Cisplatin-LNS concentrate 0.5 mg/ml, 100 ml

Cisplatin (cis-diamindichloroplatinum), is an anticancer drug containing the heavy metal platinum.

Cisplatin has properties similar to those of bifunctional alkylating agents which form inter- and intra-strand cross-links in DNA (deoxyribonucleic acid) thereby disrupting its functions, leading to cell death; the drug does not have cyclic and phase specificity.

It has immunosuppressive and radiosensitizing properties.

Indications

Active ingredient

Composition

Active substance:

Cisplatin – 0.0005 g.

Auxiliary substances:

Sodium chloride – 0.009 g,

Sodium hydroxide or hydrochloric acid – to pH 3.2,

water for injection – up to 1 ml.

How to take, the dosage

Intravenously. By infusion, for 6-8-24 h (pre-diluted in 1-2 liters of sodium chloride isotonic solution or 5% glucose solution) – 50-120 mg/m2 every 3-4 weeks. Drip, for 40-60 minutes (pre-diluted in 500 ml of isotonic solution) – 15-20 mg/m2 daily for 5 days, every 3-4 weeks. Prior to cisplatin administration it is necessary to perform hydration: 1.6-2 liters of 0.9% sodium chloride solution or 5% glucose solution should be administered by IV drip for 2-4 hours. After the end of cisplatin injection – another 400 ml of one of these solutions. To increase diuresis – during the last 30 minutes of pre-hydration, 375 ml of 20% mannitol solution for injection can be administered by IV drops. Plenty of fluids should be provided for another 24 h.

Intravesical and intravesical administration of the drug is possible, as well as in the pleural and abdominal cavities.

Interaction

The concomitant use of cisplatin with uricosuric antipodagric agents may increase the risk of nephropathy.

Combined use with antihistamines, phenothiazines, thioxanthenes may mask the symptoms of ototoxic effects of cisplatin.

Concomitant use with drugs with ototoxic, nephrotoxic, neurotoxic effects may increase the toxic effects.

Special Instructions

Cisplatin is not recommended in patients with varicella (including recent or after exposure), herpes zoster and other acute infectious diseases.

With caution, use in patients with gout or nephrolithiasis (including a history) and in patients who have previously received cytotoxic chemotherapy or radiation therapy.

Peripheral blood count, laboratory data of renal and hepatic function, parameters of water-electrolyte exchange and uric acid level, audiometry and neurological examinations should be performed before and during the treatment with cisplatin. The first manifestations of nephrotoxic effects of cisplatin occur on the 2nd week after injection and are manifested by increased levels of creatinine, uric acid, residual nitrogen and/or decreased CK. To reduce nephrotoxicity, an intravenous infusion of 0.9% sodium chloride solution or 5% glucose solution and an additional administration of mannitol are recommended before starting treatment.

Patients and family members should not be vaccinated during cisplatin therapy.

Carcinogenic and mutagenic effects of cisplatin have been established in experimental studies.

Contraindications

Side effects

Digestive system: nausea, vomiting, stomatitis, anorexia.

Hematopoietic system disorders: leukopenia, anemia, thrombocytopenia.

CNS disorders: seizures, peripheral neuropathy, optic neuritis, color perception disorders, ototoxicity.

Metabolism disorders: hyperuricemia, hypocalcemia, hypomagnesemia, ADH inadequate secretion syndrome.

Reproductive system disorders: amenorrhea, azoospermia.

Cardiovascular system disorders: tachycardia, arterial hypotension.

Allergic reactions: skin rash, angioneurotic edema, hoarseness of the voice.

Others: nephrotoxic effect.

Pregnancy use

Cisplatin is contraindicated in pregnancy. If use during lactation is necessary, discontinuation of breastfeeding should be considered.

Women of childbearing age should use reliable methods of contraception during therapy with cisplatin.

The teratogenic and embryotoxic effects of cisplatin have been established in experimental studies.