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Sultrin (Sulfathiazole, Sulfacetamide and Sulfabenzamide): Side Effects, Uses, Dosage, Interactions, Warnings

Sultrin

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/16/2022

Drug Summary

What Is Sultrin?

Sultrin (sulfathiazole, sulfacetamide and sulfabenzamide) Cream is a topical antibacterial preparation used to treat vaginitis caused by Haemophilus (Gardnerella) vaginalis bacteria. The brand name Sultrin Cream is discontinued, but generic versions may be available.

What Are Side Effects of Sultrin?

Common side effects of Sultrin (sulfathiazole, sulfacetamide and sulfabenzamide) Cream include:

  • localized irritation
  • burning
  • itching
  • an increased need to urinate, or
  • allergy

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.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Sultrin

The dose of Sultrin is one full applicator intravaginally twice daily for four to six days.

What Drugs, Substances, or Supplements Interact with Sultrin?

Sultrin may interact with other drugs. Tell your doctor all medications and supplements you use.

Sultrin During Pregnancy or Breastfeeding

During pregnancy, Sultrin should be used only if prescribed. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended while using this drug.

Additional Information

Our Sultrin (sulfathiazole, sulfacetamide and sulfabenzamide) Cream Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Description for Sultrin

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.

Uses for Sultrin

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 for Sultrin

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 for Sultrin

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 for Sultrin

No Information Provided.

Warnings for Sultrin

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 for Sultrin

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 Information for Sultrin

No Information Provided.

Contraindications for Sultrin

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 for Sultrin

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 for Sultrin

No Information Provided.

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