Consists of Miconazole, Mometasone
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Elica-M Pregnancy |
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Consists of Miconazole, Mometasone
Pregnancy predisposes patients to the development of vaginal candidiasis due to changes in the vaginal tract. Miconazole (Elica-M) has been used in several clinical trials for the treatment of vaginal candidiasis, generally during the second and third trimester, without evidence of fetal harm. In a review of 229,101 deliveries to Michigan Medicaid patients, 7266 first-trimester exposures to Miconazole (Elica-M) and 31,503 exposures any time during pregnancy were recorded. A total of 304 birth defects were reported with first trimester exposure (273 expected) and included (observed/expected) 77/73 cardiovascular defects, 14/13 clefts, 3 spina bifida, 4/4 oral clefts, 22/15 polydactyly, 12/9 limb reductions, and 20/17 hypospadias (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). These data do not support an association between first-trimester Miconazole (Elica-M) use and birth defects.
Miconazole (Elica-M) has not officially been assigned to a pregnancy category by the FDA. In clinical trials, Miconazole (Elica-M) treatment of vaginal candidiasis has not been associated with fetal harm. Miconazole (Elica-M) is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
There are no data on the excretion of Miconazole (Elica-M) into human milk. The manufacturer recommends that caution be used when administering Miconazole (Elica-M) to nursing women.
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Animal reproduction studies in mice, rats, and rabbits revealed evidence of teratogenicity, such as increased fetal malformations and decreased fetal growth (measured by lower fetal weights and/or delayed ossification). Dystocia and related complications were also observed when administered in late gestation. In mice, subcutaneous administration produced cleft palate at approximately one-third of the maximum recommended daily human dose (MRHD). In rats, topical administration produced umbilical hernia at doses approximately 6 times the MRHD. Subcutaneous administration in rats, throughout pregnancy or late in gestation, had caused prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at doses approximately 8 times the MRHD. In rabbits, topical administration caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 3 times the MRHD. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: C Comments: -Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. -Monitor signs of hypoadrenalism in infants born to mothers taking substantial corticosteroid doses during pregnancy.
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A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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