Results from First Comparative Study Show Fosamax-R- Increased BMD in the Hip and Spine More Than Actonel in Postmenopausal Women with Osteoporosis

Business Wire, Sept 29, 2002

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). FOSAMAX is not recommended for patients with more severe renal insufficiency (creatinine clearance less than 35 mL/min) due to lack of experience.

Treatment of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE) The recommended dosage is:

-- one 70 mg tablet once weekly or

-- one 10 mg tablet once daily

Treatment to increase bone mass in men with osteoporosis The recommended dosage is one 10 mg tablet once daily.

Alternatively, one 70 mg tablet once weekly may be considered.

Prevention of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE) The recommended dosage is:

-- one 35 mg tablet once weekly

or -- one 5 mg tablet once daily

The safety of treatment and prevention of osteoporosis with FOSAMAX has been studied for up to 7 years.

Treatment of glucocorticoid-induced osteoporosis in men and women

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily. 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

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(tm) 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 MRK 212 on one side and FOSAMAX on the other. They are supplied as follows: