DRUGS & SUPPLEMENTS

Sulfamylon

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Sulfamylon uses


DESCRIPTION

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 Sulfamylon 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, Sulfamylon acetate is α-Amino-ρ-toluenesulfonamide monoacetate and has the following structural formula:

Sulfamylon Cream Structural Formula

CLINICAL PHARMACOLOGY

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 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.

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INDICATIONS AND USAGE

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

CONTRAINDICATIONS

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

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.

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, ρ-carboxybenzenesulfonamide, 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 ; change in arterial pO2 is variable. The etiology and significance of these findings are unknown.

Sulfamylon 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 Sulfamylon. 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 Sulfamylon 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.

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ADVERSE REACTIONS

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.

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 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.

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).

For External Use Only.

Keep this and all medications out of the reach of children.

Rx only

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

REVISED JULY 2013

030.4

PRINCIPAL DISPLAY PANEL - 2 oz.

NDC 51079-623-81

Sulfamylon®

CREAM (Sulfamylon acetate

cream, USP)

For Topical Use Only

Rx only 2 oz. (56.7 g)

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A

MI:623:81:1C:R6

523.6

Each gram contains Sulfamylon acetate equivalent to 85 mg base in a water-miscible cream

of cetyl alcohol, stearyl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate,

glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate

disodium as preservatives.

For dosage and administration, read accompanying package insert.

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

For external use only.

Keep this and all medications out of the reach of children.

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Sulfamylon pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Sulfamylon available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Sulfamylon destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Sulfamylon Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Sulfamylon pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."SULFAMYLON (MAFENIDE ACETATE) CREAM [MYLAN INSTITUTIONAL INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "mafenide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "mafenide". http://www.drugbank.ca/drugs/DB0679... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Sulfamylon?

Depending on the reaction of the Sulfamylon after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sulfamylon not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Sulfamylon addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Sulfamylon, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Sulfamylon consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported doses

What is the dose of Sulfamylon drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 11-50mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
11-50mg1
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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