SULFAMYLON Cream is a soft, white, nonstaining, water-miscible, anti-infective cream for topical administration to burn wounds.

SULFAMYLON Cream spreads, easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of SULFAMYLON Cream contains mafenide acetate equivalent to 85 mg of the base. The cream vehicle consists of cetyl alcohol, steryl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate, glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate disodium as preservatives.

Chemically, mafenide acetate is α-Amino-p-toluenesulonamide mono acetate and has the following structural formula:

Last updated on RxList: 7/17/2008

SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third- degree bums.

Prompt institution of appropriate measures for controlling shock and pain is of prime importance. The burn wounds are then cleansed and debrided, and SULFAMYLON Cream is applied with a sterile gloved hand. Satisfactory results can be achieved with application of the cream once or twice daily, to a thickness of approximately 1/16 Inch; thicker application is not recommended. The burned areas should be covered with SULFAMYLON Cream at all times. Therefore, whenever necessary, the cream should be reapplied to any areas from which it has been removed (e.g., by patient activity). The routine of administration can be accomplished in minimal time, since dressings usually are not required, if individual patient demands make them necessary, however, only a thin layer of dressings should be used.

When feasible, the patient should be bathed daily to aid in debridement. A whirlpool bath is particularly helpful, but the patient may be bathed in bed or In a shower.

The duration of therapy with SULFAMYLON Cream depends on each patient's requirements. Treatment is usually continued until healing is progressing well or until the burn site is ready for grafting. SULFAMYLON Cream should not be withdrawn from the therapeutic regimen while there is the possibility of infection. However, if allergic manifestations occur during treatment with SULFAMYLON Cream, discontinuation of treatment should be considered.

If acidosis occurs and becomes difficult to control, particularly in patients with pulmonary dysfunction, discontinuing therapy SULFAMYLON Cream for 24 to 48 hours while continuing fluid therapy may aid in restoring acid-base balance.

16 oz. Plastic Jar (453.6 g) - NDC 51079-623-83
4 oz. Tube (113.4 g) - NDC 51079-623-82
2 oz. Tube (56.7 g) - NDC 51079-623-81

Avoid exposure to excessive heat (temperature above 104° F or 40° C).

Manufactured by: Mylan Bertek Pharmaceuticals Inc. Sugar Land, TX 77478. Distributed by: UDL Laboratories, Inc. Rockford, IL 61103. REVISED APRIL 2O06. FDA rev date: 12/13/2002

Last updated on RxList: 7/17/2008

It is frequently difficult to distinguish between an adverse reaction to SULFAMYLON Cream and the effect of a severe burn. A single case of bone marrow depression and a single case of acute attack of porphyria have been reported following therapy with SULFAMYLON Cream. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream.

Dermatologic: The most frequently reported reaction was pain on application or a burning sensation. Rare occurrences are excoriation of new skin and bleeding of skin.

Allergic: Rash Itching, facial edema, swelling, hive, blisters, erythema, and eosinophilia.

Respiratory: Tachypnea or hyperventilation, decrease in arterial PCO₂.

Metabolic: Acidosis, Increase In serum chloride.

Accidental ingestion of SULFAMYLON Cream has been reported to cause diarrhea.

No information provided.

Last updated on RxList: 7/17/2008

Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6- phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream.

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 in nonasthmatic people.

SULFAMYLON and Its metabolite, p-carboxybenzenesulfonamlde, inhibit carbonic anhydrase, which may result in metabolic acidosis, usually compensated by hyperventilation. In the presence of impaired renal function, high blood levels of SULFAMYLON and Its metabolite may exaggerate the carbonic anhydrase inhibition. Therefore, close monitoring of acid-base balance is necessary, particularly in patients with extensive second- degree or partial-thickness burns and In those with pulmonary or renal dysfunction. Some burn patients treated with SULFAMYLON Cream have also been reported to manifest an unexplained syndrome of marked hyperventilation with resulting respiratory alkalosis (slightly alkaline blood pH, low arterial pC0₂ and decreased total CO₂); change in arterial p0₂ is variable. The etiology and significance of these findings are unknown.

Mafenide acetate cream should be used with caution in burn patients with acute renal failure.

SULFAMYLON Cream should be administered with caution to patients with history of hypersensitivity to mafenide. It is not known whether there Is cross sensitivity to other sulfonamides.

Fungal colonization In and below eschar may occur concomitantly with reduction of bacterial growth In the burn wound. However, fungal dissemination through the infected burn wound Is rare.

Carcinogenesis. Mutagenesis. Impairment of Fertility

No long-term animal studies have been performed to evaluate the drug's potential in these areas.

Pregnancy Category C

Animal reproduction studies have not been conducted with SULFAMYLON. It is also not known whether SULFAMYLON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, the preparation is not recommended for the treatment of a women of childbearing potential, unless the burned area covers more than 20% of the total body surface, or the need for the therapeutic benefit of SULFAMYLON Cream is, In the physician's judgment, greater than the possible risk to the fetus.

Nursing Mothers

It is not known whether mafenide acetate is excreted in human milk. Because many drugs are excreted In human milk and because of the potential for serious adverse reaction in nursing infants from SULFAMYLON, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Same as for adults. (See DOSAGE AND ADMINISTRATION.)

Last updated on RxList: 7/17/2008

No information provided.

SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.

Last updated on RxList: 7/17/2008

SULFAMYLON Cream, applied topically, produces a marked reduction in the bacterial population present in the avascular tissues of second- and third-degree burns. Reduction In bacterial growth after application of SULFAMYLON Cream has also been reported to permit spontaneous healing of deep partial-thickness burns, and thus prevent conversion of burn wounds from partial-thickness to full-thickness. It should be noted, however, that delayed eschar separation has occurred in some cases.

Absorption and Metabolism

Applied topically, SULFAMYLON Cream diffuses through devascularized areas, is absorbed, and rapidly converted to a metabolite (p-carboxybenzenesulfonamide) which is cleared through the kidneys. SULFAMYLON is active in the presence of pus and serum, and Its activity is not altered by changes in the acidity of the environment.

Antibacterial Activity

SULFAMYLON exerts bacteriostatic action against many gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and certain strains of anaerobes.

Last updated on RxList: 7/17/2008

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 7/17/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

MAFENIDE ACETATE SOLUTION - TOPICAL

(MAY-feh-nide)

COMMON BRAND NAME(S): Sulfamylon

USES: This medication is used alone or with other medications to help prevent and treat wound infections in patients with severe burns. Mafenide is a drug applied to the skin that belongs to a class of drugs known as sulfa antibiotics. It works by killing bacteria that may infect an open wound. Killing bacteria helps to promote wound healing and to decrease the risk of the bacteria spreading to surrounding skin or to the blood, thereby helping to prevent a serious blood infection (sepsis).

HOW TO USE: Follow all instructions for proper preparation and use of this drug. Consult your pharmacist.

Wash hands before and after using this medication. Use with wound dressings on the skin only. Soak the dressing completely with this medication. Keep the dressing wet by applying this medication every 6 to 8 hours or as directed by your doctor.

Length of treatment is based on your medical condition and response to treatment.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition persists or worsens or if you notice increasing redness/tenderness of the skin around the wound.

SIDE EFFECTS: Pain, burning, or redness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blisters, fast breathing, nausea, vomiting, diarrhea, headache, change in alertness, shaking (tremors), seizures.

Tell your doctor immediately if any of these rare but very serious side effects occur: weakness, dark urine, stomach/abdominal pain, arm/leg/back pain, fast heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using mafenide, tell your doctor or pharmacist if you are allergic to it; or to other sulfa drugs (e.g., sulfamethoxazole); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung problems (e.g., asthma), kidney disease, metabolism problems (e.g., glucose-6-phosphate dehydrogenase deficiency-G6PD), blood disorders.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible harm to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later on other wounds unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (e.g., wound cultures, acid-base balance, complete blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store unmixed packets at room temperature between 59-86 degrees F (15-30 degrees C) away from moisture. Do not store in the bathroom.

Mix the powder with the correct solution, and then close the container tightly. After mixing, if the container stays closed, you may store it for up to 28 days between 68-77 degrees F (20-25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Once a container is opened for use, the solution is good for only 48 hours. Discard any unused portion. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.