Vincristine Sulphate For Injection B. P. Lyophilised


 

COMPOSITION
Each vial of 1 mg contains :
Vincristine Sulphate (anhydrous) B.P. 1 mg.
Lactose B.P. q.s

Each vial of 2mg contains :
Vincristine Sulphate (anhydrous) B.P. 2 mg.
Lactose B.P. q.s

Each vial of 5mg contains :
Vincristine Sulphate (anhydrous) B.P. 5mg.
Lactose B.P. q.s

PREPARATION OF SOLUTION
Dissolve contents of the 1 mg, 2 mg and 5 mg vials in 10 ml Sodium Chloride Injection B.P.

STORAGE
Store in a refrigerator between 2° to 8° C.

PRESENTATION
Vial containing 1 mg plus diluent
Vial containing 2 mg plus diluent
Vial containing 5 mg

ACTIONS
It inhibits microtubule formation in the mitotic spindle resulting in an arrest of dividing cells at the metaphase stage.

INDICATIONS
Vincristine Sulphate is indicated in acute leukemia. Also useful in combination with other oncolytic agents in Hodgkin's disease, non-Hodgkin's malignant lymphomas (lymphocytic, mixed-cell histolytic, undifferentiated, nodular, and diffuse types), rhabdomyosarcoma, neuroblastoma and Wilms tumor.

CONTRAINDICATIONS
Contraindicated in patients with the demyelinating form of Charcot-Marie-Tooth syndrome.

PREGNANCY
The drug can cause fetal harm administered to a pregnant woman.

DRUG INTERACTIONS
Combination chemotherapy (including Vincristine Sulphate) may decrease plasma levels of digoxin and phenytoin.

ADVERSE REACTIONS
In general, adverse reactions are reversible and are related to dosage. Most common is hair loss. Hypersensitivity, gastrointestinal toxicity, genitourinary toxicity, cardiovascular toxicity, neuromuscular side effects, endocrine toxicity, hematologic toxicity etc. are reported.

OVERDOSAGE
In children under 13 years of age, death has occurred following doses of the drug that were 10 times those recommended for therapy. Adults can experience severe symptoms after single doses of 3 mg / m2 or more. Supportive care should include prevention of side effects resulting from the syndrome of inappropriate antidiuretic hormone secretion, administration of anticonvulsant, monitoring the cardiovascular system.

DOSAGE AND ADMINISTRATION
Administer IV only, at weekly intervals. Inject solution either directly into a vein or into the tubing of a running IV infusion . Injection may be completed in about 1 minute.
For adults 1.4 mg to1.5 mg / m2 upto a maximum weekly dose of 2 mg / m2.
For children 2 mg / m2. For children weighing less than 10 kg or less or having a body surface area less than 1 m2 give 0.05 mg / kg once a week. In hepatic function impairment a 50% reduction in the dose is recommended for patients having a direct serum bilirubin value > 3 mg / dl.

 
Copyright © 2009 Serum Institute of India Limited. Legal Disclaimer.