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.