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Zoledronic Acid (Zoledronic Acid)

Trade Name : zoledronic acid

Sagent Pharmaceuticals

INJECTION, SOLUTION, CONCENTRATE

Strength 0.8 mg/mL

ZOLEDRONIC ACID Diphosphonates [CS],Bisphosphonate [EPC]

Delivery Process

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Disclaimer

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 Sagent Pharmaceuticals. It is available in strength of 0.8 mg/mL 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

Validated Cold Chain Shipment

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
  • No data
  • Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of:n
  • Limitations of Use
  • 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
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.n
  • Hypercalcemia of malignancy ()n
  • Multiple myeloma and bone metastasis from solid tumors. ()n
  • Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation-containing solutions. ()n
  • Zoledronic Acid Injection: 4 mg per 5 mL (0.8 mg per mL) single-dose vial for dilution prior to intravenous infusion.n
  • Zoledronic Acid Injection: 4 mg per 5 mL (0.8 mg per mL) single-dose vial for dilution prior to intravenous infusion ()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 .n
  • Hypersensitivity to any component of Zoledronic Acid Injection ()n
  • No data
  • Patients being treated with Zoledronic Acid Injection should not be treated with Reclast. ()n
  • Adequately rehydrate patients with hypercalcemia of malignancy prior to administration of Zoledronic Acid Injection and monitor electrolytes during treatment. ()n
  • 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. ()n
  • Osteonecrosis of the jaw (ONJ) has been reported. Preventive dental exams should be performed before starting Zoledronic Acid Injection. Avoid invasive dental procedures. ()n
  • Severe incapacitating bone, joint, and/or muscle pain may occur. Discontinue Zoledronic Acid Injection if severe symptoms occur. ()n
  • 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. ()n
  • Hypocalcemia
  • Zoledronic Acid Injection can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (, , )n
  • The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea. ()n n
  • No data
  • Aminoglycosides
  • Loop Diuretics
  • Nephrotoxic Drugs
  • No data
  • Lactation
  • Females and Males of Reproductive Potential
  • Pediatric Use
  • Geriatric Use
  • 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.n
  • 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.n
  • 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 100 unit/L, each value unknown). The outcome of this case is not known.n
  • 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 .n
  • 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:n
  • 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.n
  • Zoledronic Acid Injection is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion.n
  • 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).n
  • 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.n
  • 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 pre-implantation losses and a decrease in the number of implantations and live fetuses.n
  • No data
  • Zoledronic Acid Injection is supplied as follows:n
  • Storage Conditions
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 and 30u00b0C (59u00b0 and 86u00b0F). [See USP Controlled Room Temperature.]
  • Discard unused portion.n
  • Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.
  • No data
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Labeln
  • NDC 25021-801-66n
  • Zoledronic Acid Injectionn
  • 4 mg per 5 mLn
  • (0.8 mg per mL)n
  • Rx onlyn
  • Sterile Concentraten
  • For Intravenous Infusion after Dilutionn
  • 5 mL Single-Dose Vialn

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