FOSAMAX is indicated for:

• Treatment and prevention of osteoporosis in postmenopausal women
  • For the treatment of osteoporosis, FOSAMAX increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.)
  • For the prevention of osteoporosis, FOSAMAX may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture.
• Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of FOSAMAX for prevention of osteoporosis.
• Treatment to increase bone mass in men with osteoporosis
• Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density (see PRECAUTIONS, Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
• Treatment of Paget's disease of bone in men and women
  • Treatment is indicated in patients with Paget's disease of bone having alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.

FOSAMAX must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of FOSAMAX (see PRECAUTIONS, DRUG INTERACTIONS). Waiting less than 30 minutes, or taking FOSAMAX with food, beverages (other than plain water) or other medications will lessen the effect of FOSAMAX by decreasing its absorption into the body.

FOSAMAX should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX tablet should be swallowed with a full glass of water (6-8 oz). To facilitate gastric emptying FOSAMAX oral solution should be followed by at least 2 oz (a quarter of a cup) of water. Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences (see WARNINGS, PRECAUTIONS, Information for Patients).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

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 <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 bottle of 70 mg oral solution once weekly

or

• one 10 mg tablet once daily

Treatment to increase bone mass in men with osteoporosis

The recommended dosage is:

• one 70 mg tablet once weekly

or

• one bottle of 70 mg oral solution once weekly

or

• one 10 mg tablet once daily

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.

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.

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:
NDC 0006-0212-31 unit-of-use bottles of 30.

No. 3814 — Tablets FOSAMAX, 70 mg, are white, oval, uncoated tablets with code 31 on one side and an outline of a bone image on the other. They are supplied as follows:
NDC 0006-0031-44 unit-of-use blister package of 4
NDC 0006-0031-21 unit dose packages of 20.

No. 3833 — Oral Solution FOSAMAX, 70 mg, is a clear, colorless solution with a raspberry flavor and is supplied as follows:
NDC 0006-3833-34 unit-of-use cartons of 4 single-dose bottles containing 75 mL each. Storage

FOSAMAX Tablets:

Store in a well-closed container at room temperature, 15-30°C (59-86°F).

FOSAMAX Oral Solution:

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Do not freeze.

MERCK & CO., INC,Whitehouse Station, NJ 08889, USA
Issued February 2006. Printed in USA. FDA rev date: 12/28/2006

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