Paklitaksel

Паклитаксел Drug photo

The description is actual on 08.12.2014

  • Latin name: Paclitaxel
  • ATH code: L01CD01
  • Active ingredient: Paklitaksel (Paclitaxel)
  • Producer: BIOLIK (Ukraine)

Structure

1 ml of a concentrate contains 6 mg of Paklitaksel. Additional components: the anhydrous ethanol purified makrogolglitserol ricinoleate, nitrogen.

Release form

Paclitaxel is issued in the form of a translucent concentrate of a yellow color for preparation of the solution entered infusionally. Volumes of glass bottles: 5, 16.7, 25, 35, 41, 50 ml. Each bottle is packed into a pack from a cardboard with the enclosed instruction from the producer.

Pharmacological action

Antineoplastic medicine. Active ingredient has a plant origin, Paklitaksel receive by semi-synthetic methods from Taxus Baccata plant. Active component inhibits process of a mitosis. The mechanism of influence is based on specific linkng with a beta tubulinom in microtubules that breaks a depolymerization of the main protein, causing suppression of dynamics of normally functioning reorganization of a network of the microtubules playing an important role in interphase and a mitosis. Paclitaxel promotes formation of abnormally developed bunches of microtubules during a full cellular cycle.

Medicine possesses ability dozozavisimo to suppress a marrowy hemopoiesis. It was experimentally proved that the medicine has embriotoksichesky and mutagen effect, and also suppresses reproductive functions of an organism.

Pharmacodynamics and pharmacokinetics

Active agent contacts plasma proteins for 89-98%. Biological transformation is carried out in hepatic system. Active and inactive metabolites are removed both with bile, and through renal system.

Indications to use

  • cancer of ovaries (pervolineyny therapy of patients with a common form of an oncological disease or with a residual tumor more than 10 mm in size) after the performed operation of a laparotomy together with Cisplatinum. Therapy of the second line of patients with the diagnosed metastasises after the classical scheme of treatment which did not yield sharply positive takes is possible;
  • breast cancer (together with damage of lymphatic system after carrying out the classical combined scheme of treatment – adjuvant therapy). The medicine can be applied also at recurrence within half a year after the carried-out adjuvant therapy. Medicine is included into the scheme of treatment of the second line – at metastatic defeats;
  • Kaposha's sarcoma at the persons having AIDS. The medicine is appointed at inefficiency of therapy liposomal anthracyclines;
  • not small-celled form of lung cancer. It is appointed together with Cisplatinum to patients to whom carrying out radiation therapy and surgical treatment is not planned.

Contraindications

  • the maintenance of neutrophils is less 1500/mkl at persons with the diagnosed solid onkoobrazovaniye;
  • the maintenance of neutrophils is less 1000/mkl at the persons having AIDS with the diagnosed Kaposha's sarcoma;
  • breastfeeding;
  • individual hypersensitivity;
  • pregnancy.

States and diseases at which the medicine has to be appointed with care:

There is no reliable information about safety of use of a medicine in pediatric practice.

Side effects of Paklitaksel

Expressiveness of negative reactions has dozozavisimy character.

Collateral effect from system of a hemopoiesis:

  • anemia;
  • neutropenia;
  • decrease in number of thrombocytes.

Suppression of activity of a granulotsitarny sprout is the main toxic effect which is not allowing to increase a medicine dose. For 8-11 day of antineoplastic therapy the maximum falling of number of neutrophils is celebrated. The indicator is normalized for the 22nd days.

Allergic answers:

In isolated cases retrosternal pains, pains in a back, a fever appear.

Cardiovascular system:

Respiratory path:

  • beam pneumonitis after radiation therapy;
  • embolism of a pulmonary artery;
  • intersticial pneumonia;
  • fibrosis of pulmonary fabric.

Nervous system:

  • convulsive attacks as grand mal;
  • paresthesias;
  • vegetative neuropathy (orthostatic hypotension and intestinal impassability of paralytic character);
  • encephalopathy;
  • ataxy;
  • disturbance of visual perception.

Musculoskeletal system:

  • mialgiya;
  • arthralgia.

Digestive tract:

  • mukozita;
  • nausea;
  • diarrheal syndrome;
  • locks;
  • vomiting;
  • anorexia;
  • ischemic colitis;
  • perforation of intestines;
  • acute intestinal impassability;
  • thrombosis of a mesenteric artery.

From a liver:

  • increase in bilirubin and alkaline phosphatase in blood;
  • increase of ALT, nuclear heating plant;
  • hepatic encephalopathy;
  • gepatonekroz.

Local manifestations:

  • erythema;
  • puffiness;
  • pigmentation of integuments;
  • skin induration;
  • pain syndrome;
  • nekrotizirovaniye of hypodermic cellulose;
  • inflammation after an ekstravazation.

Other reactions:

  • alopecia;
  • febricula;
  • adynamy;
  • change of a color of a nail bed.

The instruction on Paklitaksel (A way and a dosage)

Intravenous administration of Dexamethasone in number of 20 mg before injection of antineoplastic means allows to prevent negative allergic reactions.
Paklitaksel is intended for intravenous administration (3 or 24 hours) with course intervals of 3 weeks. The medicine can be appointed in monotherapy, but to appoint more often more productively in addition Cisplatinum (at oncology of ovaries and not small-celled form of a pulmonary cancer) or Doxorubicine (at pathology of mammary glands).

At Kaposha's sarcoma the medicine is entered by each 2 weeks for 3 hours in a dose of 100 mg/sq.m. Treatment is carried out until the level of neutrophils does not make 1500/mkl, and the indicator of thrombocytes will not reach figure 100000/mkl. At registration of the expressed neutropenia at once after infusion it is recommended to lower the following dose by 20%. Introduction of an antineoplastic medicine is carried out by means of the system equipped with the built-in membrane filter.

Overdose

Peripheral neuropathy, aplasia of marrowy fabric, mukozita is registered. The specific antidote is not developed. Posindromny therapy is carried out.

Interaction

Laboratory researches showed that consecutive introduction of Paklitaksel and Cisplatinum increases expressiveness of myelotoxic influence. At the same time the general clearance of Paklitaksel decreases by 20%.

Introduction of Cimetidinum does not make impact on average values of the general clearance. Suppression of a metabolism of Paklitaksel it is observed at patients who at the same time received Ketokonazol.

Terms of sale

Paklitaksel is on sale in pharmaceutical points. Presentation of the medical prescription form is obligatory.

Storage conditions

The medicine belongs to the list B. The recommended producer temperature range: 15-25 degrees. To limit the uncontrolled admission of small children to bottles with solution.

Period of validity

2 years.

Special instructions

Treatment can be appointed and be carried out only under supervision of the oncologist who has experience of treatment of oncological patients chemotherapeutic antineoplastic medicines.

Premedication with glucocorticosteroids and purpose of antihistamines allow to prevent heavy reactions at medicinal intolerance. At development of the negative reactions which are not described in appropriate section, injection of a medicine is stopped and carry out posindromny therapy. Repeated infusions are strictly contraindicated. Storage, preparation and administration of solution has to be carried out by means of the equipment which is not containing details from PVC. Control over blood indicators, level of a blood pressure, pulse, a respiration rate, ECG indicators is obligatory. At registration of disturbances of atrioventricular conductivity the round-the-clock cardiomonitoring is required. At a combination therapy of Paklitaksel with Cisplatinum, first of all Paklitaksel is entered. Use of methods of contraception is obligatory.

Active component has cytotoxic effect that demands respect for extra care: use of protective gloves, careful washing of skin and mucous at solution hit.

Analogs

Coincidence on the ATH code of the 4th level:
  • Abitaksel;
  • Paktalek;
  • Intaksel;
  • Taxol;
  • Yutaksan.

Zdravzona

  • Paklitaksel-Teva a concentrate for solution 6mgml 5 of ml No. 1 flakonteva Pharmaceutical
  • Paklitaksel-Teva a concentrate for No. 1 solution 6mgml 16,7ml flakonteva Pharmaceutical
  • Paklitaksel-LENS a concentrate for solution 6mgml 5 of ml No. 1 flakonlens-Farm Ltd company
  • Paklitaksel of 6% konts.dlya infusions 43,4ml No. 1 fl.
  • Paklitaksel-Teva a concentrate for solution 6mgml 50 of ml No. 1 flakonteva Pharmaceutical

Drugstore of IFC

  • Paklitaksel a solution concentrate for infusions 6mg/mg fl 5 ml No. 1, Ebeweavstriya
to show still

Apteka24

  • Paklitakselpharmachemie (Netherlands)
  • Paklitakselebewe Pharma (Austria)
  • Paklitaksel
  • Paklitakselebewe Pharma (Austria)
  • Paklitaksel

Paniapteka

  • Paklitaksel konts inf solution 300 of mg of 50 ml No. 1ebeve
  • Paklitaksel konts inf solution 300 of mg of 50 ml No. 1ebeve
  • Paklitaksel konts inf solution 300 of mg of 50 ml No. 1ebeve
  • Paklitaksel konts inf solution 300 of mg of 50 ml No. 1ebeve
Section: Antineoplastic
in more detail

Education: Graduated from the Bashkir state medical university majoring in "Medical business". In 2011 gained the diploma and the certificate in Therapy. In 2012 received 2 certificate and the diploma in "Functional diagnosis" and "Cardiology". In 2013 completed courses on "Topical issues of otorhinolaryngology in therapy". In 2014 completed advanced training courses in "A clinical echocardiography" and courses in "Medical rehabilitation".

Experience: From 2011 to 2014 the Policlinic No. 33 Ufa worked as the therapist and the cardiologist in MBUZ. Since 2014 the Policlinic No. 33 Ufa works as the cardiologist and the doctor of functional diagnosis in MBUZ.

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