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CEPLATIN

CISPLATIN · by PHARMEDIC

ANTINEOPLASTICS Alkylating agent Platinum Compounds PHARMEDIC

Composition

Inj 5 mg/ 10 mg/ 25 mg/ 50 mg/ 100 mg: Solution ready for use of 5 mg/ 10 mg/ 25 mg/ 50 mg/ 100 mg cisplatinum

Indications & Dosage

Treatment of testicular, lung, cervical, bladder, head and neck, and ovarian cancer (alone or in combination): BY IV INF: Adult: See product literature. Metastatic testicular tumours: Adults: 20 mg/m2 daily for 5 consecutive days (days 1 to 5) every 3rd week for 4 courses, 30 units of bleomycin on the 2nd day of each week for 12 consecutive doses, 0.2 mg/kg body weight of vinblastine on days 1 and 2 of every 3rd week four courses. Metastatic ovarian tumours: Adult: Once every 3 wk 50 mg/m2and 500 mg/m2of cyclophosphamide. As a monotherapy: 100 mg/m2by intravenous route every 4th wk.

Administration

Pretreatment hydration with 1-2 Litre of fluid is recommended prior to cisplatin administration, adequate hydration and urinary output (> 100 ml/hour), Should be maintained for 24 hours after administration. Aluminuim containing IV infusion sets and needles should not be used due to binding with platinum. Rate of administration has varied from a 15 to 120 mins infusion, 1 mg/min infusion, 6-8 hour infusion, 24 hour infusion or per protocol. Maximum rate of infusion: 1 mg/min in patients with CHF. When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before platinum derivatives to limit myelosuppression and to enhance efficacy. Standard IV dilution: Dose 250-1000 ml NS, D5/NS or 05/0.45% NaCI; stable for 72 hours at 4 C to 25 C (in combination with mannitol).

Compatibility

Stable in D5/NS, D51/4NS, D5NS, 1/4NS, 1/3NS, 1/4NS, NS; incompatible with sodium bicarbonate 5%.

Contraindications

Pre-existing severe renal impairment, history of allergic reactions.

Precautions

Hepatic disorders, myelosuppression, renal and hearing impairment, myelosuppression. Discontinue in case of elevated BUN and serum creatinine and decreased CrCl.

Interactions

Anti-neoplastic agents, radiotherapy

Pregnancy

Positive evidence of risk: Avoid

Lactation

Contraindicated. Discontinue breast-feeding.

Side Effects

Alopecia, bone-marrow suppression, Extravasation, hyperuricaemia ,hypomagnesaemia, myelosuppression, nephrotoxicity, oral mucositis, ototoxicity, peripheral neuropathy, severe nausea, severe vomiting, thromboembolism, tumourlysis syndrome, hearing loss, anaphylactic reactions (e.g. drug eruption), elevated GOT OPT ALP; malaise, dizziness, flush, oedema.