Sigmaderm Pregnancy

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• Pregnancy of Sigmaderm in details
• Sigmaderm breastfeeding
• Sigmaderm reviews

Pregnancy of Sigmaderm in details

Pregnancy predisposes patients to the development of vaginal candidiasis due to changes in the vaginal tract. Sigmaderm has been used in several clinical trials for the treatment of vaginal candidiasis during the second and third trimester without evidence of fetal harm. One trial included 57 patients in their first trimester. Again no adverse effects were attributed to Sigmaderm. In a review of 229,101 deliveries to Michigan Medicaid patients, 2624 first-trimester exposures to Sigmaderm and 8590 exposures any time during pregnancy were recorded. A total of 118 birth defects were reported with first trimester exposure (112 expected) and included (observed/expected) 27/26 cardiovascular defects, 3/1 spina bifida, 4/4 oral clefts, 9/6 polydactyly, 1 limb reduction, and 6/6 hypospadias. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between first-trimester Sigmaderm use and birth defects.

Sigmaderm has been assigned to pregnancy category C by the FDA when given as oral troches, and pregnancy category B when used intravaginally or topically. Animals given high doses intravaginally and orally have not shown evidence of teratogenicity. In clinical trials involving women in their second and third trimester, Sigmaderm treatment of vaginal candidiasis has not been associated with fetal harm. Sigmaderm use has not been well studied during the first trimester. Sigmaderm is only recommended for use during pregnancy when benefit outweighs risk.

Sigmaderm breastfeeding

There are no data on the excretion of Sigmaderm into human milk.

See references

References for pregnancy information

1. "Product Information. Mycelex (Sigmaderm)." Bayer, West Haven, CT.
2. Haram K, Digranes A "Vulvovaginal candidiasis in pregnancy treated with Sigmaderm." Acta Obstet Gynecol Scand 57 (1978): 453-5
3. Frerich W, Gad A "The frequency of Candida infections in pregnancy and their treatment with Sigmaderm." Curr Med Res Opin 4 (1977): 640-4
4. Tan CG, Good CS, Milne LJ, Loudon JD "A comparative trial of six day therapy with Sigmaderm and nystatin in pregnant patients with vaginal candidiasis." Postgrad Med J 50 Suppl 1 (1974): 102-5
5. Lindeque BG, van Niekerk WA "Treatment of vaginal candidiasis in pregnancy with a single Sigmaderm 500 mg vaginal pessary." S Afr Med J 65 (1984): 123-4

References for breastfeeding information

1. "Product Information. Mycelex (Sigmaderm)." Bayer, West Haven, CT.

References

1. DailyMed. "GENTAMICIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. PubMed Health. "Mycelex: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology