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Canadian Pharmacy |
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Estrogen/ hormone replacement therapy
(HRT)
simultaneously use of HRT (estrogen ± progestin) and Fosamax was
assessed in two clinical studies of one or two years' duration in postmenopausal
osteoporotic women. According to these studies, the safety profile of the
combination was constant with those of the individual treatments; however,
the degree of suppression of bone turnover was significantly greater with
the combination than with either component alone. The long-term effects
of combined Fosamax and HRT on fracture occurrence have not been studied.
Calcium Supplements/ Antacids
The interference between calcium supplements, antacids, some oral medications
with absorption of Fosamax is possible, so it is advisable to wait at least
one-half hour after taking Fosamax before taking any other oral medications.
Aspirin
In clinical studies, the incidence of upper gastrointestinal adverse events
was increased in patients receiving concomitant therapy with daily doses
of Fosamax greater than 10 mg and aspirin-containing products. Nonsteroidal
Anti-inflammatory Drugs Fosamax may be administered to patients taking Nsaid's.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Harderian gland - a retro-orbital gland not present in humans. Adenomas
were increased in high-dose female mice (p= 0.003) in a 92-week oral carcinogenicity
study at doses of alendronate of 1, 3, and 10 mg/ kg/ day (males) or 1,
2, and 5 mg/ kg/ day (females). These doses are equivalent to 0.12 to 1.2
times a maximum recommended daily dose of 40 mg based on surface area, mg/
m 2. Where as Parafollicular cell (thyroid) adenomas were increased in high-dose
male rats (p= 0.003) in a 2-year oral carcinogenicity study at doses of
1 and 3.75 mg/ kg body weight. These doses are equivalent to 0.26 and 1
times a 40 mg human daily dose based on surface area, mg/ m 2. The relevance
of this finding to humans is unidentified. Alendronate was not genotoxic
in the in vitro microbial mutagenesis assay with and without metabolic activation,
in an in vitro mammalian cell mutagenesis assay, in an in vitro alkaline
elution assay in rat hepatocytes, and in an in vivo chromosomal aberration
assay in mice. In an in vitro chromosomal aberration assay in Chinese hamster
ovary cells, however, alendronate gave equivocal results. Alendronate had
no effect on fertility (male or female) in rats at oral doses up to 5 mg/
kg/ day (1. 3 times a 40 mg human daily dose based on surface area, mg/
m 2
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