Sulfamylon Cream

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 ?-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...

Read All Potential Side Effects and See Pictures of Sulfamylon Cream

What are the precautions when taking mafenide acetate cream (Sulfamylon Cream)?

Before using mafenide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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 unknown if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Sulfamylon Cream


Sulfamylon Cream Consumer (continued)

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 (especially of the face/tongue/throat), 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.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using mafenide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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 unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Sulfamylon Cream Patient Information Including Side Effects

Brand Names: Sulfamylon

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

  • What is mafenide (Sulfamylon Cream)?
  • What are the possible side effects of mafenide (Sulfamylon Cream)?
  • What is the most important information I should know about mafenide (Sulfamylon Cream)?
  • What should I discuss with my health care provider before receiving mafenide (Sulfamylon Cream)?
  • How is mafenide used (Sulfamylon Cream)?
  • What happens if I miss a dose (Sulfamylon Cream)?
  • What happens if I overdose (Sulfamylon Cream)?
  • What should I avoid while being treated with mafenide (Sulfamylon Cream)?
  • What other drugs will affect mafenide (Sulfamylon Cream)?
  • Where can I get more information?

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.

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.

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