Index of drugs

Treatment of depression. Anxiety disorder with anxiety attacks with or without agoraphobia. Obsessive-compulsive disorder. Treatment to prevent the recurrence of depression.

1 tabl powl. contains 40 mg of citalopram in the form of hydrobromide. The product contains mannitol.

Antidepressant - a strong and selective serotonin reuptake inhibitor in brain neurons. Citalopram has almost no effect on the neuronal reuptake of norepinephrine, Dopamine and gamma-aminobutanoic acid. It does not show or has very low affinity for cholinergic, hisaminergic and various adrenergic, serotonergic and dopaminergic receptors. Citalopram is rapidly absorbed after oral administration: the maximum plasma concentration is reached after about 4 hours (1-7 h). The bioavailability after oral administration is about 80%. The drug and its metabolites bind to plasma proteins in less than 80%. Citalopram is metabolised to demethyl citalopram, didmethylcitalopram, citalopram N-oxide and the propionic acid derivative deamino. The propionic acid derivative is pharmacologically inactive. Demethylcitalopram, didmethylcycalopram and citalopram N-oxide are selective serotonin reuptake inhibitors, however weaker than the parent substance. The main metabolizing enzyme is CYP2C19. A small proportion of CYP3A4 and CYP2D6 are also possible. T_0,5 in plasma it is approx. 36 h (28-42 h). Citalopram is mainly excreted by the liver (85%), but also partly (15%) via the kidneys. 12-23% of the daily dose is excreted in the urine in unchanged form. Plasma levels at steady-state are achieved after 1-2 weeks.

Hypersensitivity to citalopram or any of the excipients. Do not administer citalopram to patients using MAO inhibitors, including selegiline in a daily dose of more than 10 mg. Do not use citalopram for 14 days after discontinuation of irreversible MAO inhibitors, or at the specified time indicated in the SPC after treatment with the reversible MAO type A inhibitors. Do not start treatment with MAO inhibitors within 7 days after discontinuing citalopram. Citalopram is contraindicated in combination with linezolid unless there is a possibility of close observation and monitoring of blood pressure. Citalopram is contraindicated in patients with a known prolongation of the QT interval or congenital long QT syndrome. Do not use with medicines known to prolong the QT interval. Do not use simultaneously with pimozide.

Depression is accompanied by an increased risk of suicidal thoughts, self-mutilation and suicide (suicide related events). This risk persists until significant remission. The patient should be closely monitored for improvement and in the early stage of symptom relief (increased risk of suicide). When treating patients with other mental disorders, the same precautions should be taken as when treating patients with major depressive disorder. Patients with a history of suicide or significant suicidal ideation before commencing treatment show a higher risk of suicidal thoughts and suicide attempts, and should therefore be closely monitored during treatment, particularly patients under 25 years of age. Do not use citalopram for the treatment of children and young people under 18 years of age. Suicide-related behaviors (suicide attempts and suicidal thoughts) and hostility (mostly aggression, rebellious behavior, anger) were more frequently observed in clinical trials conducted among children and adolescents treated with antidepressants compared to those treated with placebo. If, however, for clinical reasons, a decision to treat is made, the patient should be carefully monitored for suicidal symptoms. In addition, there are no long-term data on the safety of children and adolescents regarding growth, maturation and cognitive and conservative development. In patients who develop symptoms of akathisia, increasing the dose may be harmful. Due to the risk of QT prolongation, caution is recommended in patients with significant bradycardia or in patients with recent myocardial infarction or decompensated heart failure. Electrolyte abnormalities such as hypokalaemia and hypomagnesaemia increase the risk of malignant arrhythmias and should be corrected before starting treatment.In patients with stable cardiac disease, ECG should be considered before starting treatment. If signs of cardiac arrhythmia occur during treatment with citalopram, discontinue treatment and ECG. In patients with bipolar disorder, the patient should be discontinued if a manic phase occurs. Citalopram should be discontinued in any patient who develops seizures. The use of the drug should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be carefully monitored. Taking the drug should be discontinued if there is an increase in seizure frequency. In patients with diabetes, the use of SSRIs may modify glycemic control - adjustments in insulin dosage and / or oral hypoglycaemic agents may be required. Because of the risk of abnormal bleeding, caution is advised in patients taking SSRIs, particularly when co-administered with known platelet or other active agents that may increase the risk of hemorrhage, as well as in patients with bleeding disorders. interview. In case of symptoms of serotonin syndrome (eg agitation, tremor, myoclonus and hyperthermia), citalopram should be stopped immediately and appropriate symptomatic treatment should be initiated. Some patients with panic disorder may experience increased anxiety symptoms in the initial period of antidepressant medication - this paradoxical response usually disappears after 2 weeks of uninterrupted treatment; a low initial dose is recommended. Use of the drug in psychotic patients with depressive episodes may result in worsening of psychotic symptoms. Clinical experience in the concurrent use of SSRIs and electroconvulsive therapy is limited - caution is advised. Caution is recommended in patients with severe renal impairment (creatinine clearance less than 30 ml / min).

A large amount of data on pregnant women (over 2,500 cases of use of the drug) indicates no toxic effect causing deformation of the fetus / newborn. If there are clinical indications, the drug can be used during pregnancy, taking into account the following aspects. Newborns should be observed if the mother continued the use of citalopram in the late stages of pregnancy, particularly in the third trimester. During pregnancy, sudden withdrawal of the drug should be avoided. In neonates whose mothers have taken SSRI / SNRIs in the later stages of pregnancy, the following symptoms may occur: respiratory distress, cyanosis, apnea, seizures, fluctuations in body temperature, difficulty in feeding, vomiting, hypoglycaemia, hypertonia, hypotension, hyperreflexia, trembling, jittery, irritability, lethargy, constant crying, drowsiness and difficulty falling asleep. These symptoms can be both a result of serotoninergic effects and withdrawal symptoms. In most cases, complications appear immediately or soon (<24 h) after delivery. The use of SSRIs during pregnancy, especially at a late stage of pregnancy, may increase the risk of developing chronic pulmonary hypertension in newborns (PPHN). Citalopram is excreted in breast milk. It is estimated that a breast-fed infant will receive about 5% of the dose intended for the mother based on body weight (mg / kg). No symptoms were observed in infants or only minor symptoms were observed. Caution is recommended. Data obtained on animals have shown that the drug may reduce sperm quality. Reports on the effects of some SSRIs on humans have shown that the effect on sperm quality is reversible. No effects on human fertility have been observed so far.

Very often: drowsiness, insomnia, dry mouth, nausea, increased sweating. Common: reduced appetite, weight loss, agitation, decreased libido, anxiety, nervousness, confusion, orgasmic disorders in women, unusual dreams, tremors, paresthesia, dizziness, attention disorders, tinnitus, yawning, vomiting, diarrhea, constipation, pruritus, muscle pain, arthralgia, impotence, ejaculation problems, lack of ejaculation, fatigue.Uncommon: increased appetite, weight gain, aggression, depersonalization, hallucinations, mania, syncope, mydriasis, bradycardia, tachycardia, urticaria, alopecia, rash, purpura, sensitivity to light, urinary retention, excessive monthly bleeding (heavy bleeding) women, swelling. Rare: hyponatraemia, epileptic seizures, dyskinesia, dysgeusia, haemorrhage, hepatitis, fever. Not known: thrombocytopenia, hypersensitivity, anaphylactic reaction, abnormal secretion of antidiuretic hormone (ADH), hypokalemia, panic attacks, bruxism, psychomotor anxiety, suicidal thoughts, suicidal behavior, convulsions, serotonin syndrome, extrapyramidal disorder, akathisia, movement disorders, visual disturbances , QT prolongation (mainly in patients with pre-existing heart disease), ventricular arrhythmia incltorsade de pointes, orthostatic hypotension, epistaxis, gastrointestinal bleeding (including rectal bleeding), abnormal liver function tests, ecchymosis, angioneurotic edema, off-cycle bleeding (bleeding between menses) in women, priapism and menopausal men. Cases of QT prolongation and ventricular arrhythmia, incltorsade de pointes, were reported post-marketing, predominantly in female patients with hypokalaemia or pre-existing QT prolongation or other cardiac conditions. The results of epidemiological studies conducted mainly among patients over 50 years indicate an increased risk of bone fractures in patients receiving SSRIs and TCAs.
Discontinuation of citalopram (especially sudden) often leads to withdrawal symptoms. The most frequently reported reactions are: dizziness, sensory disturbances (including paraesthesia), sleep disorders (including insomnia and expressive dreams), agitation or anxiety, nausea and / or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances.

Orally. Adults.Depression20 mg once a day. Depending on the patient's individual response to treatment, the dose can be increased to a maximum of 40 mg per day. The antidepressant effect will not be visible for at least 2 weeks from the start of treatment. Treatment should continue until symptoms occur for 4-6 months.Anxiety disorders. For the first week of treatment, a dose of 10 mg once a day is recommended, which can then be increased to 20 mg daily. Depending on the patient's individual response to treatment, the dose can be increased to a maximum of 40 mg per day. The onset of the therapeutic effect usually occurs after 2-4 weeks. The period required to achieve a full therapeutic response may be up to 3 months. It may be necessary to continue treatment for the following months. Documentation from clinical efficacy studies over 6 months is insufficient.Obsessive-compulsive disorder. The recommended starting dose is 20 mg a day. Depending on the patient's individual response to treatment, the dose can be increased to a maximum of 40 mg per day. The onset of the therapeutic effect usually occurs after 2-4 weeks, and the improvement of the patient's condition occurs while continuing the therapy.Preventive treatment. The duration of treatment depends on the individual condition of the patient and usually takes several years. Discontinuation of treatment should be under strict control to avoid recurrence.Elderly patients (> 65 years). Treatment of severe depressive episodes: the starting dose should be reduced to half the recommended dose, e.g. 10-20 mg per day; the recommended maximum dose is 20 mg per day.Treatment of anxiety disorders: the starting dose is 10 mg once a day; after one week the dose may be increased to 20 mg daily. Depending on the patient's individual response, the dose may be increased to a maximum of 40 mg per day. Doses above 30 mg can only be used after careful consideration.
No dose adjustment is required in patients with mild to moderate renal impairment. In patients with mild or moderate hepatic insufficiency, an initial dose of 10 mg per day is recommended for the first 2 weeks of treatment. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg per day. No special precautions are recommended when increasing the dose in patients with severe hepatic impairment.Patients should be clinically monitored. For patients known to be slow metabolizing CYP2C19 medication, an initial dose of 10 mg daily for the first 2 weeks of treatment is recommended. Depending on the response to treatment, the dose may be increased up to a maximum of 20 mg per day.
The product should be taken in the morning or evening. The tablets can be taken during or between meals, washed down with water.