Cesalin 50 mg

Cesalin 50 mg

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Product Description

Description
Cesalin® (Cisplatin BP), (cis-diamminedichloroplatinum) is a heavy metal-salt complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is a white powder with the molecular formula PtCl2H6N2 and the molecular weight of 300.05 and the structural formula is:
Composition
Each vial contains Cisplatin BP 10 mg and 50 mg lyophilized powder for injection.
Mechanism of action
Cisplatin causes 1,2–intrastrand cross-links with purine bases, interfering with cell division by mitosis. The damaged DNA elicits DNA repair mechanisms, which in turn activate apoptosis.
Pharmacokinetics
Bioavailability Complete Protein binding >90%
Metabolism Hepatic
Half-life 30-100 hours
Excretion Renal
Indications
Cesalin® is indicated as first line therapy for lung cancer, head & neck cancer and for the treatment of advanced and metastatic ovarian carcinoma, bladder carcinoma and testis carcinoma. Inj.
Cisplatin BP 10 mg & 50 mg
Dosage and administration
Usual dosage and schedule 40 to 120 mg/m2 I.V. on day 1 as infusion every 3 weeks. 15 to 20 mg/m2 I.V. on days 1 to 5 as infusion every 3 to 4 weeks. The usual dose in adults and children when used as single agent therapy is 50-100 mg/m2 .
Possible side effects
Mild to moderate nephrotoxicity, electrolyte disturbance, gastrointestinal tract effects, myelotoxicity, ototoxicity, neurotoxicity may occur.
Contraindications
Cesalin® is contraindicated in patients with pre-existing renal impairment. Cisplatin should not be employed in myelosuppressed patients, or patients with hearing impairment. It is also contraindicated in patients with a history of allergic reactions to cisplatin or other
platinum-containing compounds.
Drug interactions
Potentially nephrotoxic or ototoxic drugs, e.g. aminoglycoside antibiotics and loop diuretics, may potentiate the nephrotoxic and ototoxic effects of Cisplatin.
Special precautions
Cesalin® should not be administered if serum creatinine level is more than 1.5 mg/dL. Irreversible renal tubular damage may occur if vigorous diuresis is not maintained, particularly with higher dose (higher than 40 mg/m2), and with additional concurrent nephrotoxic drugs such as the aminoglycosides. At higher doses, diuresis with
mannitol with or without furosemide vigorous hydration may occur.
Reconstitution
Cesalin® lyophilized powder for injection 10 mg and 50 mg should be reconstituted with 10 mL and 50 mL of water for inj. respectively.
Cesalin® solution after reconstitution should be added to 2 liters of 5% glucose/ 0.9% saline and intravenously administered in 6-8 hours; after administration an adequate hydration and diuresis should be maintained during 24 hours.
Stability
The cisplatin remaining in vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.
Storage
Product should be stored at controlled room temperature 25oC and protected from light.
Presentations
Cesalin® 50 mg injection: Each vial contains Cisplatin BP 50 mg lyophilized power for injection.

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