Ind; Treatment of- i. osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures, ii. prevention of clinical fractures after a hip fracture; iii. treatment and prevention of glucocorticoid-induced secondary osteoporosis; iv. treatment of osteoporosis in men; and v. treatment of paget’s disease of bone. Treatment should be restricted to three annual doses.

C/I; S/E; Precaution; See above under the text. Dosage & admin: In all indications, the recom­mended dose is a single intravenous infusion of 5mg (100ml) zoledronic acid solution administered once a year. In all cases an adequate supplemental calcium and vitamin-D intake is important if dietary intake is inadequate.

In cases of patients with a recent low-trauma hip fracture, it is recommended to give the first zoledronic acid i.v infusion two or more weeks after hip fracture repairs. It is also recommended to have a loading dose of 50,000 to 125,000 IU of vitamin-D given orally or via intramuscular route prior to the first administration of zoledronic acid i.v infusion. Supplemental calcium and vitamin-D intake is recommended for patients treated to prevent clinical fractures after a hip fracture.

In case of paget's disease of bone, re-treatment with zoledronic acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, in patients who failed to achieve normalization of serum alkaline phosphatase, or in patients with symptoms, as dictated by medical practice 12 months after the initial dose.

In addition, it is strongly advised that adequate supplemental calcium corresponding to at least 500mg elemental calcium twice daily is ensured in patients with paget's disease for at least 10 days following zoledronic acid administration.

Zoledronic acid should be administered intravenously via a infusion line, given at a constant infusion rate. It must not be mixed with calcium or other divalent cation- containing infusion solutions, such as Lactated Ringer's solution.

The infusion time must not be less than 15 minutes.

Patients with renal impairment: The use of Zolenic in patients with creatinine clearance <35ml/min is not recommended due to limited clinical safety data in such patients. No dose adjustment is necessary in patients with creatinine clearance >35ml/min.

Patients with hepatic impairment:

No dose adjustment is required for patients with hepatic impairment.

After opening, if not used, can be stored for at least 24 hours at 2°C to 8°C. If refrigerated, allow the refrigerated solution to reach room temperature before administration.

Drug inter: See above under the text.

Note: For further information consult full prescribing information.

5mg in 100ml bot x.l’s pack: 5947.00 MRP