Vexonib-4

Vexonib-4

zoledronic acid

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma
Full Prescribing Info
Contents
Zoledronic acid.
Description
Each vial contains: Zoledronic acid, Eq. to Zoledronic acid Anhydrous 4 mg, Mannitol USP 220 mg, Sodium Citrate USP 24 mg (As sterile freeze-dried powder for reconstitution). Zoledronic acid is a white to almost white crystalline powder. It is soluble in 0.1 M Sodium Hydroxide, sparingly soluble in water & 0.1 N Hydrochloric acid practically insoluble in organic solvent. Zoledronic Acid is described chemically as (1-hydroxy-2-(1H-imidazol-1-yl)ethane-1.1-diyl]bis(phosphonic acid).
Molecular formula: CHNOP.
Molecular weight: 272.09.
Action
Pharmacology: Zoledronic acid; belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
General: Principal pharmacological action of Zoledronic acid is bone resorption inhibition. Although it is not completely known the mechanism of action for the antiresorptive activity, it is believed that several factors contribute to this action. Zoledronic acid in vitro inhibits the activity of osteoclasts and induces their apoptosis. Zoledronic acid also blocks the osteoclastic.
Indications/Uses
For the prevention of skeletal events in patients with advanced bone malignancies and for treatment of hypercalcemia of malignancy, Paget's disease of bone, and osteoporosis in postmenopausal women. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Dosage/Direction for Use
Zoledronic acid is given as an intravenous infusion over not less than 15 minutes. It is used or hypercalcemia of malignancy, in a single dose of 4 mg, diluted with 100 mL of sodium chloride 0.9% or glucose 5%. The treatment may be repeated if necessary after at least 7 days, at a dose of 4 mg. Individual doses should not exceed 4 mg, as there is an increased risk of adverse renal effects, including renal failure.
Zoledronic acid is given for the prevention of skeletal events in patients with advanced bone malignancies at a dose of 4 mg, diluted as above, every 3 to 4 weeks. For the treatment of Paget's disease of bone, zoledronic acid is given as a single intravenous infusion of 5 mg.
Zoledronic acid is also used for the treatment of osteoporosis in postmenopausal women; the recommended dose is a single.
Overdosage
Clinical experience with acute overdose of Zoledronic acid is limited. The administration of doses up to 48 mg of zoledronic acid in error has been reported. Patients who have received doses higher than those recommended should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed. In the event of hypocalcemia, calcium gluconate infusions should be administered as clinically indicated.
Caution For Usage
Solution Preparation: Each vial of Zoledronic acid is reconstituted with 5 ml of sterile water for injection, aseptically. Agitate until total dissolution. To prepare a solution for infusion containing 8 mg Zoledronic acid, two 4 mg vials must be aseptically reconstitute by adding 5 ml of sterile water for injection to each of them, as described above. In both cases, the resulting solution must be diluted in 50 ml sodium chloride solution at 0.9% w/v or glucose solution at 5% w/v.
Patients must be maintained well hydrated prior to and following administration of Zoledronic acid.
Zoledronic acid concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Patients must be maintained well hydrated prior to and following administration of Zoledronic acid.
solution should be used immediately. Otherwise, storage prior to use is responsibility of the healthcare professional, and should be stored at 2°C and 8°C, and let the solution return to room temperature before administration. The time from reconstitution, to dilution and administration, should not exceed 24 hours in total.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Shelf-Life: 24 months from the date of manufacturing.
ATC Classification
M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Powd for inj (lyophilized, white powder) (vial) 4 mg x 10 mL x 1's.
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