Indications
Pharmacology
Dosage & Administration
Recommended dose is a single intravenous infusion of 5 mg Zolenic administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in women with osteoporosis if dietary intake is inadequate.Prevention of clinical fractures after a hip fracture
Recommended dose is a single intravenous infusion of 5 mg Zolenic administered once a year. In patients with a recent low-trauma hip fracture, it is recommended to give the first Zolenic solution for 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 Zolenic solution for infusion. Supplemental Calcium and Vitamin-D intake is recommended for patients treated to prevent clinical fractures after a hip fracture.
Treatment of osteoporosis in men
Recommended dose is a single intravenous infusion of 5 mg Zolenic administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in men with osteoporosis if dietary intake is inadequate.
Treatment and prevention of glucocorticoid-induced osteoporosis
Recommended dose is a single intravenous infusion of 5 mg Zolenic administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in patients with osteoporosis if dietary intake is inadequate.
Treatment of paget’s disease of bone
Recommended dose is a single intravenous infusion of 5 mg Zolenic. Re-treatment with Zolenic 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 patients with paget’s disease, adequate Vitamin-D intake is recommended in association with Zolenic administration. In addition, it is strongly advised that adequate supplemental Calcium corresponding to at least 500 mg elemental Calcium twice daily is ensured in patients with paget’s disease for at least 10 days following Zolenic administration.
Zolenic should be administered intravenously via a infusion line, given at a constant infusion rate. The infusion time must not be less than 15 minutes.
Patients with renal impairment
The use of Zolenic in patients with creatinine clearance <35 mL/min is not recommended due to limited clinical safety data in such patients. No dose adjustment is necessary in patients with creatinine clearance >35 mL/min.
Patients with hepatic impairment
No dose adjustment is required for patients with hepatic impairment.
Elderly patients
No dose adjustment is required. However, because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.
Zolenic must not be mixed or given intravenously with any other medication and must be given through a separate infusion line at a constant infusion rate. If refrigerated, allow the refrigerated solution to reach room temperature before administration. Aseptic techniques must be followed during the preparation of the infusion. Any unused solution should be discarded. Only clear solution free from particles and discoloration should be used.
After opening, the solution is chemically and physically stable for at least 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. Zolenic solution for infusion must not be allowed to come into contact with any Calcium or other divalent cation-containing solutions.
The dose of 5 mg Zoledronic acid must be administered over at least 15 minutes.
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