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CISPLATIN EBEWE

Package(a):
VIAL: 1 x 20 ml (10 mg cisplatin).
Dosage(a):
Dosage depends on the primary disease, the expected reaction, and on whether it is used for monotherapy or as a component of a combination chemotherapy, for both adults and children. 
For monotherapy: Single dose of 50 to 120 mg/m² body surface every 3 to 4 weeks; 15 to 20 mg/m²/day for five days, every 3 to 4 weeks. 
For combination therapy, the dose must be reduced. A typical dose is 20 mg/m² or more, once every 3 to 4 weeks.
Prescribing Restrictions:  None

Package(b):
VIAL: 1 x 50 ml (25 mg cisplatin).
Dosage(b):
Dosage depends on the primary disease, the expected reaction, and on whether it is used for monotherapy or as a component of a combination chemotherapy, for both adults and children. 
For monotherapy: Single dose of 50 to 120 mg/m² body surface every 3 to 4 weeks; 15 to 20 mg/m²/day for five days, every 3 to 4 weeks. 
For combination therapy, the dose must be reduced. A typical dose is 20 mg/m² or more, once every 3 to 4 weeks.
Prescribing Restrictions:  None

Package(c):
VIAL: 1 x 100 ml (50 mg cisplatin).
Dosage(c):
Dosage depends on the primary disease, the expected reaction, and on whether it is used for monotherapy or as a component of a combination chemotherapy, for both adults and children. 
For monotherapy: Single dose of 50 to 120 mg/m² body surface every 3 to 4 weeks; 15 to 20 mg/m²/day for five days, every 3 to 4 weeks. 
For combination therapy, the dose must be reduced. A typical dose is 20 mg/m² or more, once every 3 to 4 weeks.
Prescribing Restrictions:  None


Indications:
Palliative therapy either alone or in established combination therapy with other approved chemotherapeutic agents and in patients who have already received appropriate surgical and/or radiotherapeutic procedures, in the management of metastatic testicular tumors, metastatic ovarian tumors and advanced bladder cancer.
Contra-Indications:
Hypersensitivity. Renal dysfunction. Dehydrated condition (pre- and post-hydration is required to prevent serious renal dysfunction.) Myelosuppression. A hearing impairment. Neuropathy caused by cisplatin. Pregnancy or lactation. In combination with yellow fever vaccine and phenytoin in prophylactic use.
Special Precautions:
Reduce dose in renal dysfunction or bone marrow depression. Should be administered by I.V. infusion over 6-8 hours. Adequate hydration (by I.V. infusion of one of the following solutions: NaCl solution 0.9%; or mixture of NaCl solution 0.9% and glucose solution 5% (1:1) at 100 to 200 ml/hour) must be maintained 2-12 hours prior to administration until minimum of 6 hours after administration. Forced diuresis may be required if urine secretion is less than 100-200 ml/hour after hydration. Patient should drink large quantities of liquids for 24 hours after the infusion. Should only be administered under the supervision of a physician qualified in oncology. Is proven to be cumulative ototoxic, nephrotoxic, and neurotoxic. Toxicity may be amplified by combination with other products that are toxic for the said organs or systems. Audiograms must be made before treatment. Before, during and after administration, the following organ functions parameters must be determined, and repeated every week during treatment: Renal, hepatic and hematopoiesis functions, and serum electrolytes. Repeating administrations must be delayed until the following parameters are achieved: Serum creatinine lower or equal to 130 micromol. resp. 1.5 mg/dl. Urea <25 mg/dl white blood cells >4,000/mcl resp.>4.0 x 10⁹/l. Blood platelets >100,000 mcl resp. >100 x 10⁹/l. Audiogram: Normal range results. Peripheral neuropathy. In cases of extravasation: Immediately end the infusion. Do not move needle, aspirate the extravasate from the tissue, and rinse with NaCl solution 0.9%. Prophylactic anti-emetic may be effective. Both male and female patients must use contraceptives during and for at least 6 months after treatment. Use of living virus vaccinations is not recommended within 3 months to 1 year following the end of treatment. Avoid contact with persons having bacterial infections, especially during periods of low blood counts. May reduce driving skills and ability to operate machinery.
Side Effects:
Severe nausea and vomiting. Serious toxic effects on the kidneys, bone marrow and ears. Benign and malignant neoplasms (including cysts and polyps). Mostly reversible leucopenia, thrombocytopenia and anemia. Rashes, urticaria, erythema, or pruritis. Hypomagnesemia, hypocalcemia, hyponatremia, hypophosphatemia, hypokalemia. Increased serum amylase. Neurotoxicity, loss of vision during a combination treatment. Hearing impairment, cardiac dysarrhythmias. Liver dysfunction, renal dysfunction. Local edema and pain, erythema, skin ulceration and phlebitis may occur in the area of the injection.
Drug Interactions:
Myelosuppressives, radiation. Antihypertensives containing furosemide, hydralazine, diazoxide and propanol. Nephrotoxics, otoxics. Predominantly renally eliminated substances. Allopurinol, colchicines, probenecid, sulfinpyrazone. Except for patients receiving doses of cisplatin exceeding 60 mg/m², whose urine secretion is less than 1,000 ml per 24 hours, no forced diuresis with loop diuretics should be applied. Antihistamines, buclizine, cyclizine, loxapine, meclozine, phenotheizines, thioxanthenes, trimethobenzamides. Ifosphamide, pyridoxine, hexamethylmelamine. Bleomycin, vinblastin, paclitaxel, docetaxel. Etoposide, phenytoin, penicillamine, ciclosporine.