Active substancePipophheysinPipophheysin
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  • Azafen®
    pills inwards 
    NIZHFARM, JSC     Russia
  • Azafen® MB
    pills inwards 
    NIZHFARM, JSC     Russia
  • Dosage form: & nbspmodified release tablets

    Composition:Each modified release tablet contains:
    active substance: Azafen® (pipothezin) in terms of dry matter - 150 mg;
    Excipients: (methocel K4M Premium) - 90.7 mg, povidone (collidon 25) - 5.6 mg, microcrystalline cellulose - 102.0-98.7 mg, silicon colloidal dioxide (aerosil) - 5.5 mg, magnesium hydrosilicate ( talc) - 7.1 mg, magnesium stearate - 3.7 mg.

    Description:

    ATX: & nbsp

    N.06.A.X   Other antidepressants

    Pharmacodynamics:Blocking the reverse neuronal capture of monoamines by presynaptic membranes, increases their content in the synaptic cleft, which leads to relief of the symptoms of depression. Timoleptic action of the drug is combined with sedative activity and anxiolytic effect.
    In contrast to tricyclic antidepressants it does not possess anticholinergic properties, does not affect the activity of monoamine oxidase (MAO), does not have cardiotoxic effect.

    Pharmacokinetics:In Azafen® MB tablets, the active substance is enclosed in a special carrier matrix, which allows the gradual release of the pipophasin in the gastrointestinal tract. The released pipethiazine quickly and almost completely absorbed in the gastrointestinal tract. To a large extent, it undergoes biotransformation in the liver with the formation of inactive metabolites.
    In the study in vitro shown, that pipethiazine is not a substrate of cytochrome P-450 isoenzymes CYP2C9, CYP2C19, CYP2D6 and CYP3A4, but is predominantly metabolized by CYP1A2. Connection with blood plasma proteins - 90%.
    With a single oral application of Azafen ®, prolonged 150 mg, the maximum concentration of the drug in the blood is reached after 3-4 hours and is 111 ng / ml. Half-life is 9 hours. Time of the drug in the body (MRT) - an average of 13.4 hours (10 to 20 hours). At repeated receptions of fluctuation of concentration of a preparation in a blood plasma in an interval between two doses are smoothed out. It is excreted mainly by the kidneys.

    Contraindications:Hypersensitivity to the main and / or auxiliary components of the drug, expressed violations of the liver and kidneys, pregnancy, lactation, simultaneous administration of MAO inhibitors.

    Carefully:Chronic heart failure, myocardial infarction, ischemic heart disease,condition after acute cerebrovascular accident, infectious diseases, diabetes, children's age (insufficient information about safety of use).

    Overdose:There is no information about overdose.

    Interaction:Potentiates the effects of alcohol and other drugs that depress the central nervous system, antihistamines and anticoagulants.
    Reduces the effectiveness of anticonvulsant therapy.
    An in vitro study showed that Azafen® is not an inhibitor or inducer of cytochrome P-450 isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, so it is unlikely that Azafen® interacts with drugs that are substrates of these isoenzymes. Fluvoxamine, propafenone, mexiletine, ciprofloxacin, being inhibitors of CYP1A2, can increase the concentration of pipophezin in the blood plasma.

    Special instructions:After the transfer from therapy with MAO inhibitors to Azafen®, an interval of 2 weeks is necessary.
    Periodic monitoring of liver and kidney function is necessary.
    During the treatment period, alcohol is not allowed.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, one should refrain from engaging in potentially hazardous activities,requiring increased attention and speed of psychomotor reactions, for example, driving.

    Form release / dosage:Tablets with a modified release of 150 mg.

    Packaging:For 10 or 14 tablets in a contour mesh package. 3 contour packs of 10 tablets or 2 out-of-round packs of 14 tablets together with instructions for use are placed in a cardboard pack.

    Storage conditions:In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000002
    Date of registration:06.05.2010/07.12.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp04.02.2017
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