Aclasta

Zoledronic acid

Treatment of osteoporosis in postmenopausal women & in men. Treatment of osteopenia in postmenopausal women who have at least 1 risk factor. Prevention of clinical fractures after hip fracture. Treatment & prevention of glucocorticoid-induced osteoporosis. Treatment of Paget's disease of the bone.

Osteoporosis 5 mg once a yr as a single 15-min IV infusion. Osteopenia in postmenopausal women 5 mg as a single 15-min IV infusion. Paget's disease 5 mg as a single 15-min IV infusion.

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

Treat pre-existing hypocalcemia & mineral metabolism disturbances prior to treatment initiation. Risk of renal adverse reactions. Monitor serum creatinine in patients w/ underlying impaired renal function. Ensure adequate hydration prior to administration especially in elderly & patients receiving diuretic therapy. Ensure adequate supplemental Ca & vit D intake. Reports of severe & occasionally incapacitating bone, joint, &/or muscle pain; osteonecrosis of the jaw; osteonecrosis of the external auditory canal, mainly associated w/ long-term therapy; atypical subtrochanteric & diaphyseal femoral fractures, primarily in long-term treatment for osteoporosis. Advise women of childbearing potential to avoid becoming pregnant while receiving Aclasta. Not recommended in childn & adolescents <18 yr.

Treatment of postmenopausal osteoporosis, osteoporosis in men, prevention of clinical fractures after low trauma hip fracture, treatment & prevention of glucocorticoid-induced osteoporosis & Paget's disease of the bone: Pyrexia. Headache, dizziness; nausea, vomiting, diarrhea; myalgia, arthralgia, bone & back pain, pain in extremity; flu-like illness, chills, fatigue, asthenia, pain, malaise. Prevention of postmenopausal osteoporosis: Headache; nausea; myalgia; pain, chills. Decreased appetite; tremor, lethargy; conjunctivitis, eye pain, iritis; abdominal pain, abdominal pain upper, constipation; night sweats; musculoskeletal pain, muscle spasms, musculoskeletal chest pain, pain in jaw, neck pain; peripheral oedema, infusion-related reaction, non-cardiac chest pain.

Caution when Aclasta is administered in conjunction w/ medicinal products that can significantly impact renal function (eg, aminoglycosides or diuretics that may cause dehydration). In patients w/ renal impairment, systemic exposure to concomitant medicinal products that are primarily excreted via the kidneys may increase.

Agents Affecting Bone Metabolism

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

P₁S₁S₃