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)]
Pharmacology
Mechanism of Action
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
Dosage and Administration
Dosing: Adult
Vulvovaginitis: Intravaginal: Insert one applicatorful intravaginally once or twice daily for 30 days
Dosing: Geriatric
Refer to adult dosing.
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%, postmarketing, and/or case reports: 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
Pregnancy Considerations
Sulfanilamide crosses the placenta.
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. When treatment for vulvovaginitis in pregnancy is needed, other agents are recommended (CDC [Workowski 2015]).
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?)
- Have patient report immediately to prescriber signs of a severe sulfonamide reaction (rash; red, swollen, blistered, or peeling skin; red or irritated eyes; mouth, throat, nose, or eye sores; fever, chills, or sore throat; cough that is new or worse; loss of strength and energy; any bruising or bleeding), signs of liver problems (dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, or yellow skin), or severe application site irritation (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.
