Alendronicdosage

Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg tablet once weekly. Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly.

Glucocorticoid-induced osteoporosis: 5 mg daily; or 10 mg daily in postmenopausal women not receiving estrogen. Paget's disease: 40 mg daily for six months.

Instruct patients to: Swallow tablets whole with 6 to 8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day. Not lie down for at least 30 minutes after taking alendronate sodium tablets and until after food.

2.1 Treatment of

Osteoporosis in Postmenopausal Women The recommended dosage is: one 70 mg tablet once weekly or one 10 mg tablet once daily

2.2 Prevention of

Osteoporosis in Postmenopausal Women The recommended dosage is: one 35 mg tablet once weekly or one 5 mg tablet once daily

2.3 Treatment to

Increase Bone Mass in Men with Osteoporosis The recommended dosage is: one 70 mg tablet once weekly or one 10 mg tablet once daily

2.4 Treatment of

Glucocorticoid-Induced Osteoporosis 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.

2.5 Treatment of

Paget's Disease of Bone The recommended treatment regimen is 40 mg once a day for six months. Re-treatment of Paget’s Disease Re-treatment with alendronate sodium tablets 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. Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

2.6 Important

Administration Instructions Instruct patients to do the following: Take alendronate sodium tablets at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets. Waiting less than 30 minutes, or taking alendronate sodium tablets with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium tablets by decreasing its absorption into the body. Take alendronate sodium tablets upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an alendronate sodium tablet should be swallowed with a full glass of water (6 to 8 ounces). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets 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.

2.7 Recommendations for

Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium if dietary intake is inadequate. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

2.8 Administration

Instructions for Missed Doses If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.