/Sulfacetamide Drops:

Use Prednisolone/Sulfacetamide Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

To use Prednisolone/Sulfacetamide Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed. To clear up your infection completely, use Prednisolone/Sulfacetamide Drops for the full course of treatment. Keep using it even if you feel better in a few days. Do not use Prednisolone/Sulfacetamide Drops if it is dark brown or has darkened since you began using it. Contact your doctor or pharmacist if you have questions about whether you should use Prednisolone/Sulfacetamide Drops. Do not wear contact lenses while you are using Prednisolone/Sulfacetamide 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 Prednisolone/Sulfacetamide 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 Prednisolone/Sulfacetamide Drops.

Important safety information: Prednisolone/Sulfacetamide Drops may cause blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Prednisolone/Sulfacetamide Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. If your symptoms do not get better within 2 days or if they get worse, check with your doctor. Be sure to use Prednisolone/Sulfacetamide Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Prednisolone/Sulfacetamide Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Tell your doctor or dentist that you take Prednisolone/Sulfacetamide Drops before you receive any medical or dental care, emergency care, or surgery. Do not use Prednisolone/Sulfacetamide Drops for future eye problems unless directed by your doctor. Lab tests, including eye pressure, may be performed while you use Prednisolone/Sulfacetamide Drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Prednisolone/Sulfacetamide Drops should be used with extreme caution in CHILDREN younger than 6 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 Prednisolone/Sulfacetamide Drops while you are pregnant. It is not known if Prednisolone/Sulfacetamide Drops are found in breast milk. Do not breast-feed while using Prednisolone/Sulfacetamide Drops. Possible side effects of Prednisolone/Sulfacetamide 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:

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; eye pain, itching, redness, swelling, irritation, or sores not present when you began using Prednisolone/Sulfacetamide Drops; fever, chills, or sore throat; red, swollen, or blistered skin; severe or persistent blurred vision; unusual tiredness or weakness; yellowing of the eyes or 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: Prednisolone/Sulfacetamide 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 Prednisolone/Sulfacetamide Drops:

Store Prednisolone/Sulfacetamide Drops at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Store away from heat and light. Keep Prednisolone/Sulfacetamide Drops out of the reach of children and away from pets.

General information: If you have any questions about Prednisolone/Sulfacetamide Drops, please talk with your doctor, pharmacist, or other health care provider. Prednisolone/Sulfacetamide 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 Prednisolone/Sulfacetamide 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 Prednisolone/Sulfacetamide resources Prednisolone/Sulfacetamide Side Effects (in more detail) Prednisolone/Sulfacetamide Use in Pregnancy & Breastfeeding Prednisolone/Sulfacetamide Drug Interactions Prednisolone/Sulfacetamide Support Group 1 Review for Prednisolone/Sulfacetamide - Add your own review/rating Compare Prednisolone/Sulfacetamide with other medications Blepharitis Conjunctivitis, Bacterial Keratitis Keratoconjunctivitis Uveitis
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Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit


Pronunciation: SOE-dee-um SUL-fa-SET-a-mide/SUL-fur in ue-REE-a
Generic Name: Sulfacetamide Sodium/Sulfur in Urea with Sunscreen
Brand Name: Rosula CLK
Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is used for:

Treating certain skin conditions (eg, acne vulgaris, acne rosacea, seborrheic dermatitis). It may also be used for other conditions as determined by your doctor.

Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is a kit containing a sulfonamide antibiotic/keratolytic combination along with sunscreen. The wash works by killing sensitive bacteria on the skin. It also helps to loosen and shed hard, scaly skin. The sunscreen helps to prevent sunburn.

Do NOT use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit if: you are allergic to any ingredient in Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit, to sulfur, or to sulfonamides (eg, sulfamethoxazole) you have kidney problems

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

Before using Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit:

Some medical conditions may interact with Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit. 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 eczema if the skin at the application site is scraped, cut, or damaged.

Some MEDICINES MAY INTERACT with Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit. Because little, if any, of Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit 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 Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit:

Use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wet the skin and apply a generous amount of the wash to the affected area. Gently massage it into the skin for 10 to 20 seconds, working into a full lather. Rinse the skin well, and pat dry. Wash your hands immediately after using the medicine, unless your hands are part of the affected area. If your skin becomes dry, you may need to wash the medicine off a little sooner or use it less often. To use the sunscreen, apply a generous amount to areas that will be exposed to the sun. Reapply as needed, including after drying with a towel, swimming, and sweating. Use the wash on a regular schedule to get the most benefit from it. Continue to use it even if your condition improves. Do not miss any doses. If you miss a dose of the wash, 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 Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit.

Important safety information: Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is for external use only. Do not get it in your eyes or on the inside of your nose or mouth. If you get Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit in any of these areas, rinse right away with cool water. Talk with your doctor before you use any other medicines or cleansers on your skin. Do not apply Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit over large areas of the body or to open wounds or scraped, infected, or burned skin without first checking with your doctor. Do not use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit for other skin conditions at a later time. Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit may be harmful if swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit while you are pregnant. It is not known if Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is found in breast milk after topical use. If you are or will be breast-feeding while you use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit:

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 redness or peeling; minor skin irritation

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); fever, chills, or sore throat; purple or brownish spots on the skin; red, swollen, blistered, or peeling skin; severe or persistent skin irritation; unusual tiredness or weakness; yellowing of the skin or eyes.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit:

Store Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Store away from heat and light. Keep Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit out of the reach of children and away from pets.

General information: If you have any questions about Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit, please talk with your doctor, pharmacist, or other health care provider. Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit 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 Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit. 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 Sulfacetamide Sodium/Sulfur in Urea with Sunscreen resources Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Use in Pregnancy & Breastfeeding Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Drug Interactions Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Support Group 0 Reviews for Sulfacetamide Sodium/Sulfur in Urea with Sunscreen - Add your own review/rating Compare Sulfacetamide Sodium/Sulfur in Urea with Sunscreen with other medications Acne Rosacea Seborrheic Dermatitis
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Sodium Sulfacetamide Sulfur Cleansing Pads


Generic Name: sulfacetamide sodium and sulfur swab
Dosage Form: swab
Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads In a vehicle containing Green Tea and Aloe Rx Only

DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent.
Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.
The structural formula is:


Each pad of Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are coated with a cleanser-based formulation. Each gram of this cleanser-based
formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: purified water, sodium cocoyl isethionate
disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate methyl paraben, propyl
paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl
taurate, white petrolatum.

CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact
that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption
through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in
the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of
acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are contraindicated for use by patients having known hypersensitivity
to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are not to be used by
patients with kidney disease.

WARNINGS: Although rare, sensitivity to sodium sulfacetaminde may occur. Therefore, caution and careful supervision should be observed when
prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute
hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should
be employed if areas of denuded or abraded skin are involved.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

PRECAUTIONS: General - If irritaition develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be
carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desqamation withour
irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of
acne vulfaris, but patients should be cautioned about the possibility.
Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive
irritation develops, discontinue use and consult your physician.

PREGNANCY: Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 4% Cleansing
Pads. It is not known whether Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads can cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% -
Sulfur 4% Cleansing Pads. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of
this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are
administered to a nursing woman.

PEDIATRIC USE: Safety and effectiveness in children under the age of 12 have not been established.

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION: Wash affected area(s) with cleansing pad once or twice dialy, or as directed by your physician. Wet area(s) with
water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry.
Discard pad. Do not flush.

HOW SUPPLIED: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are available in boxes of 60 cloths (3.7 g), (NDC 42192-113-60).
Store at controlled room temperature, 15° - 25° (59° - 77°F).
All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book
product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution
using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active
ingredients, incipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802

Sodum Sulfacetamide 10%-

Sulfur 4% Cleansing Pads


In a vehicle containing Green Tea and Aloe
Rx Only
60 cleansing pads
Net wegith 3.7g each
Acella pharmaceuticals
Directions: Wash affected areas with Sodium Sulfacetamide 10% - Sulfur 4% once or twice daily or as direted by your physician.
1. Wet affected areas with water
2. Wet Sodium Sulfacetamide 10% - Sulfur 4% cleansing pad with water and work into a full lather.
3. Cleanse face with Sodium Sulfacetamide 10% - Sulfur 4% for 10 -20 seconds, avoiding eyes
4. Rinse thoroughly and pat dry
5. Discard pad. Do not flush.
Warnings for external use only. Keep out of reach of children. Avoid contact with eyes.
Indications: for the typical control of acne vulgaris and seborrheic dermatitis. See package insert for full prescribing information.
Contraindications: Sodium Sulfacetamide 10% - Sulfur 4% cleansing pads are contraindicated for use in patients having known hypersensitivity to sulfonamides, sulfur or anyother component of the preparation. Sodium Sulfacetamide 10% - Sulfur 4% cleansing pads are not to be used by patients with kidney disease.
 
Contents: Sodium Sulfacetamide 10% - Sulfur 4%. Other Ingredients: purified water, sodium cocoyl isethionate, disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate methyl paraben, propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosufate, disodium EDTA, magnesium aluminum siliate, xanthan gum, sodium methyl cocoyl l-taurate, white petrolatum
Acella Pharmaceuticals
Store at 15 degrees to 25 degrees C or 59-77 degrees F)
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE. This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Please see package insert for more information.
Manufactured For:
Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802


SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS 
sodium sulfacetamide, sulfur  swab Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42192-113 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 10 g  in 100 g SULFUR (SULFUR) SULFUR 4 g  in 100 g Inactive Ingredients Ingredient Name Strength WATER   ALOE VERA LEAF   SODIUM THIOSULFATE   EDETATE DISODIUM   MAGNESIUM ALUMINUM SILICATE   XANTHAN GUM   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 42192-113-60 60 POUCH In 1 BOX contains a POUCH 1 3.7 g In 1 POUCH This package is contained within the BOX (42192-113-60)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/16/2010
Labeler - Acella Pharmaceuticals, LLC (825380939) Revised: 12/2010Acella Pharmaceuticals, LLC
More Sodium Sulfacetamide Sulfur Cleansing Pads resources Sodium Sulfacetamide Sulfur Cleansing Pads Side Effects (in more detail)Sodium Sulfacetamide Sulfur Cleansing Pads Use in Pregnancy & BreastfeedingSodium Sulfacetamide Sulfur Cleansing Pads Drug InteractionsSodium Sulfacetamide Sulfur Cleansing Pads Support Group18 Reviews for Sodium Sulfacetamide Sulfur Cleansings - Add your own review/rating Compare Sodium Sulfacetamide Sulfur Cleansing Pads with other medications AcneRosaceaSeborrheic Dermatitis
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Sulfamylon


Generic Name: Mafenide Acetate
Class: Local Anti-infectives, Miscellaneous
ATC Class: D06BA03
VA Class: DE101
CAS Number: 13009-99-9

Introduction

Synthetic anti-infective agent.a

Uses for Sulfamylon Treatment and Prevention of Burn Infections

Mafenide acetate cream is used topically as adjunctive therapy in second- and third-degree burns to prevent septicemia caused by susceptible organisms, especially Pseudomonas aeruginosa.a b

Control of bacterial growth may prevent conversion of second-degree (partial-thickness) wounds to third-degree (full-thickness) wounds; however, delayed eschar separation reported.a b

Although controlled, comparative studies are lacking, mafenide and silver sulfadiazine are considered by many clinicians to be among the topical anti-infective agents of choice in burn patients.d e g h i

Mafenide appears to penetrate burn eschar better than silver sulfadiazine and may be more effective in minimizing the growth of bacteria and early treatment of wound sepsis.d i Unlike mafenide, silver sulfadiazine does not alter acid-base balance and does not have a limited duration of therapy and area of topical application; softening action of silver sulfadiazine cream may aid in eschar removal and preparation of wound for grafting.d f

Alternative therapies include wet dressings of 0.5% silver nitrate; appears to be of equal efficacy as mafenide cream; mafenide cream may cause more pain on application.a

Mafenide acetate solution is used topically as adjunctive therapy to control bacterial infections under moist dressings over meshed autografts on excised burn wounds.c

Sulfamylon Dosage and Administration Administration Topical Administration

Administer topically as a cream or solution; not for injection.a b c

Cream

Apply cream only after instituting appropriate measures to control shock and pain.a b

Apply to cleansed, debrided burn wounds using a sterile, gloved hand.a b

Bathe patient daily, preferably in a whirlpool bath, to aid in debridement.a b

Dressings generally not required; if necessary, use only a thin layer.a b Some clinicians apply dressings when the eschar begins to separate (16–20 days) to expedite the separation of the eschar.a

Solution

Apply topically as a 5% reconstituted solution.c

Consult manufacturer's information for complete directions for use.c

Reconstitution

Reconstitute 50-g packet of sterile mafenide acetate powder with 1 L of sterile water for irrigation or 0.9% sodium chloride irrigation by adding powder to solution in suitable container and mixing until completely dissolved.c (See Storage under Stability.)

Dosage

Available as mafenide acetate; dosage expressed in terms of mafenide.a b c

Each gram of mafenide acetate cream provides the equivalent of 85 mg of mafenide.a

Pediatric Patients Treatment and Prevention of Burn Infections Topical (Cream)

Children: Apply sufficient amount to cover affected area to a thickness of 1/16th inch, once or twice daily.a b Thicker application is not recommended.a b

Burned areas should be covered with cream at all times.a b Reapply whenever necessary if cream removed from any area.a b

Continue therapy until healing is progressing well or until site is ready for grafting.a b Generally, do not discontinue mafenide topical therapy while there is the possibility of infection.a b (See Dosage Modification for Toxicity under Dosage and Administration.)

Topical (Solution)

Infants and children ?3 months to 16 years of age: Inject solution into the irrigation tubing every 4 hours or irrigate dressing with a syringe every 6–8 hours; may repeat as necessary to keep dressing wet.c

May leave wound dressings undisturbed for up to 5 days, except for irrigations.c May initiate additional soaks until engraftment is complete.c Maceration of skin may result from wet dressings applied for intervals as short as 24 hours.c Continue treatment until autograft vascularization occurs and healing is progressing, usually about 5 days.c

Adults Treatment and Prevention of Burn Infections Topical (Cream)

Apply sufficient amount to cover affected area to a thickness of 1/16th inch, once or twice daily.a b Thicker application is not recommended.a b

Burned areas should be covered with cream at all times.a b Reapply whenever necessary if cream removed from any area.a b

Continue therapy until healing is progressing well or until site is ready for grafting.a b Generally, do not discontinue mafenide topical therapy while there is the possibility of infection.a b (See Dosage Modification for Toxicity under Dosage and Administration.)

Topical (Solution)

Inject solution into the irrigation tubing every 4 hours or irrigate dressing with a syringe every 6–8 hours; may repeat as necessary to keep dressing wet.c

May leave wound dressings undisturbed for up to 5 days, except for irrigations.c May initiate additional soaks until engraftment is complete.c Maceration of skin may result from wet dressings applied for intervals as short as 24 hours.c Continue treatment until autograft vascularization occurs and healing is progressing, usually about 5 days.c

Dosage Modification for Toxicity Topical (Cream, Solution

Allergic manifestations: Consider mafenide discontinuance if hypersensitivity reactions occur.a b c (See Sensitivity Reactions under Cautions.)

Systemic acidosis: If systemic acidosis occurs and is difficult to control, especially in pulmonary dysfunction, discontinuing mafenide therapy for 24–48 hours may aid in restoring acid-base balance.a b c (See Systemic Acidosis under Cautions.)

During the interruption in mafenide therapy, adjust dressing changes and monitoring of site for bacterial growth accordingly.c

Prescribing Limits Pediatric Patients Topical (Solution)

Safety and efficacy not established for use >5 days for an individual grafting procedure.c

Adults Topical (Solution)

Safety and efficacy not established for use >5 days for an individual grafting procedure.c

Special Populations

No special population dosage recommendations at this time.a b c (See Pulmonary Dysfunction and also Renal Impairment under Cautions.)

Cautions for Sulfamylon Contraindications

Known hypersensitivity to mafenide or any ingredient in the formulation.a b Unknown if cross-sensitivity to other sulfonamides occurs.b c (See Sensitivity Reactions under Cautions.)

Warnings/Precautions Warnings Hemolytic Anemia

Fatal hemolytic anemia with disseminated intravascular coagulation reported, presumably related to glucose-6-phosphate dehydrogenase deficiency.a b c

Sensitivity Reactions Hypersensitivity

Hypersensitivity reactions (e.g., rash, pruritus, facial edema, swelling, urticaria, blisters, erythema, eosinophilia) reported 10–14 days after initiation of therapy.a

If hypersensitivity reaction occurs, consider discontinuing mafenide therapy temporarily or initiating concomitant antihistamine therapy.a

Potential for cross-sensitivity with other sulfonamides is unknown.b c

Sulfite Sensitivity

Cream contains a sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.b j k l m n o p q

Major Toxicities Systemic Acidosis

May cause systemic acidosis (tachypnea or hyperventilation, increased serum chloride concentration, and decreased arterial pCO2).a b c Closely monitor acid-base balance in patients with extensive second-degree (partial-thickness) burns, pulmonary dysfunction, or renal impairment.b c (See Dosage Modification for Toxicity under Dosage and Administration and see Pulmonary Dysfunction and also Renal Impairment under Cautions.)

Syndrome of marked hyperventilation with resulting respiratory alkalosis (slightly alkaline blood pH, low arterial pCO2, decreased total CO2) has been reported; change in arterial pO2 is variable.a b c Etiology and significance unknown.a b c

General Precautions Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi, both in and below burn eschar.a

Fungal colonization in wound and in and below burn eschar may occur concomitantly with reduction of bacterial growth; however, systemic fungal infection via dissemination through the burn wound is rare.a b c

Pulmonary Dysfunction

Closely monitor acid-base balance in pulmonary dysfunction.a b c (See Systemic Acidosis under Cautions.)

Specific Populations Pregnancy

Category C.b c

Not recommended for women of childbearing potential unless the burned area covers >20% of total body surface area or the therapeutic benefits justify the possible risks to the fetus.a b c

Lactation

Not known whether mafenide is distributed into milk.a b c Discontinue nursing or the drug.a b c

Pediatric Use

Safety and efficacy of topical solution not established in infants <3 months of age.c

Renal Impairment

Increased risk for metabolic acidosis in renal impairment due to substantial carbonic anhydrase inhibition.a b c Closely monitor acid-base balance.a b c (See Systemic Acidosis under Cautions.)

Use with caution in acute renal failure.a b c

Common Adverse Effects

Pain on application, burning sensation. a b c

Sulfamylon Pharmacokinetics Absorption Bioavailability

Topically applied cream and solution diffuse through devascularized areas, including burn eschar.a b c Peak concentrations in burned skin tissue occur at 2 and 4 hours, respectively.c Peak tissue concentrations are similar for cream and solution.c

Peak plasma concentrations of topical cream and its metabolite occur at 2 and 3 hours, respectively.c

Distribution Extent

Not known whether distributed into human milk.a b c

Elimination Metabolism

Rapidly metabolized in the liver to p-carboxybenzenesulfonamide, a weak carbonic anhydrase inhibitor.a b c

Elimination Route

Rapidly excreted in urine as metabolite.a b c

Stability Storage Topical Cream

Avoid exposure to excessive heat (>40°C).b

Solution

Packets: 15–30°C in a dry place.c

Reconstituted solution: 20–25°C (may be exposed to 15–30°C); up to 28 days in unopened containers.c Once opened, discard within 48 hours.c

Actions and SpectrumActions

Exact mechanism of action unknown, but appears to interfere with bacterial cellular metabolism.a

Related chemically, but not pharmacologically, to the sulfonamides.a c

Not antagonized by p-aminobenzoic acid (PABA), pus, serum, or tissue exudates; activity not altered by environmental acidity changes.a b c

Bacteriostatic against many gram-negative and gram-positive organisms and several strains of anaerobes.a b c

Active in vitro against Clostridium species, Pseudomonas aeruginosa, coagulase-positive and-negative staphylococci, and hemolytic streptococci.a b c

Less active against Escherichia coli and Proteus species.a

Resistance not reported.a

Advice to Patients

Importance of understanding that mafenide preparations are for external topical use only.a b c

Importance of informing clinician if any signs or symptoms of an allergic reaction occur (e.g., rash, itching, facial or other swelling, blisters, redness).b c

Importance of informing clinicians of existing concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., kidney or lung disease).b c

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b c

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

Preparations

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

Mafenide Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

8.5% (of mafenide)

Sulfamylon

UDL

Topical

Solution

5% w/v (of mafenide)

Sulfamylon

UDL

Disclaimer

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

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

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

References

a. AHFS drug information 2008. McEvoy GK, ed. Mafenide acetate. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3568-9.

b. UDL Laboratories, Inc. Sulfamylon (mafenide acetate, USP) cream prescribing information. Rockford, IL; 2006 Apr.

c. UDL Laboratories, Inc. Sulfamylon (mafenide acetate, USP) for 5% topical solution prescribing information. Rockford, IL; 2008 Apr.

d. AHFS drug information 2008. McEvoy GK, ed. Silver sulfadiazine. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3570-71.

e. Palmieri TL, Greenlaugh DG. Topical treatment of pediatric patients with burns: a practical guide. Am J Clin Dermatol. 2002; 3:529-34. [PubMed 12358554]

f. Liebman PR, Kennelly MM, Hirsch EF. Hypercarbia and acidosis associated with carbonic anhydrase inhibition: a hazard of topical mafenide acetate use in renal failure. Burns Incl Therm Inj. 1982; 8:95-8.

g. Castellano JJ, Shafii SM, Ko F et al. Comparative evaluation of silver-containing antimicrobial dressings and drugs. Int Wound J. 2007; 4:114-22. [PubMed 17651227]

h. Atiyeh BS, Costagliola M, Hayek SN et al. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007; 33:139-48. [PubMed 17137719]

i. Monafo WW, West MA. Current treatment recommendations for topical burn therapy. Drugs. 1990; 40:364-73. [PubMed 2226220]

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

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

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

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

n. 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]

o. 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]

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

q. 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.

More Sulfamylon resources Sulfamylon Side Effects (in more detail) Sulfamylon Use in Pregnancy & Breastfeeding Sulfamylon Support Group 0 Reviews for Sulfamylon - Add your own review/rating Sulfamylon Prescribing Information (FDA) Sulfamylon Concise Consumer Information (Cerner Multum) Sulfamylon Topical Advanced Consumer (Micromedex) - Includes Dosage Information Sulfamylon Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Sulfamylon with other medications Burns, External
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sipuleucel-t Intravenous


si-pu-LOO-sel - tee

Commonly used brand name(s)

In the U.S.

Provenge

Available Dosage Forms:

Suspension Uses For sipuleucel-t

Sipuleucel-T is used to treat certain types of advanced prostate cancer. sipuleucel-t is made from your own immune cells (autologous cellular immunotherapy).

sipuleucel-t is available only with your doctor's prescription.

Before Using sipuleucel-t

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 sipuleucel-t, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sipuleucel-t 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

No information is available on the relationship of age to the effects of sipuleucel-T in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sipuleucel-T in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 sipuleucel-t. Make sure you tell your doctor if you have any other medical problems, especially:

Heart disease or Heart rhythm problems (e.g., arrhythmia) or Lung disease or breathing problems or Stroke, history of—Use with caution. May make these conditions worse. Proper Use of sipuleucel-t

A nurse or other trained health professional will give you sipuleucel-t in a hospital. sipuleucel-t is given through a needle placed in one of your veins.

Your doctor will tell you to have your immune cells collected three days before each scheduled infusion of sipuleucel-t at a cell collection center. This collection process is called leukapheresis. Your collected blood cells are mixed with a protein to make them ready for your infusion.

The medicine is usually given as 3 doses, spaced 2 weeks apart. sipuleucel-t must be given slowly, so the needle will remain in place for one hour. You may also receive acetaminophen (e.g., Tylenol®) and diphenhydramine (e.g., Benadryl®) to help prevent possible infusion reactions.

It is very important that you receive all doses of sipuleucel-t. Try to keep all scheduled appointments. If you miss a dose, your medicine will not be usable. Your doctor will work with you to schedule a new appointment at the cell collection center. You may also get a new appointment for your infusion.

Precautions While Using sipuleucel-t

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that sipuleucel-T is working properly and to check for unwanted effects.

sipuleucel-t may cause fever; chills; dizziness; fast heartbeat; joint pain; nausea and vomiting; shortness of breath; troubled breathing; or unusual tiredness or weakness within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.

Call your doctor right away if you start to have a cough, weight loss, fever, or redness or pain at the infusion or collection sites. These may be signs that you have an infection.

Check with your doctor right away if you have chest pain or discomfort, dizziness, fainting, pounding or rapid pulse, or fast, slow, or uneven heartbeat. These maybe symptoms of a heart rhythm problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

sipuleucel-t Side Effects

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

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

More common Bladder pain bloating or swelling of the face, arms, hands, lower legs, or feet bloody or cloudy urine body aches or pain chest pain chills confusion cough diarrhea difficult, burning, or painful urination difficulty with breathing difficulty with speaking double vision ear congestion fever frequent urge to urinate general feeling of discomfort or illness headache inability to move the arms, legs, or facial muscles inability to speak joint pain loss of appetite loss of voice lower back or side pain muscle aches and pains nasal congestion nausea pale skin rapid weight gain runny nose shivering shortness of breath slow speech sneezing sore throat sweating tightness in the chest tingling of the hands or feet trouble sleeping troubled breathing with exertion unusual bleeding or bruising unusual tiredness or weakness unusual weight gain or loss vomiting wheezing

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:

More common Back pain burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings decreased weight dizziness feeling of warmth lack or loss of strength loss of appetite muscle ache muscle or bone pain muscle spasms neck pain rash redness of the face, neck, arms, and occasionally, upper chest sleeplessness sudden sweating unable to sleep weight loss Less common Shakiness in the legs, arms, hands, or feet trembling or shaking of the hands or feet

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

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

See also: sipuleucel-t Intravenous side effects (in more detail)

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