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Sulfanilamide

Pronunciation

(sul fa NIL a mide)

Index Terms

  • p-amino-benzenesulfonamide

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, Vaginal:

AVC Vaginal: 15% (120 g) [contains methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]

Brand Names: U.S.

  • AVC Vaginal

Pharmacologic Category

  • Antifungal Agent, Vaginal

Pharmacology

Interferes with microbial folic acid synthesis and growth via inhibition of para-aminiobenzoic acid metabolism; exerts a bacteriostatic action

Use: Labeled Indications

Vulvovaginitis: Treatment of vulvovaginitis caused by Candida albicans

Contraindications

Hypersensitivity to sulfanilamide, any sulfonamide, or any component of the formulation

Dosing: Adult

Vulvovaginitis: Intravaginal: Insert one applicatorful intravaginally once or twice daily for 30 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling

Administration

Intravaginal: Use applicator provided by manufacturer. Insertion should be as far as possible into the vagina without causing discomfort. Wash applicator after each use; allow to dry thoroughly before putting back together.

Storage

Store below 30°C (86°F). Protect from cold. Cream darkens with age; potency is maintained through labeled expiration date when stored as directed.

Drug Interactions

Ajmaline: Sulfonamides may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Monitor therapy

Dexketoprofen: May enhance the adverse/toxic effect of Sulfonamides. Monitor therapy

Mecamylamine: Sulfonamides may enhance the adverse/toxic effect of Mecamylamine. Avoid combination

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination

Adverse Reactions

<1% (Limited to important or life-threatening): Local hypersensitivity reaction (localized burning, local discomfort)

Warnings/Precautions

Concerns related to adverse effects:

• Blood dyscrasias: Severe reactions (some fatal), including agranulocytosis, aplastic anemia, and other blood dyscrasias, have occurred with sulfonamides (regardless of route).

• Dermatologic reactions: Severe reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred with sulfonamides (regardless of route).

• Hepatic necrosis: Fatalities associated with fulminant hepatic necrosis have occurred with sulfonamides (regardless of route).

• Hypersensitivity reactions: Have occurred (some fatal) with sulfonamides (regardless of route).

• Sulfonamide allergy: Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling; however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.

Other warnings/precautions:

• Appropriate use: Topical antifungal agents or oral fluconazole are generally considered to be the preferred treatment for uncomplicated vulvovaginal candidiasis (Pappas, 2009; Reef, 1993; Sobel, 2007). Sulfanilamide is not recognized as a preferred or as an alternative agent for the treatment of uncomplicated vulvovaginitis candidiasis in the available literature.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies with sulfonamides, including sulfanilamide. Sulfonamides cross the placenta and distribute to amniotic fluid. The fetal concentration is 50% to 90% of that measured in the maternal blood. Use of vaginal products (eg, applicators and inserts) should be used with caution after the seventh month of pregnancy. Because of the theoretical risk of kernicterus in the newborn, neonatal care providers should be informed if maternal sulfonamide therapy is used close to delivery (DHHS, 2014).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), severe vaginal irritation, severe skin irritation, bruising, bleeding, pale skin, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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