Composition, structure and packing
The tablets are yellowish-greenish color, ploskotsilindricheskie, with beveled; exception of marbling.
1 tab. pipofezin (in form of hydrochloride), 25 mg.
Excipients: potato starch, colloidal silicon dioxide (Aerosil), microcrystalline cellulose, lactose, povidone (polyvinylpyrrolidone low molecular medicine), magnesium stearate.
Clinico-pharmacological group: Antidepressants.
Pharmacological action
Tricyclic antidepressant of the group of indiscriminate capture of inhibitors of neuronal monoamines. Has timoanalepticheskoe and sedative effect.
The mechanism of antidepressant action linked to the indiscriminate inhibition of reverse neuronal capture of serotonin and norepinephrine, which leads to an increase in their concentration in the CNS. Almost does not have the m-anticholinergic activity and no effect on the activity of MAO. It has no cardiotoxic action.
Pharmacokinetics
Absorption
Quickly and completely absorbed from the gastrointestinal tract. Bioavailability - 80%. Time to reach C max - 2 hours
Distribution and Metabolism
Binding to plasma proteins - 90%. Metabolised in the liver to form inactive metabolites.
Withdrawal
T1 / 2 - 16 hours excreted mainly by the kidneys.
Statement
depressive disorders of mild to moderate severity (including depression with chronic somatic diseases).
Dosage regimen
The initial dose for adults is 25-50 mg in 2 divided doses (morning and lunch). With good endurance gradually increase the dose to 150-200 mg / day (3-4 reception, the last reception before going to sleep), in some cases - up to 400 mg / day. The optimum daily dosage - 150-200 mg, the maximum daily dose - 400-500 mg.
Upon reaching the desired effect of switching to maintenance doses - 25-75 mg / day.
The course of treatment - up to 1 year (at least 1-1.5 months).
Side effect
From the CNS: headache, dizziness.
On the part of the digestive system: nausea, vomiting.
Other: allergic reactions.
Contraindications
severe hepatic and / or renal failure;
simultaneous reception of MAO inhibitors;
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug.
Precautions should be prescribed the drug for chronic heart failure, myocardial infarction, ischemic heart disease, conditions after a stroke, infectious diseases, diabetes mellitus, children.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation.
Application for violations of liver function
The drug is contraindicated in severe renal failure.
Application for violations of renal function
The drug is contraindicated in severe renal insufficiency.
Cautions
In the period of treatment prohibited use of alcohol.
Effects on ability to drive vehicles and management mechanisms
During the reception Azafena patients is not recommended to perform work that requires quick reaction (to drive vehicles and to perform other potentially dangerous activities).
Overdose
In case of overdose may gain side effects.
Treatment: perform symptomatically.
Drug Interactions
With simultaneous application Azafen enhances the effects of anticoagulants, ethanol, antihistamines and other drugs that depress the central nervous system. With simultaneous application Azafen reduces the effectiveness of anti-epileptic drugs.
Terms and Conditions of storage
List B. The drug should be stored in dry, light, reach of children, at a temperature not above 25 ° C. Period of validity - 5 years.
The tablets are yellowish-greenish color, ploskotsilindricheskie, with beveled; exception of marbling.
1 tab. pipofezin (in form of hydrochloride), 25 mg.
Excipients: potato starch, colloidal silicon dioxide (Aerosil), microcrystalline cellulose, lactose, povidone (polyvinylpyrrolidone low molecular medicine), magnesium stearate.
Clinico-pharmacological group: Antidepressants.
Pharmacological action
Tricyclic antidepressant of the group of indiscriminate capture of inhibitors of neuronal monoamines. Has timoanalepticheskoe and sedative effect.
The mechanism of antidepressant action linked to the indiscriminate inhibition of reverse neuronal capture of serotonin and norepinephrine, which leads to an increase in their concentration in the CNS. Almost does not have the m-anticholinergic activity and no effect on the activity of MAO. It has no cardiotoxic action.
Pharmacokinetics
Absorption
Quickly and completely absorbed from the gastrointestinal tract. Bioavailability - 80%. Time to reach C max - 2 hours
Distribution and Metabolism
Binding to plasma proteins - 90%. Metabolised in the liver to form inactive metabolites.
Withdrawal
T1 / 2 - 16 hours excreted mainly by the kidneys.
Statement
depressive disorders of mild to moderate severity (including depression with chronic somatic diseases).
Dosage regimen
The initial dose for adults is 25-50 mg in 2 divided doses (morning and lunch). With good endurance gradually increase the dose to 150-200 mg / day (3-4 reception, the last reception before going to sleep), in some cases - up to 400 mg / day. The optimum daily dosage - 150-200 mg, the maximum daily dose - 400-500 mg.
Upon reaching the desired effect of switching to maintenance doses - 25-75 mg / day.
The course of treatment - up to 1 year (at least 1-1.5 months).
Side effect
From the CNS: headache, dizziness.
On the part of the digestive system: nausea, vomiting.
Other: allergic reactions.
Contraindications
severe hepatic and / or renal failure;
simultaneous reception of MAO inhibitors;
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug.
Precautions should be prescribed the drug for chronic heart failure, myocardial infarction, ischemic heart disease, conditions after a stroke, infectious diseases, diabetes mellitus, children.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation.
Application for violations of liver function
The drug is contraindicated in severe renal failure.
Application for violations of renal function
The drug is contraindicated in severe renal insufficiency.
Cautions
In the period of treatment prohibited use of alcohol.
Effects on ability to drive vehicles and management mechanisms
During the reception Azafena patients is not recommended to perform work that requires quick reaction (to drive vehicles and to perform other potentially dangerous activities).
Overdose
In case of overdose may gain side effects.
Treatment: perform symptomatically.
Drug Interactions
With simultaneous application Azafen enhances the effects of anticoagulants, ethanol, antihistamines and other drugs that depress the central nervous system. With simultaneous application Azafen reduces the effectiveness of anti-epileptic drugs.
Terms and Conditions of storage
List B. The drug should be stored in dry, light, reach of children, at a temperature not above 25 ° C. Period of validity - 5 years.
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