Avezol Use In Pregnancy & Lactation





Full Prescribing Info
Use In Pregnancy & Lactation
Use during pregnancy: There have been reports of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150mg of fluconazole as a single or repeated dose in the first trimester.
Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom Avezol may be used if the anticipated benefit outweighs the possible risk to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus.
Effective contraceptive measures should be considered in women of child-bearing potential and should continue throughout the treatment period and for approximately 1 week (5 to 6 halflives) after the final dose.
There have been reports of multiple congenital abnormalities in infants whose mothers were treated with high-dose (400mg/day to 800mg/day) fluconazole therapy for coccidioidomycosis (an unapproved indication). The relationship between fluconazole use and these events is unclear. Adverse fetal effects have been seen in animals only at high-dose levels associated with maternal toxicity. There were no fetal effects at 5 mg/kg or 10 mg/kg; increases in fetal anatomical variants (supernumerary ribs, renal pelvis dilation) and delays in ossification were observed at 25 mg/kg and 50 mg/kg and higher doses. At doses ranging from 80 mg/kg (approximately 20-60 times the recommended human dose) to 320 mg/kg, embryolethality in rats were increased and fetal abnormalities included wavy ribs, cleft palate and abnormal craniofacial ossification.
Case reports describe a distinctive and a rare pattern of birth defects among infants whose mothers received high dose (400-800mg/day) fluconazole during most or all of the first trimester of pregnancy. The features seen in these infants include brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease.
Use during lactation: Fluconazole is found in human breast milk at concentrations similar to plasma. Breast-feeding may be maintained after a single dose of 150mg fluconazole. Breast-feeding is not recommended after repeated use or after high-dose fluconazole.
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