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Home - Products - Oncology(Anti-Cancer-Injectables) - Zolendronic Acid

Zolendronic Acid

Category: Anti-neoplastic
Each vial contains:-
Zoledronic acid 4mg
Chromatographic Purity: NLT 99.5%

Zoledronic acid is a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (l-Hydroxy-2-imidazol-l-yl-phosphonoethyl) phosphonic acid monohydrate. Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2•H2O 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.

Composition : Each vial contains:
Zoledronic acid monohydrate 4.264mg
eq to Zoledronic acid……………..4mg
Indication : Zoledronic acid is indicated for the treatment of hypercalcemia, multiple myeloma, bone metastases, osteoporosis in men and women.
Dosage :- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The maximum recommended dose of Zoledronic acid in hypercalcemia of malignancy (albumin-corrected serum calcium greater than or equal to 12 mg/dL [3.0 mmol/L]) is 4 mg. The 4-mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes. Patients who receive Zoledronic acid should have serum creatinine assessed prior to each treatment.
Contra Indications:- Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported.
Precautions:- Patients with hypercalcemia of malignancy must be adequately rehydrated prior to administration of Zoledronic acid, treatment is not recommended in patients with bone metastases with severe renal impairment and in hepatic impairement.
Pharmacological Action: The principal pharmacological action of Zoledronic acid is inhibition of bone resorption. In vitro, zoledronic acid inhibits osteoclastic activity and induces osteoclast apoptosis. Zoledronic acid also blocks the osteoclastic resorption of mineralized bone and cartilage through its binding to bone. Zoledronic acid inhibits the increased osteoclastic activity and skeletal calcium release induced by various stimulatory factors released by tumors.
Drug interaction: In-vitro studies indicate that Zoledronic acid is approximately 22% bound to plasma proteins. In-vitro studies also indicate that Zoledronic acid does not inhibit microtonal CYP450 enzymes. In-vivo studies showed that Zoledronic acid is not metabolized, and is excreted into the urine as the intact drug.
Adverse effect: Administration of Zoledronic acid 4 mg given as a 5-minute intravenous infusion has been shown to result in an increased risk of renal toxicity The most frequently observed adverse events were fever, nausea, constipation, anemia, and dyspnea. rash, pruritus.
Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
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