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Zoledronic acid monohydrate 4mg / 5ml injection

Ferron Par Pharmaceuticals

Product packaging may vary from one country to another.

Ingredients in every 5 ml

Zoledronic acid monohydrate 4 mg

Each package contains

1 vial of 5 ml

Other details

Dosage form:Injection
Flavour None

W.H.O. classification

ATC Level 1 M - Musculo-skeletal system
ATC Level 2 M05 - Drugs for Treatment of Bone Diseases
ATC Level 3 M05B - Drugs Affecting Bone Structure and Mineralization

Warnings

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.

Available in

Indonesia

Dosage information

18 YEARS OLD AND ABOVE
— Prevention of skeletal related events in patients with advanced malignancies involving bone:
The recommended dose is 4 mg infusion given every 3 to 4 weeks. Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily

— Treatment of hypercalcemia of malignancy:
The recommended dose in hypercalcemia (albumin-corrected serum calcium ≥12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid. Patients must be maintained well hydrated prior to and following administration of zoledronic acid.

Zoledronic acid must only be administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zoledronic acid must not be mixed with calcium or other divalent cation containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs in no less than 15 minutes.
Patients must be maintained in a well hydrated state prior to and following administration of Zoledronic acid.

0 TO 18 YEARS OLD
The safety and efficacy of zoledronic acid in pediatric patients have not been established.

Zoledronic acid must only be administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zoledronic acid must not be mixed with calcium or other divalent cation containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs in no less than 15 minutes.
Patients must be maintained in a well hydrated state prior to and following administration of Zoledronic acid.

PATIENTS WITH IMPAIRED RENAL FUNCTION
— Hypercalcemia of malignancy (HCM):
Zoledronic acid treatment in adult patients with HCM who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment. No dose adjustment is necessary in HCM patients with serum creatinine <400 µmol/l or <4.5 mg/dl — Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumors, serum creatinine levels and creatinine clearance (Clcr) should be determined. Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as Clcr 60 : recommended dose of zoledronic acid is 4.0 mg
CrCl 50-60 : recommended dose of zoledronic acid is 3.5* mg
CrCl 40-49 : recommended dose of zoledronic acid is 3.3* mg
CrCl 30-39 : recommended dose of zoledronic acid is 3.0* mg
*Doses have been calculated assuming target AUC of 0.66 (mg.hr/l) (Clcr= 75 ml/min).

Indication

– Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumor-induced hypercalcemia) in patients with advanced malignancies involving bone
– Treatment of hypercalcemia of malignancy