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Sulfanilamide (United States: Not available): Drug information

Sulfanilamide (United States: Not available): Drug information
(For additional information see "Sulfanilamide (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • AVC Vaginal [DSC]
Pharmacologic Category
  • Antifungal Agent, Vaginal
Dosing: Adult

Note: AVC Vaginal cream has been discontinued in the United States for more than 1 year.

Vulvovaginitis

Vulvovaginitis: Intravaginal: Insert 1 applicatorful intravaginally once or twice daily for 30 days.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

<1%, postmarketing, and/or case reports: Local hypersensitivity reaction (localized burning, local discomfort)

Contraindications

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

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.

Product Availability

AVC Vaginal cream has been discontinued in the United States for more than 1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, Vaginal:

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

Generic Equivalent Available: US

No

Pricing: US

Cream (AVC Vaginal Vaginal)

15% (per gram): $2.26

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Use: Labeled Indications

Vulvovaginitis: Treatment of vulvovaginitis caused by Candida albicans

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

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

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

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 2021]).

Breastfeeding Considerations

Sulfonamides are present in breast milk.

Absorbed sulfonamides are transferred to breast milk and have caused kernicterus in the newborn. Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug.

Mechanism of Action

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PK) Pakistan: Cibamid | Sulphakream-n | Vagisulph;
  • (PR) Puerto Rico: Avc;
  • (UA) Ukraine: Streptocid;
  • (UG) Uganda: Sulphakream-n
  1. AVC (sulfanilamide) [prescribing information]. Somerset, NJ: Meda Pharmaceuticals Inc; June 2018.
  2. Pappas PG, Kauffman CA, Andes D, et al; Infectious Diseases Society of America. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009;48(5):503-535. [PubMed 19191635]
  3. Reef SE, Levine WC, McNeil MM, et al. Treatment of options for vulvovaginal candidiasis, 1993. Clin Infect Dis. 1995;20(suppl 1):80-90. [PubMed 7795112]
  4. Sobel JD. Vulvovaginal candidosis. Lancet. 2007;369(9577):1961-1971. [PubMed 17560449]
  5. Sobel JD, Faro S, Force RW, et al. Vulvovaginal candidiasis: epidemiologic, diagnostic, and therapeutic considerations. Am J Obstet Gynecol. 1998;178(2):203-211. [PubMed 9500475]
  6. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
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