Information About FOSAMAX PLUS D™

The information on this site is intended for healthcare professionals in the United States and is not intended for the general public.

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About FOSAMAX PLUS D

In the treatment of women with postmenopausal osteoporosis
Only FOSAMAX PLUS D offers both proven fracture protection plus once-weekly vitamin D.1,2

The Institute of Medicine guidelines recommend 400 IU/day for women between 51 and 70 years of age and 600 IU/day for women 71 years and older.4

FOSAMAX PLUS D (70 mg/5600 IU) provides 7 days' worth of 800 IU per day in a single, once-weekly dose.

FOSAMAX PLUS D (70 mg/2800 IU) provides 7 days' worth of 400 IU per day in a single, once-weekly dose.

Important Information About FOSAMAX® (alendronate sodium) and FOSAMAX PLUS D

FOSAMAX and FOSAMAX PLUS D are contraindicated in patients with esophageal abnormalities which delay esophageal emptying (eg, stricture or achalasia) and in patients unable to stand or sit upright for at least 30 minutes. Patients at increased risk of aspiration should not receive FOSAMAX oral solution. FOSAMAX and FOSAMAX PLUS D are contraindicated in patients with hypocalcemia (see WARNINGS AND PRECAUTIONS) and in patients with hypersensitivity to any component of these products. Hypersensitivity reactions including urticaria and angioedema have been reported. FOSAMAX and FOSAMAX PLUS D, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa.

FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency (commonly defined as 25-hydroxyvitamin D level below 9 ng/mL).

Patients at increased risk for vitamin D insufficiency (eg, those who are over the age of 70 years, nursing-home bound, or chronically ill) or with gastrointestinal malabsorption syndromes may need additional vitamin D supplementation.

In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue use if severe symptoms develop. Most patients had relief of symptoms after stopping treatment.

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