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ZOLEDRONIC ACID is a brand name for Zoledronic Acid, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ......................................................................................... 3 CONTRAINDICATIONS ............................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Patients who are hypersensitive to this drug or to any ingredient in the formulation, or to any bisphosphonates or component of the container. Severe renal impairment with creatinine clearance <35 mL/min and in those with evidence of acute renal impairment.
WARNINGS AND PRECAUTIONS General Zoledronic acid injection contains the same active ingredient that is found in ZOMETA® (zoledronic acid). Patients being treated with ZOMETA should not be treated with Zoledronic acid injection. Patients being treated with Zoledronic acid injection should not be treated with other bisphosphonates concomitantly.
Patients must be appropriately hydrated prior to administration of Zoledronic acid injection, especially for patients who are elderly or on diuretic therapy. Infusion duration The 5 mg single dose of Zoledronic acid injection (zoledronic acid 5 mg/100 mL) should be infused in no less than 15 minutes.
Cardiovascular Atrial fibrillation There have been reports of serious atrial fibrillation in patients treated with zoledronic acid. Atrial fibrillation may occur at any time during treatment. 9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
6% (22 out of 3,852) in patients receiving zoledronic acid and placebo, respectively. 3 % (5 out of 153) for zoledronic acid-treated patients compared to 2% (3 out of 148) for alendronate-treated patients. 7% (1/148) for alendronate-treated patients.
0% (0 out of 417) for risedronate-treated patients. The rate of atrial fibrillation serious adverse events was 0% for zoledronic acid-treated patients and 0% for risedronate-treated patients. This increased incidence of atrial fibrillation was not observed in clinical trials conducted in Paget’s disease, in the HORIZON-RFT trial in post-hip 5 fracture patients, or in the trial for the prevention of postmenopausal osteoporosis.
The mechanism behind the increased incidence of atrial fibrillation is unknown. Cerebrovascular Accident There have been reports of serious cerebrovascular accidents in patients treated with zoledronic acid, some with a fatal outcome.
The signs and symptoms of cerebrovascular accidents can occur at any time during treatment. , as part of their annual examination). Pre- existing hypocalcemia must be treated by adequate administration of calcium and vitamin D before initiating Zoledronic acid injection (see CONTRAINDICATIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
, diminished parathyroid reserve; thyroid surgery, parathyroid surgery, intestinal calcium malabsorption) must also be effectively treated. It is strongly advised that patients receive adequate calcium and vitamin D supplementation.
All patients should be counseled regarding the importance of calcium and vitamin D supplementation in maintaining serum calcium levels and on the symptoms of hypocalcemia. The recommended daily vitamin D supplement should be determined by the treating physician based on the patient's individual needs.
In the postmenopausal osteoporosis trial (HORIZON- PFT), patients received 1000 to 1500 mg of elemental calcium plus 400 to 1200 IU of vitamin D supplements per day. Renal The use of Zoledronic acid injection in patients with severe renal impairment (creatinine clearance <35 mL/min) and in those with evidence of acute renal impairment is contraindicated due to an increased risk of renal failure in this population (see DOSAGE AND ADMINISTRATION).
Zoledronic acid has been associated with renal dysfunction manifested as deterioration in renal function, and acute renal failure (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions and Post-Market Adverse Drug Reactions).
Renal impairment has been observed following the administration of Zoledronic acid injection, including after a single administration. Renal failure requiring dialysis or with a fatal outcome has occurred especially in patients with history of renal impairment or other risk factors.
Risk factors include advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see DRUG INTERACTIONS), or dehydration occurring after Zoledronic acid injection administration. It may increase with underlying renal disease and dehydration secondary to fever, sepsis, gastrointestinal losses, diuretic therapy, advanced age, etc.
(see Post-Market Adverse Drug Reactions). In some post marketing cases, acute renal failure has occurred in patients with no underlying risk factors for renal impairment. Renal impairment may lead to increased exposure of concomitant medications and/or their metabolites that are primarily renally excreted (see DRUG INTERACTIONS).
6 The following precautions should be taken to minimize the risk of renal adverse reactions: Creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each Zoledronic acid injection […]