Cisplasan

Cisplasan

cisplatin

Manufacturer:

Sanbe
Concise Prescribing Info
Contents
Cisplatin
Indications/Uses
Palliative monotherapy or in combination w/ other approved chemotherapeutic against & in patients who have already received appropriate surgical &/or radio therapeutic procedures in the management of metastatic testicular or ovarian tumors & advanced bladder cancer.
Dosage/Direction for Use
IV Prehydration therapy 8-12 hr before administration. Consist of 1-2 L physiological saline soln/m2/infusion over at least 2-3 hr. Short-term infusion: IV infusion over 15 min, dose is given immediately following an IV administration of 62.5 mL 20% mannitol soln. Long-term infusion: IV infusion over 1-8 hr, dose to be administered is diluted w/ 1-2 L physiological saline soln containing 50 g glucose & 18.75 g mannitol/L. Monochemotherapy 50-120 mg/m2 at 3-4 wk intervals; or 50 mg/m2 on day 1 & 8 at 3-4 wk intervals; or 15-20 mg/m2 on day 1-5 at 3-4 wk intervals. Post hydration therapy Adequate fluids must be given during the period after administration, eg, in the (6-12) 24 hr following drug administration (this consist of 2-31 physiological saline soln/m2 together w/ a 5% glucose soln at a ratio 1:1.5). Forced diuresis Doses >60 mg/m2, mannitol administration (8 g/m2) is obligatory immediately prior to the 1st administration. Only after the onset of a min diuresis of 250 mL w/in 30 min may the administration be started. Patient w/ impaired renal function serum creatinine ≥2 mg/dL Stop therapy until the serum creatinine is again ≤2 mg/dL. Serum creatinine ≤2 mg/dL Dose reduction of 50% of the standard dose already in the serum creatinine range 1.5-2 mg/dL.
Contraindications
Hypersensitivity to cisplatin or other platinum containing compd. Myelosupressed patients, hearing impairment, preexisting renal impairment.
Special Precautions
Anaphylactic-like reactions in patients w/ prior exposure to this drug. May cause precipitate formation & a loss of potency w/ needles or IV sets containing Al parts. Potentiates severe cumulative renal toxicity w/ aminoglycoside antibiotics. Measure serum creatinine, BUN, CrCl, Mg, K, & Ca levels prior to initiating therapy & to each subsequent course. Not to be given more frequently than once every 3-4 wk. Perform audiometric testing prior to initiating therapy & to each subsequent dose of drug. Dose-related myelosuppression. Monitor peripheral blood counts wkly. Severe neuropathies & may be irreversible in some patients. Perform neurologic exam regularly. Monitor liver function periodically. Elevated SGOT may occur. Pregnancy.
Adverse Reactions
Elevated BUN & creatinine, serum uric acid, decreased CrCl; tinnitus, hearing loss; myelosuppression, anemia; nausea, vomiting, anorexia; peripheral neuropathies; facial edema, wheezing tachycardia, hypotension; hypocalcemia, hypokalemia, hypophosphatemia; hyperuricemia.
Drug Interactions
Increased bone marrow toxicity w/ other myelosuppressants or therapeutic measures eg, radiotherapy. Increased nephrotoxicity & ototoxicity w/ nephrotoxic & ototoxic substances (eg, aminoglycoside, amphotericine-β). Decreased efficacy w/ chelating agents eg, penicillamine. Reduced renal excretion of other cytostatic agents eg, bleomycin & methotrexate. May negatively influence the therapeutic response w/ pyridoxine & hexamethylamine in advanced ovarian cancer. Raynaud's phenomenon may occur w/ bleomycin or vinblastine. Decreased plasma conc of anti-convulsants. May cause more pronounced neuropathy w/ docetaxel. Vaccinations w/ live vaccines.
ATC Classification
L01XA01 - cisplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Cisplasan inj 1 mg/mL
Packing/Price
50 mL x 1's
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