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Fosamax Plus D

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Fosamax Plus D

Indications
Dosage
How Supplied

INDICATIONS

Treatment of Osteoporosis in Postmenopausal Women

FOSAMAX® PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies]

Treatment to Increase Bone Mass in Men with Osteoporosis

FOSAMAX PLUS D is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies].

Important Limitations of Use

FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.

The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

DOSAGE AND ADMINISTRATION

Treatment of Osteoporosis in Postmenopausal Women

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

Treatment to Increase Bone Mass in Men with Osteoporosis

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

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 [see PATIENT 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.
  • 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 [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take 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 400-800 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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

  • 70 mg/2800 international units 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 international units 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.

Storage And Handling

No. 3870 — Tablets FOSAMAX PLUS D 70 mg/2800 international units 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 70 mg/5600 international units 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. By: FROSST IBERICA, S.A., 28805 Alcalá de Henares, Madrid, Spain. Revised: 11/2013

Last reviewed on RxList: 11/22/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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