Zoruxa

Zoruxa

zoledronic acid

Manufacturer:

Gland Pharma

Distributor:

Zuellig Pharma

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Zoledronic acid
Indications/Uses
Treatment & prevention of osteoporosis in postmenopausal women. Osteoporosis in men. Treatment & prevention of glucocorticoid-induced osteoporosis in men & women. Paget's disease of bone in men & women.
Dosage/Direction for Use
Administer as IV infusion over no less than 15 min. Osteoporosis in postmenopausal women & in men 5 mg once a yr. Prevention of osteoporosis 5 mg given once every 2 yr. Treatment & prevention of glucocorticoid-induced osteoporosis 5 mg once a yr. Paget's disease 5 mg w/ infusion time not be <15 min given over a constant infusion rate. Patients w/ CrCl >35 mL/min 5 mg.
Contraindications
Hypersensitivity to zoledronic acid or any other biphosphonate. Hypocalcemia. Renal failure (CrCl <35 mL/min) & w/ evidence of acute renal impairment.
Special Precautions
Renal impairment. Concomitant use w/ other drugs containing zoledronic or other biphosphonates. Treat preexisting hypocalcemia & mineral metabolism disturbances before initiation of therapy. Maintain Ca & vit D supplementation for serum Ca level maintenance. Monitor Ca & mineral levels. Withhold therapy if history or physical signs suggest dehydration, & until normovolemic status has been achieved & severe musculoskeletal pain occurs. Concomitant use w/ other nephrotoxic drugs. Osteonecrosis of the jaw may occur. Consider dental exam prior to therapy in patients w/ history of concomitant risk factors (eg, cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, preexisting dental disease or infection, anemia, coagulopathy). Avoid invasive dental procedures during treatment. Interrupt therapy if patient is presenting w/ an atypical femur fracture. Aspirin-sensitive patients. May affect ability to drive or use machines. Pregnancy & lactation. Elderly.
Adverse Reactions
Arthralgia, fever, headache, HTN, myalgia, extremity pain, flu-like illness, dizziness, shoulder pain, diarrhea, bone pain, fatigue, chills, asthenia; nausea, vomiting, dyspepsia, abdominal pain, constipation, muscle spasms, musculoskeletal pain, neck pain, generalized pain, pyrexia, chills, peripheral edema, non-cardiac chest pain, malaise, dyspnea, rigors, lethargy.
Drug Interactions
Additive effect to lower Ca levels w/ aminoglycosides. Increased risk of hypocalcemia w/ loop diuretics. Nephrotoxic drugs. Drugs primarily renally excreted (eg, digoxin).
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
Zoruxa inj 5 mg/100 mL
Packing/Price
1's
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