Fosamax Plus™ 70mg/2800IU Tablet
II. INDICATIONS
FOSAMAX PLUS is indicated for:
- Treatment of osteoporosis in postmenopausal women where vitamin D supplementation is recommended. FOSAMAX PLUS reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
- Treatment of osteoporosis in men where Vitamin D supplementation is recommended.
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 PLUS 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 alendronate (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 PLUS 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 PLUS 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).
The recommended dosage is one 70 mg/2800 international units or one 70 mg/5600 international units tablet once weekly. For most osteoporotic patients the appropriate dose is 70 mg/5600 international units once weekly.
Patients should receive supplemental calcium and/or vitamin D, if intake is inadequate (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Physicians should consider the vitamin D intake from vitamins and dietary supplements. FOSAMAX PLUS 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.
Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
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 is not recommended for patients with more severe renal insufficiency (creatinine clearance < 35 mL/min) due to lack of experience.
