FOSAMAX PLUS D contains alendronate sodium, a bisphosphonate, and cholecalciferol (vitamin D 3 ). Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C 4 H 12 NNaO 7 P 2 ...

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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. 1.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX ® PLUS D is indic...

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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. 2.1 Treatment of Osteoporosis in Postmenopausal Women The recommended dosage is one 70 mg alendronate/2800 international units vitamin ...

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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 le...

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Alendronate Sodium Significant lethality after single oral doses with alendronate was seen in female rats and mice at 552 mg/kg (3256 mg/m 2 ) and 966 mg/kg (2898 mg/m 2 ), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m 2 ). No specific information is available on the treatment of overdosage with alendronate. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events,...

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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 Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out an incomplete femoral fracture. 5.1 Upper Gastrointest...

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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. ( 7.4 , 7.5 , 12.3 ) 7.1 Calcium Supplements/Antacids Co-administration of FOSAMAX PLUS D and calcium,...

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Available data on the use of FOSAMAX plus vitamin D use in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue FOSAMAX PLUS D when pregnancy is recognized. Alendronate Sodium In animal reproduction studies, daily oral administration of alendronate to rats from before mating through the end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than h...

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