Alendronicdosage

70 mg alendronate/2800 international units vitamin D 3 or 70 mg alendronate/5600 international units vitamin D 3 tablet once weekly.

Instruct patients to: Swallow tablets whole with 6-8 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 FOSAMAX PLUS D and until after food.

2.1 Treatment of

Osteoporosis in Postmenopausal Women The recommended dosage is one 70 mg alendronate/2800 international units vitamin D 3 or one 70 mg alendronate/5600 international units vitamin D 3 tablet once weekly. For most osteoporotic women, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 international units vitamin D 3 ) once weekly.

2.2 Treatment to

Increase Bone Mass in Men with Osteoporosis The recommended dosage is one 70 mg alendronate/2800 international units vitamin D 3 or one 70 mg alendronate/5600 international units vitamin D 3 tablet once weekly. For most osteoporotic men, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 international units vitamin D 3 ) once weekly.

2.3 Important

Administration Instructions Instruct patients to do the following: Take FOSAMAX PLUS D 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. Waiting less than 30 minutes, or taking FOSAMAX PLUS D with food, beverages (other than plain water) or other medications will lessen the effect of alendronate by decreasing its absorption into the body. Take FOSAMAX PLUS D upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX PLUS D 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. FOSAMAX PLUS D 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.

2.4 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 additional 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. The recommended intake of vitamin D is 400-800 international units daily. FOSAMAX PLUS D 70 mg/2800 international units and 70 mg/5600 international units are intended to provide seven days' worth of 400 and 800 international units daily vitamin D in a single, once-weekly dose, respectively.

2.5 Administration

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