Zolenic 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
• Inhibitor of osteoclast-mediated bone resorption
• Selective action based on high affinity for mineralized bone
• Rapidly partitions to bone and localizes preferentially at sites of high bone turnover

Dosage

• 5 mg infusion once a year for postmenopausal osteoporosis treatment
• 5 mg infusion once every 2 years for postmenopausal osteoporosis prevention
• 5 mg infusion once a year for osteoporosis in men
• 5 mg infusion once a year for glucocorticoid-induced osteoporosis
• 5 mg infusion for Paget’s Disease of Bone treatment
• Calcium and Vitamin D Supplementation instructions

Administration

• Intravenous infusion over no less than 15 minutes
• Appropriate hydration prior to administration
• Visual inspection for particulate matter and discoloration
• Normal saline flush of the intravenous line after infusion

Interaction

• Aminoglycosides may lower serum calcium
• Loop diuretics may increase risk of hypocalcemia
• Nephrotoxic drugs use with caution
• Monitor serum creatinine in patients at risk

Contraindications

• Hypocalcemia
• Creatinine clearance less than 35 mL/min
• Evidence of acute renal impairment
• 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

• Can cause fetal harm
• Not for nursing women

Precautions & Warnings

• Hypocalcemia supplementation with calcium and vitamin D
• Renal Impairment monitoring
• Osteonecrosis of the Jaw (ONJ) risk
• Atypical Femur Fractures risk
• Severe Bone, Joint, and Muscle Pain management

Use in Special Populations

• Not indicated for use in pediatric patients
• Special care for geriatric use
• Use with renal or hepatic impairment

Overdose Effects

• Clinically significant renal impairment
• Hypocalcemia
• Hypophosphatemia
• Hypomagnesemia

Therapeutic Class

• Bisphosphonate preparations

Storage Conditions

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

Related Brands

• Aclasta 5 mg/100 ml (IV Infusion) - sandoz-a-novartis-division