Company: Teva Pharmaceuticals Ireland.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Alendronic acid (as alendronate sodium monohydrate)/colecalciferol (vitamin D3)70mg /2800 IU (70mcg), 70mg/5600 IU (140mcg).
Description: White capsule-shaped tablets marked with A70 on one side and 2800 or 5600 on reverse, respectively.
Presentation: 70mg/2800 IU-4, €9.86; 70mg/5600 IU-4, €7.49.
Indications: Treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency, reduces risk of vertebral or hip fractures.
Pharmacology: Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption. Vitamin D3 is an essential dietary nutrient (in the absence of adequate sunlight exposure). The active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 increases intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
Dosage: Adult: One tablet once weekly. Consider supplemental calcium. Consider additional vitamin D supplementation. Swallow whole. Take at least 30 minutes before first food, drink, or drug of the day with plain water only and do not lie down for at least 30 minutes. Elderly: As per adults. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active substances or to any of the excipients. Abnormalities of the oesophagus and other factors which delay oesophageal emptying (such as stricture or achalasia). Inability to stand or sit upright for at least 30 minutes. Hypocalcaemia. Pregnancy, lactation.
Special precautions: Not recommended: Glomerular filtration rate (GFR) less than 35 ml/min. Caution: Active upper gastrointestinal problems (such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers), recent history of major gastrointestinal disease (such as peptic ulcer), active gastrointestinal bleeding, surgery of the upper gastrointestinal tract other than pyloroplasty. Re-evaluate periodically based on the benefit/risk ratio, particularly after 5 or more years of use. Barrett’s oesophagus (assess benefit/risk). Reported: Osteonecrosis of the jaw (consider dental examination prior to therapy in patients at risk, avoid invasive dental procedures); oesophagitis, oesophageal ulcers, oesophageal erosions; bone, joint and/or muscle pain; atypical subtrochanteric and diaphyseal femoral fractures (consider discontinuation pending evaluation). Discontinue if dysphagia, pain on swallowing, retrosternal pain, new or worsening heartburn develops. Reported rarely, gastric and duodenal ulcers (severe). Correct hypocalcaemia and other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) before starting treatment. Vitamin D deficiency (monitor serum calcium and symptoms of hypocalcaemia). Monitor urine and serum calcium in patients with disease associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis). Patients with malabsorption may not adequately absorb vitamin D3. Contains sucrose. Driving/using machines.
Drug interactions: Caution: Non steroidal anti-inflammatory drugs. Olestra, mineral oils, orlistat, bile acid sequestrants (e.g. cholestyramine, colestipol), anticonvulsants, cimetidine, thiazides, glucocorticoids, digitalis and other cardiac glycosides, actinomycin, imidazole. Food, beverages (including mineral water), antacids, calcium supplements, vitamins, some medicinal products.
Adverse drug reactions: Headache, dizziness, vertigo, gastrointestinal disorders, alopecia, pruritus, musculoskeletal (bone, muscle or joint) pain, joint swelling, asthenia, peripheral oedema.
Full prescribing information and references available from Teva Pharmaceuticals Ireland. Telephone: 1800 201700.
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