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Canadian Pharmacy |
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Category C
Pregnancy
The reproduction 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 above ranged of doses starts
from 0.26 times (1 mg/ kg) to 2.6 times (10 mg/ kg) a maximum recommended
daily dose of 40 mg based on surface area, mg/ m2. No same changes 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/ m 2). Protracted
parturition due to maternal hypocalcemia occurred in rats at doses as low
as 0.5 mg/ kg/ day (0. 13 times a 40 mg human daily dose based on surface
area, mg/ m 2 ) when rats were treated from before mating through gestation.
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 growth;
these deaths were lessened but not eliminated by the termination of treatment.
Either Calcium supplementation in the drinking water or by minipump could
not improve the hypocalcemia or prevent maternal and neonatal deaths due
to delays in delivery; calcium supplementation IV prevented maternal, but
not fetal deaths. There are no studies in pregnant women.
This medicine should be used during pregnancy only if the potential benefit
justifies the potential risk to the mother and fetus.
Nursing Mothers
It is unknown whether alendronate is excreted in human milk. Because
many drugs are excreted in human milk so caution is advisable when Fosamax
is administered to nursing women.
Pediatric Use
For elders Safety and effectiveness have not been established. More than
71% of the patients receiving Fosamax in the Fracture Intervention Trial
(FIT) were 65 years of age. And 17% (n= 550) were 75 years of age. . Of
the patients receiving Fosamax in the United States and Multinational osteoporosis
treatment studies in women, the osteoporosis study in men, glucocorticoid-induced
osteoporosis studies, and Paget's disease studies 45%, 50%, 37%, and 70%,
respectively, were 65 years of age or over. It has been observed that there
is no difference between these patients and younger patients. , but more
sensitivity of some older individuals cannot be ruled out. |
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