alendronic acid, calcium and colecalciferol, sequential

M05BB05

Forms & Strengths

Alendronate sodium 70 mg tablet + Colecalciferol (Vitamin D3) 2800 IU or 5600 IU tablet/capsule (combination pack)
Sequential regimen: Alendronate taken once weekly; Colecalciferol daily or co-administered

Adult Dosing

Treatment of postmenopausal osteoporosis: Alendronate 70 mg once weekly (on the same day each week) combined with Colecalciferol supplementation (minimum 400-800 IU daily via the fixed combination pack or separate supplements)
Administration: Swallow whole with a full glass of plain water (not mineral water) at least 30 minutes before the first food, beverage, or medication of the day
Patients must remain upright (sitting or standing) for at least 30 minutes post-dose and until after first food to reduce esophageal irritation

Pediatric Dosing

Indications

Treatment of postmenopausal osteoporosis in women at risk of Vitamin D deficiency
Prevention of osteoporosis in postmenopausal women
Increase bone mass in men with osteoporosis

Mechanism of Action

Alendronic acid: Potent nitrogen-containing bisphosphonate that binds to hydroxyapatite crystals in bone, inhibiting osteoclast-mediated bone resorption and decreasing bone turnover
Colecalciferol (Vitamin D3): Essential for calcium absorption in the small intestine and adequate mineralization of bone matrix, preventing secondary hyperparathyroidism and osteomalacia

Contraindications

Abnormalities of the esophagus and other factors delaying esophageal emptying (e.g., stricture or achalasia)
Inability to stand or sit upright for at least 30 minutes
Hypocalcemia
Hypersensitivity to alendronate, colecalciferol, or any excipients
Severe renal impairment (CrCl < 35 mL/min)

Adverse Reactions

Esophagitis, esophageal ulcers, or erosions (potentially leading to stricture or perforation)
Musculoskeletal pain (severe bone, joint, or muscle pain)
Abdominal pain, dyspepsia, acid regurgitation, nausea, constipation, or diarrhea
Osteonecrosis of the jaw (ONJ) and atypical femoral fractures (with long-term use)
Hypercalcemia or hypercalciuria (due to vitamin D component in high doses)

Drug Interactions

Calcium supplements, antacids, and multivalent cation-containing medications interfere with alendronate absorption (separate administration by at least 30-60 minutes)
Aspirin and NSAIDs may increase the incidence of gastrointestinal adverse events
Thiazide diuretics may increase the risk of hypercalcemia when combined with vitamin D
Systemic corticosteroids may synergize to increase osteoporosis risk or blunt bone formation response

Curated Content: Needs Vetting Before Put to Clinical Use