Sandronic

Sandronic

zoledronic acid

Manufacturer:

Sanbe
Concise Prescribing Info
Contents
Zoledronic acid
Indications/Uses
Treatment of hypercalcemia of malignancy (HCM). Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumor induced hypercalcemia) in patients w/ advanced malignancies involving bone.
Dosage/Direction for Use
IV infusion Prevention of skeletal related events in patients w/ advanced malignancies involving bone Adult & Elderly 4 mg every 3-4 wk. Patients should also be administered an oral Ca supplement 500 mg & vit D 400 IU daily. Mild to moderate renal impairment CrCl >60 mL/min 4 mg/100 mL, CrCl 50-60 mL/min 3.5 mg/100 mL, CrCl 40-49 mL/min 3.3 mg/100 mL, CrCl 30-39 mL/min 3 mg/100 mL. Hypercalcemia of malignancy (HCM) Adult & Elderly Single 4 mg infusion.
Contraindications
Hypersensitivity to zoledronic acid monohydrate or other bisphosphonates. Pregnancy & breast feeding women.
Special Precautions
Consider discontinuation of treatment in patients suspected to have an atypical femur fracture. Avoid overhydration in patients at risk of cardiac failure. Monitor serum albumin-corrected levels of Ca, phosphate, Mg, serum creatinine; renal function. Not to be given w/ other bisphosphonates. Patients should maintain good oral hygiene & should have a dental exam w/ preventive dentistry prior to treatment. Avoid invasive dental procedures. Osteonecrosis of other anatomical sites. Musculoskeletal pain. Synergistic effect w/ other hypocalcemia causing drugs. Not recommended in severe renal impairment. Hepatic impairment. Women of child-bearing potential should avoid becoming pregnant. Not to be used during pregnancy & breast-feeding women.
Adverse Reactions
Anaphylactic reaction, ocular adverse events, osteonecrosis of the jaw, atypical femoral fracture, atrial fibrillation, renal function impairment, acute phase reaction & hypocalcemia. Hypophosphatemia. Anemia; headache, paraesthesia; sleep disorder; conjunctivitis; nausea, vomiting, decreased appetite, constipation; hyperhidrosis; bone pain, myalgia, arthralgia, generalized body pain, joint stiffness; HTN.
Drug Interactions
Additive effect w/ aminoglycosides & loop diuretics. Other potentially nephrotoxic drugs. Increased incidence of osteonecrosis of the jaw w/ anti-angiogenic drugs.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Sandronic infusion 4 mg/100 mL
Packing/Price
100 mL x 1's (Rp3,075,000/boks)
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