Active substancePipophheysinPipophheysin Similar drugsTo uncover Azafen® pills inwards NIZHFARM, JSC Russia Azafen® MB pills inwards NIZHFARM, JSC Russia Dosage form: & nbsppills Composition:Composition per one tablet:active substance - Pipofezin dihydrochloride monohydrate 25 mg;Excipients - potato starch 4.0 mg, silicon dioxide colloid (aerosil) 1.75 mg, microcrystalline cellulose 45.0 mg, lactose monohydrate 22.0 mg, povidone (polyvinylpyrrolidone low molecular weight medical) 1.25 mg, magnesium stearate 1.0 mg . Description:Tablets are flat-cylindrical with a facet, yellowish-greenish color. Presence of marble is admissible. Pharmacotherapeutic group:Antidepressant ATX: & nbspN.06.A.X Other antidepressants Pharmacodynamics:Tricyclic antidepressant from the group of indiscriminate inhibitors of neuronal capture of monoamines. The mechanism of antidepressant action is associated with indiscriminate inhibition of reverse neuronal seizure of serotonin and norepinephrine, which leads to an increase in their concentrations in the central nervous system. Timoleptic action of the drug is combined with sedative activity and anxiolytic effect.Virtually does not possess m-cholinoblocking activity, does not affect the activity of monoamine oxidase (MAO). Does not have cardiotoxic action. Pharmacokinetics:Quickly and completely absorbed in the gastrointestinal tract.Bioavailability is about 80%. After oral administration of a single dose of 25 mg of Azaphenum, the maximum concentration is 24.5 ng / ml and is determined after 1-2 hours. The connection with plasma proteins is 90%.Metabolized in the liver with the formation of inactive metabolites. In an in vitro study, it was shown that pipethiazine is not a substrate of the isoenzymes CYP2C9, CYP2C19, CYP2D6 and CYP3A4, but is mainly metabolized under the influence of the CYP1A2 isoenzyme.The drug is quickly removed from the bloodstream, the half-life is 4.3 hours. It is excreted mainly by the kidneys. Indications:Depressive episodes of mild and moderate severity (including in chronic somatic diseases). Contraindications:Hypersensitivity to the main and / or auxiliary components of the drug; severe degree of hepatic and / or renal insufficiency; simultaneous administration of MAO inhibitors; pregnancy; lactation period; children under 18 years of age (experience of medical use in children is limited).Rare hereditary problems of lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the preparation contains lactose). Carefully:Chronic heart failure, myocardial infarction, coronary heart disease, stroke status, infectious diseases, diabetes mellitus (due to insufficiency of safety data). Dosing and Administration:Inside. The initial dose for adults is 25-50 mg, in 2 divided doses (morning and lunch). With good tolerability, the dose is gradually increased to 150-200 mg / day (3-4 doses, the last intake before bedtime), in some cases - up to 400 mg / day. The optimal daily dose is 150-200 mg, the maximum is 400-500 mg. When the desired effect is achieved, they pass to maintenance doses: 25-75 mg / day. The course of treatment is up to 1 year (not less than 1-1,5 months). Side effects:Headache, dizziness, nausea, vomiting, allergic reactions.At the beginning of therapy, there may appear weakness, drowsiness, impaired concentration, dry mouth, which are leveled without additional treatment. Overdose:There is no information about overdose. Interaction:Strengthens the effects of ethanol, antihistamines and other drugs, depressing the central nervous system, anticoagulants. Reduces the effectiveness of antiepileptic drugs.In an in vitro study,that azafen is not an inhibitor or inducer of the isoenzymes CYPlA2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, so the interaction of azafen with the drugs that are substrates of these isoenzymes is unlikely. Fluvoxamine, propafenone, mexiletine, ciprofloxacin (inhibitors of the isoenzyme CYPlA2) can increase the concentration of azaphene in blood plasma. Special instructions:After the transfer from therapy with MAO inhibitors to Azafen, an interval of 1-2 weeks is necessary.During treatment should refrain from drinking alcohol.Any depressive disorder in itself increases the risk of suicide. Therefore, during treatment, patients should be monitored for early detection of abnormalities or behavioral changes, as well as suicidal tendencies. Effect on the ability to drive transp. cf. and fur:In connection with the possible decrease in concentration during the treatment period, one should refrain from engaging in potentially dangerous activities requiring increased attention and speed of psychomotor reactions (vehicle management, working with moving mechanisms, dispatcher and operator work, etc.). Form release / dosage:Tablets of 25 mg. Packaging:For 10 or 14 tablets in a contour mesh package.On 100, 200, 250, 300 tablets in cans of polymeric, ukuporennye covers.A can of polymer or 3, 4, 5 contour cell packs of 10 tablets or 1, 2, 3, 4 contour cell packs of 14 tablets together with the instructions for use are placed in a pack of cardboard. 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:5 years.Do not use at the end of the expiration date printed on the package. Terms of leave from pharmacies:On prescription Registration number:LS-000325 Date of registration:12.04.2010/24.11.2014 Expiration Date:Unlimited The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia Manufacturer: & nbspMAKIZ-PHARMA, LLC RussiaHEMOFARM, LLC Russia Information update date: & nbsp04.02.2017 Illustrated instructions × Illustrated instructions Instructions