Flamazine Topical

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.

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:

• 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:

• 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.

Applies to silver sulfadiazine topical: compounding powder, topical cream

General

The serum sulfa levels have approached adult therapeutic levels (8 mg% to 12 mg%) when the drug was used on extensive areas of the body. Although rare, side effects associated with sulfonamides may occur, such as blood dyscrasias (including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia), dermatologic and allergic reactions (including life-threatening cutaneous reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis, and exfoliative dermatitis]), gastrointestinal reactions, hepatitis, hepatocellular necrosis, CNS reactions, and toxic nephrosis.[Ref]

Hematologic

Rare (less than 0.1%): Blood dyscrasias (including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia)
Frequency not reported: Transient leukopenia (several cases)[Ref]

Leukopenia associated with silver sulfadiazine topical was primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurred within 2 to 4 days of starting therapy. Rebound to normal leukocyte levels followed onset within 2 to 3 days. Recovery was not affected by continuation of silver sulfadiazine topical.

Hemolytic anemia has been reported in patients with glucose-6-phosphate deficiency.[Ref]

Dermatologic

Rare (less than 0.1%): Skin necrosis, erythema multiforme, skin discoloration, rashes, dermatologic reactions (including life-threatening cutaneous reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis])[Ref]

Renal

Rare (less than 0.1%): Interstitial nephritis, toxic nephrosis[Ref]

Genitourinary

Rare (less than 0.1%): Sulfa crystals in urine

Sulfa crystals have been reported following the use of silver sulfadiazine topical on extensive areas of the body.

Hypersensitivity

Rare (less than 0.1%): Allergic reactions
Frequency not reported: Possibility of cross-hypersensitivity[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, hepatocellular necrosis[Ref]

Other

Frequency not reported: Changes in serum osmolality that may affect laboratory test interpretation, increased possibility of kernicterus, delayed separation[Ref]

Changes in serum osmolality (which can interfere with some laboratory test results) have been reported. This was attributed to the amount of propylene glycol vehicle absorbed following use on extensive areas of the body.

Reduction in bacterial growth after use of topical antibacterial agents has been reported to permit spontaneous healing of deep partial-thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.[Ref]

Nervous system

Rare (less than 0.1%): Burning sensation, CNS reactions

Gastrointestinal

Rare (less than 0.1%): Gastrointestinal reactions

Some side effects of silver sulfadiazine topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Silver sulfadiazine topical is contraindicated in pregnant women approaching or at term, premature infants, or newborn infants during the first 2 months of life, because the drug is known to increase the possibility of kernicterus.

There is potential cross sensitivity between silver sulfadiazine topical and other sulfonamides. If allergic reactions associated with silver sulfadiazine topical occur, therapy continuation should be weighed against the potential risks of the particular allergic reaction.

In some patients with glucose-6-phosphate dehydrogenase deficiency, the use of silver sulfadiazine topical may be hazardous, as hemolysis may occur.

If renal and hepatic functions become impaired and elimination of drug decreases, accumulation may occur and discontinuation of silver sulfadiazine topical should be weighed against the therapeutic benefit being achieved.

Serum sulfa concentrations may approach adult therapeutic levels during the treatment of burn wounds involving extensive areas of the body. Therefore, sulfa concentrations should be monitored in these patients. Renal function should be closely monitored and the urine should be checked for sulfa crystals.

Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.

Of the total number of patients in clinical studies of silver sulfadiazine topical, seven percent were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Data not available

Because sulfonamides are known to increase the possibility of kernicterus, silver sulfadiazine topical should not be used on pregnant women approaching or at term.

Silver sulfadiazine topical has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetotoxicity. There are no controlled data in human pregnancy. Silver sulfadiazine topical is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.