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Fosamax Plus D (Alendronate Sodium / Cholecalciferol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

FOSAMAX PLUS D1 is indicated for:

Treatment of Osteoporosis in Postmenopausal Women

For the treatment of osteoporosis, FOSAMAX PLUS D 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 alone should not be used to treat vitamin D deficiency.

DOSAGE AND ADMINISTRATION

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 (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 (70 mg alendronate/5600 IU vitamin D3) once weekly.

Dosing Instructions

FOSAMAX PLUS D must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information]. 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 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 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 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; Patient Counseling Information].

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 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 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.

HOW SUPPLIED/STORAGE AND HANDLING

No. 3870 — Tablets FOSAMAX PLUS D 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

NDC 0006-0710-21 unit dose packages of 20.

No. 6746 — Tablets FOSAMAX PLUS D 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.

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