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DRUG DESCRIPTION
Mafenide acetate, USP is a synthetic antimicrobial agent designated chemically as a-amino-p- toluenesulfonamide monoacetate. It has the following structural formula:
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C7H10N2O2S • C2H4O2
M.W. 246.29
Mafenide acetate, USP is a white, crystalline powder which is freely soluble in water.
SULFAMYLON® (mafenide acetate) For 5% Topical Solution is provided in packets containing 50 g of sterile mafenide acetate to be reconstituted in 1000 mL of Sterile Water for irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. After mixing, the solution contains 5% w/v of mafenide acetate. The solution is an antimicrobial preparation suitable for topical administration. The solution Is not for Injection. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20° to 25°C (68° to 77°F). Limited storage periods at 15° to 30°C (59° to 86°F) are acceptable.
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 »
What are the precautions when taking mafenide acetate (Sulfamylon)?
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 »
Sulfamylon Consumer (continued)
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 Patient Information Including Side Effects
Brand Names: Sulfamylon
Generic Name: mafenide topical (Pronunciation: MAF en ide)
- What is mafenide (Sulfamylon)?
- What are the possible side effects of mafenide (Sulfamylon)?
- What is the most important information I should know about mafenide (Sulfamylon)?
- What should I discuss with my health care provider before receiving mafenide (Sulfamylon)?
- How is mafenide used (Sulfamylon)?
- What happens if I miss a dose (Sulfamylon)?
- What happens if I overdose (Sulfamylon)?
- What should I avoid while being treated with mafenide (Sulfamylon)?
- What other drugs will affect mafenide (Sulfamylon)?
- Where can I get more information?
What is mafenide (Sulfamylon)?
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)?
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)?
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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Sulfamylon, Mafenide, Acetate, Buy Sulfamylon