Aclasta Dosage & Drug Information

Concise Prescribing Info

Contents

Anhydrous oledronic acid

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Indications/Uses

Osteoporosis in postmenopausal women & men at increased risk of fracture including those w/ recent low-trauma hip fracture. Prevention of glucocorticoid-induced bone mineral density loss; to increase bone mineral density in postmenopausal women & men on long-term glucocorticoid use who are at increased risk of fracture. Prevention of osteoporosis in postmenopausal women w/ increased risk of osteoporosis. Paget's bone disease.

Dosage/Direction for Use

IV Doses to be given as single infusion for ≥15 min. Concomitant adequate intake of Ca & vit D is recommended. Osteoporosis, prevention & treatment of osteoporosis associated w/ long-term systemic glucocorticoid therapy Men & postmenopausal women 5 mg once yrly. Patient w/ recent low-trauma hip fracture 5 mg to be given ≥2 wk after hip fracture repair. Loading dose of vit D 50,000-125,000 IU orally or IM is recommended prior to 1st infusion. Prevention of postmenopausal osteoporosis 5 mg, assessed annually if re-treatment is necessary. Paget's disease 5 mg once yrly. Supplement w/ Ca 500 mg bd for at least 10 days following administration.

Contraindications

Hypersensitivity to zoledronic acid or any biphosphonate. Hypocalcemia. Severe renal impairment (CrCl <35 mL/min). Pregnancy & lactation.

MIMS Class

Agents Affecting Bone Metabolism

ATC Classification

M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

Regulatory Classification

POM

Presentation/Packing

Form

Aclasta soln for infusion 5 mg/100 mL

Packing/Price

1's

Aclasta

zoledronic acid

Manufacturer:

Fresenius Kabi