Description

Alendronic acid is indicated for the- Treatment of Osteoporosis in Postmenopausal Women: Alendronic acid is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendronic acid increases bone mass and reduces the incidence of fractures, including those of the hip and spine. Prevention of Osteoporosis in Postmenopausal Women: Alendronic acid is indicated for the prevention of postmenopausal osteoporosis. Treatment to Increase Bone Mass in Men with Osteoporosis: Alendronic acid is indicated for treatment to increase bone mass in men with osteoporosis. Treatment of Glucocorticoid-Induced Osteoporosis: Alendronic acid is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. Treatment of Paget's Disease of Bone: Alendronic acid is indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.

Alendronic acid 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. Do not administer Alendronic acid oral solution to patients at increased risk of aspiration. Hypocalcemia. Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported.

The commonest symptomatic side effects are constipation, diarrhoea, oesophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache, rarely rash, erythema, transient decrease in serum calcium and phosphate, nausea, vomiting, peptic ulceration, hypersensitivity reactions including urticaria and angio-oedema.

Alendronic acid should not be given to pregnant women or nursing mother.

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.

Pediatric Use: Alendronic acid is not indicated for use in pediatric patients. Renal Impairment: Alendronic acid is not recommended for patients with creatinine clearance less than 35 mL/min. No dosage adjustment is necessary in patients with creatinine clearance values between 35-60 mL/min. Hepatic Impairment: As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary.

Bisphosphonate preparations