Sulfanilamide (Cream)

Sulfanilamide (Cream)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Sulfanilamide (Cream) is an antibiotic that is FDA approved for the treatment of vaginal infections. Common adverse reactions include burning, itching, irritation of the skin, or an increased need to urinate.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Dosage: One applicatorful (about 6 g) intravaginally once or twice daily. Improvements in symptoms should occur within a few days, but treatment should be continued for a period of 30 days. Douching with a suitable solution before insertion may be recommended for hygienic purposes.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfanilamide (Cream) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfanilamide (Cream) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Sulfanilamide (Cream) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfanilamide (Cream) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfanilamide (Cream) in pediatric patients.

Contraindications

Sulfanilamide should not be used in patients known to be sensitive to this product or to the sulfonamides.

Warnings

• Because sulfonamides are absorbed from the vaginal mucosa, the usual precautions for oral sulfonamides apply. *Patients should be observed for skin rash or evidence of systemic toxicity, and if these develop, the medications should be discontinued.
• Deaths associated with administration of oral sulfonamides have reportedly occurred from hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood dyscrasias.
• Goiter production, diuresis, and hypoglycemia have reportedly occurred rarely in patients receiving oral sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has reportedly produced thyroid malignancies in this species.
• Vaginal applicators or inserters should be used with caution after the seventh month of pregnancy.

Adverse Reactions

Clinical Trials Experience

• Local sensitivity reactions such as increased discomfort or a burning sensation have occasionally been reported following the use of topical sulfonamides. With the use of Sulfanilamide cream, sensitivity reactions (only local) were reported for 0.2% of the investigational patients. Treatment should be discontinued if either local or systemic manifestations of sulfonamide toxicity or sensitivity occur.

Postmarketing Experience

There is limited information regarding Sulfanilamide (Cream) Postmarketing Experience in the drug label.

Drug Interactions

• Drug interactions have not been documented with Sulfanilamide cream

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Animal reproductive studies have been conducted with sulfonamides, including sulfanilamide (see below). It is not known whether AVC can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. AVC should be given to a pregnant woman only if clearly needed.
• Sulfonamides, including sulfanilamide, readily pass through the placenta and reach fetal circulation. The concentration in the fetus is from 50-90% of that in the maternal blood and if high enough, can cause toxic effects. The safe use of sulfonamides, including sulfanilamide, in pregnancy has not been established. The teratogenic potential of most sulfonamides has not been thoroughly investigated in either animals or humans. However, a significant increase in the incidence of cleft palate and other bony abnormalities of offspring has been observed with certain sulfonamides of the short-, intermediate- and long-acting types (including sulfanilamide) when given to pregnant rats and mice at high oral doses (seven to 25 times the human therapeutic oral dose.)

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sulfanilamide (Cream) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sulfanilamide (Cream) during labor and delivery.

Nursing Mothers

• Sulfanilamide should be avoided in nursing mothers because absorbed sulfonamides will appear in maternal milk and have caused kernicterus in the newborn. Because of the potential for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug.

Pediatric Use

• Safety and effectiveness of AVC in pediatric patients have not been established.

Geriatic Use

There is no FDA guidance on the use of Sulfanilamide (Cream) in geriatric settings.

Gender

There is no FDA guidance on the use of Sulfanilamide (Cream) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sulfanilamide (Cream) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sulfanilamide (Cream) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sulfanilamide (Cream) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sulfanilamide (Cream) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sulfanilamide (Cream) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sulfanilamide (Cream) Administration in the drug label.

Monitoring

There is limited information regarding Sulfanilamide (Cream) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sulfanilamide (Cream) and IV administrations.

Overdosage

• There have been no reports of accidental overdosage with Sulfanilamide cream.
• The acute oral LD50 of sulfanilamide is 3700-4200 mg/kg in mice.
• The minimum human lethal dose of AVC has not been established.
• It is not known if AVC is dialyzable.

Pharmacology

Mechanism of Action

There is limited information regarding Sulfanilamide (Cream) Mechanism of Action in the drug label.

Structure

Pharmacodynamics

There is limited information regarding Sulfanilamide (Cream) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sulfanilamide (Cream) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sulfanilamide (Cream) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sulfanilamide (Cream) Clinical Studies in the drug label.

How Supplied

• NDC 0037-6631-04 4 oz tube with applicator

Storage

• Store at room temperature, below 86°F.
• Protect from cold.
• Product darkens with age. Potency is maintained throughout labeled shelf life when stored as directed.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Sulfanilamide (Cream) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sulfanilamide (Cream) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• AVC

Look-Alike Drug Names

There is limited information regarding Sulfanilamide (Cream) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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