Clomipramine is an antidepressant from the group of tricyclic compounds.
Release form and composition
Clomipramine is available in the form of tablets:
- 30 pieces each in plastic bottles, 1 bottle in a carton box;
- 10 pcs. in blisters, 1 or 3 packs in a carton box;
- On 5 kg in plastic bags, on 1 package in the plastic container.
The active ingredient of the drug is clomipramine hydrochloride (25 mg in 1 tablet).
Indications for use
- Depressive states of various etiologies, incl. neurotic, endogenous, organic, reactive, masked and involutional depressions;
- Obsessive-compulsive syndromes (phobias) and panic attacks of fear;
- Presenile and senile depression;
- Depressive syndrome in personality disorders and schizophrenia;
- Depressive conditions in chronic somatic diseases or long-term pain syndrome;
- Depressive disorders of a neurotic, psychopathic and reactive nature, including their somatic equivalents in children;
- Narcolepsy, accompanied by cataplexy;
- Chronic pain syndrome (post-traumatic neuropathy, migraine, atypical facial pain, rheumatic diseases, diabetic or other peripheral neuropathy, postherpetic neuralgia, chronic pain in cancer patients);
- Headache;
- Prevention of migraine.
Contraindications
Absolute contraindications:
- Arrhythmias;
- Blockade of the myocardial conducting system;
- A recent myocardial infarction;
- Mania;
- Angle-closure glaucoma;
- Severe liver failure;
- Urinary retention;
- First trimester of pregnancy;
- Lactation period;
- Age up to 6 years;
- Hypersensitivity to clomipramine or other tricyclic antidepressants from the group of dibenzoazepine derivatives.
With caution, the drug is used in the following cases: low convulsive threshold, severe kidney / liver disease, the period of treatment with steroid hormones, pheochromocytoma, neuroblastoma, hyperthyroidism, diabetes mellitus.
In the second and third trimesters of pregnancy, clomipramine is prescribed only in cases of extreme necessity, since adequate and well-controlled studies on the safety of the drug during pregnancy in humans have not been conducted.
Dosing and Administration
Clomipramine should be taken orally.
Adults are prescribed 25-50 mg of clomipramine hydrochloride (1-2 tablets) 2-3 times a day, children 25-50 mg per day depending on age.
The maximum allowable daily dose: for adults undergoing outpatient treatment - 250 mg, in a hospital - 300 mg; children over 10 years old - 3 mg / kg, but not more than 200 mg.
Side effects
Possible side effects from various body systems:
- Central nervous (CNS): often - increased fatigue, visual disturbances, dizziness, myoclonus, tremor, headache; rarely - hallucinations (more often in the elderly and patients with Parkinson’s disease), fever, disorientation, taste disturbances, mydriasis, agitation, anxiety, hypomania, mania, aggression, depersonalization, sleep disorders, speech, memory and concentration, nightmarish dreams, delirium, yawning, paresthesia, tinnitus, ataxia, muscle tone disorders, increased depression, convulsions; in some cases, glaucoma, increased psychotic symptoms;
- Metabolism: often - increased appetite, weight gain;
- Cardiovascular: rarely - changes on the electrocardiogram, sinus tachycardia, palpitation, increased blood pressure, postural hypotension, arrhythmias; in some cases - a violation of cardiac conduction, changes in the electroencephalogram;
- Digestive: often - constipation, dry mouth, nausea; rarely - discomfort in the abdomen, anorexia, diarrhea, increased transaminase activity, vomiting; in some cases - jaundice, hepatitis;
- Hematopoiesis: in some cases - eosinophilia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia;
- Endocrine: often - an increase in the mammary glands, galactorrhea, disorders of libido and potency; in some cases, edema, syndrome of inadequate secretion of antidiuretic hormone;
- Allergic reactions: rarely - skin rash and itching;
- Dermatological reactions: rarely - photosensitivity;
- Other: often - increased sweating; in some cases - an increase in body temperature.
With the abrupt cancellation of clomipramine may develop withdrawal syndrome.
special instructions
Before starting to use the drug, it is necessary to control blood pressure, during reception - a picture of peripheral blood, with long-term treatment - functions of the heart and liver.
Patients receiving monoamine oxidase inhibitors (MAO) can be prescribed Clomipramine no earlier than 14 days after their withdrawal.
Patients with a tendency to suicide need constant medical supervision at the beginning of treatment.
During treatment should not consume alcoholic beverages and engage in potentially hazardous activities.
The use of electric shock during therapy is possible only under strict indications and under the special supervision of a physician.
Drug interaction
Clomipramine should not be used simultaneously with quinidine-like antiarrhythmic drugs and sympathomimetic agents (epinephrine, ephedrine, phenylephrine, isoprenaline, phenylpropanolamine, norepinephrine).
If necessary, the appointment of alprazolam or disulfiram should reduce the dose of clomipramine.
When using clomipramine in combination, there is a possibility of drug interaction and the development of undesirable reactions:
- Drugs that have a depressant effect on the central nervous system - respiratory depression, a significant increase in the hypotensive effect and inhibitory effect on the central nervous system;
- Antiadrenergic agents affecting neuronal excitation transfer (reserpine, betanidin, clonidine, guanethidine, alpha methyldopa) - reducing or completely eliminating the antihypertensive effect;
- MAO inhibitors - hypertensive crisis, myoclonus, hyperpyrexia, generalized convulsions, delirium, coma;
- Selective serotonin reuptake inhibitors (including fluoxetine and fluvoxamine) - increased action on the serotonin system, increased concentrations of clomipramine in the blood and the development of appropriate side effects;
- Ademetionin - serotonin syndrome;
- Agents with anticholinergic activity - increased anticholinergic action;
- Thioridazine - the occurrence of severe arrhythmias;
- Neuroleptics - increased concentration of clomipramine in plasma, lowering the threshold of convulsive readiness, convulsions;
- Adrenergic and sympathomimetic agents (including if they are combined with local anesthetics) - enhancing the effect on the cardiovascular system;
- Estrogens - a violation of the metabolism of clomipramine;
- Ethanol - enhancing its action, especially in the first days of treatment.
The following drugs can increase the concentration of clomipramine (sometimes its main metabolite, desmethylclomipramine) in the blood plasma: sodium valproate, carbamazepine, paroxetine, cimetidine, erythromycin.
Barbiturates can reduce the concentration of clomipramine in the blood plasma.
Terms and conditions of storage
Store at a temperature of 15-25 ºC in a dry, dark place.
Shelf life - 2 years.