Klomipramin

Klomipramin – antidepressant with psychogogic, sedative and timoleptichesky action.

Form of release and structure

Dosage form – tablets, coated: round, yellow color, on one of the parties marking "25" (on 10, 20, 30 or 50 pieces in polymeric banks; on 10, 20, 30 or 50 pieces in blisters, in one packaging there can be 10, 20, 30, 40, 50, 60, 80, 90 or 100 tablets).

Active ingredient: a klomipramina a hydrochloride – 25 mg.

Excipients: microcrystallic cellulose, silicon dioxide colloid, croscarmellose sodium, magnesium stearate, gipromelloz, titanium dioxide, monohydrate of lactose, macrogoal, dye ferrous oxide yellow.

Indications to use

• Depressions of various genesis: organic, neurotic, larvirovanny, reactive, involutional and endogenous forms;
• The depressions caused by chronic somatopathies or a chronic pain syndrome;
• Depression at schizophrenia and a psychopathia;
• Presenile and senile depression;
• Obsessivno-kompulsivnoye frustration;
• Panic frustration;
• Phobias;
• The cataplexy accompanying a narcolepsy;
• Night enuresis at children is more senior than 5 years and teenagers.

Contraindications

Absolute:

• Children's age up to 5 years;
• Alcoholism;
• Recently postponed myocardial infarction;
• Inborn syndrome of lengthening of a QT interval;
• Concomitant use with monoamine oxidase inhibitors and within 2 weeks after their cancellation;
• Lactation (or feeding should be stopped);
• Hypersensitivity to components of drug or other dibenzazepines.

Relative:

• The lowered convulsive threshold;
• Serious illness of livers/kidneys;
• Pheochromocytoma;
• Neuroblastoma;
• Hyper thyroidism;
• Diabetes mellitus;
• Simultaneous use of steroid hormones.

There are no reliable data and clinical tests concerning safety of use of Klomipramin during pregnancy therefore during this period of life of the woman drug can be appointed only if the expected advantage of therapy exceeds potential risks for pre-natal fetation.

Route of administration and dosage

Klomipramin it is necessary to accept inside in time or after food.

In each case the therapeutic dose is selected the doctor individually.

To adult patients, as a rule, appoint on 1-2 tablet 2-3 times a day. The most admissible daily dose of a klomipramin of a hydrochloride makes 250 mg (10 tablets), at use in the conditions of a hospital – 300 mg (12 tablets).

The initial dose for children makes 1-2 tablets a day. The most admissible daily dose for children is more senior than 10 years – 3 mg/kg, but no more than 200 mg of a klomipramin.

Side effects

• Central nervous system: often – a tremor, increased fatigue, a headache, vision disorders, a myoclonus, dizziness; seldom – feeling of heat, disturbance of flavoring feelings, a disorientation, agitation, a condition of alarm, a mydriasis, aggression, a mania, a hypomania, disturbances of concentration of attention, memory disturbance, yawning, dreadful dreams, sleep disorders, a sonitus, a delirium, depersonalization, hallucinations (are most probable at elderly people and patients with parkinsonism), disturbances of the speech, strengthening of a depression, an ataxy, disturbances of a muscle tone, paresthesia, a spasm; in some cases – glaucoma, strengthening of psychotic symptoms;
• Cardiovascular system: seldom – changes of the electrocardiogram, increase in arterial pressure, arrhythmia, sinus tachycardia, postural hypotension, palpitation; in some cases – disturbances of cordial conductivity, change of the electroencephalogram;
• Alimentary system: often – a lock, dryness in a mouth, nausea; seldom – unpleasant feelings in a stomach, anorexia, diarrhea, vomiting, increase in activity of transaminases; in some cases – jaundice, hepatitis;
• System of a hemopoiesis: in some cases – an eosinophilia, thrombocytopenia, a Werlhof's disease, an agranulocytosis, a leukopenia;
• Metabolism: often – appetite strengthening, increase in body weight;
• Endocrine system: often – increase in chest glands, a galactorrhoea, disturbances of a libido and a potentiality; in some cases – hypostases, a syndrome of inadequate secretion of antidiuretic hormone;
• Dermatological and allergic reactions: seldom – an itch, skin rash, a photosensitization;

• Others: often – sweating strengthening; seldom – fervescence.

Special instructions

Before Klomipramin's appointment control of arterial pressure, during treatment – a picture of peripheral blood is necessary, at prolonged use – function of heart and a liver.

The patients inclined to suicide acts, during therapy, especially in an initial stage, have to be under constant medical control.

Use of an electroshock during treatment klomipraminy is possible only according to strict indications and under careful observation of the doctor.

Drug cannot be cancelled sharply as there is a risk of development of a withdrawal.

During treatment it is forbidden to take alcoholic beverages, it is necessary to refrain from control of vehicles and performance of potentially dangerous types of the works demanding the speed of reactions and special attention.

Medicinal interaction

Klomipramin it is not necessary to apply along with hinidinopodobny antiarrhytmic means, and also sympathomimetic drugs, such as Epinephrinum, ephedrine, изопреналин, Norepinephrinum, Phenylephrinum, фенилпропаноламин.

In need of simultaneous use of Disulfiramum or an alprazolam it is necessary to lower a dose of a klomipramin.

Possible reactions of interaction in case of the combined use of Klomipramin with other medicines:

• The drugs exerting the oppressing impact on the central nervous system: considerably the oppressing and hypotensive action amplifies, respiratory depression is possible;
• Anticholinergics (fenotiazina, atropine, antihistamines): their pharmacological action amplifies;
• The anti-adrenergic drugs influencing neyronalny transfer of excitement (a clonidine, гуанетидин, Reserpinum, бетанидин, alpha Methyldopum): decreases or completely their anti-hypertensive action is eliminated;
• Monoamine oxidase inhibitors: risk of development of a myoclonus, hyper pyrexia, generalized spasms, hypertensive crisis, delirium and coma;
• Ethanol: its action, especially in the first days of therapy klomipraminy amplifies;
• Neuroleptics: concentration of a klomipramin in a blood plasma increases, the threshold of convulsive readiness decreases, spasms develop;
• Thioridazine: the risk of the toxic influence on heart which is shown heavy arrhythmias increases;
• Barbiturates: concentration of a klomipramin in a blood plasma decreases;
• Selective serotonin reuptake inhibitors (for example, флувоксамин, fluoxetine), адеметионин, noradrenaline: the risk of development of a serotoninovy syndrome (between administrations of drugs it is necessary to take at least a 2 weeks break) increases; флувоксамин and fluoxetine can increase concentration of a klomipramin in a blood plasma that leads to development of the corresponding side effects;
• Adreno-and sympathomimetic means (Epinephrinum, Norepinephrinum, ephedrine, Phenylephrinum, изопреналин, including in cases when these substances are combined with local anesthetics), medicines with high linkng with proteins (digoxin, warfarin): their action on cardiovascular system amplifies;
• Sodium Valproatum, carbamazepine, пароксетин: concentration in a blood plasma of a klomipramin and its main metabolite of a dezmetilklomipramin increases;
• Cimetidinum, erythromycin, haloperidol: concentration of a klomipramin in a blood plasma increases;
• Estrogen: metabolism of a klomipramin is broken;
• Inductors _{of P450, CYP3A and CYP2C cytochrome} (rifampicin, phenobarbital, tobacco smoking): removal of a klomipramin from an organism accelerates, its efficiency decreases.

Terms and storage conditions

To store in the place protected from children at the room temperature (to 25 º).

Period of validity – 3 years.