Flamazine

Generic Name: silver sulfadiazine (Topical route)

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

Commonly used brand name(s):

In the U.S.

• Silvadene
• SSD AF
• Thermazene

In Canada

• Flamazine
• Ssd

Available Dosage Forms:

• Cream

Therapeutic Class: Antibacterial

Chemical Class: Sulfonamide

Uses For Flamazine

Silver sulfadiazine , 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.

Before Using Flamazine

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.

Pediatric

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.

Geriatric

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.

Pregnancy

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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:

• 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

Proper Use of silver sulfadiazine

This section provides information on the proper use of a number of products that contain silver sulfadiazine. It may not be specific to Flamazine. Please read with care.

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 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 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

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.

Precautions While Using Flamazine

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.

Flamazine Side Effects

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:

• 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

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:

• Burning feeling on treated area(s)

• Brownish-gray skin discoloration
• itching or skin rash

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.

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