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Zoledronic Acid (Zoledronic Acid)

Trade Name : Zoledronic acid

Heritage Pharmaceuticals Inc.

INJECTION, SOLUTION, CONCENTRATE

Strength 4 mg/5mL

ZOLEDRONIC ACID Diphosphonates [CS],Bisphosphonate [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Zoledronic Acid (Zoledronic Acid) which is also known as Zoledronic acid and Manufactured by Heritage Pharmaceuticals Inc.. It is available in strength of 4 mg/5mL per ml. Read more

Zoledronic Acid (Zoledronic Acid) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Zoledronic acid injection is a bisphosphonate indicated for the treatment of:
  • Important limitation of use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or nontumor-related hypercalcemia. n
  • Hypercalcemia of malignancy. n
  • Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.n
  • Hypercalcemia of malignancy () u00a0
  • Multiple myeloma and bone metastasis from solid tumors. ()
  • Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation-containing solutions. ()
  • 4 mg/5 mL single-dose vial of concentrate
  • 4 mg/5 mL single-dose vial of concentrate n
  • Hypersensitivity to Zoledronic Acid or Any Components of zoledronic acid injection
  • Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [].
  • Hypersensitivity to any component of zoledronic acid injection n
  • No data
  • Patients being treated with zoledronic acid injection should not be treated with Reclast. ()
  • Adequately rehydrate patients with hypercalcemia of malignancy prior to administration of zoledronic acid injection and monitor electrolytes during treatment. ()
  • Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4 mg. Treatment in patients with severe renal impairment is not recommended. Monitor serum creatinine before each dose. ()
  • Osteonecrosis of the jaw has been reported. Preventive dental exams should be performed before starting zoledronic acid injection. Avoid invasive dental procedures. ()
  • Severe incapacitating bone, joint, and/or muscle pain may occur. Discontinue zoledronic acid injection if severe symptoms occur. ()
  • Zoledronic acid injection can cause fetal harm. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant. (, )
  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy. These fractures may occur after minimal or no trauma. Evaluate patients with thigh or groin pain to rule out a femoral fracture. Consider drug discontinuation in patients suspected to have an atypical femur fracture. ()
  • Hypocalcemia: Correct before initiating zoledronic acid injection Adequately supplement patients with calcium and vitamin D. Monitor serum calcium closely with concomitant administration of other drugs known to cause hypocalcemia to avoid severe or life-threatening hypocalcemia ()
  • The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or .
  • No data
  • Aminoglycosides: May have an additive effect to lower serum calcium for prolonged periods. ()u00a0
  • Loop diuretics: Concomitant use with zoledronic acid injection may increase risk of hypocalcemia. ()
  • Nephrotoxic drugs: Use with caution. ()
  • No data
  • Nursing Mothers: It is not known whether zoledronic acid injection is excreted in human milk. ()
  • Pediatric Use: Not indicated for use in pediatric patients. ()
  • Geriatric Use: Special care to monitor renal function. ()
  • Clinical experience with acute overdosage of zoledronic acid injection is limited. Two patients received zoledronic acid injection 32 mg over 5 minutes in clinical trials. Neither patient experienced any clinical or laboratory toxicity. Overdosage may cause clinically significant hypocalcemia, hypophosphatemia, and hypomagnesemia. Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.
  • In an open-label study of zoledronic acid 4 mg in breast cancer patients, a female patient received a single 48-mg dose of zoledronic acid in error. Two days after the overdose, the patient experienced a single episode of hyperthermia (38u00b0C), which resolved after treatment. All other evaluations were normal, and the patient was discharged seven days after the overdose.
  • A patient with non-Hodgkin's lymphoma received zoledronic acid 4 mg daily on four successive days for a total dose of 16 mg. The patient developed paresthesia and abnormal liver function tests with increased GGT (nearly 100U/L, each value unknown). The outcome of this case is not known.
  • In controlled clinical trials, administration of zoledronic acid injection 4 mg as an intravenous infusion over 5 minutes has been shown to increase the risk of renal toxicity compared to the same dose administered as a 15-minute intravenous infusion. In controlled clinical trials, zoledronic acid injection 8 mg has been shown to be associated with an increased risk of renal toxicity compared to zoledronic acid injection 4 mg, even when given as a 15-minute intravenous infusion, and was not associated with added benefit in patients with hypercalcemia of malignancy [see ].
  • Zoledronic acid injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:
  • Zoledronic acid is a white crystalline powder. Its molecular formula is CHNOPu2022HO and its molar mass is 290.1g/mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0.
  • Zoledronic acid injection is available in vials as a sterile liquid concentrate solution for intravenous infusion.
  • Inactive Ingredients:
  • No data
  • Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Mice were given oral doses of zoledronic acid of 0.1, 0.5, or 2.0 mg/kg/day. There was an increased incidence of Harderian gland adenomas in males and females in all treatment groups (at doses greater than or equal to 0.002 times a human intravenous dose of 4 mg, based on a comparison of relative body surface areas). Rats were given oral doses of zoledronic acid of 0.1, 0.5, or 2.0 mg/kg/day. No increased incidence of tumors was observed (at doses less than or equal to 0.2 times the human intravenous dose of 4 mg, based on a comparison of relative body surface areas).
  • Zoledronic acid was not genotoxic in the Ames bacterial mutagenicity assay, in the Chinese hamster ovary cell assay, or in the Chinese hamster gene mutation assay, with or without metabolic activation. Zoledronic acid was not genotoxic in the rat micronucleus assay.
  • Female rats were given subcutaneous doses of zoledronic acid of 0.01, 0.03, or 0.1 mg/kg/day beginning 15 days before mating and continuing through gestation. Effects observed in the high-dose group (with systemic exposure of 1.2 times the human systemic exposure following an intravenous dose of 4 mg, based on AUC comparison) included inhibition of ovulation and a decrease in the number of pregnant rats. Effects observed in both the mid-dose group (with systemic exposure of 0.2 times the human systemic exposure following an intravenous dose of 4 mg, based on an AUC comparison) and high-dose group included an increase in preimplantation losses and a decrease in the number of implantations and live fetuses.
  • No data
  • Arrayn- 4 mg/5 mL single-dose vial of concentrate
  • Carton of 1 vial ..................................................................................................................... NDC 23155-170-31
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15 to 30u00b0C (59 to 86u00b0F) [see USP Controlled Room Temperature].
  • RECLAST is a registered trademark of Novartis.
  • Manufactured by:
  • Emcure Pharmaceuticals Ltd.,
  • Sanand, Ahmedabad - 382110, India.
  • Distributed by:
  • Avet Pharmaceuticals Inc.
  • East Brunswick, NJ 08816
  • 1.866.901.DRUG (3784)
  • Revised: 11/2019
  • NDCn- 170
  • Zoledronic Acid Injection
  • 4 mg/5 mL
  • (0.8 mg/mL)
  • Rx only
  • Concentrate for Intravenous Infusion
  • Not for direct injection.
  • Dose must be diluted.
  • Arrayn- 5 mL
  • NDCn- 170
  • Zoledronic Acid Injection
  • 4 mg/5 mL
  • (0.8 mg/mL)
  • Rx only
  • Concentrate for Intravenous Infusion
  • Not for direct injection.
  • Dose must be diluted.
  • Arrayn- 5 mL

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