Sultrin

What is Sultrin and how is it used?

Sultrin is a prescription medicine used to treat the symptoms of Vaginitis. Sultrin may be used alone or with other medications.

Sultrin belongs to a class of drugs called Sulfonamides.

It is not known if Sultrin is safe and effective in children.

What are the possible side effects of Sultrin?

The most common side effects of Sultrin include:

• localized irritation,
• burning,
• itching,
• an increased need to urinate, and
• allergic reaction

Tell the doctor if you have any side effect that bothers you or that does not go away.

Sultrin may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• severe dizziness,
• itching,
• burning,
• skin rash,
• redness or swelling of the skin,
• burning at the application site, and
• rash or irritation of the penis of sexual partner

Get medical help right away, if you have any of the symptoms listed above.

These are not all the possible side effects of Sultrin. For more information, ask your doctor or pharmacist.

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

DESCRIPTION

SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream contains sulfathiazole (Benzenesulfonamide,4-amino-N-2-thiazolyl-N ¹ -2-thiazolylsulfanilamide) 3.42%, sulfacetamide (Acetamide,N-[(4-aminophenyl) sulfonyl]-N-Sulfanilylacetamide) 2.86%, and sulfabenzamide (Benzamide,N-[(4-aminophenyl) sulfonyl]-N-Sulfanilylbenzamide) 3.7%, compounded with cetyl alcohol 2%, cholesterol, diethylaminoethyl stearamide, glyceryl monostearate, lanolin, lecithin, methylparaben, peanut oil, phosphoric acid, propylene glycol, propylparaben, purified water, stearic acid and urea.

SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream is a topical antibacterial preparation available for intravaginal administration.

INDICATIONS

SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream is indicated for the treatment of vaginitis caused by Haemophilus (Gardnerella) vaginalis bacteria.

The diagnosis of a Haemophilus (Gardnerella) vaginalis vaginitis should be firmly established before initiation of treatment with SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) .

DOSAGE AND ADMINISTRATION

SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream. One full applicator intravaginally twice daily for four to six days. This course of therapy may be repeated if necessary; the dosage may be reduced one-half to one-quarter.

HOW SUPPLIED

Cream 78 g tubes with the ORTHO* Measured-Dose Applicator.

NDC 0062-5440-77

SIDE EFFECTS

There has been one reported case of Agranulocyctosis in a patient receiving SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream. The most frequent adverse reactions to SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) are localized irritation and/or allergy including rare reports of Stevens-Johnson syndrome which may be fatal.

DRUG INTERACTIONS

No Information Provided.

WARNINGS

Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias.

The presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.

PRECAUTIONS

Because sulfonamides may be 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.

Laboratory tests:  Standard office diagnostic procedures for vaginitis are usually sufficient to establish the diagnosis of Haemophilus (Gardnerella) vaginalis and to rule out a trichomonal or monilial infection. These include noting a fish-like odor upon addition of 10% KOH to vaginal discharge and microscopic identification of "clue cells" in a wet mount preparation. If cultures are obtained, care must be taken to use appropriate media and methods for Haemophilus (Gardnerella) vaginalis.

Carcinogenesis, mutagenesis, impairment of fertility:  The sulfonamides bear certain chemical similarities to some goitrogens. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has produced thyroid malignancies in this species.

Pregnancy:

Teratogenic Effects:  Pregnancy Category C:  The safe use of sulfonamides in pregnancy has not been established. The teratogenicity 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 when certain sulfonamides of the short, intermediate and long-acting types were given to pregnant rats and mice at high oral doses (7 to 25 times the human therapeutic dose).

Nursing Mothers:  Because of the potential for serious adverse reactions in nursing infants from SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. See CONTRAINDICATIONS .

Pediatric use:  Safety and effectiveness in children have not been established.

OVERDOSE

No Information Provided.

CONTRAINDICATIONS

SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) is contraindicated in the following circumstances: kidney disease; hypersensitivity to sulfonamides; in pregnancy at term and during the nursing period because sulfonamides cross the placenta, are excreted in breast milk and may cause Kernicterus.

CLINICAL PHARMACOLOGY

The mode of action of SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) is not completely known. SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) Cream is a topical antibacterial preparation used intravaginally against Haemophilus (Gardnerella) vaginalis bacteria. Indirect effects, such as lowering the vaginal pH, may be equally important mechanisms.

PATIENT INFORMATION

No Information Provided.