FOSAMAX TABLET 70 mg

II. INDICATIONS

FOSAMAX is indicated for the treatment of osteoporosis in postmenopausal women.

For the treatment of osteoporosis, FOSAMAX reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).

FOSAMAX is indicated for the treatment of osteoporosis in men.

The optimal duration of use of bisphosphonates for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

V. CONTRAINDICATIONS

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
• Inability to stand or sit upright for at least 30 minutes
• Hypersensitivity to any component of this product
• Hypocalcemia (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

III. DOSAGE AND ADMINISTRATION

FOSAMAX must be taken 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 FOSAMAX (see DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, FOSAMAX should only be swallowed upon arising for the day with a full glass of water and patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX 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 PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

Treatment of osteoporosis in postmenopausal women and in men

The recommended dosage is one 70 mg tablet once weekly.