Zoldix

Description

Zoldix 100 ml Infusion

Indications
Zoledronic Acid is indicated in-
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
Limitations of Use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.

Pharmacology
Zoledronic Acid is a bisphosphonate and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption. The selective action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic Acid rapidly partitions to bone and localizes preferentially at sites of high bone turnover. The main molecular target of Zoledronic Acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase. The relatively long duration of action of Zoledronic Acid is attributable to its high binding affinity to bone mineral.

Dosage
Treatment of Osteoporosis in Postmenopausal Women: The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

Prevention of Osteoporosis in Postmenopausal Women: The recommended regimen is a 5 mg infusion given once every 2 years intravenously over no less than 15 minutes.

Osteoporosis in Men: The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

Treatment of Paget’s Disease of Bone: The recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate.

Re-treatment of Paget’s Disease: Re-treatment with Zoledronic Acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.

Calcium and Vitamin D Supplementation: Instruct patients being treated for Paget’s disease of bone on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels, and on the symptoms of hypocalcemia. All patients should take 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 international units vitamin D daily, particularly in the 2 weeks following Zoledronic Acid administration.

Instruct patients being treated for osteoporosis to take supplemental calcium and vitamin D if their dietary intake is inadequate. An average of at least 1200 mg calcium and 800-1000 international units vitamin D daily is recommended.