sulfanilamide

Sulfanilamide is a topical vaginal antibiotic cream used to treat vulvovaginal inflammation (vulvovaginitis) caused by Candida albicans yeast (fungus) infection and susceptible bacterial infections. Sulfanilamide works by interfering with processes essential for microbial growth and arrests the growth of bacteria (bacteriostatic) and Candida fungus (fungistatic). Sulfanilamide vaginal cream is not currently available in the U.S.

Sulfanilamide is an organic sulfur compound with antimicrobial properties that is structurally similar to para-aminobenzoic acid (PABA), a nutrient in the vitamin B complex. PABA is essential for the synthesis of folic acid that bacteria and yeast require to grow. Sulfanilamide gets incorporated into dihydrofolic acid, the precursor of folic acid, preventing the incorporation of PABA and synthesis of folic acid.

• Do not use sulfanilamide in patients with hypersensitivity to any sulfonamide, sulfanilamide or any component of the formulation.
• Sulfanilamide is systemically absorbed from the vaginal mucosa and precautions for the use of oral sulfonamides apply for vaginal sulfanilamide. Adverse reactions have been observed regardless of the route of administration.
• Sulfanilamide can cause severe and sometimes fatal hypersensitivity reactions.
• Sulfanilamide has chemical similarities to sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid), and carries a risk of cross-reaction in patients with allergy to any of these compounds. Do not use sulfanilamide in patients who have had a previous severe reaction to any of these drugs.
• There have been severe and sometimes fatal blood disorders with the use of sulfanilamide, including anemia due to lack of red blood cell production (aplastic anemia), and severely low count of granulocyte immune cells (agranulocytosis).
• Sulfanilamide can cause severe dermatological reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Discontinue sulfanilamide if patient develops skin rash or evidence of systemic toxicity.
• There have been reports of goiter, low blood sugar (hypoglycemia) and excessive urination (diuresis) with sulfanilamide use. Use with caution.
• Prolonged use of sulfanilamide was associated with thyroid malignancy in animal studies.
• Sulfanilamide can injure the liver and cause acute liver failure (fulminant hepatic necrosis).
• Use vaginal applicators and inserters with extreme caution after the seventh month of pregnancy.
• Other topical or oral antifungal agents are preferred over sulfanilamide for uncomplicated vulvovaginitis candidiasis.

Common side effects of sulfanilamide include:

• Itching
• Burning
• Discomfort
• Redness
• Swelling
• Skin rash

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Vaginal cream

• 15%

Adult:

Candida Vulvovaginitis

• 1 applicatorful (6 g) intravaginally once daily or once every 12 hours for 30 days

Pediatric:

Safety and efficacy not established.

Overdose

There are no reports of sulfanilamide overdose. Vaginal sulfanilamide is systemically absorbed through the vaginal mucous membranes. Excessive use of sulfanilamide vaginal cream may intensify its side effects, which should resolve with discontinuation of the drug. Long term use of sulfanilamide can cause cancer of the thyroid gland.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of sulfanilamide include:
  • mecamylamine
  • progesterone
• Sulfanilamide has no known serious interactions with other drugs.
• Moderate interactions of sulfanilamide include:
  • ajmaline
  • dexketoprofen
• Sulfanilamide has no known mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate and well-controlled studies in the use of sulfanilamide vaginal cream in pregnant women. Animal studies show sulfanilamide is systemically absorbed by the mucous membranes in the vagina and can cause fetal harm.
• Sulfanilamide vaginal cream should be used during pregnancy only if it is clearly needed. Vaginal products should be used with extreme caution after the seventh month of pregnancy.
• Sulfanilamide is present in breastmilk and can increase the bilirubin levels and associated brain damage (kernicterus) in the breastfed infant. Breastfeeding or sulfanilamide should be discontinued, because of the potential for serious adverse reactions in the breastfed infant.

• Use sulfanilamide exactly as prescribed.
• Sulfanilamide is a vaginal cream meant for external use in the vaginal region only.
• If you experience excessive local burning or itching, or develop any unusual symptoms, discontinue sulfanilamide and consult with your physician.
• Inform your physician if you experience any rash or other skin reactions.
• Store sulfanilamide safely out of reach of children.
• In case of overdose, report to your physician or Poison Control.