Platosin

Platosin

cisplatin

Manufacturer:

Teva

Distributor:

KLN Pharma
Concise Prescribing Info
Contents
Cisplatin
Indications/Uses
Monotherapy or combination therapy for the treatment of advanced or metastasized testicular cancer, ovarian cancer, bladder carcinoma, squamous cell carcinoma of the head & neck, non-small cell lung carcinoma, & small cell lung carcinoma. In combination w/ RT for the treatment of cervical carcinoma.
Dosage/Direction for Use
IV Adult & childn Infuse over a period of 6-8 hr. Monotherapy 50-120 mg/m2 single dose every 3-4 wk, or 15-20 mg/m2/day for 5 days every 3-4 wk. Combination chemotherapy ≥20 mg/m2 once every 3-4 wk. Combination w/ RT for cervical cancer 40 mg/m2 wkly for 6 wk.
Contraindications
Patients w/ history of allergic reactions to cisplatin or other platinum-containing compd; myelosuppression; neuropathy caused by cisplatin in dehydrated patients; pre-existing renal impairment (CrCl <60 mL/min) or hearing impairment. Concurrent administration w/ yellow fever vaccine. Lactation.
Special Precautions
Do not administer undiluted. Avoid Al-containing IV sets, needles, catheters & syringes. Determine renal function, hepatic function, hematopoiesis functions, serum electrolytes (Ca, Na, K, Mg) before, during & after administration, & repeat every wk over entire treatment duration. Delay repeating administration until normal values are achieved (serum creatinine ≤130 μmol/L or 1.5 mg/dL; urea <25 mg/dL; WBC >4 x 109/L; platelets >100 x 109/L; audiogram results w/in normal range). Risk of severe cumulative nephrotoxicity. Maintain adequate hydration from 2-12 hr prior to & until min of 6 hr after administration. Administer mannitol or diuretic when cisplatin dose is >60 mg/m2. Drink large quantities of liqd for 24 hr after infusion to ensure adequate urine secretion. Hyperuricaemia & hyperalbuminaemia may predispose to cisplatin-induced nephrotoxicity. Reports of severe cases of neuropathies. Perform neurologic exam at regular intervals. Caution in patients w/ peripheral neuropathy not caused by cisplatin. Risk of ototoxicity & vestibular toxicity. Ototoxic effect may be more pronounced in childn. Carefully monitor by audiometry/audiogram prior to treatment initiation & prior to subsequent doses. Risk of hypersensitivity reactions during perfusion. Reports of cross reactions (sometimes fatal) w/ all platinum compd. Carcinogenicity is possible but has not been demonstrated. Risk of inj site reactions during administration. Closely monitor infusion site for possible infiltration/extravasation during administration. Caution in patients w/ acute bacterial or viral infections. Nausea, vomiting & diarrhoea often occurs after administration. Risk of skin lesions due to accidental exposure. Vigorously wash skin or mucous membranes w/ soap & water in case of contact w/ cisplatin soln. Consider 3.5 mg Na per mL of soln for patients on controlled Na diet. May impair ability to drive or operate machinery. May be toxic to foetus when administered to pregnant woman. Avoid pregnancy during treatment & for min of the following 6 mth. May cause irreversible infertility in men.
Adverse Reactions
Leukopenia, thrombocytopenia, anaemia, bone marrow failure; hyponatraemia; hearing impairment, ototoxicity; anorexia, nausea, vomiting, diarrhoea; renal failure, nephrotoxicity, hyperuricaemia; fever. Infections, sepsis; neurotoxicity; deafness, vestibular toxicity, vertigo; arrhythmia (including bradycardia, tachycardia & other ECG changes); phlebitis; dyspnoea, pneumonia, resp failure; abnormal hepatic function (increased transaminases & blood bilirubin); erythema, skin ulcer; inj site extravasation.
Drug Interactions
Potentiated renal toxic effect w/ nephrotoxic medicinal products (eg, cephalosporins, aminoglycosides, amphotericin B, contrast media). Potentially reduced renal elimination of predominantly renally eliminated substances eg, cytostatic agents (eg, bleomycin, MTX). Increased renal toxicity of ifosfamide when used w/ cisplatin or in patients who have previously been given cisplatin. Reduced blood lithium values after treatment w/ cisplatin combined w/ bleomycin & etoposide. Intensified nephrotoxicity w/ antihypertensives containing furosemide, hydralazine, diazoxide, & propranolol. Adjust dose of allopurinol, colchicine, probenecid, or sulfinpyrazone if used w/ cisplatin, since cisplatin causes increase in serum uric acid conc. Simultaneous use w/ ifosfamide causes increased protein excretion. Potentiated auditory toxic effect w/ ototoxic medicinal products (eg, aminoglycosides, loop diuretics). Ifosfamide may increase hearing loss due to cisplatin. Risk of fatal systemic vaccinal disease w/ yellow fever vaccine. Live virus vaccination is not recommended to be given w/in 3 mth following end of cisplatin treatment. Regularly check INR in case of simultaneous use w/ oral anticoagulants. Masked ototoxicity symptoms w/ antihistamines, buclizine, cyclizine, loxapine, meclozine, phenothiazines, thioxanthenes or trimethobenzamides. Serum conc of anticonvulsants may remain at subtherapeutic levels during cisplatin treatment. Reduced absorption of phenytoin. Response time was unfavourably affected when pyridoxine was used in combination w/ altretamine & Platosin. Reduced clearance of paclitaxel. Boosted myelosuppressive effects w/ myelosuppressives or radiation. Risk of Raynaud phenomenon if cisplatin is given in combination w/ bleomycin & vinblastine. Docetaxel in combination w/ cisplatin induced more severe neurotoxic effects than either drug as single agent in similar doses. Diminished effectiveness w/ chelating agents (eg, penicillamine). Consider excessive immunosuppression w/ risk of lymphoproliferation during concomitant use of cisplatin & ciclosporin. May be inactivated by antioxidants (eg, Na metabisulphite), bicarbonates (Na bicarbonate), sulfates, fluorouracil & paclitaxel in infusion systems.
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
Platosin conc for soln for infusion 1 mg/mL
Packing/Price
1's
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