Sulfamylon Cream (Mafenide Acetate Cream)
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Sulfamylon Cream (Mafenide Acetate Cream)

SULFAMYLON® Cream
(mafenide acetate) Cream, USP

Topical Antibacterial Agent for Adjunctive Therapy In Second- and Third-Degree Burns

DRUG DESCRIPTION

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

SULFAMYLON Cream (mafenide acetate cream) spreads, easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of SULFAMYLON Cream (mafenide acetate 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:

SULFAMYLON (mafenide acetate) structural formula illustration

What are the possible side effects of mafenide (Sulfamylon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have a serious side effect such as:

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • chest pain, fast or pounding heartbeats, headache, confusion;
  • nausea, vomiting, stomach pain, appetite changes, muscle weakness, bone pain, and weight loss;
  • rapid breathing, gasping, or feeling short of breath; or
  • severe skin rash,...

Read All Potential Side Effects and See Pictures of Sulfamylon Cream »

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

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 (mafenide acetate 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 (mafenide acetate 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 (mafenide acetate 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 (mafenide acetate 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 (mafenide acetate cream) for 24 to 48 hours while continuing fluid therapy may aid in restoring acid-base balance.

HOW SUPPLIED

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 reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

It is frequently difficult to distinguish between an adverse reaction to SULFAMYLON Cream (mafenide acetate 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 (mafenide acetate 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 (mafenide acetate 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 (mafenide acetate cream) has been reported to cause diarrhea.

Read the Sulfamylon Cream (mafenide acetate cream) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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

PRECAUTIONS

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 (mafenide acetate 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 (mafenide acetate 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 (mafenide acetate 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 reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

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

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

SULFAMYLON Cream (mafenide acetate 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 (mafenide acetate 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 (mafenide acetate 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 reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

SULFAMYLON® Cream
(mafenide acetate) Cream, USP

Topical Antibacterial Agent for Adjunctive Therapy In Second- and Third-Degree Burns

DRUG DESCRIPTION

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

SULFAMYLON Cream (mafenide acetate cream) spreads, easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of SULFAMYLON Cream (mafenide acetate 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:

SULFAMYLON (mafenide acetate) structural formula illustration

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

SULFAMYLON® Cream
(mafenide acetate) Cream, USP

Topical Antibacterial Agent for Adjunctive Therapy In Second- and Third-Degree Burns

DRUG DESCRIPTION

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

SULFAMYLON Cream (mafenide acetate cream) spreads, easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of SULFAMYLON Cream (mafenide acetate 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:

SULFAMYLON (mafenide acetate) structural formula illustration

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

SULFAMYLON® Cream
(mafenide acetate) Cream, USP

Topical Antibacterial Agent for Adjunctive Therapy In Second- and Third-Degree Burns

DRUG DESCRIPTION

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

SULFAMYLON Cream (mafenide acetate cream) spreads, easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of SULFAMYLON Cream (mafenide acetate 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:

SULFAMYLON (mafenide acetate) structural formula illustration

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Sulfamylon Cream Patient Information Including Side Effects

Brand Names: Sulfamylon

Generic Name: mafenide topical (Pronunciation: MAF en ide)

What is mafenide (Sulfamylon Cream)?

Mafenide is an antibiotic that fights bacteria in the body.

Mafenide topical (for the skin) is used to prevent infection in severe burn wounds.

Mafenide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mafenide (Sulfamylon Cream)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have a serious side effect such as:

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • chest pain, fast or pounding heartbeats, headache, confusion;
  • nausea, vomiting, stomach pain, appetite changes, muscle weakness, bone pain, and weight loss;
  • rapid breathing, gasping, or feeling short of breath; or
  • severe skin rash, bruising, severe tingling, numbness, or pain.

Less serious side effects may include:

  • mild skin rash, redness, or itching; or
  • pain or burning of treated skin areas.

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

Read the Sulfamylon Cream (mafenide acetate cream) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about mafenide (Sulfamylon Cream)?

You should not receive this medication if you are allergic to mafenide.

Before being treated with mafenide, tell your doctor if you are allergic to any drugs (especially sulfa drugs), or if you have kidney disease or glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Before you are treated with mafenide topical, tell your doctor if you are pregnant or breast-feeding.

Tell your caregivers right away if you have a serious side effect such as pale or yellowed skin, dark colored urine, fever, confusion or weakness, chest pain, fast or pounding heartbeats, confusion, vomiting, appetite changes, muscle weakness, bone pain, rapid breathing, gasping, or feeling short of breath, or severe skin rash with bruising, severe tingling, numbness, or pain.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are being treated with mafenide.

Side Effects Centers

Sulfamylon Cream Patient Information including How Should I Take

What should I discuss with my health care provider before receiving mafenide (Sulfamylon Cream)?

You should not use this medication if you are allergic to mafenide.

Before using mafenide, tell your doctor if you are allergic to any drugs (especially sulfa drugs), or if you have:

  • kidney disease; or
  • glucose-6-phosphate dehydrogenase (G6PD) deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant.

It is not known whether mafenide passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is mafenide used (Sulfamylon Cream)?

Your doctor will determine the correct amount and type of this medication to use. You will receive this medication in a hospital or burn unit setting.

Mafenide cream is usually applied to the burn wound once or twice a day. The wound should be kept covered with this medication at all times during treatment.

Mafenide powder is usually mixed together with a saline solution and applied over a gauze dressing using a syringe or irrigation tube. Mafenide is usually applied several times per day in order to keep the bandaging wet.

Side Effects Centers

Sulfamylon Cream Patient Information including If I Miss a Dose

What happens if I miss a dose (Sulfamylon Cream)?

Since this medication is usually applied by a healthcare professional, it is unlikely that you will miss a dose.

What happens if I overdose (Sulfamylon Cream)?

An overdose of this medication is unlikely to occur.

What should I avoid while being treated with mafenide (Sulfamylon Cream)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are being treated with mafenide.

What other drugs will affect mafenide (Sulfamylon Cream)?

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

Where can I get more information?

Your pharmacist can provide more information about mafenide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.04. Revision date: 12/15/2010.

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