FOSAMAX PLUS D® (alendronate sodium & cholecalciferol) is indicated for:

Treatment of Osteoporosis in Postmenopausal Women

For the treatment of osteoporosis, FOSAMAX PLUS D (alendronate sodium & cholecalciferol) increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).

Treatment to Increase Bone Mass in Men with Osteoporosis

Important Limitations of Use

FOSAMAX PLUS D (alendronate sodium & cholecalciferol) alone should not be used to treat vitamin D deficiency.

The safety and effectiveness of FOSAMAX PLUS D (alendronate sodium & cholecalciferol) for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is one 70 mg alendronate/2800 IU vitamin D₃ or one 70 mg alendronate/5600 IU vitamin D₃ tablet once weekly. For most osteoporotic women, the appropriate dose is FOSAMAX PLUS D (alendronate sodium & cholecalciferol) (70 mg alendronate/5600 IU vitamin D₃) once weekly.

Treatment to Increase Bone Mass in Men with Osteoporosis

The recommended dosage is one 70 mg alendronate/2800 IU vitamin D₃ or one 70 mg alendronate/5600 IU vitamin D₃ tablet once weekly. For most osteoporotic men, the appropriate dose is FOSAMAX PLUS D (alendronate sodium & cholecalciferol) (70 mg alendronate/5600 IU vitamin D₃) once weekly.

Dosing Instructions

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

To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, FOSAMAX PLUS D (alendronate sodium & cholecalciferol) should only be swallowed upon arising for the day with a full glass of water (6-8 oz) and patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 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; Medication Guide].

Recommendations for Calcium and Vitamin D Supplementation

Patients should receive supplemental calcium if dietary intake is inadequate [see WARNINGS AND PRECAUTIONS]. 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 IU-800 IU daily. FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 70 mg/2800 IU and 70 mg/5600 IU are intended to provide seven days' worth of 400 and 800 IU daily vitamin D in a single, once-weekly dose, respectively.

Causes of osteoporosis other than estrogen deficiency, aging, and glucocorticoid use should be considered.

Dosing in Elderly and Renal Insufficiency

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 PLUS D (alendronate sodium & cholecalciferol) is not recommended for patients with more severe renal insufficiency (creatinine clearance < 35 mL/min) due to lack of experience.

Dosage Forms and Strengths

• 70 mg/2800 IU tablets are white to off-white, modified capsule-shaped tablets with code 710 on one side and an outline of a bone image on the other.
• 70 mg/5600 IU tablets are white to off-white, modified rectangle-shaped tablets with code 270 on one side and an outline of a bone image on the other.

No. 3870 — Tablets FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 70 mg/2800 IU are white to off-white, modified capsule-shaped tablets with code 710 on one side and an outline of a bone image on the other. They are supplied as follows:

NDC 0006-0710-44 unit of use blister packages of 4.

No. 6746 — Tablets FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 70 mg/5600 IU are white to off-white, modified rectangle-shaped tablets with code 270 on one side and an outline of a bone image on the other. They are supplied as follows:

NDC 0006-0270-44 unit of use blister packages of 4
NDC 0006-0270-21 unit dose packages of 20.

Storage

Store at 20-25°C (68-77°F), excursions between 15-30°C (59-86°F) are allowed. [See USP Controlled Room Temperature.] Protect from moisture and light. Store tablets in the original blister package until use.

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co Inc., Whitehouse Station, NJ 08889, USA. Manuf By: Frosst Iberica, S.A. 28805 Alcala de Henares, Madrid, Spain. Issued January 2011.

Last reviewed on RxList: 3/11/2011
This monograph has been modified to include the generic and brand name in many instances.