Pronunciation:

SIL-ver sul-fa-DYE-a-zeen

Brand Names:

• Silvadene
• SSD
• SSD AF
• Thermazene
• Flamazine
• Ssd

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Antibacterial

Chemical—

Sulfonamide

Uses of This Medicine:

Silver sulfadiazine cream is used to prevent and treat wound infections in patients with second- and third-degree burns. Patients with severe burns or burns over a large area of the body must be treated in a hospital.

Silver sulfadiazine is an antibiotic. It works by killing the bacteria or preventing its growth.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of silver sulfadiazine topical in the pediatric population. Safety and efficacy have not been established.

Use of silver sulfadiazine topical is not recommended in premature or newborn babies 2 months of age and younger.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of silver sulfadiazine topical in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Methenamine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methotrexate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aminolevulinic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—Use with caution. May cause blood problems in patients with this condition.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

Proper Use of This Medicine:

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina.

To use:

• Before applying this medicine, clean the affected areas. Remove dead or burned skin and other debris.
• Wear sterile gloves to apply this medicine. Apply a thin layer (about 1/16 inch) of silver sulfadiazine to the affected areas. Keep the affected areas covered with the medicine at all times.
• If this medicine is rubbed off the affected areas 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 areas may be covered with a dressing or left uncovered as desired.

To help clear up your skin or burn infection completely, keep using this medicine 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For burn wound infections:
    • Adults—Apply to the affected areas one or two times a day.
    • Children older than 2 months of age—Use and dose must be determined by the doctor.
    • Premature infants and infants 2 months of age and younger—Use is not recommended.

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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any problems or unwanted effects that may be caused by this medicine.

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.

Do not use this medicine for a skin problem that has not been checked by your doctor.

Check with your doctor right away if you have the following symptoms while using this medicine: bleeding gums, cough or hoarseness, fever with or without chills, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, unusual bleeding, bruising, or weakness, or yellow skin or eyes. These could be symptoms of a blood disorder.

Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

This medicine may rarely stain skin brownish gray.

Side Effects of This Medicine:

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 any of the following side effects occur:

Incidence not known

Back, leg, or stomach pains

blistering, peeling, or loosening of the skin

blue-green to black skin discoloration

dark urine

fever with or without chills

general body swelling

increased sensitivity of the skin to sunlight, especially in patients with burns on large areas

intense itching of burn wounds

light-colored stools

lower back or side pain

nausea or vomiting

pinpoint red spots on the skin

red skin lesions, often with a purple center

red, swollen skin

skin rash

sores, ulcers, or white spots in the mouth or on the lips

swollen or painful glands

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

yellow eyes and skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Brownish-gray skin discoloration

burning feeling on treated areas

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

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