Natulan (Natulan)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceProcarbazineProcarbazine
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  • Natulan
    capsules inwards 
    Sigma-Tau United Pharmaceutical Industries SpA     Italy
    • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    active substance: procarbazine hydrochloride 58.3 mg (corresponding to base 50.0 mg);

    Excipients: starch, talc, magnesium stearate, mannitol;

    composition of the capsule: gelatin, titanium dioxide, E 172.

    Description:

    Hard gelatin capsule of oval ivory. Contents of capsules: finely granulated powder white or white with a yellowish tinge.

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

    L.01.X.B   Methylhydrazines

    L.01.X.B.01   Procarbazine

    Pharmacodynamics:

    An antineoplastic agent alkylating a compound from the group of methylhydrazines. The mechanism of action of procarbazine has not been studied with accuracy. The drug inhibits the synthesis of proteins, DNA and RNA, disrupting the processes of transmethylation - the transfer of methyl radicals from methionine to transport RNA (tRNA). The lack of a normally functioning tRNA causes a disruption in the synthesis of DNA, RNA and proteins (refers to Sphase-specific means). An important component in the mechanism of action is the formation of hydrogen peroxide as a result of autooxygenation. Hydrogen peroxide,interacting with sulfhydryl groups of tissue proteins, promotes a more dense spiralization of the DNA molecule and hinders transcription processes. It blocks the activity of MAO, which causes the accumulation of tyramine and, as a result, an increase in the content of noradrenaline in the endings of the sympathetic nervous system and an increase in blood pressure.

    Pharmacokinetics:

    Quickly and completely absorbed in the gastrointestinal tract, it penetrates the blood-brain barrier. The maximum concentration after ingestion is reached within 30-60 minutes.

    Metabolised in the liver and kidneys with the formation of active metabolites. The half-life is 10 minutes. It is excreted mainly by the kidneys (70% excreted in the urine in 24 hours, mainly in the form of N-isopropyl terephthalic acid, less than 5% - unchanged) and light in the form of methane and carbon dioxide.

    Indications:

    Hodgkin's disease (lymphogranulomatosis), non-Hodgkin's lymphomas, reticulosarcoma, chronic lymphocytic leukemia, Brill-Simmers disease, brain tumors.

    Contraindications:

    Hypersensitivity to procarbazine or other components of the drug.

    Hypoplasia of the bone marrow.

    Pronounced impairment of kidney and / or liver function, pheochromocytoma.

    Pregnancy and lactation.

    Carefully:

    With arrhythmias and other cardiovascular diseases, diabetes, hyperthyroidism, cerebral vascular diseases, paranoid schizophrenia and other conditions, accompanied by increased excitability, epilepsy, alcoholism, parkinsonism, chicken pox, herpes zoster, other systemic infections, chronic viral diseases preceding cytotoxic or radiotherapy, sympathectomy in history, old age.

    Dosing and Administration:

    Inside, after eating.

    When choosing the doses and the regimen of the drug in each individual case, you should refer to the special literature.

    In monotherapy, Natulan is started with 50 mg, with a daily increase of 50 mg to a daily dose of 250-300 mg. Give the drug in 1-2-3 daily intake for 15-20 days or until the development of leukopenia and thrombocytopenia. With the onset of the effect, the dose is gradually reduced to a maintenance dose, usually 150-50 mg per day. The total dose for treatment is usually 4-7 g.

    In combination with other antitumour agents, Natulan is administered at a dose of 100 mg / m2 daily for 10-14 days.

    Side effects:

    On the part of the organs of hematopoiesis: leukopenia, thrombocytopenia, eosinophilia, hemolytic anemia, bleeding and hemorrhage.

    On the part of the digestive system: nausea, vomiting, anorexia, dysphagia, dry mouth, diarrhea / constipation, abdominal pain, stomatitis, impaired liver function, cholestatic jaundice.

    From the nervous system and sensory organs: headache, dizziness, paresthesia, peripheral neuropathy, ataxia (rarely), increased excitability, hypomanic and manic conditions, convulsions, hallucinations, depression, nightmares, fatigue, confusion, coma, weakness; diplopia, nystagmus, photophobia, optic nerve edema, intraocular hemorrhage, hearing loss.

    From the cardiovascular system: decrease in arterial pressure, tachycardia, syncope.

    On the part of the respiratory system: pneumonitis, pleurisy, cough.

    From the genitourinary system: disturbance of kidney function, hematuria, amenorrhea, azoospermia.

    From the skin: dermatitis, pruritus, rash, hives, alopecia, hyperpigmentation, hot flushes or redness of the face.

    Other: arthralgia, myalgia, tremor, immunosuppression (attachment of infections), fever, gynecomastia, risk of developing secondary malignant tumors, allergic reactions.

    Overdose:

    Symptoms: nausea, vomiting, enteritis, diarrhea, lowering blood pressure, tremor, convulsions, coma, severe oppression of bone marrow hematopoiesis, impaired liver function.

    Treatment: induction of vomiting or gastric lavage (in the first hour after an overdose), symptomatic therapy, monitoring of vital functions (during signs of an overdose and for at least 2 weeks after normalization of the patient's condition).

    Interaction:

    With the simultaneous use of other myelotoxic drugs and radiotherapy, additive inhibition of bone marrow function is possible.

    Increases the activity of sympathomimetics, barbiturates, antihistamines, narcotic, hypotensive drugs, tricyclic antidepressants and phenothiazine.

    Incompatible with ethyl alcohol (possible development of a disulfiram-like reaction).

    Potentsiruet action of hypoglycemic agents and anticonvulsant drugs.

    Nonspecific anti-inflammatory drugs increase the risk of bleeding.

    Special instructions:

    Natulan treatment is performed under the supervision of a doctor who has experience in the use of antitumor drugs.

    During therapy with procarbazine, careful monitoring of hematologic parameters (before treatment, then once every 3-4 days) and biochemical (before treatment, then once a week) blood values ​​is necessary.

    With the appearance of CNS disorders (paresthesia, peripheral neuropathy, confusion), leukopenia (<4000 / μl), thrombocytopenia (<100,000 / μL), allergic reactions, stomatitis, diarrhea, increased bleeding or bleeding, Natulan should be discontinued immediately.

    During the period of treatment, alcohol, sleeping pills (barbiturates, benzodiazepines) and sympathomimetic agents are contraindicated.

    From the diet should exclude foods with increased content of tyramine (aged cheeses, wine, beer, yeast / protein extracts, yogurt, bananas).

    Men and women of childbearing age during Natulan treatment and at least 3 monthsafter you should use reliable methods of contraception.

    Effect on the ability to drive transp. cf. and fur:During Natulan's treatment, care must be taken when driving a car and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions.
    Form release / dosage:Capsules, 50.0 mg.
    Packaging:

    For 50 capsules in a bottle of dark glass, screwed with a plastic stopper of white color ("hard" unscrewing).

    1 bottle with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C in a dry place.

    Keep out of the reach of children.

    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N 016232/01
    Date of registration:23.03.2005
    The owner of the registration certificate:Sigma-Tau United Pharmaceutical Industries SpASigma-Tau United Pharmaceutical Industries SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspPharma Riace Co., Ltd. Pharma Riace Co., Ltd. United Kingdom
    Information update date: & nbsp04.09.2015
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