Bexxam 15

Bexxam 15 Use In Pregnancy & Lactation





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Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Adequate and well-controlled studies in humans have not been done. Meloxicam may cause premature closure of the ductus arteriosus. Therefore, use of Meloxicam is not recommended during pregnancy, especially late pregnancy.
Meloxicam crosses the placenta.
Meloxicam caused an increased incidence of septal defect of the heart at an oral dose 64.5-fold the human dose (15 mg/day for a 50 Kg adult based on body surface area conversion) and embryolethality at oral doses greater than 5.4 times the human dose in rabbits treated throughout organogenesis. Meloxicam was not teratogenic in rats at a dose equivalent to 2.2 times the human dose when given throughout organogenesis. An increased incidence of stillbirths occurred in rats given doses ≥1 mg/Kg/day throughout organogenesis. When female rats were given Meloxicam at half the human dose 2 weeks before mating and during early embryonic development, there was increased incidence of embryolethality. The birth index, the number of live births, and neonatal survival were reduced in rats given oral doses ≥0.125 mg/Kg/day (0.07-fold the human dose) during the late gestation and lactation periods.
Breastfeeding: Studies of distribution of Meloxicam into human breast milk have not been done. However, Meloxicam has been found in the milk of lactating rats at concentrations higher than those in plasma. Because many drugs are distributed in human milk and because of the potential for serious adverse reactions in nursing infants from Meloxicam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Fertility: Meloxicam did not impair male and female fertility in rats at oral doses up to 9 and 5 mg/Kg/day, respectively (4.9-fold and 2.5-fold the human dose of 15 mg/day for a 50 Kg adult based on body surface area conversion).
Labor and delivery: Studies in rats with Meloxicam showed an increased incidence of stillbirths, increased length of delivery time, and delayed parturition at doses 0.5-fold the human dose of 15 mg/day for a 50 Kg adult based on body surface area conversion, and decreased pup survival at an oral dose of 2.1-fold the human dose given throughout organogenesis.
Similar results were observed in rats at 0.07-fold the human dose given during late gestation and lactation period.
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