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 Tablet 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 Tablet at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information (17.2)]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of Alendronate Sodium Tablet [see Drug Interactions (7.1)]. Waiting less than 30 minutes, or taking Alendronate Sodium Tablet with food, beverages (other than plain water) or other medications will lessen the effect of Alendronate Sodium by decreasing its absorption into the body.
Take Alendronate Sodium Tablet 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 (6-8 ounces). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate Sodium Tablet 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 and Precautions (5.1) and Patient Counseling Information (17.2)].
2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. 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 Tablet 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.
