AVC

Gynecological Antibiotics and Sulfonamides

Sulfanilamide preparations are for intravaginal use only; do not apply to the eye, mouth, or skin.
Cream and suppositories: Use applicator(s) supplied by the manufacturer. Instruct patient on proper administration and treatment course (see Patient information).
If an adequate response is not achieved, the diagnosis should be reconfirmed and other pathogens commonly associated with vulvovaginitis ruled out.

vaginal irritation / Early / 0.2-0.2

AVC

Rx

Topical antiinfective agent for vaginal use. Only for treatment of vulvovaginal candidiasis due to Candida albicans. Specially compounded to a pH approximately equal to that of the normal vagina (about 4.3) which helps to encourage growth of Doderlein's bacilli.

Use 1 applicatorful (roughly 6 g) PV once or twice daily for 30 days.[47303] Sulfanilamide is not included in the CDC's sexually transmitted diseases guidelines for VVVC.

No dosage adjustment appears needed. However, use with caution since sulfonamides are absorbed systemically via the vaginal mucosa and metabolized by the liver.

No dosage adjustment appears needed. However, use with caution since sulfonamides are absorbed systemically via the vaginal mucosa and some excretion via the kidney occurs.

There are no drug interactions associated with Sulfanilamide products.

AVC Vaginal Cream: 15%

2 applicatorfuls of cream/day PV; 2 suppositories/day PV.

2 applicatorfuls of cream/day PV; 2 suppositories/day PV.

Safe and effective use has not been established.

Safe and effective use has not been established.

Sulfonamides, including sulfanilamide, inhibit bacterial dihydropteroate synthase by competing with p-aminobenzoic acid (PABA). This action interferes with the conversion of PABA into folic acid, an essential component of bacterial development. Folic acid is a coenzyme responsible for the transport of one-carbon fragments from one molecule to another, and it is crucial during the synthesis of thymidine, purines, and certain amino acids. When used intravaginally, sulfanilamide is in a specially compounded base buffered to the pH (about 4.3) of the normal vagina to encourage the presence of the normally occurring Doderlein’s bacilli of the vagina.

Sulfanilamide is administered intravaginally. Metabolism of any systemically-absorbed drug occurs in the liver, with renal excretion of the metabolites.

Intravaginal Route
Like other vaginally administered sulfonamides, sulfanilamide is absorbed systemically through the vaginal mucosa. There are no pharmacokinetic data available describing how much of an intravaginal dose reaches the systemic circulation.

Use sulfanilamide during pregnancy only when clearly needed as it is unknown if it can cause fetal harm. Sulfonamides should generally be avoided near term due to the potential for jaundice, hemolytic anemia, and kernicterus in the newborn. Sulfanilamide is absorbed through the vaginal mucosa, and sulfonamides readily cross the placenta with fetal concentrations averaging 70% to 90% of maternal concentrations. In a nested, case-control study (n = 87,020 controls; 8,702 cases) within the Quebec Pregnancy Cohort, sulfonamide use during early pregnancy was associated with an increased risk of spontaneous abortion (adjusted odds ratio (aOR) 2.01; 95% CI: 1.36 to 2.97; 30 exposed cases); residual confounding by severity of infection may be a potential limitation of this study. However, other studies such as the Collaborative Perinatal Project, which included 1,455 mothers with first trimester sulfonamide exposure and 5,689 with exposure anytime during pregnancy, found no evidence to suggest a relationship between sulfonamide use during and fetal malformations.

According to the manufacturer, because of the potential risk to a nursing neonate, either breast feeding or sulfanilamide should be discontinued. Sulfonamides are absorbed through the vaginal mucosa and are excreted in breast milk in low concentrations. Sulfanilamide should not be used in mothers who are breast-feeding infants less than 2 months of age because sulfonamides may promote kernicterus in the newborn by displacing bilirubin from plasma proteins. Sulfanilamide may be considered for use when breast-feeding healthy infants; however, caution should be used in infants with jaundice, hyperbilirubinemia, or G-6-PD deficiency or in infants who are critically ill, stressed, or premature. Fluconazole is generally considered compatible with breast-feeding by the American Academy of Pediatrics (AAP) and may be a potential alternative to consider during breast-feeding. However, site of infection, patient factors, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.