Zoldix 5 mg/100 ml (IV Infusion)

Indications

• Treatment and prevention of postmenopausal osteoporosis
• Treatment to increase bone mass in men with osteoporosis
• Treatment and prevention of glucocorticoid-induced osteoporosis
• Treatment of Paget's disease of bone in men and women

Pharmacology

• Acts primarily on bone
• Inhibits osteoclast-mediated bone resorption
• High affinity for mineralized bone
• Rapid partitioning to bone
• Localizes at sites of high bone turnover
• Molecular target is farnesyl pyrophosphate synthase
• Long duration of action

Dosage

• Recommended regimen for treatment of osteoporosis in postmenopausal women
• Recommended regimen for prevention of osteoporosis in postmenopausal women
• Recommended regimen for osteoporosis in men
• Recommended regimen for glucocorticoid-induced osteoporosis
• Recommended dose for treatment of Paget's disease of bone
• Re-treatment of Paget's disease
• Calcium and Vitamin D Supplementation

Administration

• Intravenous infusion over no less than 15 minutes
• Hydration prior to administration
• Visual inspection for particulate matter and discoloration
• Normal saline flush of the intravenous line
• Avoid contact with calcium or other divalent cation-containing solutions
• Room temperature administration
• Refrigerated solution stability

Interaction

• Aminoglycosides may lower serum calcium
• Loop diuretics may increase risk of hypocalcemia
• Use of nephrotoxic drugs with caution
• Excretion monitoring with renal impairment

Contraindications

• Hypocalcemia
• Patients with creatinine clearance less than 35 mL/min
• Hypersensitivity to any component of Zoledronic Acid

Side Effects

• Pyrexia
• Myalgia
• Headache
• Arthralgia
• Pain in extremity
• Flu-like illness
• Nausea
• Vomiting
• Diarrhea
• Eye inflammation

Pregnancy & Lactation

• Fetal harm
• Not for nursing women

Precautions & Warnings

• Hypocalcemia supplementation
• Renal Impairment monitoring
• Osteonecrosis of the Jaw (ONJ) evaluation
• Atypical Femur Fractures evaluation
• Severe Bone, Joint, and Muscle Pain monitoring

Use in Special Populations

• Not indicated for pediatric use
• Special care for geriatric use
• No dosage adjustment in renal impairment
• No clinical data for hepatic impairment

Overdose Effects

• Clinically significant renal impairment
• Hypocalcemia
• Hypophosphatemia
• Hypomagnesemia
• Correction through intravenous administration of specific compounds

Therapeutic Class

• Bisphosphonate preparations

Storage Conditions

• Store below 30°C
• Protect from moisture and light
• Keep out of the reach and sight of children

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