Fosamax

[Alendronate]

Paget's disease of bone in men and women

The recommended treatment regimen is 40 mg once a day for six months.

Retreatment of Paget's disease

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In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with FOSAMAX. Specific retreatment data are not available, although responses to FOSAMAX were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment with FOSAMAX may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

HOW SUPPLIED

No. 3759 - Tablets FOSAMAX, 5 mg, are white, round, uncoated tablets with an outline of a bone image on one side and code MRK 925 on the other. They are supplied as follows:

NDC 0006-0925-31 unit-of-use bottles of 30
NDC 0006-0925-58 unit-of-use bottles of 100. No. 3797 - Tablets FOSAMAX, 10 mg, are white, oval, wax-polished tablets with code MRK on one

side and 936 on the other. They are supplied as follows:
NDC 0006-0936-31 unit-of-use bottles of 30
NDC 0006-0936-58 unit-of-use bottles of 100
NDC 0006-0936-28 unit dose packages of 100
NDC 0006-0936-82 bottles of 1,000
NDC 0006-0936-72 carton of 25 UNIBLISTER cards of 31 tablets each. No. 3813 - Tablets FOSAMAX, 35 mg, are white, oval, uncoated tablets with code 77 on one side

and a bone image on the other. They are supplied as follows:
NDC 0006-0077-44 unit-of-use blister package of 4
NDC 0006-0077-21 unit dose packages of 20. No. 3592 - Tablets FOSAMAX, 40 mg, are white, triangular-shaped, uncoated tablets with code

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