Eposide 50 MG CAP

Eposide

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Product Description

Description
Eposide® (Etoposide BP), is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. Its chemical name is 4′-Demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-ß-D-glucopyranoside]. Eposide is highly lyophilic. Its molecular formula is C29H32O13 and molecular weight is 588.56. Eposide has the following structural formula:

Composition
Each vial contains Etoposide BP 100 mg at a concentration of 20 mg/mL .

Mechanism of action
Eposide® forms a ternary complex with DNA and the topoisomerase II enzyme, preventing religation of the DNA strands. This causes errors in DNA synthesis and promotes apoptosis of the cancer cell.

Pharmacokinetics
Bioavailability N/A
Protein binding 97%
Metabolism Hepatic (CYP3A4 involved)
Half-life Oral: 6 hr, I.V. in children: 3 hr
Excretion Renal and fecal

Indications
Eposide® is indicated for the treatment of testicular tumors in combination with other chemotherapeutic agents and small cell lung cancer in combination with other chemotherapeutic agents. It is also used for the treatment of monoblastic leukemia & acute
myelomonoblastic leukemia. 25

Dosage and administration
Usual dosage and schedule 120 mg/m2 I.V. on days 1 to 3 every 3 weeks. 50 to 100 mg/m2 I.V. on days 1 to 5 every 2 to 4 weeks. 125 to 140 mg/m2 on days 1, 3
and 5 every 3 to 5 weeks. 50 mg/m2 PO daily for 21 days. This should be repeated after 1 to 2 weeks of rest. High dose therapy (750 to 2400 mg/m2) is investigational and should be used only with progenitor cell recue.

Possible side effects
Mild to moderate cardiac disorders, eye disorders, hepato-biliary disorder, nervous system disorders, skin and subcutaneous tissue disorders, immune system disorders, gastrointestinal disorders, renal and urinary disorders, blood and lymphatic system disorders, erythema, facial and tongue oedema, coughing, sweating, cyanosis,
convulsions, laryngospasm may occur.

Contraindications
Pregnancy category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.

Drug interactions
Drug interact with antifungal agents (e.g, ketoconazole), cyclosporine, grape-juice & warfarin.

Special precautions
Etoposide should be administered as a 30 to 60 min infusion to avoid severe hypotension. Blood pressure should be monitored during infusion of etoposide and may be administered as 5-min bolus infusion.

How to use
Eposide® concentrate for infusion 20 mg/mL must be diluted immediately prior to use with either 5% dextrose in water, or 0.9% sodium chloride solution to give a final concentration of 0.2 to 0.4 mg/mL. Reconstituted solution is administrated via continuous infusion over 30 minutes for 3-5 days, followed by a resting period of 10-20 days.

Stability
Unopened vials of Etoposide Injection are stable for 24 months at mroom temperature (25°C). Vials diluted as recommended to a concentration of 0.2 or 0.4 mg/mL are stable for 96 and 24 hours.

Storage
This product should be stored below 25oC without freezing.

Presentations
Eposide® 100 mg injection: Each vial contains 5 mL of solution containing Etoposide BP 100 mg.

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