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MUSCULO-SKELETAL SYSTEM › DRUGS FOR TREATMENT OF BONE DISEASES › DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION › Bisphosphonates, combinations
alendronic acid and colecalciferol
M05BB03
Forms & Strengths
- Alendronate 70 mg / Cholecalciferol 2,800 IU oral tablet
- Alendronate 70 mg / Cholecalciferol 28,000 IU oral tablet
Adult Dosing
- Treatment of postmenopausal osteoporosis: 1 tablet (70 mg alendronate / 2,800 IU or 28,000 IU cholecalciferol) once weekly
- Must be taken in the morning at least 30 minutes before the first food, beverage, or medication of the day with a full glass of plain water
- Patients must remain upright (sitting or standing) for at least 30 minutes and until after food
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established; use is not recommended
Indications
- Treatment of osteoporosis in postmenopausal women to reduce the incidence of fractures
- To provide vitamin D supplementation in patients with postmenopausal osteoporosis
Mechanism of Action
- Alendronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption by binding to hydroxyapatite in bone, reducing bone turnover
- Cholecalciferol (Vitamin D3) is essential for efficient calcium and phosphate absorption in the small intestine and for normal bone mineralization
Contraindications
- Abnormalities of the esophagus which delay esophageal emptying such as stenosis or achalasia
- Inability to stand or sit upright for at least 30 minutes
- Hypocalcemia
- Known hypersensitivity to alendronate, cholecalciferol, or any component of the formulation
- Vitamin D toxicity or hypervitaminosis D
Adverse Reactions
- Abdominal pain, acid reflux, nausea, constipation, or diarrhea
- Esophagitis, esophageal erosion, or esophageal ulceration
- Musculoskeletal pain (bone, joint, or muscle)
- Headache and dizziness
- Rare: Osteonecrosis of the jaw, atypical femoral fractures
Drug Interactions
- Antacids, calcium supplements, and multivalent cation-containing medications interfere with the absorption of alendronate (space by at least 30 minutes)
- Aspirin and NSAIDs may increase the incidence of gastrointestinal adverse reactions
- Orlistat may decrease the absorption of vitamin D (cholecalciferol)
- Thiazide diuretics may increase the risk of hypercalcemia when combined with vitamin D supplementation
Curated Content: Needs Vetting Before Put to Clinical Use