Silver sulfadiazine is an antibiotic. It fights bacteria and yeast on the skin.

Silvadene (for the skin) is used to treat or prevent serious infection on areas of skin with second- or third-degree burns.

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

Silvadene may cause serious medical problems in a newborn if you use Silvadene during late pregnancy (close to your delivery date). This medicine should also not be used on premature babies or any child younger than 2 months old.

Follow all directions on your prescription label. Do not use Silvadene in larger or smaller amounts or for longer than recommended.

Wash your hands before and after applying silver sulfadiazine cream.

The person applying silver sulfadiazine to burn wounds should wear sterile disposable gloves. Take care to keep the treatment area as clean as possible to prevent further infection.

Clean the area to be treated as directed by your doctor. Apply enough silver sulfadiazine to cover the affected area evenly. This medicine should be applied in a layer about one 16th (1/16) of an inch thick, or 1.6 millimeters.

If needed, apply more cream to replace any medicine that has come off on bandages, clothing, or bed linens. Reapply the cream after bathing or water therapy.

Silver sulfadiazine cream is usually applied 1 or 2 times daily. Burn wounds must be kept covered with this medicine at all times. Treated skin areas can be left uncovered, or you may use a gauze bandage if directed by your doctor.

While using Silvadene, you may need frequent blood tests. Your kidney function may also need to be tested.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Store at room temperature away from moisture and heat.

You should not use this medicine if you are allergic to silver sulfadiazine.

Silvadene may cause serious medical problems in a newborn if you use this medicine during late pregnancy (close to your delivery date). This medicine should also not be used on premature babies or any child younger than 2 months old.

To make sure Silvadene is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease;

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency; or

• an allergy to sulfa drugs.

FDA pregnancy category B. Silvadene is not expected to harm an unborn baby. However, this medicine can cause serious medical problems in a newborn and should not be used during late pregnancy.

It is not known whether silver sulfadiazine topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

An overdose of Silvadene is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

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

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

Although the risk of serious side effects is low when silver sulfadiazine is applied to the skin, side effects can occur if the medicine is absorbed into your bloodstream.

Silvadene may cause serious side effects. Call your doctor at once if you have:

• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• kidney problems--red or pink urine, little or no urinating, swelling, rapid weight gain;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with silver sulfadiazine topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.