Zoldron-4

Zoldron-4

zoledronic acid

Manufacturer:

Getwell Pharma

Distributor:

Distriphil

Marketer:

Ambica
Concise Prescribing Info
Contents
Zoledronic acid monohydrate
Indications/Uses
Used for hypercalcemia of malignancy. Prevention of skeletal events in patients w/ advanced bone malignancies. Treatment of Paget's disease of bone & for osteoporosis in postmenopausal women.
Dosage/Direction for Use
Malignant hypercalcemia Max: 4 mg in no <15 min. Multiple myeloma & metastatic bone lesions of solid tumors Patients w/ CrCl >60 mL/min 4 mg in no <15 min every 3-4 wk. Administer as single dose & IV infusion only.
Contraindications
Women w/ childbearing potential.
Special Precautions
Patients must be supplemented w/ Ca & vit D. Adequately rehydrate patients w/ malignant hypercalcemia prior to administration for inj & monitor electrolytes during treatment. Osteonecrosis of the jaw; severe & occasionally incapacitating bone, joint &/or muscle pain. Patients w/ asthma. Avoid invasive dental procedures. Bronchoconstriction in aspirin-sensitive patients. Do not mix w/ Ca-containing infusion soln. Concomitant use w/ nephrotoxic drugs. Monitor serum creatinine before each dose. Not recommended to renal (severe) & hepatic impairment. Not to be used during pregnancy. Not indicated for childn.
Adverse Reactions
Nausea, fatigue, anemia, bone pain, constipation, fever, vomiting & dyspnea.
Drug Interactions
Additive effect to lower serum Ca levels w/ aminoglycosides for prolonged periods. Increased risk of hypocalcemia w/ loop diuretics. Increased risk of renal dysfunction w/ thalidomide. Other potentially nephrotoxic drugs.
ATC Classification
M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Zoldron-4 lyophilized powd for infusion 4 mg
Packing/Price
5 mL x 1's
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