Fosdin Pack

Fosdin Pack Use In Pregnancy & Lactation

calcium citrate + vitamin d3

alendronic acid

Manufacturer:

Hersil

Distributor:

MedChoice Endocrine Group
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy/reproduction: Fertility: Alendronic acid had no effect on the fertility or reproductive performance (male or female) in rats at oral doses up to 5 mg/kg/day.
Pregnancy: no proper and well-controlled studies have been conducted for alendronic acid. Reproductive studies in rats showed decreased post-implantation survival at 2 mg/kg/day and decreased body weight gain in normal pups at 1 mg/kg/day. Sites of incomplete fetal ossification were statistically significantly increased in rats beginning at 10 mg/kg/day in vertebral (cervical, thoracic, and lumbar), skull, and sternebral bones. The previously mentioned doses ranged from 0.26 times (1 mg/kg) to 2.6 times (10 mg/kg) a maximum recommended daily dose of 40 mg (Paget's disease) based on surface area, mg/sq m. No similar fetal effects were seen when pregnant rabbits were treated at doses up to 35 mg/kg/day (10.3 times a 40 mg human daily dose based on surface area, mg/sq m). Both total and ionized calcium decreased in pregnant rats at 15 mg/kg/day (3.9 times a 40 mg human daily dose based on surface area, mg/sq m) resulting in delays and failures of delivery. Maternotoxicity (late pregnancy deaths) occurred in the female rats treated with 15 mg/kg/day for varying periods of time ranging from treatment only during pre-mating to treatment only during early, middle, or late gestation; these deaths were lessened but not eliminated by cessation of treatment.
Pregnancy Category C.
Nursing: It is not known whether alendronic acid is excreted into human breast milk. Given the indication, alendronic acid should not be used by breast-feeding women.
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