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TARO-ZOLEDRONIC ACID CONCENTRATE 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.
Hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of TARO-ZOLEDRONIC ACID CONCENTRATE (Zoledronic acid for injection) (see DOSAGE FORMS, COMPOSITION AND PACKAGING). Non-corrected hypocalcaemia at the time of infusion (see WARNINGS AND PRECAUTIONS, Hypocalcaemia) Pregnancy and breastfeeding women (see WARNINGS AND PRECAUTIONS, Special populations) WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Osteonecrosis of the jaw (ONJ), (See Musculoskeletal, Osteonecrosis of the Jaw below ) Deterioration in renal function (See Renal below) The use of TARO-ZOLEDRONIC ACID CONCENTRATE (Zoledronic acid for Injection) is not recommended in patients with severe renal impairment (See Special Populations below) Hypocalcaemia (See General, Hypocalcaemia below) Single doses of TARO-ZOLEDRONIC ACID CONCENTRATE should not exceed 4 mg and the duration of the infusion should be no less than 15 minutes.
(See Renal and DOSAGE AND ADMINISTRATION below) General Drug Interactions TARO-ZOLEDRONIC ACID CONCENTRATE contains the same active ingredient that is contained in TARO-ZOLEDRONIC ACID (zoledronic acid). Patients being treated with TARO-ZOLEDRONIC ACID CONCENTRATE should not be treated with TARO- ZOLEDRONIC ACID concomitantly.
TARO-ZOLEDRONIC ACID CONCENTRATE should not be given together with other bisphosphonates since the combined effects of these agents are unknown. TARO-ZOLEDRONIC ACID CONCENTRATE is eliminated by renal excretion. g. g. diuretics, ACE inhibitors, leading to dehydration).
Caution is advised when TARO-ZOLEDRONIC ACID CONCENTRATE is administered with anti-angiogenic drugs, as the incidence of ONJ is increased when these drugs are used concomitantly (see Osteonecrosis of the Jaw, DRUG INTERACTIONS, Drug-Drug Interactions).
Caution is advised when TARO-ZOLEDRONIC ACID CONCENTRATE is administered with loop diuretics (particularly in patients treated for TIH), with aminoglycosides, or with calcitonin, since there may be an additive effect on the risk of developing hypocalcaemia.
TARO-ZOLEDRONIC ACID CONCENTRATE should be used with extreme caution in conjunction with other antineoplastic agents that are known to produce renal dysfunction (it is advised that renal function be monitored) or where the dose depends upon renal function (for example platinum-containing agents).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Zoledronic Acid in Canada.
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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.
TARO-ZOLEDRONIC ACID CONCENTRATE should not be mixed with calcium-containing intravenous infusions. Effects on ability to drive or use machines In rare cases, somnolence and/or dizziness may occur, in which case the patient should not drive, operate potentially dangerous machinery or engage in other activities that may be hazardous.
Hypocalcaemia Hypocalcaemia has been reported in patients treated with zoledronic acid. QTc prolongation and neurologic adverse events (tonic-clonic seizures, tetany and numbness) have been reported secondary to cases of severe hypocalcaemia.
In some instances, the hypocalcaemia required hospitalization and/or was life-threatening. Caution is advised when TARO-ZOLEDRONIC ACID CONCENTRATE is administered with other hypocalcaemia-causing drugs (including aminoglycosides, calcitonin, or loop diuretics), as they may have an additive effect resulting in severe hypocalcaemia (see also DRUG INTERACTIONS).
Patients who have undergone thyroid surgery may be particularly susceptible to develop hypocalcaemia due to relative hypoparathyroidism. Serum albumin-corrected calcium should be measured prior to each dose and during therapy with TARO-ZOLEDRONIC ACID CONCENTRATE (see Monitoring and Laboratory Tests).
TARO-ZOLEDRONIC ACID CONCENTRATE is contraindicated in patients who have non-corrected hypocalcaemia at the time of infusion (see CONTRAINDICATIONS). Tumour-Induced Hypercalcaemia Taro-Zolendronic Acid Concentrate Page 6 of 55 It is essential in the initial treatment of tumour-induced hypercalcaemia that intravenous rehydration be instituted to restore urine output.
All patients, including patients with mild to moderate renal impairment, should be hydrated adequately throughout treatment, but overhydration must be avoided. In patients with cardiac disease, especially in the elderly, additional saline overload may precipitate cardiac failure (left ventricular failure or congestive heart failure).
Fever (influenza- like symptoms) may also contribute to this deterioration. Carcinogenesis and Mutagenesis In carcinogenicity studies, zoledronic acid was administered orally (gavage) to rats and mice for at least 104 weeks without evidence of carcinogenic potential.
Chronic parenteral administration was not feasible given the potential of the compound to cause severe local irritation. The pharmacological bone changes (nonproliferative hyperostosis) typically observed following long term bisphosphonate administration to young animals with growing skeletons gave clear evidence of systemic exposure to zoledronic acid in both species at all doses.
Six mutagenicity studies were conducted with zoledronic acid: three Ames Assays (using E. coli and/or S. typhimurium), a gene mutation assay using V79 hamster cells, a cytogenetics test with Chinese hamster cells and an in vivo micronucleus assay in rats.
There was no evidence of mutagenic potential. Cardiovascular In a 3-year, randomized, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg dose once yearly vs. 9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
The rate of atrial fibrillation serious adverse […]