Anafranil, pills 25mg, 30pcs

Composition

1 tablet contains clomipramine hydrochloride 25 mg

Pharmacological action

Anafranil is a tricyclic antidepressant, norepinephrine and serotonin reuptake inhibitor.

Anafranil acts on depressive syndrome in general, including especially on its typical manifestations such as psychomotor retardation, depressed mood and anxiety. The clinical effect is usually noted after 2-3 weeks of treatment.

In addition, Anafranil has a specific (different from its antidepressant effect) effect in obsessive-compulsive disorders.

The effect of Anafranil in chronic pain syndromes, both caused and not caused by somatic diseases, is probably associated with facilitating the transmission of nerve impulses mediated by serotonin and norepinephrine.

Indications

Adults treatment of depressive states of various etiologies, occurring with various symptoms: endogenous, reactive, neurotic, organic, masked, involutional forms of depression; depression in patients with schizophrenia and psychopathies; depressive syndromes that occur in old age, due to chronic pain syndrome or chronic somatic diseases; depressive mood disorders of a reactive, neurotic or psychopathic nature; obsessive-compulsive syndromes; chronic pain syndrome; phobias and panic attacks; cataplexy associated with narcolepsy. Children and adolescents with obsessive-compulsive syndromes; nocturnal enuresis (only in patients over the age of 5 years and subject to the exclusion of organic causes of the disease). Before starting therapy with Anafranil for nocturnal enuresis in children and adolescents, the ratio of potential benefit and risk for the patient should be evaluated. The possibility of alternative therapy should be considered. Currently, there is insufficient evidence for the efficacy and safety of clomipramine in children and adolescents in the treatment of depressive states of various etiologies, occurring with different symptoms, phobias and panic attacks, cataplexy, concomitant narcolepsy and chronic pain syndrome. Therefore, the use of Anafranil in children and adolescents (0-17 years) with these indications is not recommended.

Use during pregnancy and lactation

Experience with Anafranil during pregnancy is limited. Since there are isolated reports of a possible association between tricyclic antidepressants and fetal developmental disorders, Anafranil should be avoided during pregnancy, unless the expected effect of treatment on the mother clearly exceeds the potential risk to the fetus. In cases where tricyclic antidepressants were used during pregnancy up to the onset of labor, newborns developed a withdrawal syndrome during the first few hours or days, manifested by shortness of breath, drowsiness, colic, irritability, hypotension or hypertension, tremor, spastic phenomena or convulsions. To avoid the development of this syndrome, Anafranil should be phased out as gradually as possible, at least 7 weeks before the expected delivery. Since the Active ingredient of the drug is excreted in breast milk, you should either stop breastfeeding, or gradually cancel Anafranil.

Contraindications

-hypersensitivity to clomipramine and other components of the drug, cross-hypersensitivity to tricyclic antidepressants from the dibenzazepine group— – simultaneous use of MAO inhibitors, as well as a period of less than 14 days before and after their use— – simultaneous use of selective MAO inhibitors of reversible action (such as moclobemide);— recent myocardial infarction; – congenital QT prolongation syndrome— – pregnancy and lactation.

Side effects

Side effects of Anafranil are most often mild, somewhat similar to the symptoms of depression. As a rule, such effects disappear during treatment or after reducing and reaching the minimum active dosage. If the side effects are serious and life-threatening, the medication should be discontinued. Especially often and clearly side effects occur in the elderly. There may be: drowsiness, dry mucous membranes, fatigue, sweating, increased appetite, tremor; constipation, myoclonus, headache, visual disturbances, nausea, weight gain; paresthesia, hot flashes, palpitations, increased muscle tone or weakness, speech disorders, mydriasis; tachycardia, severe decrease in AP, slight distortions of the ECG, vomiting, diarrhea, epigastric pain, increased activity of liver enzymes; urticaria, galactorrhea, tinnitus, itching skin rashes, enlarged mammary glands, taste distortion; sleep disorders, disorientation, hallucinations, anxiety and aggression, delirium, memory problems; seizures, fever, ataxia, changes in the electroencephalogram; glaucoma, intracardiac conduction disorders, urinary retention, edema, burning and swelling at the injection site; pneumonitis, anaphylactic and anaphylactoid reactions, purpura, leukopenia, thrombocytopenia etc. If the drug is abruptly discontinued, a withdrawal syndrome occurs. Nausea, diarrhea, vomiting, irritability and anxiety, headaches and insomnia appear. Dosage should be reduced gradually.

Interaction

With the combined use of ethanol and drugs that depress the central nervous system (including other antidepressants, barbiturates, benzodiazepines and general anesthetics), a significant increase in the depressive effect on the central nervous system, respiratory depression and hypotensive effect is possible. Increases sensitivity to drinks containing ethanol. Increases the anticholinergic effect of amantadine, etc. Drugs with anticholinergic activity (for example, phenothiazines, antiparkinsonian drugs, atropine, biperiden, antihistamines), which increases the risk of side effects (from the central nervous system, vision, intestines and bladder). When combined with antihistamines, clonidine-increased depressive effect on the central nervous system; with atropine-increases the risk of paralytic intestinal obstruction; with drugs that cause extrapyramidal reactions-an increase in the severity and frequency of extrapyramidal effects. Concomitant use of clomipramine and indirect anticoagulants (coumarin or indadione derivatives) may increase the anticoagulant activity of the latter. Clomipramine may increase depression caused by corticosteroids. When combined with anticonvulsant drugs, it is possible to increase the depressing effect on the central nervous system, reduce the threshold of convulsive activity (when used in high doses) and reduce the effectiveness of the latter. Drugs for the treatment of thyrotoxicosis increase the risk of agranulocytosis. Reduces the effectiveness of phenytoin and alpha-blockers. Microsomal oxidation inhibitors (cimetidine) prolong T1 / 2, increase the risk of toxic effects of clomipramine (it may be necessary to reduce the dose of clomipramine by 20-30%), inducers of microsomal liver enzymes (barbiturates, carbamazepine, phenytoin, nicotine and oral contraceptives) reduce the plasma concentration and reduce the effectiveness of clomipramine. Fluoxetine and fluvoxamine increase the concentration of clomipramine in plasma (it may be necessary to reduce the dose of clomipramine by 50%). When combined with holinoblokatorami, phenothiazines and benzodiazepines-mutual strengthening of sedative and central holinoblokiruyushchy effects and increased risk of epileptic seizures (lowering the threshold of convulsive activity); phenothiazines, in addition, can increase the risk of neuroleptic malignant syndrome. Concomitant use of clomipramine with clonidine, guanethidine, betanidine, reserpine and methyldopa reduces the hypotensive effect of the latter; with cocaine – the risk of cardiac arrhythmias. Estrogen-containing oral contraceptives and estrogens may increase the bioavailability of clomipramine; antiarrhythmic drugs (such as quinidine) may increase the risk of rhythm disorders (clomipramine metabolism may slow down). Combined use with disulfiram and other acetaldehydrogenase inhibitors provokes delirium. Incompatible with MAO inhibitors (may increase the frequency of periods of hyperpyrexia, severe seizures, hypertensive crises and death of the patient). Pimozide and probucol may increase cardiac arrhythmias, which is manifested in prolongation of the Q-T interval on the ECG. Increases the effect of epinephrine, norepinephrine, isoprenaline, ephedrine, and phenylephrine on the cardiovascular system (including when these drugs are part of local anesthetics) and increases the risk of heart rhythm disorders, tachycardia, and severe arterial hypertension. Combined use with alpha-adrenostimulants for intranasal administration or for use in ophthalmology (with significant systemic absorption) may increase the vasoconstrictive effect of the latter. When taken together with thyroid hormones, there is a mutual increase in the therapeutic effect and toxic effect (including cardiac arrhythmias and stimulating effect on the central nervous system). M-holinoblokatorov and antipsychotic drugs (neuroleptics) increase the risk of hyperpyrexia (especially in hot weather). Solution for injection is not compatible with diclofenac solution for injection. When co-administered with other hematotoxic drugs, it is possible to increase hematotoxicity.

How to take it, course of administration and dosage

Doses of the drug are selected individually, taking into account the patient’s condition.

The goal of treatment is to achieve the optimal effect against the background of using as small doses of the drug as possible, as well as to carefully increase them, especially in elderly patients and adolescents, who are generally more sensitive to Anafranil CP than patients of intermediate age groups.

The initial daily dose is 75 mg (25 mg 2-3 times a day).

Overdose

The symptoms that develop with an overdose of Anafranil are similar to those described with an overdose of other tricyclic antidepressants. The main complications are disorders of the heart and neurological disorders. In children, accidental ingestion of the drug at any dose should be considered a very serious and potentially fatal event. Symptoms usually appear within 4 hours of taking the drug and reach maximum severity after 24 hours. Due to the delayed absorption (anticholinergic effect of the drug), a long half-life and hepatoenteral recirculation of the Active ingredient, the time period during which the patient remains in the “risk zone” is 4-6 days. From the central nervous system: drowsiness, stupor, coma, ataxia, restlessness, agitation, increased reflexes, muscle rigidity, choreoathetoid movements, convulsions. In addition, there may be manifestations of serotonin syndrome (fever, myoclonus, delirium, coma). From the cardiovascular system: marked decrease in blood pressure, tachycardia, prolongation of the QTc interval, arrhythmias (including ventricular arrhythmias of the “pirouette” type) intracardiac conduction disorders, shock, heart failure; in very rare cases – cardiac arrest. Other: possible respiratory depression, cyanosis, vomiting, fever, mydriasis, sweating, oliguria or anuria. Treatment: There is no specific antidote; treatment is mainly symptomatic and supportive. If an Anafranil overdose is suspected, especially in children, the patient should be hospitalized and closely monitored for at least 72 hours. If the patient is conscious, gastric lavage or vomiting should be performed as soon as possible. If the patient is unconscious, tracheal intubation should be performed using a tube with a cuff before starting gastric lavage to prevent aspiration; in this case, vomiting is not caused. These measures are recommended if 12 hours or even more have passed since the overdose, since the anticholinergic effect of Anafranil can slow down gastric emptying. To slow down the absorption of the drug, the use of activated carbon is useful. Treatment is based on the use of modern methods of intensive care with constant monitoring of heart function, gas composition and blood electrolytes, as well as the use of urgent measures such as anticonvulsant therapy, mechanical ventilation and resuscitation methods, if necessary. Since there have been reports that physostigmine can cause severe bradycardia, asystole and seizures, the use of this drug for the treatment of Anafranil overdose is not recommended. Hemodialysis and peritoneal dialysis are not effective because clomipramine plasma concentrations are low.

Special instructions

Before starting treatment with Anafranil, hypokalemia should be eliminated. In the presence of liver diseases, the activity of liver enzymes should be monitored during therapy with the drug. A good effect is given by the combination of Anafranil with benzodiazepines. At the same time, during treatment, the dosage of the drug is gradually increased (depending on tolerability), and benzodiazepine is discontinued. It is advisable that the treatment lasts at least six months. When treating with Anafranil, you should avoid driving vehicles and operating potentially dangerous mechanisms that require high concentration of attention. Discontinue the drug gradually (to avoid adverse reactions).

Form of production

Tablets coated with a light yellow color, sugar; round, biconvex.

Storage conditions

In a dry place

Shelf life

5 years

Active ingredient

Clomipramine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, Children over 5 years of age, Children as prescribed by a doctor

Indications

Obsessive-compulsive disorder, Psychiatric Disorders, Enuresis, Depression, Phobias and Panic attacks