Instruction for use: Melipramin

Dosage form: tablets, dragee, solution

Active substance: Imipramine*

ATX

N06AA02 Imipramine

Pharmacological groups:

Antidepressant [Antidepressants]

The nosological classification (ICD-10)

F31 Bipolar affective disorder: Mood disorders bipolar; Affective bipolar psychosis; Manic-melancholic psychosis; Intermittent psychosis; Circular psychosis; Cyclophrenia; Bipolar disorders; Bipolar disorders; Bipolar psychosis; Affective insanity; Manic-depressive syndrome; Psycho Manic-Depressive; Depressive episode of bipolar disorder

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F33 Recurrent depressive disorder: Major depressive disorder; Secondary depression; Double Depression; Depressive pseudodement; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive syndrome; Depressed masks; Depression; Depression is smiling; Involutional depression; Involutional depression; Masked Depression; Melancholic Attack; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F41.0 Panic disorder [episodic paroxysmal anxiety]: Panic state; Panic attack; Panic; Panic disorders

F41.9 Unspecified anxiety disorder: Neurotic disorders with anxiety syndrome; Severe anxiety; Neurosis-like symptoms; Neuro-like disorders; Neuro-like conditions; Neuroses with anxiety symptoms; Neuroses with a sense of anxiety; Acute situational and stress anxiety; Acute attack of anxiety; Abrupt anxiety; Situational Anxiety Disorder; State of anxiety; Anxious-delirious component; Alarming state; Anxiety; Anxiety Disorders; Anxiety syndrome; Sense of anxiety; Alarm states; Chronic neurotic anxiety; Susto; Psychopathy with a predominance of anxiety and anxiety; Anxiety disorders in neurotic and neurosis-like states; Anxious neuroses; Anxious and delusional state; Acute situational stress alarm; Depressed mood with elements of anxiety

N39.4 Other specified incontinence: Urinary incontinence; Bed-wetting; Frequent nighttime urination; Urinary incontinence in women; Anishuriya; Primary bedwetting; Primary nocturnal enuresis in children

Composition

Tablets covered with a film membrane 1 tab.

active substance:

imipramine hydrochloride 25 mg

auxiliary substances: lactose monohydrate - 110.5 mg; magnesium stearate - 1.5 mg; crospovidone - 3 mg; talcum powder - 3 mg; Povidone K-25 - 7 mg

membrane film: hypromellose - 2.61 mg; magnesium stearate - 0.24 mg; ferric oxide red oxide - 0.68 mg; ferric oxide black oxide - 0.12 mg; dimethicone (E-1049 39%) 0.35 mg

Pharmachologic effect

Mode of action - antidepressant.

Dosing and Administration

Inside.

The dose and the frequency of reception are determined individually, depending on the nature and severity of the symptoms. As with the use of other antidepressants, to achieve a therapeutic effect requires at least 2-4 weeks (maybe 6-8 weeks). Treatment should begin with low doses with a gradual increase in them to select the lowest effective support. Dose titration before the achievement of efficacy requires special care in the elderly and patients younger than 18 years.

Depression

Out-patients are 18-60 years old. The standard dose is 25 mg 1-3 times a day, the dose can be gradually increased to a daily dose of 150-200 mg by the end of the first week of therapy. The standard maintenance dose is 50-100 mg / day.

Patients of hospitals 18-60 years. In hospital in very severe cases, the initial dose is 75 mg / day, the dose may be increased by 25 mg / day to a daily dose of 200 mg (in exceptional cases, the daily dose may reach 300 mg).

Patients older than 60 years. In elderly patients, due to reduced metabolic clearance, imipramine concentrations are higher than in young patients. Side effects can be more severe in elderly and younger patients, therefore, especially at the beginning of treatment, lower doses are required.

In these age groups, a marked response to the above doses may be noted, so treatment should be started from the lowest possible doses. The initial dose can gradually increase to a total daily dose of 50-75 mg. It is recommended to reach the optimal dose for 10 days and maintain this dose throughout the treatment period.

Panic disorders

Since this group of patients has an increased incidence of drug side effects, treatment should begin with the lowest possible dose. The transient worsening of anxiety at the onset of antidepressant medication can be prevented or cured by benzodiazepines, the dose of which gradually decreases as the symptoms of anxiety improve. The dose of Melipramin® can gradually increase to 75-100 mg / day (in exceptional cases - up to 200 mg). The minimum duration of treatment is 6 months. Upon completion of treatment, it is recommended to cancel Melipramin gradually.

Bedwetting in children

Use in children under 6 years is contraindicated.

The drug should be administered only to children over 6 years of age solely as a temporary adjuvant therapy for nocturnal enuresis with the exception of organic pathology.

Recommended doses are: for children 6-8 years (with a body weight of 20-25 kg) - 25 mg / day; 9-12 years (with body weight 25-35 kg) - 25-50 mg / day; over 12 years old (body weight above 35 kg) - 50-75 mg / day.

Exceeding the recommended doses is justified only in those cases when there is no satisfactory response to therapy after the first week of treatment with the drug at lower doses.

The daily dose for children should not exceed 2.5 mg / kg.

It is recommended to use the lowest dose from the above range of doses. The daily dose is recommended to be taken only once after eating before going to bed. If nocturnal enuresis is noted in the early evening hours, it is recommended to divide the daily dose into 2 doses: one by day and one by night. Duration of treatment should not exceed 3 months. Depending on the changes in the clinical picture of the disease, the maintenance dose may be reduced. Upon completion of therapy, Melipramin should be discontinued gradually.

If relapse occurs, treatment should not be resumed until a full medical examination is performed.

Release form

Film-coated tablets, 25 mg. For 50 tables. in the bottle of brown glass, PE lid, with the control of the first penetration and the shock-absorber. 1 f. placed in a cardboard box.

Conditions of leave from pharmacies

On prescription.

Storage conditions for Melipramin

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Melipramin

3 years.

Do not use after the expiry date printed on the package.