Active material: Clomipramine
When ATH: N06AA04
CCF: Antidepressant
When CSF: 02.02.01
Manufacturer: Sun Pharmaceutical Industries Ltd. (India)
Pills, covered shell blue, round, with dividing risk on the one hand.
| 1 tab. | |
| Klomipramine hydrochloride | 25 mg |
Excipients: lactose, starch, microcrystalline cellulose, colloidal silicon dioxide, sodium methylparaben, talc, magnesium stearate, Diamond blue, sodium starch glycolate, polyethylene glycol, Eudrahit E100, sodium lauryl.
10 PC. – упаковки безъячейковые контурные (5) – пачки картонные.
Antidepressant from a group of tricyclic compounds. The effect of the drug is associated with the stimulation of adrenergic and serotonergic mechanisms in the central nervous system due to the oppression of the reverse neuronal seizure of mediators. More affects the capture of serotonin; This, apparently, its effectiveness is due to the treatment of intrusive and compulsive disorders. The antidepressant effect occurs relatively quickly (at the first week of treatment). It has adrenal -locking (Mostly alpha1), holin -locking and antihistamine activity.
The psychostimulating effect of clomipromin is less expressed, than Imipramin, а седативный эффект – слабее, than amitriptylin.
After administration orally or in/m, the introduction is absorbed quickly and completely. Cmax plasma achieved through 1.5-4 hours after ingestion. Plasma protein binding - 97.6%. Vd – 12 l. Subjected to intensive metabolism with the formation of an active metabolite of desmethyllomipramine.
T1/2 in the final phase of 21 no. Displayed with urine in the form of metabolites and unchanged substance, через кишечник – в виде метаболитов.
Depressive states of various etiologies (incl. Endogenous, reactive, neurotic, Organic, masked and involutionary depression); Depressive syndrome for schizophrenia and personality disorders; Preight and Senile Depression; Depressive states with prolonged pain syndrome and chronic somatic diseases; Depressive reactive disorders, neurotic and psychopathic nature, including their somatic equivalents in children; obsessive-compulsive syndromes (phobia), Panic attacks of fear, chronic pain syndrome (chronic pain in cancer patients, migraine, rheumatic diseases, atypical facial pain, postgerpeticheskaya neuralgia, Posttraumatic neuropathy, Diabetic or others. perifericheskaya neuropathy), Narcolepsy, accompanied by a cataplexion; headache; prevention of migraine
Внутрь взрослым – по 25-50 mg 2-3 times / day; детям в зависимости от возраста – 25-50 mg / day. Adults in/m 25-100 mg / day, / drip 50-75 mg 1 time / day.
The maximum dose: при приеме внутрь взрослым амбулаторно – 250 mg / day, в условиях стационара – 300 mg / day; older children 10 years - 3 mg / kg / day, but not more 200 mg / day.
CNS: often - dizziness, fatigue, tremor, headache, myoclonus, visual impairment; редко – нарушения вкусовых ощущений, feeling the heat, midriaz, disorientation, hallucinations (most likely in elderly patients and in Parkinson's disease), anxiety state, ažitaciâ, sleep disorders, craze, hypomania, aggressiveness, memory impairment, depersonalization, zevota, nightmares, increased depression, impaired concentration, delirium, speech disorders, paresthesia, Muscular tone disorders, noise in ears, convulsions, ataxia; в отдельных случаях – усиление психотических симптомов, glaucoma.
Cardio-vascular system: редко – постуральная гипотензия, sinus tachycardia, ECG changes, palpitation, Arrhythmia, increased blood pressure; в отдельных случаях – изменения ЭЭГ, cardiac conduction disorders.
From the digestive system: often - nausea, dry mouth, constipation; редко – рвота, abdominal discomfort, diarrhea, anorexia, increase in transaminases; в отдельных случаях – гепатит, jaundice.
From the hematopoietic system: в отдельных случаях – лейкопения, agranulocytosis, thrombocytopenia, eozinofilija, trombotsitopenicheskaya purpura.
Metabolism: часто – повышение аппетита, weight gain.
On the part of the endocrine system: часто – нарушения либидо и потенции, galactorrhea, An increase in the pectoral glands; в отдельных случаях – синдром неадекватной секреции АДГ, swelling.
Dermatological reactions: rarely - photosensitivity.
Allergic reactions: редко – кожная сыпь, itch.
Other: часто – усиление потоотделения; в отдельных случаях – повышение температуры тела.
Recent myocardial infarction, Blockade of the conductive myocardial system, Arrhythmia, craze, severe liver failure, zakrыtougolynaya glaucoma, urinary retention, I trimester of pregnancy, lactation, Increased sensitivity to clomipramine and other tricyclic antidepressants from the group of dibenzoazepine derivatives.
Contraindicated for use in the I trimester of pregnancy. Do not use in the 2nd and 3rd trimesters of pregnancy, except in cases of emergency. Adequate and well -controlled studies of the safety of the use of clomipromin during pregnancy in humans were not carried out.
Klomipramine in a small amount is released with breast milk, Therefore, if it is necessary to apply the issue of stopping breastfeeding during lactation..
Caution is used in patients with a reduced convulsive threshold; In severe liver diseases or kidneys; during treatment with steroid hormones; with pheochromocytoma and neuroblastoma due to the risk of developing hypertensive crisis; in hyperthyroidism; diabetes (Correction of the dosing of hypoglycemic drugs is required).
Before starting treatment, blood pressure control is necessary, During the treatment period, it is recommended to control the picture of peripheral blood, при длительной терапии – контроль функций сердца и печени.
Clomipramine can be used no earlier than through 14 days after discontinuation of MAO inhibitors, Starting therapy with a minimum dose. Should not be used simultaneously with sympathomy, incl. with epinephrine, ephedrine, isoprenalin, norepinephrine, phenylephrine, fenilpropanolaminom; with quinidine -like antiarrhythmic drugs. With the simultaneous use of clomipromin with alprazolam or disulfiram, a reduction in the dose of clomipromin is required.
Patients with a tendency to suicide in the initial period of treatment need constant medical control.
The use of electric shock against the background of the use of clomipramine is possible only according to strict indications and with a careful observation of a doctor.
With a sudden cessation of treatment, it is possible to develop cancellation syndrome.
During treatment, avoid alcohol.
It is not recommended for oral administration to children to the age of 6 years, парентерально – детям до 12 years.
Effects on ability to drive vehicles and management mechanisms
During the period of treatment should refrain from potentially hazardous activities, requiring attention and quick emotional reactions.
In an application with drugs, have a depressing effect on the central nervous system, possibly significant strengthening of oppressive action on the central nervous system, gipotenzivnogo actions, respiratory depression.
If you are applying with tools, having anticholinergic activity, it is possible to strengthen anticholinergic action.
With the simultaneous use of clomipromin, it can reduce or completely eliminate the antihypertensive effect of anti -adreno., affecting the neuronal transmission of excitation (guanethidine, ʙetanidina, reserpine, clonidine and alpha-methyldopa).
While the use of antipsychotics (neuroleptics) it is possible to increase the level of bloodupomine in blood plasma, reduction of the threshold of convulsive readiness and the development of seizures. Combination with thyoridazin can lead to severe arrhythmias.
It is possible to reduce the concentration of clomipromin in blood plasma due to the induction of microsomal liver enzymes under the influence of barbiturates.
Together with the use of MAO inhibitors are possible hypertonic Kriz, hyperpyrexia, myoclonus, generalized seizures, delirium and coma.
With the simultaneous use of selective inhibitors of the reverse capture of serotonin (incl. Fluoxetine and Fluoxamine) it is possible to strengthen the action on the serotonin system. Fluoxetine and fluvkamin can increase the concentration of bloodupomine in blood plasma, which is accompanied by the development of appropriate side effects.
Klomipramine can enhance the effect on the cardiovascular system of adreno- and sympathomimetic agents (epinephrine, norepinephrine, isoprenaline, Ephedrine and phenylefrin), including, When these substances are included in a combination with local anesthetics.
With simultaneous use with ademetionine, the case of the development of serotonin syndrome is described; с вальпроатом натрия – описан случай повышения концентрации в плазме крови кломипрамина и его метаболита дезметилкломипрамина.
There is a message about increasing the concentration in the blood plasma of clomipramine and its main metabolite (Desmethyllomipramine) With simultaneous use with carbamazepine.
With simultaneous use with paroxetin, the concentration of the bloodpramine of its metabolite S-dezethyllomipramine in the blood plasma of the blood, apparently, In connection with the inhibiting of the isoenzyme CYP2D6 .
With simultaneous use with cimetidin, it is possible to increase the concentration of clomipromin in blood plasma due to the inhibiting of microsomal liver enzymes under the influence of cimetidine.
The case of increasing the concentration of clomipromin in blood plasma is described, What is due to the inhibiting of cyp3a3/4 isoenzymes under the influence of erythromycin.
With simultaneous use with estrogens, a violation of the metabolism of clomipromin is possible.
It is possible to strengthen ethanol, especially during the first few days of therapy with clomipramine.
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