PRECAUTIONS
General
Discontinue drug if sensitization or irritation is reported during use. The base contained in the suppository formulation may interact with certain latex products, such as that used in vaginal contraceptive diaphragms. Concurrent use is not recommended. MONISTAT 7 Vaginal Cream may be considered for use under these conditions.
Laboratory Tests
If there is a lack of response to MONISTAT 3 Vaginal Suppositories, appropriate microbiological studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies to determine carcinogenic potential have not been performed.
Fertility (Reproduction)
Oral administration of miconazole nitrate in rats has been reported to produce prolonged gestation. However, this effect was not observed in oral rabbit studies. In addition, signs of fetal and embryo toxicity were reported in rat and rabbit studies, and dystocia was reported in rat studies after oral doses at and above 80 mg per kg. Intravaginal administration did not produce these effects in rats.
Pregnancy
Since imidazoles are absorbed in small amounts from the human vagina, they should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.
Clinical studies, during which miconazole nitrate vaginal cream and suppositories were used for up to 14 days, were reported to include 514 pregnant patients. Follow-up reports available in 471 of these patients reveal no adverse effects or complications attributable to miconazole nitrate therapy in infants born to these women.
Nursing Mothers
It is not known whether miconazole nitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when miconazole nitrate is administered to a nursing woman.
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