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Zoledronic Acid (Zoledronic Acid)

Trade Name : Zoledronic acid

Northstar RxLLC

INJECTION

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 Northstar RxLLC. 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
  • No data
  • ZOLEDRONIC ACID Injection is a bisphosphonate indicated for the treatment of:
  • Limitations of Use
  • Hypercalcemia of malignancy. (n n n )n n n 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 n n )n n n
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permitn n n n
  • Hypercalcemia of malignancy (n n n )n nn
  • Multiple myeloma and bone metastasis from solid tumors. (n n n )n nn
  • Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation-containing solutions. (n n n )n nn
  • Injection: 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion.
  • Injection: 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion (n n n )n nn
  • Hypersensitivity to any component of zoledronic acid injection (n n n )n nn
  • No data
  • Patients being treated with zoledronic acid injection should not be treated with Reclastn n n . (n n n )n n n n
  • Adequately rehydrate patients with hypercalcemia of malignancy prior to administration of zoledronic acid injection and monitor electrolytes during treatment. (n n n )n n n 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 n n )n n n 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 n n )n n n n
  • Severe incapacitating bone, joint, and/or muscle pain may occur. Discontinue zoledronic acid injection if severe symptoms occur. (n n n )u00a0n n n n
  • nttttttt 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 n n ) n n n
  • Hypocalcemia:
  • nttttttt Zoledronic acid injection can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (n n n , n n n , n n n ) n n n
  • The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea (n n n )n nn
  • 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 32u00a0mg over 5u00a0minutes 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 zoledronicu00a0acid 4u00a0mg in breast cancer patients, a female patient received a single 48-mg dose of zoledronicu00a0acid 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-Hodgkinu2019s lymphoma received zoledronicu00a0acid 4u00a0mg daily on four successive days for a total dose of 16u00a0mg. The patient developed paresthesia and abnormal liver function tests with increased GGT (nearly 100unit/L, each value unknown). The outcome of this case is not known.
  • In controlled clinical trials, administration of zoledronic acid injection 4u00a0mg as an intravenous infusion over 5u00a0minutes 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 8u00a0mg has been shown to be associated with an increased risk of renal toxicity compared to zoledronic acid injection 4u00a0mg, even when given as a 15-minute intravenous infusion, and was not associated with added benefit in patients with hypercalcemia of malignancy [n n n ].n nn
  • Zoledronic Acid Injection contains zoledronicu00a0acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronicu00a0acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:
  • Zoledronicu00a0acid is a white crystalline powder. Its molecular formula is Cn n n Hn n n Nn n n On n n Pn n n u2022 Hn n n O and its molar mass is 290.1g/mol. Zoledronicu00a0acid is highly soluble in 0.1Nu00a0sodium hydroxide solution, sparingly soluble in water and 0.1Nu00a0hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronicu00a0acid in water is approximatelyu00a02.0.n nn
  • Zoledronic Acid Injection is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion.
  • Arrayn- Inactive Ingredients:
  • No data
  • Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Mice were given oral doses of zoledronicu00a0acid of 0.1, 0.5, or 2.0u00a0mg/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 0.002u00a0times a human intravenous dose of 4u00a0mg, based on a comparison of relative body surface areas). Rats were given oral doses of zoledronicu00a0acid of 0.1, 0.5, or 2.0u00a0mg/kg/day. No increased incidence of tumors was observed (at doses less than or equal to 0.2u00a0times the human intravenous dose of 4u00a0mg, based on a comparison of relative body surface areas).
  • Zoledronicu00a0acid 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. Zoledronicu00a0acid was not genotoxic in the n n n n rat micronucleus assay.n nn
  • Female rats were given subcutaneous doses of zoledronicu00a0acid of 0.01, 0.03, or 0.1u00a0mg/kg/day beginning 15u00a0days before mating and continuing through gestation. Effects observed in the high-dose group (with systemic exposure of 1.2u00a0times the human systemic exposure following an intravenous dose of 4u00a0mg, 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 0.2u00a0times the human systemic exposure following an intravenous dose of 4u00a0mg, 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
  • 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion
  • Carton of 1 vialu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDCu00a016714-815-01
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F-86u00b0F) [see USP Controlled Room Temperature].
  • Discard unused portion.
  • Drugs With Same Active Ingredient or in the Same Drug Class
  • u2022u00a0Inform patients not to take Reclast or other bisphosphonates during the course of their zoledronic acid injection therapy n n n .n nn
  • Renal Impairment
  • u2022u00a0Instruct patients to tell their doctor if they have kidney problems before being given zoledronic acid injection.n
  • u2022u00a0Inform patients of the importance of getting their blood tests (serum creatinine) during the course of their zoledronic acid injection therapy n n n n
  • Osteonecrosis of the Jaw (ONJ)
  • u2022u00a0Advise patients to have a dental examination prior to treatment with zoledronic acid injection and to avoid invasive dental procedures during treatment.n
  • u2022u00a0Inform patients of the importance of good dental hygiene, routine dental care, and regular dental check-ups.n
  • u2022u00a0Advise patients to immediately tell their doctor about any oral symptoms such as loosening of a tooth, pain, swelling, or non-healing of sores or discharge during treatment with zoledronic acid injection n n n n
  • Musculoskeletal Pain
  • u2022u00a0Advise patients to immediately tell their doctor about any severe bone, joint, and/or muscle pain n n n n
  • Atypical Subtrochanteric and Diaphyseal Femoral Fracture
  • u2022Advise patients to report any thigh, hip, or groin pain. It is unknown whether the risk of atypical femur fracture continues after stopping therapy n n n n
  • Patients with Asthma
  • There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including zoledronic acid. Before being given zoledronic acid, instruct patients to tell their doctor if they are aspirin-sensitive n n n n
  • Hypocalcemia
  • Advise patients with multiple myeloma and bone metastasis of solid tumors to take an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily n n n n
  • Embryo-Fetal Toxicity
  • u2022u00a0Zoledronic Acid Injection should not be given if the patient is pregnant or plans to become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy n n n .n nn
  • u2022u00a0Advise females of reproductive potential to use effective contraception during and after treatment with zoledronic Acid Injection n n n .n nn
  • Lactation
  • Advise lactating women not to breastfeed during and after treatment with zoledronic Acid Injection n n n n
  • Common Adverse Reactions
  • Advise patients that the most common side effects of zoledronic acid injection are nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea.
  • Manufactured For:
  • Array
  • Memphis, TN 38141
  • Manufactured By:
  • 10 2990 1 696285n n n Revised April, 2019.n nn
  • PRINCIPAL DISPLAY PANEL - 4 mg/5 mL carton label
  • Zoledronic acid Injection
  • 4 mg/5 mL (0.8 mg/mL)
  • Rx Only
  • Concentrate for Intravenous Infusion
  • PRINCIPAL DISPLAY PANEL - 4 mg/5 mL container label
  • Zoledronic acid Injection
  • 4 mg/5 mL (0.8 mg/mL)
  • Concentrate for Intravenous Infusion
  • 5 mL Single-Dose Vial
  • Rx Only

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