Silver sulfadiazine (Topical)

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

Silver sulfadiazine is an antibiotic. It works by killing bacteria or stopping it from growing.

You can get this medicine only with a prescription from your doctor.

It is important for your doctor to check your progress at regular visits. This will help your doctor determine if the medicine is working correctly and to look for any problems or side effects that may arise from 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 gets worse, contact your doctor.

Do not use this medicine for a skin issue that has not been evaluated by your doctor.

Contact your doctor immediately if you experience 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, weakness, or yellow skin or eyes. These could indicate a blood disorder.

Contact 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 using this medicine.

Before undergoing any medical tests, inform the medical doctor in charge that you are using this medicine. The results of some tests may be influenced by this medicine.

This medicine may rarely cause the skin to stain a brownish gray color.

In deciding to use a medicine, you and your doctor will weigh the risks of the medicine against its benefits. Here are some important considerations for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research has not been done on how silver sulfadiazine topical affects children. Its safety and effectiveness have not been proven.

Do not use silver sulfadiazine topical in premature or newborn babies aged 2 months or younger.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the usefulness of silver sulfadiazine topical.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if there might be an interaction. Your doctor may adjust the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are important but may not be all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change other medicines you are taking.

• Methenamine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Methotrexate

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Aminolevulinic Acid

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

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

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from your body.

• Porphyria—Using this medicine may lead to a severe attack of porphyria.

Along with its helpful effects, this medicine may cause some unwanted effects. Not everyone will experience these side effects, but if they do happen, you may need medical help.

Contact your doctor as soon as possible if you notice any of the following side effects:

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 happen that usually do not require medical help. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects persist, 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 that are not listed may also happen in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

• Silvadene
• SSD
• SSD AF
• Thermazene

In Canada

• Flamazine
• Ssd

Available Dosage Forms:

• Cream

Therapeutic Class: Antibacterial

Chemical Class: Sulfonamide

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.