In the U.S.—

In Canada—

• Antibacterial, topical
• Antifungal, topical

Silver sulfadiazine ( SILL-ver sul-fa-DYE-a-zeen) , a sulfa medicine, is used to prevent and treat bacterial or fungus infections. It works by killing the fungus or bacteria.

Silver sulfadiazine cream is applied to the skin and/or burned area(s) to prevent and treat bacterial or fungus infections that may occur in burns. This medicine may also be used for other problems as determined by your doctor.

Other medicines are used along with this medicine for burns. Patients with severe burns or burns over a large area of the body must be treated in a hospital.

Silver sulfadiazine is available only with your doctor's prescription, in the following dosage form:

Topical
• Cream (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For silver sulfadiazine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to silver sulfadiazine or to any of the following medicines:

• Acetazolamide (e.g., Diamox)
• Antidiabetics, oral (diabetes medicine you take by mouth)
• Dichlorphenamide (e.g., Daranide)
• Furosemide (e.g., Lasix)
• Methazolamide (e.g., Neptazane)
• Sulfonamides, other (sulfa medicine)
• Thiazide diuretics (water pills)

Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Studies have not been done in humans. However, sulfa medicines may increase the chance of liver problems in newborn infants. Silver sulfadiazine has not been shown to cause birth defects or other problems in studies in rabbits treated with 3 to 10 times the usual amount of silver sulfadiazine.

Breast-feeding—It is not known whether silver sulfadiazine applied to the skin and/or burns passes into the breast milk. However, silver sulfadiazine may be absorbed into the body when used on skin and/or burns. Sulfa medicines given by mouth do pass into the breast milk. They may cause liver problems, anemia (iron-poor blood), and other unwanted effects in nursing babies, especially those with glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme). Therefore, caution is recommended when using this medicine in nursing women.

Children—Use is not recommended in premature or newborn infants up to 2 months of age. Sulfa medicines may cause liver problems in these infants. Although there is no specific information comparing use of silver sulfadiazine in older infants and children with use in other age groups, this medicine is not expected to cause different side effects or problems in older infants and children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of silver sulfadiazine in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking silver sulfadiazine, it is especially important that your health care professional know if you are taking any of the following:

• Cimetidine—May increase the risk of leukopenia (low white blood cell counts)

• Collagenase (e.g., Santyl) or
• Papain (e.g., Panafil) or
• Sutilains (e.g., Travase)—Silver sulfadiazine may prevent these enzymes from working properly

• Blood problems or
• Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)—Use of this medicine may cause blood problems or make them worse

• Kidney disease or
• Liver disease—In persons with these conditions, use may result in higher blood levels of this medicine; a smaller dose may be needed

• Porphyria—Use of this medicine may result in a severe attack of porphyria

This medicine should not be used on premature or newborn infants up to 2 months of age, unless otherwise directed by your doctor. It may cause liver problems in these infants.

To use:

• Before applying this medicine, cleanse the affected area(s). Remove dead or burned skin and other debris.
• Wear a sterile glove to apply this medicine. Apply a thin layer (about 1/16 inch) of silver sulfadiazine to the affected area(s). Keep the affected area(s) covered with the medicine at all times.
• If this medicine is rubbed off the affected area(s) by moving around or if it is washed off during bathing, showering, or the use of a whirlpool bath, reapply the medicine.
• After this medicine has been applied, the treated area(s) may be covered with a dressing or left uncovered as desired.

To help clear up your skin and/or burn infection completely, keep using silver sulfadiazine for the full time of treatment. You should keep using this medicine until the burned area has healed or is ready for skin grafting. Do not miss any doses.

Dosing—

The dose of silver sulfadiazine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of silver sulfadiazine. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical dosage form (cream):
  • For burn wound infections:
    • Adults and children 2 months of age and older—Use one or two times a day.
    • Premature and newborn infants up to 2 months of age—Use and dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits.

If your skin infection or burn does not improve within a few days or weeks (for more serious burns or burns over larger areas), or if it becomes worse, check with your doctor.

This medicine may rarely stain skin brownish gray.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if the following side effect occurs:

• Rare
  • Blistering, peeling or loosening of skin;  bloody or cloudy urine;  chills or fever;  cough;  decreased amount of urine or less frequent urination;  increased sensitivity of skin to sunlight, especially in patients with burns on large areas;  intense itching of burn wounds;  pain at site of application;  painful or difficult urination ;  red skin lesions, often with a purple center;  shortness of breath;  sore throat;  sores, ulcers or white spots on lips or in mouth;  swollen glands;  unusual bleeding or bruising;  unusual tiredness or weakness 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Burning feeling on treated area(s) 
  
  

• Less common or rare
  • Brownish-gray skin discoloration;  itching or skin rash 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.