Included in the formulation
Paxen®
concentrate
d / infusion
Taxol®
concentrate
d / infusion
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
ONLS
АТХ:L.01.C.D. Taxoids
L.01.C.D.01 Paclitaxel
Pharmacodynamics:The vegetable alkaloid of the taxane group has a cytostatic antimitotic effect. Causes irreversible polymerization of microtubule proteins of cellular cytoplasm, disrupting the dynamic equilibrium of the polymerization-depolymerization process, which ensures the functioning of intracellular structures throughout the life cycle of cells.
Promotes the formation and accumulation of abnormal assemblies - microtubule bundles in the state of interphase and microtubule stars during mitosis, which leads to a stop of the life cycle in M- or G2-phase.
Pharmacokinetics:After intravenous administration, the period of distribution of paclitaxel from plasma to tissue takes 30 minutes. It accumulates in the heart, liver, muscles, spleen, stomach, pancreas. The connection with plasma proteins is up to 98%.
Metabolism in the liver. The half-life is 6-16 hours.Elimination with feces (up to 90%) and kidneys (10%) in unchanged form and in the form of metabolites. When repeated administration does not accumulate.
Indications:It is used to treat cancer of the ovaries, mammary glands, lungs, esophagus, bladder, and head and neck tumors.
II.C64-C68.C67 Malignant neoplasm of bladder
II.C50.C50 Malignant neoplasm of breast
II.C45-C49.C49 Malignant neoplasm of other types of connective and soft tissue
II.C30-C39.C34 Malignant neoplasm of bronchi and lungs
II.C15-C26.C15 Malignant neoplasm of esophagus
Contraindications:Neutropenia (less than 1500 / mkl), individual intolerance.
Carefully:Angina, heart rhythm disturbances.
Pregnancy and lactation:Recommendations for FDA - category D. Contraindicated in pregnancy and lactation.
Dosing and Administration:Intravenously drip for 3 hours once every 3 weeks for 175 mg / m2.
The highest daily dose: 175 mg / m2.
The highest single dose: 175 mg / m2.
Side effects:The system of hematopoiesis: anemia, leukocytopenia, thrombocytopenia.
The cardiovascular system: bradycardia, arterial hypotension, peripheral edema.
Musculoskeletal system: myalgia, arthralgia.
Dermatological reactions: alopecia, with extravasation - necrosis.
Allergic reactions.
Overdose:Myelosuppression, peripheral neuropathy.
Treatment is symptomatic.
Interaction:Inhibitors of microsomal oxidation (diazepam, verapamil, ketoconazole, cimetidine, ciclosporin) inhibit the metabolism of paclitaxel.
Cyclosporine enhances the absorption of paclitaxel through the mucous membranes.
Reduces the clearance of paclitaxel, a preliminary introduction of ciplastin - it is recommended to administer ciplatin after the infusion of paclitaxel.
Special instructions:To avoid a hypersensitivity reaction before each injection of the drug, premedecation should be done: 20 mg of dexamethasone inside or intramuscularly 12 and 6 hours before infusion; blockers H2-receptors: ranitidine 50 mg or cimetidine 300 mg intravenously for half an hour before infusion.
Do not use medical supplies for infusion materials from PVC.
All manipulations with paclitaxel solution should be done with gloves, if the solution is accidentally ingested on the skin or mucous membranes, rinse them with plenty of water. When inhaled paclitaxel vapor may develop shortness of breath, the appearance of pain in the chest and throat, a burning sensation in the eyes.