Alendronate and Cholecalciferol

FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D indicated for: Treatment of osteoporosis in postmenopausal women. Treatment to increase bone mass in men with osteoporosis. Limitations of use: FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.

Alendronate Sodium Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [ 3 H]alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [ 3 H]alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active.

70 mg alendronate/2800 international units vitamin D 3 or 70 mg alendronate/5600 international units vitamin D 3 tablet once weekly. Instruct patients to: Swallow tablets whole with 6-8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day. Not lie down for at least 30 minutes after taking FOSAMAX PLUS D and until after food.

FOSAMAX PLUS D is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia Inability to stand or sit upright for at least 30 minutes Hypocalcemia Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported. Abnormalities of the esophagus which delay emptying such as stricture or achalasia. Inability to stand/sit upright for at least 30 minutes. Hypocalcemia. Hypersensitivity to any component of this product

Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur. Hypocalcemia can worsen and must be corrected prior to use. Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop. Osteonecrosis of the Jaw has been reported. Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered.

The following clinically significant adverse drug reactions are described elsewhere in the labeling: Upper Gastrointestinal Adverse Reactions Mineral Metabolism Musculoskeletal Pain Osteonecrosis of the Jaw Atypical Fractures Including Femoral Fractures Renal Impairment Most common adverse reactions (greater than or equal to 3%) for alendronate are: abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea.

Calcium supplements/antacids or oral medications containing multivalent cations interfere with absorption of alendronate. Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. Some drugs may impair the absorption or increase the catabolism of cholecalciferol (vitamin D 3 ). Additional vitamin D supplementation should be considered.

Storage Store at 68°F to 77°F (20°C to 25°C), excursions between 59°F to 86°F (15°C to 30°C). are allowed. Protect from moisture and light. Store tablets in the original blister package until use.