DRATE PLUS D
ALENDRONATE AND CHOLECALCIFEROL · by SOLACE PHARMA
Composition
OW (Once Weekly) Tab 70 mg: Alendronate sodium equiv 70 mg alendronic acid, cholecalciferol 70 mcg.
Indications & Dosage
Treatment of post-menopausal osteoporosis to reduce risk of vertebral and hip fractures: Adult: 1 tab once weekly. Children: Not recommended.
Contraindications
Renal impairment with GFR <35 ml/min, oesophageal abnormalities, stricture, achalasia or inability to remain upright for 30 min after dosing, hypocalcaemia.
Precautions
Active GI bleeding, atypical femoral fractures, duodenitis, dysphagia, exclude other causes of osteoporosis, gastritis, history (within 1 year) of ulcers, surgery of the upper gastro-intestinal tract, symptomatic oesophageal disease, ulcers, upper GI disorders. Treat hypocalcaemia or vitamin D deficiency first. Warn patient to report any symptoms such as difficulty in swallowing, retrosternal pain or worsening heartburn, and to discontinue immediately.
Interactions
Calcium supplement, antacids, NSAID.
Pregnancy
Contraindicated
Lactation
Contraindicated
Side Effects
Abdominal distension and pain, constipation, diarrhoea, dyspepsia, flatulence, headache, oesophageal reactions (oesophagitis, oesophageal ulcers, oesophageal stricture and oesophageal erosions), regurgitation, musculoskeletal pain, episcleritis, erythema, gastritis, nausea, rash, scleritis, uveitis, vomiting. Rare: Atypical femoral fractures with long-term use, hypocalcaemia, osteonecrosis of the jaw, photosensitivity, severe skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, upper gastro-intestinal ulcers