Description
Release form
25 mg tablets.
10 or 14 tablets in blister packs.
100, 200, 250, 300 tablets in polymer jars, corked with caps.
A polymer jar or 3, 4, 5 blister packs of 10 tablets, or 1, 2, 3, 4 blister packs of 14 tablets each, together with instructions for use, are placed in a pack of cardboard.
Packing
50 pcs. – blister packagings – packs of cardboard.
Pharmacological action
Pharmacodynamics
Tricyclic antidepressant from the group of non-selective monoamine neuronal uptake inhibitors.
The mechanism of antidepressant action is associated with indiscriminate inhibition of serotonin and norepinephrine reuptake, which leads to an increase in their concentration in the central nervous system. The timoleptic effect of the drug is combined with sedative activity and anxiolytic effect.
Almost no m-anticholinergic activity, does not affect the activity of monoamine oxidase (MAO). It has no cardiotoxic effect.
Pharmacokinetics
Quickly and completely absorbed in the gastrointestinal tract. Bioavailability is about 80%. After oral administration of a single dose of 25 mg of 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 showed that pipofesin is not a substrate of the isoenzymes CYP2C9, CYP2C19, CYP2D6 and CYP3A4, but is predominantly metabolized under the influence of the isoenzyme CYP1A2.
The drug is rapidly excreted from the bloodstream, the elimination half-life is 4.3 hours. It is excreted mainly by the kidneys.
Indications
Depressive episodes of mild to moderate severity (including in chronic somatic diseases).
Contraindications
Hypersensitivity to the main and / or auxiliary components of the drug severe hepatic and / or renal failure concomitant use of MAO inhibitors pregnancy lactation period children under 18 years of age (medical experience in children is limited).
Rare hereditary problems of lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the drug contains lactose).
Precautions
Chronic heart failure, myocardial infarction, coronary heart disease, condition after stroke, infectious diseases, diabetes mellitus (due to insufficient safety data).
Pregnancy and lactation
Pregnancy and lactation are contraindicated.
Special instructions
After a transfer from treatment with MAO inhibitors to Asafen, an interval of 1-2 weeks is required.
During the period of treatment should refrain from drinking alcohol. Any depressive disorder in itself increases the risk of suicide. Therefore, during treatment, patients should be monitored for the early detection of violations or changes in behavior, as well as suicidal tendencies.
Impact on the performance of potentially hazardous activities that require special attention and speed of psychomotor reactions
In connection with a possible decrease in concentration of attention during treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions (driving, work with moving mechanisms, work of the dispatcher and operator, etc.).
Composition
Active ingredient
Pipofesin dihydrochloride monohydrate 25 mg
Excipients
Potato starch, colloidal silicon dioxide (aerosil), microcrystalline cellulose, lactose monohydrohydronone, minolone, povidone
Dosage and Administration
Inside.
The initial dose for adults is 25-50 mg, in 2 divided doses (morning and 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 is 400-500 mg. Upon reaching the desired effect, they switch to maintenance doses: 25-75 mg / day. The course of treatment is up to 1 year (at least 1-1.5 months).
Side effects
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, is possible.
Drug Interactions
Enhances the effects of ethanol, antihistamines, and other drugs that depress the central nervous system, anticoagulants.
Reduces the effectiveness of antiepileptic drugs.
An in vitro study showed that Asafen is not an inhibitor or inducer of the isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, therefore, Asafen interacts with drugs that are substrates of these isoenzymes.
Fluvoxamine, propafenone, mexiletine, ciprofloxacin (inhibitors of the CYP1A2 isoenzyme) can increase the concentration of Asafen in blood plasma.
Overdose
No information available.
Storage Conditions
List B. Store in a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Shelf life
5 years.
Active ingredient
Pipofezine
Conditions of release from drugstores
Prescription
tablet dosage form of tablets
Appointment
Appointment
Adults doctor’s prescription
