Instruction for use: Anafranil

Dosage form: coated tablets

Active substance: Clomipramine*

ATX

N06AA04 Clomipramine

Pharmacological groups:

Antidepressant [Antidepressants]

The nosological classification (ICD-10)

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

F40.0 Agoraphobia: Fear of open space; Fear of being in a crowd

F42 Obsessive-compulsive disorder: Obsessive-compulsive syndrome; Obsessive compulsive states; Obsessive-compulsive syndrome; The Obsession Syndrome; The obsession neurosis; Obsessive-compulsive neurosis; Obsessions

F44 Dissociative [conversion] disorders: Psychogenic psychosis; Conversion disorder; Dissociative phenomena; Pseudodemency; Conversion symptoms

G47.4 Narcolepsy and cataplexy: Cataplexy; Narcolepsy; Jelino's disease; Narcoleptic disease; Narcolepsy is essential

R32 Urinary incontinence, unspecified: Daytime enuresis; Idiopathic instability of the bladder; Urinary incontinence; Nocturia; Disorder of the function of the sphincter of the bladder; Spontaneous urination; Mixed forms of urinary incontinence; Functional disorders of urination; Functional enuresis in children; Enuresis

R52.2 Other permanent pain: Pain syndrome of non-rheumatic origin; Pain syndrome with vertebrogenic lesions; Pain syndrome with neuralgia; Pain syndrome with burns; Pain syndrome is mild or moderate; Perioperative pain; Moderate and severe pain; Moderately or mildly expressed pain syndrome; Moderate and severe pain syndrome; Ear pain with otitis; Neuropathic pain

Composition and release form

Tablets, coated with a coating.

clomipramine hydrochloride 25 mg

auxiliary substances: lactose; corn starch; silicon dioxide colloidal anhydrous; stearic acid; talc; magnesium stearate; glycerin (85%); hydroxypropylmethylcellulose; a vinylpyrrolidone / vinyl acetate copolymer; titanium dioxide; sucrose crystalline; PVP K30; disperse yellow 15093 ansted (iron oxide yellow (EEC172) 5% + titanium dioxide 95% (EEC171), polyethylene glycol 8000 (macrogol 8000), MCC

in a blister of 10 pcs .; in a pack of cardboard 2 or 3 blisters.

Solution for intravenous and intramuscular injection 1 amp.

clomipramine hydrochloride 25 mg

excipients: glycerol; water for injections

in ampoules of 2 ml; in a pack of cardboard 10 ampoules.

Pharmachologic effect

Mode of action - antidepressant.

Dosing and Administration

Before the start of therapy, hypokalemia should be eliminated.

The dosage regimen and the way of using the drug are set individually, taking into account the patient's condition. The goal of the treatment is to achieve the optimal effect when using the lowest possible doses of the drug and carefully increasing them. Special care should be taken with increasing doses in elderly patients and adolescents, who are generally more sensitive to Anafranil® than patients in intermediate age groups.

Inside, IV (in the form of infusions), IM.

Depression, obsessive-compulsive syndromes and phobias

The initial daily dose is 75 mg; prescribe the preparation Anafranil® 25 mg 2-3 times a day or Anafranil® SR 75 mg once a day (preferably in the evening). Then, during the first week of treatment, the dose of the drug is gradually increased, for example, by 25 mg every few days (depending on tolerability) to a daily dose of 100-150 mg. In severe cases, the daily dose can be increased to a maximum of 250 mg. After the improvement is achieved, the patient is transferred to a maintenance dose of 50-100 mg (2-4 tablets of the drug Anafranil® or 1 tablet of the drug Anafranil® CP).

Panic attacks, agoraphobia

The initial dose of the drug Anafranil® is 10 mg / day. Then, depending on the tolerability of the drug Anafranil®, its dose is increased to achieve the desired effect. The daily dose of the drug Anafranil® varies considerably and can range from 25 to 100 mg. If necessary, it is possible to increase the dose to 150 mg / day. It is recommended not to stop treatment for at least 6 months, slowly reducing during this time a maintenance dose of the drug.

Cataplexy accompanying narcolepsy

The daily dose of the drug Anafranil® is 25-75 mg.

Chronic Pain Syndromes

The dosage regimen is set individually. The daily dose of the drug Anafranil® varies greatly and can range from 10 mg to 150 mg. In this case, the concomitant use of analgesic drugs and the possibility of reducing the use of the latter should be considered.

Patients of advanced age. The initial dose is 10 mg / day. Then gradually, approximately for 10 days, the daily dose of the drug is raised to the optimal level, which is 30-50 mg.

Children and teens

Obsessive-compulsive syndromes

The initial dose is 25 mg / day. During the first 2 weeks, the dose is gradually increased, taking into account tolerability, to a daily dose of either 100 mg or calculated at 3 mg / kg, whichever dose is less. Over the next few weeks, the dose is gradually increased to a daily dose of either 200 mg or calculated at 3 mg / kg, whichever is lower.

Nocturnal enuresis

The initial daily dose of the drug Anafranil® for children aged 5-8 years is 20-30 mg; for children aged 9-12 years - 25-50 mg; for children older than 12 years - 25-75 mg. The use of higher doses is indicated for those patients who have completely no clinical effect after 1 week of treatment. Usually the whole daily dose of the drug is prescribed in one session after dinner, but in cases when involuntary urination is noted in the early hours of the night, part of the dose of Anafranil® is prescribed earlier - at 16 hours. After achieving the desired effect, treatment should be continued for 1-3 month, gradually reducing the dose of the drug Anafranil®.

Injection

IM injections

Begin the treatment with the introduction of 25-50 mg (content 1-2 amp.), Then daily increase the dose by 25 mg (1 amp) until the daily dose of 100-150 mg (4-6 amp.). After the improvement is noted, the number of injections is gradually reduced, replacing them with maintenance therapy with oral forms of the drug.

Intravenous infusion

Treatment begins with IV infusion of 50-75 mg (2-3 amp.) Once a day. To prepare the infusion solution, use 250-500 ml of isotonic sodium chloride solution or glucose solution; duration of infusion is 1.5-3 hours. During the infusion, careful monitoring of the patient is necessary in order to detect possible undesirable reactions in a timely manner. Particular attention should be given to the control of blood pressure, may develop orthostatic hypotension. When achieving a clear improvement, Anafranil® is administered IV for a further 3-5 days. Then, to maintain the effect achieved, they switch to taking the drug inside; 2 tab. 25 mg are usually equivalent to 1 amp. preparation Anafranil® containing 25 mg. With the purpose of a gradual transition from the infusion therapy to the oral administration of the drug, you can first transfer the patient to the IM introduction.

The maximum therapeutic dose of the drug is 150 mg / day.

Storage conditions for Anafranil

In a dry place, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Anafranil

5 years.

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