Cisplatin BP
Composition:
Neoplat-10: Each vial contains Cisplatin BP 10 mg (1 mg/ml).
Neoplat-50: Each vial contains Cisplatin BP 50 mg (1 mg/ml).
Indications:
Neoplat injection is indicated as therapy to be employed as follows: Metastatic
Testicular Tumors - In established combination therapy with other
approved chemotherapeutic agents in patients with metastatic testicular tumors
who have already received appropriate surgical and/or radio therapeutic
procedures. Metastatic Ovarian Tumors- In established combination
therapy with other approved chemotherapeutic agents in patients with metastatic
ovarian tumors who have already received appropriate surgical and/or radio
therapeutic procedures. An established combination consists of Neoplat (Cisplatin)
and cyclophosphamide. Neoplat, as a single agent, is indicated as secondary
therapy in patients with metastatic ovarian tumors refractory to standard
chemotherapy who have not previously received Cisplatin Injection therapy. Advanced
Bladder Cancer - Neoplat (Cisplatin) is indicated as a single agent for
patients with transitional cell bladder cancer which is no longer amenable to
local treatments such as surgery and/or radiotherapy. Non Small Cell
Lung Carcinoma- Neoplat (Cisplatin) in combination with other
chemotherapeutic agent is indicated for the treatment of non small cell lung
cancer in patients who are not candidates for potential curative surgery and/
or radiation therapy.
Dosage and
Administration:
Cisplatin injection is
administered by slow intravenous infusion. It should not be given by
rapid intravenous injection. Note: Needles or intravenous sets
containing aluminum parts that may come in contact with Cisplatin Injection
should not be used for preparation or administration. Aluminum reacts with
Cisplatin Injection, causing precipitate formation and a loss of potency. Metastatic
Testicular Tumors- The usual Cisplatin Injection dose for the treatment
of testicular cancer in combination with other approved chemotherapeutic agents
is 20 mg/m2 IV daily for 5 days per cycle. Metastatic Ovarian
Tumors- The usual Cisplatin Injection dose for the treatment of metastatic
ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2
IV per cycle once every 4 weeks (DAY 1). The dose of cycloposphamide when used
in combination with Cisplatin is 600 mg/m2 IV once every four weeks
(DAY 1). In combination therapy, Cisplatin Injection and Cyclophosphamide are
administered sequentially. As a single agent, Cisplatin Injection should be
administered at a dose of 100 mg/m2 IV per cycle once every four
weeks. Advanced Bladder Cancer- Cisplatin Injection should be
administered as a single agent at a dose of 50 to 70 mg/m2 IV per
cycle once every 3 to 4 weeks depending on the extent of prior exposure to
radiation therapy and/or prior chemotherapy. For heavily pretreated patients an
initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.
Non Small Cell Lung Carcinoma- Cisplatin Injection (75 mg/m2)
should be administered in combination with Paclitaxel (135 mg/m2) in
every three weeks. Or, as directed by the registered physicians.
Use in Pregnancy and
Lactation: Pregnancy Category D. There are no adequate and
well controlled studies in pregnant women. Cisplatin has been reported to be
found in human milk. It is not known whether Cisplatin is excreted in human.
Packing:
Neoplat-10: Each box contains one vial of 10 ml solution.
Neoplat-50: Each box contains one vial of 50 ml solution.
