Anafranil® sr
It is known that tricyclic antidepressants reduce the threshold for convulsive readiness, therefore Anafranil should be used with extreme caution in patients with epilepsy, as well as in the presence of other factors predisposing to the occurrence of convulsive syndrome, for example, brain damage of any etiology, while using antipsychotic drugs, during the period of withdrawal from alcohol or withdrawal from drugs that have anticonvulsant properties (for example, benzodiazepines). It is believed that the occurrence of seizures while taking Anafranil depends on the dose of the drug. In this regard, you should not exceed the recommended daily dose of Anafranil.
Anafranil should be prescribed with extreme caution to patients with cardiovascular diseases, especially cardiovascular failure, intracardiac conduction disorders (for example, AV block I-III degrees) or arrhythmias. In such patients, as well as in elderly patients, it is necessary to regularly monitor heart function and ECG.
Before starting Anafranil therapy, it is recommended to measure blood pressure, since patients with orthostatic hypotension or lability of the cardiovascular system may experience a sharp decrease in blood pressure.
Because the drug has anticholinergic properties, it should be used with extreme caution in patients with a history of increased intraocular pressure, angle-closure glaucoma, or urinary retention (for example, due to prostate disease).
Due to the anticholinergic action characteristic of tricyclic antidepressants, there may be a decrease in tear production and accumulation of mucous secretion, which can lead to damage to the corneal epithelium in patients using contact lenses.
Caution is necessary when treating patients with severe liver disease with tricyclic antidepressants, as well as in patients with tumors of the adrenal medulla (for example, pheochromocytoma, neuroblastoma), since in this case these drugs can provoke the development of a hypertensive crisis.
It is known that patients with cyclic affective disorders taking tricyclic antidepressants may develop manic or hypomanic states during the depressive phase. In such cases, it may be necessary to reduce the dose of Anafranil or discontinue it and prescribe antipsychotic therapy. After relief of these conditions, if indicated, treatment with Anafranil in low doses can be resumed.
In predisposed patients and elderly patients, tricyclic antidepressants can provoke the development of drug-induced delirious psychoses, mainly at night. After discontinuation of the drug, these disorders disappear within a few days.
Caution should be exercised when treating patients with hyperthyroidism or receiving thyroid hormone medications, which may have cardiotoxic effects.
Although changes in white blood cell levels during treatment with Anafranil have been reported only in isolated cases, periodic examination of peripheral blood composition and attention to symptoms such as fever and sore throat are recommended, especially in the first months of therapy or with long-term use of the drug.
Caution is required when using Anafranil in patients with chronic constipation. Tricyclic antidepressants can cause paralytic ileus, mainly in elderly patients or in patients who are forced to remain in bed.
When using Anafranil in doses exceeding the average therapeutic one, or if the concentration of clomipramine in plasma exceeds the average therapeutic one, there is a risk of prolongation of the QTc interval and the occurrence of bidirectional fusiform ventricular tachycardia (ventricular disturbances). This occurs when taken together with selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. In this regard, it is necessary to avoid co-administration of clomipramine and drugs that cause its accumulation. It is also necessary to avoid co-administration with drugs that cause prolongation of the QTc interval. The use of diuretics can lead to the development of hypokalemia. It has been established that hypokalemia is a risk factor for prolongation of the QTc interval and the occurrence of bidirectional fusiform ventricular tachycardia (ventricular disorders). Therefore, hypokalemia must be eliminated before starting Anafranil therapy. Anafranil should be used with caution concomitantly with selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors, as well as with diuretics.
Due to the risk of serotonin toxicity, the recommended dosage should be adhered to and the dose should be increased with caution if Anafranil is used concomitantly with serotonergic drugs.
With simultaneous use of Anafranil with serotonergic drugs, such as selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants or lithium preparations, the development of serotonin syndrome with symptoms such as fever, myoclonus, agitation, convulsions, delirium and coma is possible. . If it is necessary to prescribe fluoxetine, it is recommended to take a two to three week break between the use of Anafranil and fluoxetine.
Many patients with panic disorders experience increased anxiety at the beginning of treatment with Anafranil. This paradoxical increase in anxiety is most pronounced in the first days of therapy and usually subsides within two weeks.
In patients with schizophrenia receiving tricyclic antidepressants, activation of psychosis is sometimes observed.
In patients with liver disease, periodic monitoring of liver enzyme activity is recommended.
Anafranil, like other tricyclic antidepressants, is prescribed in combination with electroconvulsive therapy only under close medical supervision.
Severe depression is characterized by a risk of suicidal actions, which can persist until reliable remission is achieved. Patients with depression, both adults and children, may experience increased depression and/or suicidal behavior or other psychiatric symptoms, whether or not they are receiving antidepressant therapy. Antidepressants increased the risk of suicidal ideation and behavior in short-term studies in children and adolescents with depression and other psychiatric illnesses.
All patients taking Anafranil for any indication should be monitored for worsening clinical symptoms, suicidal behavior and other psychiatric symptoms, especially during the initial phase of therapy or when the dose of the drug is changed. In such patients, changes in the treatment regimen, including possible discontinuation of the drug, should be considered, especially if such changes are pronounced, appeared suddenly, or were not observed in the patients initially.
Families and caregivers of patients (both children and adults) taking antidepressants for psychiatric or non-psychiatric indications should be warned to monitor patients due to the risk of other psychiatric symptoms, including and suicidal behavior, and immediately report such symptoms to your healthcare provider.
When writing a prescription for Anafranil, the minimum number of tablets should be specified to reduce the risk of overdose. In this case, it is necessary to follow an adequate treatment regimen.
There is evidence that while taking Anafranil, there is a lower number of deaths due to overdose than when taking other tricyclic antidepressants.
Before performing general or local anesthesia, the anesthesiologist should be warned that the patient is taking Anafranil.
An increased incidence of dental caries has been reported with long-term treatment with tricyclic antidepressants. Therefore, in case of long-term therapy with Anafranil, regular examination of the patient by a dentist is recommended.
The use of diuretics can lead to the development of hypokalemia, which increases the risk of prolongation of the QTc interval and the occurrence of bidirectional fusiform ventricular tachycardia (pirouette type). Before starting Anafranil therapy, hypokalemia must be corrected.
Abrupt withdrawal of Anafranil should be avoided, because this may lead to adverse reactions. If a decision is made to discontinue treatment, the drug should be withdrawn gradually, as quickly as the clinical situation allows. It should be borne in mind that abrupt withdrawal of the drug may be accompanied by the development of certain symptoms.
25 mg film-coated tablets contain lactose and sucrose. Patients with rare hereditary diseases such as galactose and fructose intolerance, severe lactase deficiency, sucrase-isomaltase deficiency or glucose-galactose malabsorption should not take Anafranil film-coated tablets.
It should be borne in mind that alcohol can increase adverse effects from the central nervous system, such as blurred vision and drowsiness.
Use in pediatrics
Experience of using Anafranil in children under 5 years of age
not available, therefore it is not recommended to use the drug in children of this age group.
Impact on the ability to drive vehicles and operate machinery
Patients who experience drowsiness and other central nervous system disorders (including blurred vision) while taking Anafranil should not drive a car, operate machinery, or engage in other activities that require increased attention and quick reaction.
Carefully
Clomipramine is used with caution in patients with heart disease, a history of epilepsy, breastfeeding, the elderly, liver failure, thyroid disease, pheochromocytoma, a history of psychosis (clomipramine may increase psychotic symptoms), a history of urinary retention, while undergoing electroconvulsive therapy , simultaneous anesthesia (increases the risk of arrhythmias and arterial hypotension)[3].
The use of clomipramine during pregnancy, especially in the first and third trimesters, should be avoided unless absolutely necessary[3].
When a woman takes clomipramine during breastfeeding, side effects may occur in the infant; The infant should be monitored for lethargy and drowsiness[3].
It should be taken into account that clomipramine may impair the ability to control moving machinery and impair the ability to drive a car[3].
Clomipramine should not be discontinued abruptly[3].
Side effects
The main side effects of clomipramine are anticholinergic effects[2] (accommodation disorders, constipation, urinary retention, dry mouth, confusion[2], increased intraocular pressure[3]), orthostatic hypotension, and less commonly cardiotoxic effects (ECG monitoring is required)[2] . Cardiotoxic side effects of clomipramine include ECG changes, arrhythmias, orthostatic hypotension, and tachycardia[3]. Unlike imipramine, clomipramine does not generally increase fear and anxiety. Like SSRI antidepressants, it can lead to the development of sexual dysfunction[4].
Possible dyspepsia[5], nausea, sedation, insomnia, agitation[6], behavioral disorders[3], agitation, exacerbation of paranoid symptoms, phase inversion (i.e. development of mania or hypomania), ataxia, convulsions, dyskinesias, muscle twitching[5 ] (especially in elderly patients), tremors, fainting, increased sweating, rash and hypersensitivity reactions (urticaria, photosensitivity), sexual dysfunction, changes in blood sugar levels, endocrine side effects (testicular enlargement, gynecomastia, galactorrhea), increased appetite and increased body weight (sometimes weight loss), fever, agranulocytosis, leukopenia, eosinophilia, purpura, thrombocytopenia, hyponatremia, changes in liver function tests[3].
Anticholinergic syndrome may occur when taking clomipramine[7]. When clomipramine is combined with some other antidepressants (MAOI drugs[8], SSRI drugs[9]), and sometimes with clomipramine monotherapy[10], the development of serotonin syndrome[8][9][10] is possible. In cases where clomipramine is used for liver failure, increased sedation is possible [3].
In cases of intravenous drip administration of clomipramine, careful monitoring of blood pressure should be carried out, since orthostatic collapse in these cases is frequent, especially in the first hours after infusion therapy[2].
