Bonizol 5 mg/100 ml (IV Infusion)

Indications and Usage

• 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
• Inhibitor of osteoclast-mediated bone resorption
• High affinity for mineralized bone
• Rapidly partitions to bone and localizes preferentially at sites of high bone turnover

Dosage

• Recommended regimen for 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 instructions

Administration

• Intravenous infusion over no less than 15 minutes
• Appropriately hydrated prior to administration
• Visual inspection for particulate matter and discoloration
• Normal saline flush of the intravenous line
• Optional acetaminophen administration for reducing acute-phase reaction symptoms
• Refrigeration and stability instructions

Interaction

• Aminoglycosides
• Loop diuretics
• Nephrotoxic drugs
• Drugs primarily excreted by the kidney

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 and Lactation

• Fetal harm warning
• Advisory for women of childbearing potential
• Not for nursing women

Precautions and Warnings

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

Use in Special Populations

• Pediatric Use not indicated
• Special care for geriatric use
• Contraindicated in severe renal impairment
• No data available for hepatic impairment

Overdose Effects

• Careful monitoring for patients receiving higher doses
• Clinically significant risks: renal impairment, hypocalcemia, hypophosphatemia, hypomagnesemia
• Correction measures for serum levels
• Dosage and infusion duration limits

Therapeutic Class

• Bisphosphonate preparations

Storage Conditions

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

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