Active substanceCisplatinumCisplatinum
Similar drugsTo uncover
  • Displanor
    concentrate d / infusion in / of the abdomen. 
    AKTAVIS GROUP, AO     Iceland
  • Cage plates
    concentrate d / infusion 
  • Platidiam
    concentrate in / of the abdomen. d / infusion 
    Pliva-Lahema, AO     Czech Republic
  • Tsissoter
    concentrate d / infusion 
    ARS, LLC     Russia
  • Cisplatin-LENS®
    concentrate d / infusion 
    LENS-PHARM, LLC     Russia
  • Cisplatin-RONTS®
    concentrate d / infusion 
  • Cisplatin-Teva
    lyophilizate d / infusion 
  • Cisplatin-Teva
    solution for injections 
  • Cisplatin-Ebove
    concentrate d / infusion 
  • Cytoplatin
    concentrate d / infusion 
    Cipla Ltd.     India
  • Dosage form: & nbspconcentrate for solution for infusion and intraperitoneal administration
    Composition:

    In 1 ml of concentrate for the preparation of solution contains:

    active substance: cisplatin 0.5 mg;

    Excipients: sodium chloride, hydrochloric acid or sodium hydroxide to correct the pH of the solution, water for injection.

    Description:

    Concentrate for the preparation of the solution is a clear solution with a slightly yellowish tinge.

    Pharmacotherapeutic group:antitumor agent - alkylating compound
    ATX: & nbsp

    L.01.X.A   Platinum compounds

    L.01.X.A.01   Cisplatinum

    Pharmacodynamics:

    Platidiam (cis-diamine-dichloroplatinum) is an antitumor drug containing a heavy metal platinum.

    Platidiam possesses properties similar to the properties of bifunctional alkylating agents, forming interstitial and interstitial crosslinks in DNA, thereby violating its functions, which leads to cell death; the preparation does not have cyclic and phase specificity. Has immunosuppressive and radiosensitizing properties.

    Pharmacokinetics:

    After rapid intravenous infusion (15 min-1 hour), the appearance of cisplatin in the blood plasma and the peak of its concentration is determined immediately after administration. With intravenous infusion for 6-24 hours, the concentration of the drug in the plasma increases gradually during the infusion, reaching a maximum at the end of the injection.

    Cisplatin is characterized by extensive distribution in body fluids and in tissues; with the highest concentrations being achieved in the kidneys, liver and prostate gland.Platinum, released from cisplatin, quickly binds to tissue and plasma proteins. Two hours after the end of the three-hour infusion, 90% of the platinum in the plasma is in the protein-bound state. Cisplatinum has the ability to accumulate in the body and is found in some tissues for another six months after the administration of the last dose of the drug. Biotransformation of cisplatin is carried out by rapid non-enzyme conversion with the formation of inactive metabolites. Cytotoxic effect has only cisplatin, not associated with proteins, or its platinum-containing metabolites.

    The half-life of total platinum has a very wide individual variability and ranges between 2-72 hours in healthy people, and 1-240 hours with severe renal failure. Cisplatinum is excreted mainly with urine. Cisplatinum can be excreted from the systemic blood flow by dialysis, but only within the first 3 hours after the administration of the drug.

    Indications:

    Platidiam, usually as part of combined chemotherapy regimens, is widely used in the treatment of the following solid tumors:

    - germinogenous tumors of women and men;

    - ovarian and testicular cancer;

    - lung cancer;

    - head and neck tumors.

    In addition, Platidiam has antitumor activity in the following types of tumors:

    - cervical cancer;

    - cancer of the bladder;

    - osteosarcoma;

    - melanoma;

    - neuroblastoma;

    - esophageal carcinoma.

    Contraindications:

    - Hypersensitivity to cisplatin or other compounds containing platinum, as well as to any component of the drug;

    - impaired renal function (serum creatinine level more than 115 μmol / liter);

    - severe oppression of bone marrow hematopoiesis;

    - cardiovascular insufficiency;

    - pregnancy and the period of breastfeeding;

    - generalized infections;

    - hearing loss.

    Carefully:

    Acute infectious diseases of viral (chickenpox, including recent or recent contact with a patient, herpes zoster), fungal or bacterial genesis; hyperuricemia (including manifested by gout and / or urate nephrourolythiasis), nephrourolythiasis, oppression of bone marrow hematopoiesis (including against the background of previous radiation or chemotherapy), polyneuritis.

    Dosing and Administration:

    Platidiam can be used both as a monotherapy and in combination with other cytostatics in different doses depending on the regimen of therapy. For individual dose selection, reference should be made to the literature.

    Platidiam is administered intravenously in the form of infusion or with indications (intraperitoneal tumors) in the abdominal cavity.

    Platidia in monotherapy or in combination with other chemotherapy drugs is usually administered at a dose of 50-100 mg / m2 in the form of intravenous infusion every 3-4 weeks or 15-20 mg / m2 intravenously drip daily for 5 days every 3-4 weeks.

    To stimulate diuresis (up to 100 ml / h) and to minimize the nephrotoxic effect of the drug, hydration is performed. Before administration PLATIDIAM intravenously administered to 2 liters of fluid (0.9% chloride or 5% dextrose solution sodium). After the infusion is completed, 400 ml of a 0.9% solution of sodium chloride or a 5% solution of dextrose are additionally added. Fluid intake and maintenance of diuresis must be observed within 24 hours. If intensive hydration to maintain adequate diuresis is not sufficient, you can introduce an osmotic diuretic (eg, mannitol).

    Platinum is injected intravenously at a rate of no more than 1 mg / min.Prolonged infusions are carried out within 6-8-24 hours provided sufficient diuresis before and during administration of the drug.

    Platidiam is diluted in 0.9% sodium chloride solution to a concentration of 1 mg / 1 ml. The lyophilizate of Platidiam must first be dissolved in 10-25 ml of water for injection.

    Do not use a solution of dextrose to dilute Platidiam (glucose).

    Note: Since aluminum reacts with cisplatin and inactivates it, and also causes a precipitate, it is very important not to use needles and other equipment containing aluminum when preparing and introducing Platidiam.

    Side effects:

    From the urinary system: nephrotoxicity (is cumulative in nature and is the main toxic factor limiting the dose of Platidiam). Renal lesions, which are accompanied by damage to the renal tubules, may first be detected in the second week after the dose is administered and may result in an increase in the level of creatinine, urea, uric acid in the blood serum and / or a decrease in creatinine clearance. Renal insufficiency, as a rule, is insignificant or moderately pronounced and is reversible at usual doses of Platidiam.

    From the side of the digestive system: nausea and vomiting, which usually begin within the first hour of therapy and last for 24 hours or more, occur in 65% of patients. These side effects are only partially eliminated with the use of standard antiemetic drugs. The severity of these symptoms can be reduced by dividing the total dose calculated for the therapy cycle into smaller doses that are administered once a day for five days.

    Of the other frequently observed adverse events from the gastrointestinal tract, abdominal pain, diarrhea and constipation are noted. Occasionally, minor and transient increases in the level of ACT and ALT in the serum can be noted.

    On the part of the hematopoiesis system: often - myelosuppression (in most cases, it is expressed slightly or moderately, and when using conventional doses is an invasive one). The lowest levels of leukocytes and platelets, as a rule, are detected after about 2 weeks; their baseline in most patients is restored within 4 weeks. Anemia can also occur.

    From the side of the hearing system: one-sided or bilateral tinnitus, with or without loss of hearing, occurs in about 10% of patients, usually this side effect is reversible.It is established that the damage to the hearing organ is dose-dependent and cumulative, and this side effect is more often observed in patients of very young or senile age. There are reports of a toxic effect of the drug on the vestibular apparatus.

    From the side of the central nervous system and peripheral nervous system. Peripheral neuropathies do not occur often. They are usually sensory in nature (for example, paresthesia of the upper and lower extremities), but also motor disorders (decreased reflexes and weakness in the lower limbs) may occur. Also, vegetative neuropathy, convulsions, slurred speech, loss of taste and memory loss can be noted. In the literature, the development of the Lermitt syndrome (myelopathy of the spinal column and autonomic neuropathy) has been reported. Treatment should be discontinued at the first appearance of these symptoms.

    From the immune system: sometimes there are allergic reactions, manifested in the form of redness and swelling of the face, wheezing in the lungs, tachycardia and lowering blood pressure. These reactions can occur within a few minutes after the onset of cisplatin administration.In rare cases, there may be hives and spotted-papular skin rashes.

    From the side of the vision system: In rare cases, neuritis of the optic nerve, edema of the optic nerve disk, cortical blindness are noted. There may also be a change in the perception of colors, especially in the yellow-blue part of the spectrum. The only change in the fundus can be irregular pigmentation of the retina in the area of ​​the yellow spot.

    These side effects are usually reversible and disappear after drug withdrawal.

    Violations from electrolyte balance: hypomagnesemia, hypocalcemia and hypokalemia. Hypomagnesemia and / or hypocalcemia can be manifested clinically by increased muscle sensitivity or seizures, tremor, carpopedic spasm (cramps in hands and feet) and / or tetany. Possible hyponatremia, caused by the syndrome of inadequate production of antidiuretic hormone.

    Other: disorders of the cardiovascular system (coronary heart disease, congestive heart failure, arrhythmias, orthostatic hypotension, thrombotic microangiopathy, etc.), hyperuricemia, minor alopecia, myalgia, fever and plaque gum line.

    If the product gets under the skin, it is possible to develop phlebitis, inflammation of the subcutaneous tissue and skin necrosis.

    Cases of spermatogenesis and azoospermia are noted.
    Overdose:

    The main anticipated complications of overdose are renal, hepatic, visual impairment (including retinal detachment) and hearing (deafness), severe myelosuppression, indomitable vomiting and / or severe neuritis. In case of an overdose, a lethal outcome is possible.

    Antidote to cisplatinum is not known. Treatment is symptomatic. A partial effect can be achieved with hemodialysis performed within the first three hours after an overdose.

    Interaction:

    Simultaneous or sequential use of cisplatin with antibiotics-aminoglycosides (gentamicin, kanamycin, streptomycin) or with other potentially nephrotoxic drugs (eg, amphotericin B) can potentiate its nephrotoxic and ototoxic effect.

    "Loop" diuretics (furosemide, clopamide, ethacrynic acid) can enhance the ototoxicity of cisplatin.

    It is known that cisplatin can disrupt the excretion through the kidneys of bleomycin and methotrexate (possibly,due to cisplatin-induced nephrotoxicity) and to increase the toxicity of these drugs.

    In patients receiving cisplatin and anticonvulsants, the concentration of the latter in the serum can be reduced to subtherapeutic values.

    Cisplatin may cause an increase in the concentration of uric acid in the blood. Therefore, patients who simultaneously take medicines to treat gout, such as allopurinol, colchicine, probenecid or sulfinpyrazone, it may be necessary to adjust the dosage of these drugs to control hyperuricemia and gout attacks.

    Special instructions:

    - Introduction Platidiam should be carried out. under the supervision of a doctor who has experience in the use of antitumor drugs.

    - Men and women of childbearing age during treatment with Platidiam should use reliable methods of contraception.

    - Patients on the background of treatment with Platidiam should periodically be examined by a neurologist. With obvious symptoms of toxic effects on the CNS, Platidiam therapy should be discontinued.

    - Before the start of therapy should be audiometry, and in those cases,when there are symptoms of damage to the hearing organ or a clinical hearing disorder is detected, repeated audiometry is shown. In clinically significant hearing disorders, dosage adjustment or cancellation of therapy may be required.

    - During the treatment with Platidiam, periodic blood tests, determination of the white blood cell count, platelets, hemoglobin, blood elements, renal and hepatic functional tests, as well as the level of electrolytes in blood serum are needed.

    - When applying Platidiam, all the usual instructions adopted for the use of cytotoxic drugs should be observed.

    - If the product gets into the eyes, they must be washed immediately with a large amount of water or with 0.9% sodium chloride solution. In case of contact with the skin, immediately contact the product with plenty of water. If the product is inhaled or if it gets into the mouth, immediately consult a doctor.

    Form release / dosage:

    Concentrate for the preparation of a solution for infusion and intraperitoneal administration, 0.5 mg / ml.

    Packaging:

    At 10 mg / 20 ml, 25 mg / 50 ml and 50 mg / 100 ml in bottles of brown glass, sealed with rubber stoppers with aluminum caps and polypropylene caps.

    10 bottles (20 ml each), 5 bottles (50 ml each), 1 bottle (100 ml each), along with instructions for use, are placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    2 years.

    Do not use after the expiry date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014025 / 02
    Date of registration:22.07.2008
    The owner of the registration certificate:Pliva-Lahema, AOPliva-Lahema, AO Czech Republic
    Manufacturer: & nbsp
    PLIVA-LACHEMA, a.s. Czech Republic
    Representation: & nbspPliva of Hvartska dooPliva of Hvartska doo
    Information update date: & nbsp27.09.2015
    Illustrated instructions
      Instructions
      Up