Cilatin 50

Cilatin 50

cisplatin

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Cisplatin
Indications/Uses
Palliative therapy either alone or in combination w/ other chemotherapeutic against & in patients who already received surgical &/or radiotherapeutic procedures in the management of metastatic testicular or ovarian tumors & advanced bladder cancer.
Dosage/Direction for Use
Prehydration therapy of 1-2 L/m2 physiological saline soln as infusion over at least 2-3 hr is required 8-12 hr before cisplatin administration. Short-term infusion: IV infusion over 15 min given immediately following IV administration of 62.5 mL of 20% mannitol soln. Long-term infusion: IV infusion over 1-8 hr. 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. Posthydration therapy of 2-3 L/m2 physiological saline soln w/ 5% glucose soln at ratio of 1:1.5 must be given in the (6-12) 24 hr following cisplatin administration.
Contraindications
Hypersensitivity to cisplatin or other platinum-containing compd. Myelosuppressed patients. Preexisting renal impairment. Hearing impairment.
Special Precautions
Not to be given more frequently than once every 3-4 wk. Anaphylactic-like reactions. Measure serum creatinine, BUN, CrCl & Mg, K & Ca levels & perform audiometric testing prior to initiating therapy & to each subsequent course. Monitor peripheral blood counts wkly & liver functions periodically. Perform neurological exam periodically. Renal impairment. Pregnancy.
Adverse Reactions
Renal toxicity, elevated BUN, creatinine & serum uric acid, decreased CrCl; tinnitus &/or hearing loss (unilateral/bilateral), ototoxicity; myelosuppression, anemia, leucopenia & thrombocytopenia; 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. Not to be administered concomitantly w/ nephrotoxic & ototoxic substances eg, aminoglycosides, amphotericin B; chelating agents eg, penicillamine. Possible reduced renal excretion w/ other cytostatic agents eliminated primarily via the kidneys eg, bleomycin & MTX. Simultaneous administration of pyridoxine & hexamethylamine negatively influenced therapeutic response in ovarian cancer. Raynaud's phenomenon w/ bleomycin or vinblastine. Concomitant use w/ anticonvulsants can result in their plasma conc dropping to the subtherapeutic range. Neuropathy w/ docetaxel. Avoid vaccinations w/ live vaccines.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01XA01 - cisplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Cilatin 50 inj 50 mg/50 mL
Packing/Price
1's
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