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Calcium Supplements/ Antacids Co-administration of ACTONEL and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of ACTONEL. Hormone Replacement Therapy Text Continues Below
One study of about 500 early postmenopausal women has been conducted to date in which treatment with ACTONEL (5 mg/ day) plus estrogen replacement therapy was compared to estrogen replacement therapy alone. Exposure to study drugs was approximately 12 to 18 months and the primary endpoint was change in BMD. If considered appropriate, ACTONEL may be used concomitantly with hormone replacement therapy. Aspirin/ Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Of over 5700 patients enrolled in the ACTONEL Phase 3 osteoporosis studies, aspirin use was reported by 31% of patients, 24% of whom were regular users (3 or more days per week). Forty-eight percent of patients reported NSAID use, 21% of whom were regular users. Among regular aspirin or NSAID users, the incidence of upper gastrointestinal adverse experiences in ACTONEL-treated patients (24. 5%) was similar to that in placebo-treated patients (24. 8%). H2 Blockers and Proton Pump Inhibitors (PPIs) Of over 5700 patients enrolled in the ACTONEL Phase 3 osteoporosis studies, 21% used H2 blockers and/ or PPIs. Among these patients, the incidence of upper gastrointestinal adverse experiences in the ACTONEL-treated patients was similar to that in placebo-treated patients. Drug/ Laboratory Test Interactions Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ACTONEL have not been performed. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis
In a 104-week carcinogenicity study, rats were administered daily oral doses up to 24 mg/ kg/ day (approximately 7.7 times the maximum recommended human daily dose of 30 mg based on surface area, mg/ m 2 ). There were no significant drug-induced tumor findings in male or female rats. The high dose male group of 24 mg/ kg/ day was terminated early in the study (Week 93) due to excessive toxicity, and data from this group were not included in the statistical evaluation of the study results. In an 80-week carcinogenicity study, mice were administered daily oral doses up to 32 mg/ kg/ day (approximately 6.4 times the 30-mg/ day human dose based on surface area, mg/ m 2 ). There were no significant drug-induced tumor findings in male or female mice. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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