Silvadene

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Apply the missed dose as soon as you remember. Your burn wounds should be kept covered with silver sulfadiazine cream at all times.

Do not take by mouth. Silver sulfadiazine topical is for use only on the skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a sulfa (sulfonamide) allergy, talk with your doctor.
• Be careful if you have G6PD deficiency. Anemia may happen.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Do not use longer than you have been told. A second infection may happen.
• This medicine may cause harm if swallowed. If Silvadene is swallowed, call a doctor or poison control center right away.
• This medicine may affect certain lab tests. Be sure your doctor and lab workers know you use this medicine.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Silvadene while you are pregnant.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Change in color of skin.
• Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Silvadene Cream 1% is a soft, white, water-miscible cream containing the antimicrobial agent silver sulfadiazine in micronized form, which has the following structural formula:

Each gram of Silvadene Cream 1% contains 10 mg of micronized silver sulfadiazine. The cream vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate, sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with methylparaben 0.3% as a preservative. Silvadene Cream 1% (silver sulfadiazine) spreads easily and can be washed off readily with water.

Silver sulfadiazine has broad antimicrobial activity. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast. Results from in vitro testing are listed below.

Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine.

Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell membrane and cell wall to produce its bactericidal effect.

Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy.1,2,3 Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within 2 to 4 days of initiation of therapy. Rebound to normal leukocyte levels follows onset within 2 to 3 days. Recovery is not influenced by continuation of silver sulfadiazine therapy. An increased incidence of leukopenia has been reported in patients treated concurrently with cimetidine.

Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis.

Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial-thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

Silvadene Cream 1% (silver sulfadiazine) is available in jars containing 50 g (NDC 61570-131-50), 400 g (NDC 61570-131-40), and 1000 g (NDC 61570-131-98) and tubes containing 20 g (NDC 61570-131-20) , 25 g (NDC 61570-131-25), 50 g (NDC 61570-131-55) and 85 g (NDC 61570-131-85).

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).