Cisplatin B.P.


Injection
 


COMPOSITION
Each ml of CISPLATIN injection contains :
Cisplatin B.P. 1 mg
Mannitol B.P. q.s.
Sodium Chloride B.P. q.s.
Water for Injection B.P. q.s.

STORAGE
Store between 15° to 25° C. Do not freeze. Protect unopened vial from light.

PRESENTATION
10 mg / 10 ml vial
25 mg / 25 ml vial
50 mg / 50 ml vial

ACTIONS
Cisplatin appears to be cycle phase non-specific. It binds to DNA and inhibits DNA synthesis. Protein and RNA synthesis are also inhibited.

INDICATIONS
Cisplatin is indicated as a single agent or in established combination therapy with other approved chemotherapeutic agents in metastatic testicular tumors; metastatic ovarian tumors; advanced bladder cancer.

CONTRAINDICATIONS
Pre-existing renal impairment, myelosuppression, hearing impairment, history of allergic reactions to platinum-containing compounds.

PREGNANCY
Cisplatin can cause fetal harm when administered to a pregnant woman.

DRUG INTERACTIONS
Potentially nephrotoxic or ototoxic drugs e.g. aminoglycoside, antibiotics and loop diuretics may potentiate the nephrotoxic and ototoxic effects of Cisplatin.

ADVERSE REACTIONS
Nephrotoxicity, ototoxicity, myelosuppression, gastrointestinal toxicities, serum electrolyte disturbances, hyperuricemia, ocular toxicity, neurotoxicity, anaphylactic-like reactions, hepatoxicity have been reported.

OVER DOSAGE
Caution should be exercised to prevent inadvertent overdosage with Cisplatin. Acute overdosage with this drug may result in kidney failure, deafness, ocular toxicity ( including detachment of the retina ), significant myelosuppression, intractable nausea and vomiting and/or neuritis. Management of overdosage should include general supportive measures to sustain the patient through any period of toxicity that may occur.

DOSAGE AND ADMINISTRATION
The recommended dose of Cisplatin in adults and children as single agent therapy is 50-100 mg / m2 as a single IV dose every 3-4 weeks or 15-20 mg / m2IV daily for 5 days every 3-4 weeks.
Hydration : Perform pretreatment hydration with 1 to 2 L fluid infused for 8 to 12 hours prior to dose, then dilute the drug in 2 L of 5 % Dextrose in 1/2 or 1/3 Normal saline solution containing 37.5 g mannitol and infuse over 6 to 8 hours.


Note : needles or intravenous administration sets containing aluminum parts that may come in contract with cisplatin should not be used for administration of the drug. Aluminum can react with Cisplatin causing precipitate and loss of potency.

 

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