Zoruxa

Zoledronic acid

Treatment & prevention of osteoporosis in postmenopausal women & glucocorticoid-induced osteoporosis in men & women. Osteoporosis in men. Paget's disease of bone in men & women.

IV infusion Administer over no <15 min followed by a 10 mL normal saline flush of the IV line. Osteoporosis in postmenopausal women 5 mg infusion once a year. Prevention of osteoporosis in postmenopausal women 5 mg infusion given once every 2 yr. Osteoporosis in men 5 mg infusion once a yr. Treatment & prevention of glucocorticoid-induced osteoporosis 5 mg infusion once a yr. Paget's disease of bone 5 mg infusion given over a constant infusion rate. Renal impairment CrCl >35 mL/min 5 mg.

Hypersensitivity to zoledronic acid or any other bisphosphonate. Hypocalcemia. Patients w/ CrCl <35 mL/min & in those w/ evidence of acute renal impairment. Pregnancy.

Concomitant use w/ drug products containing zoledronic acid used for oncology indications. Pre-existing hypocalcemia & disturbances of mineral metabolism (eg, hypoparathyroidism, thyroid & parathyroid surgery; malabsorption syndromes, excision of small intestine) must be treated before initiating therapy; monitor Ca & mineral (P & Mg) levels. Symptoms of hypocalcemia & importance of Ca & vit D supplementation in maintaining serum Ca levels. Osteonecrosis of the jaw. Perform routine oral exam prior to initiation of bisphosphonate treatment. Consider dental exam w/ appropriate preventive dentistry in patients w/ a history of concomitant risk factors (eg, cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, pre-existing dental disease or infection, anemia, coagulopathy). Avoid invasive dental procedures while on treatment in patients w/ concomitant risk factors. Atypical subtrochanteric & diaphyseal femoral fractures. Musculoskeletal pain. Aspirin-sensitive patients. May affect ability to drive & operate machines. Chronic renal impairment. Avoid becoming pregnant while on therapy in women of childbearing potential. Lactation. Elderly.

Arthralgia, fever, headache, HTN, myalgia, extremity pain, flu/flu-like illness, dizziness, diarrhea, bone pain, back pain, fatigue, chills, nausea, dyspepsia, abdominal pain, constipation, musculoskeletal pain, asthenia, dyspnea. Osteoporosis in postmenopausal women: shoulder pain. Osteoporosis prevention in postmenopausal women: hypoesthesia, vomiting, muscle spasms, neck pain, generalized pain, pyrexia, peripheral edema, noncardiac chest pain. Osteoporosis in men: pain (unspecified), malaise. Paget's disease of bone: rigors, lethargy, pain.

Additive effect to lower serum Ca level for prolonged periods w/ aminoglycosides. Increased risk of hypocalcemia w/ loop diuretics. Concomitant use w/ potentially nephrotoxic drugs eg, NSAIDs. May increase renal impairment w/ drugs primarily excreted by the kidney (eg, digoxin).

Agents Affecting Bone Metabolism

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

Rx