Sulfanilamide

The common side effects involved in using Sulfanilamide are Local sensitivity, Discomfort, Rashes, Burning sensation , Redness

Sulfanilamide functions as a competitive inhibitor of the bacterial enzyme dihydropteroate synthetase. This particular enzyme typically utilizes para-aminobenzoic acid (PABA) to produce the essential folic acid required by the organism. By inhibiting this reaction, which is vital for folic acid synthesis, sulfanilamide prevents bacterial replication as the bacteria are unable to proceed without it.

• Vulvovaginitis

• Vulvovaginitis

• Vulvovaginitis treatment: For intravaginal administration, insert one applicatorful into the vagina once or twice daily for a duration of 30 days.

Method:

• Prior to and following use, it is important to wash your hands.
• Before utilizing the product, carefully read the instructions provided on the packaging.
• Attach the applicator to the end of the tube by screwing it on and then squeeze the tube to fill the applicator.
• Remove the applicator from the tube.
• Position yourself on your back.
• Gently insert the applicator tip deeply into the vagina and push the plunger to release the cream into the vagina.
• Carefully remove the applicator.
• Thoroughly cleanse the applicator using warm water and soap.
• Follow the instructions of your healthcare professional regarding the recommended frequency of use.
• Complete the entire prescribed treatment duration, even if your symptoms improve.
• Do not discontinue the use of this medication if your menstrual period begins during the treatment period.

Dosage strength of  sulfanilamide in Vaginal cream: 15%

• Sulfanilamide is contraindicated in patients who have demonstrated hypersensitivity to the drug.

General precautions for oral sulfonamides also apply to their absorption from the vaginal mucosa. Patients need to be closely monitored for any signs of skin rash or systemic toxicity, and if these symptoms occur, the medications should be discontinued.

Hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood disorders have been associated with fatalities related to the use of oral sulfonamides.

Rare occurrences of goiter production, diuresis, and hypoglycemia have been reported in patients who receive oral sulfonamides. It is possible that cross-sensitivity exists with these agents. Rats are particularly vulnerable to the goitrogenic effects of sulfonamides, and prolonged administration of these drugs in this species has reportedly led to thyroid malignancies.

After the seventh month of pregnancy, it is advised to exercise caution when using vaginal applicators or inserters.

General precautions for oral sulfonamides also apply to their absorption from the vaginal mucosa. Patients need to be closely monitored for any signs of skin rash or systemic toxicity, and if these symptoms occur, the medications should be discontinued.

Hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood disorders have been associated with fatalities related to the use of oral sulfonamides.

Rare occurrences of goiter production, diuresis, and hypoglycemia have been reported in patients who receive oral sulfonamides. It is possible that cross-sensitivity exists with these agents. Rats are particularly vulnerable to the goitrogenic effects of sulfonamides, and prolonged administration of these drugs in this species has reportedly led to thyroid malignancies.

After the seventh month of pregnancy, it is advised to exercise caution when using vaginal applicators or inserters.

Nursing mothers should avoid the use of sulfanilamide due to the presence of absorbed sulfonamides in breast milk, which have been known to cause kernicterus in newborns. Considering the potential for significant adverse effects in breastfeeding infants from sulfonamides, it is necessary to decide whether to discontinue nursing or discontinue the medication.

Teratogenic Effects - Category C

Sulfonamides, including sulfanilamide (refer to details below), have been subject to animal reproductive studies and are categorized as Pregnancy Category C. The potential impact of Sulfanilamide on fetal development or reproductive capacity in pregnant women is currently unknown. Administration of Sulfanilamide to pregnant women should be considered only if absolutely necessary. Sulfonamides, including sulfanilamide, have the ability to cross the placenta and reach the fetal bloodstream, with concentrations ranging from 50-90% of those found in the maternal blood. When present in sufficiently high levels, these substances can cause toxic effects. The safe usage of sulfonamides, including sulfanilamide, during pregnancy has not been definitively established. The teratogenic potential of most sulfonamides has not been extensively studied in either animals or humans. However, when given orally to pregnant rats and mice at high doses (seven to 25 times the human therapeutic oral dose), certain sulfonamides of different durations (including sulfanilamide) have shown a significant increase in the occurrence of cleft palate and other skeletal abnormalities in offspring.

Common:

● Local sensitivity

● Discomfort

● Rashes

● Burning sensation

● Redness

● Local sensitivity

● Discomfort

● Rashes

● Burning sensation

● Redness

Teratogenic Effects - Category C

Sulfonamides, including sulfanilamide (refer to details below), have been subject to animal reproductive studies and are categorized as Pregnancy Category C. The potential impact of Sulfanilamide on fetal development or reproductive capacity in pregnant women is currently unknown. Administration of Sulfanilamide to pregnant women should be considered only if absolutely necessary. Sulfonamides, including sulfanilamide, have the ability to cross the placenta and reach the fetal bloodstream, with concentrations ranging from 50-90% of those found in the maternal blood. When present in sufficiently high levels, these substances can cause toxic effects. The safe usage of sulfonamides, including sulfanilamide, during pregnancy has not been definitively established. The teratogenic potential of most sulfonamides has not been extensively studied in either animals or humans. However, when given orally to pregnant rats and mice at high doses (seven to 25 times the human therapeutic oral dose), certain sulfonamides of different durations (including sulfanilamide) have shown a significant increase in the occurrence of cleft palate and other skeletal abnormalities in offspring.

Lactation:

Nursing mothers should avoid the use of sulfanilamide due to the presence of absorbed sulfonamides in breast milk, which have been known to cause kernicterus in newborns. Considering the potential for significant adverse effects in breastfeeding infants from sulfonamides, it is necessary to decide whether to discontinue nursing or discontinue the medication.

Pediatric:

The safety and efficacy of Sulfanilamide in pediatric patients have not been confirmed or established.

Geriatric Use:

No specific information is available.

Sulfanilamide has not been linked to any accidental overdoses based on available reports. In mice, the acute oral LD50 of sulfanilamide ranges from 3700 to 4200 mg/kg, indicating the lethal dose for this substance in a single oral instance. However, the minimum lethal dose of Sulfanilamide for humans has not yet been established. Furthermore, it remains unclear whether Sulfanilamide is dialyzable, as no information is currently available on its potential removal through dialysis.

● Sulfanilamide, an ingredient used in vaginal formulations for approximately four decades, acts by inhibiting specific metabolic processes necessary for the growth of susceptible bacteria.

● In Sulfanilamide cream, sulfanilamide is incorporated into a specially formulated base that is buffered to match the pH (around 4.3) of the normal vagina, promoting the presence of Döderlein's bacilli, which naturally occur in the vagina.

● The efficacy of Sulfanilamide in treating vulvovaginitis caused by Candida albicans is supported by three clinical studies.

● These three studies demonstrate that Sulfanilamide with sulfanilamide is significantly more effective (p ≤ 0.01) than placebo, with the following results:

○ In Study I, the effectiveness ratio was 71% for Sulfanilamide with sulfanilamide compared to 49% for placebo after 30 days of treatment.

○ In Study II, the percentages were 48% and 24% respectively, with 15 days of treatment.

○ In Study III, the percentages were 66% versus 33% respectively, with 30 days of treatment.

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