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Tricyclic antidepressant from the group of indiscriminate inhibitors of neuronal monoamine uptake.
The mechanism of antidepressant action is associated with the indiscriminate inhibition of the reverse neuronal capture of serotonin and norepinephrine, which leads to an increase in their concentrations in the central nervous system. Thymoleptic effect of the drug combined with sedative activity and anxiolytic effect.
Practically does not possess m-anticholinergic activity, does not affect the activity of monoamine oxidase (MAO). It has no cardiotoxic effect.
Quickly and completely absorbed in the gastrointestinal tract. Bioavailability is about 80%. After oral administration of a single dose of 25 mg Azafen, the maximum concentration is 24.5 ng / ml and is determined after 1-2 hours. Communication with plasma proteins - 90%.
Metabolized in the liver to form inactive metabolites. An in vitro study has shown that pipofesin is not a substrate of CYP2C9, CYP2C19, CYP2D6, and CYP3A4 isoenzymes, but is primarily metabolized by the CYP1A2 isoenzyme.
The drug is rapidly removed from the bloodstream, the half-life is 4.3 hours. Excreted mainly by the kidneys.
Depressive episodes of mild and moderate severity (including chronic somatic diseases).
Pipofesin dihydrochloride monohydrate 25 mg;
Potato starch, colloidal silicon dioxide (aerosil), microcrystalline cellulose, lactose monohydrate, povidone (low-molecular medical polyvinylpyrrolidone), magnesium stearate.
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Dosage and Administration
The initial dose for adults is 25-50 mg, in 2 doses (in the morning and in the afternoon). With good tolerance, the dose is gradually increased to 150-200 mg / day (in 3-4 doses, the last dose before bedtime), and in some cases up to 400 mg / day. The optimal daily dose is 150-200 mg, the maximum - 400-500 mg. At achievement of desirable effect pass to supporting doses: 25-75 mg / days. The course of treatment is up to 1 year (at least 1-1.5 months).
Headache, dizziness, nausea, vomiting, allergic reactions.
At the beginning of therapy, the appearance of weakness, drowsiness, impaired concentration, dry mouth, which are leveled without additional treatment.
Hypersensitivity to the main and / or auxiliary components of the drug; severe hepatic and / or renal failure; simultaneous administration of MAO inhibitors; pregnancy; lactation period; children's age up to 18 years (experience of medical use for children is limited).
Rare hereditary problems of lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the product contains lactose).
Chronic heart failure, myocardial infarction, coronary heart disease, post-stroke condition, infectious diseases, diabetes mellitus (due to insufficient safety data).
Enhances the effects of ethanol, antihistamines and other means of oppressive central nervous system, anticoagulants.
Reduces the effectiveness of antiepileptic drugs.
An in vitro study showed that Azafen is not an inhibitor or inducer of CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 isoenzymes, therefore, it is unlikely that Azafen will interact with drugs that are substrates of these isoenzymes.
Fluvoxamine, propafenone, mexiletin, ciprofloxacin (inhibitors of the CYP1A2 isoenzyme) can increase the concentration of azaphen in the blood plasma.
Pregnancy and Lactation
Use during pregnancy and lactation is contraindicated.
After transferring from therapy with MAO inhibitors to Azafen, a 1-2 week interval is required.
During the period of treatment should refrain from taking alcohol. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment, patients should be monitored for the purpose of early detection of disorders or behavioral changes, as well as suicidal tendencies.
Impact on the implementation of potentially hazardous activities that require special attention and speed of psychomotor reactions
In connection with a possible decrease in concentration during the period of treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions (driving, working with moving mechanisms, work of the dispatcher and operator, etc.).
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- Brand name: Azafen
- Active ingredient: Pipofezine
- Dosage form: 25 mg pills.
10 or 14 pills in a blister pack.
On 100, 200, 250, 300 pills in polymeric cans, corked by covers.
Polymer can or 3, 4, 5 blister packs of 10 pills or 1, 2, 3, 4 blister packs of 14 pills together with instructions for use are placed in a pack of cardboard.
- Manufacturer: Makiz-Pharma
- Country of Origin: Russia