Zolennic

Zolennic

zoledronic acid

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Zoledronic acid monohydrate
Indications/Uses
Adjunct to antineoplastic therapy for bone metastases of solid tumors & osteolytic lesions of multiple myeloma. Paget's bone disease. Hypercalcemia of malignancy (HCM).
Dosage/Direction for Use
IV infusion Infuse over not <15 min. Adjunct to antineoplastic therapy for bone metastases of solid tumors & osteolytic lesions of multiple myeloma & Paget's bone disease Adult & elderly 4 mg once every 3-4 wk. Administer supplemental Ca 500 mg & vit D 400 IU daily. Renal impairment w/ CrCl 50-60 mL/min 3.5 mg, 40-49 mL/min 3.3 mg, 30-39 mL/min 3 mg. HCM Adult & elderly 4 mg as single dose.
Contraindications
Hypersensitivity to zoledronic acid or other bisphosphonates. Hypocalcemia. Pregnancy & lactation.
Special Precautions
Severe jaw, muscle or joint pain. Patients who develop osteonecrosis of the jaw while on therapy. Hydrate prior to administration & throughout treatment. Avoid overhydration in patients w/ cardiac failure; invasive dental procedure. Maintain urinary output of 2 L daily throughout therapy; good oral hygiene. Monitor for hypercalcemia-related metabolic parameters including serum Ca, phosphate, Mg & creatinine conc prior to each administration & throughout treatment. Monitor renal function. Investigate patients having hypercalcemia associated w/ malignancy after post-treatment evaluation at least 7 days after drug initiation. Short-term supplemental therapy if hypocalcemia, hypophosphatemia or hypomagnesemia occur. Perform preventive dental exam prior to treatment. Not to be mixed w/ Ca-containing infusion soln or other Ca-containing drug or product. Concomitant use w/ bisphosphonates or nephrotoxic drugs. Not recommended in severe renal impairment. Pregnancy & lactation. Not recommended to use in ped patients.
Adverse Reactions
Hypophosphatemia. Anemia; headache; anxiety, insomnia; conjunctivitis; nausea, vomiting, anorexia; bone, back & skeletal pain, myalgia, arthralgia; renal deterioration; fever, flu-like syndrome including fatigue, rigors, malaise & flushing; increased blood creatinine & urea, hypocalcemia.
Drug Interactions
Lowered serum Ca conc w/ aminoglycosides. Increased risk of hypocalcemia w/ loop diuretics. Hypomagnesemia & increased risk of renal dysfunction w/ nephrotoxic agents. Potentiated risk of renal dysfunction w/ thalidomide.
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
Zolennic soln for infusion 4 mg/5 mL
Packing/Price
1's
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