Index of drugs

Treatment of depression and prophylaxis of recurrent depressive disorder. Anxiety disorder with anxiety attacks with agoraphobia or without agoraphobia.

1 tabl powl. contains 20 mg of citalopram, equivalent to 24.98 mg of citalopram hydrobromide. The preparation contains lactose.

Antidepressant - a strong and selective serotonin reuptake inhibitor. It practically does not affect the uptake of norepinephrine, Dopamine and GABA. It does not show affinity or has very little affinity for 5-HT receptors_1A, 5-HT₂, DA, D₁ and D₂, adrenergic α₁, β₂ and β, histamine H₁, muscarinic cholinergic, benzodiazepine and opioid. Citalopram is absorbed almost completely, regardless of food intake. The bioavailability after oral administration is about 80%. Citalopram and its major metabolites bind to plasma proteins in less than 80%. The drug is metabolised to the active metabolites: demethylcitalopram, didemethylcitalopram, citalopram N-oxide and inactive deaminated propionic acid derivative. Biotransformation of citalopram with demethylcitalopram is performed with the participation of cytochrome CYP2C19 (approximately 38%), CYP3A4 (approximately 31%) and CYP2D6 (approximately 31%). T_0,5 in the elimination phase, it is about 1.5 days. Citalopram is excreted primarily in the bile (85%), and the remainder (15%) is excreted via the kidneys. 12-23% of the daily dose is excreted in the urine in unchanged form.

Hypersensitivity to the active substance or to any of the excipients. Concurrent treatment with pimozide. Citalopram must not be used in combination with an MAO inhibitor, including selegiline, in a dose exceeding 10 mg daily. Treatment with citalopram may be started 14 days after discontinuation of non-selective MAO inhibitors and at least 1 day after discontinuation of moclobemide. Treatment with MAO inhibitors can be initiated 7 days after discontinuation of citalopram. Citalopram is contraindicated in patients with a prolonged QT interval and in patients with congenital long QT syndrome. Citalopram is contraindicated for concomitant use with drugs that prolong QT interval.

The preparation should not be used to treat children and adolescents under 18 years of age. In the course of clinical trials, suicidal behavior (suicide attempts and suicidal thoughts) and hostility (especially aggression, rebel behavior and anger) were more frequently observed in children and adolescents treated with antidepressants than in the placebo group. If, based on the existing clinical need, however, a decision to treat is made, the patient should be carefully monitored for signs of suicide. In addition, there are no long-term data on the safety of children and adolescents regarding growth, maturation and cognitive development and behavioral development. Some patients with panic disorder may experience increased anxiety symptoms in the initial period of antidepressants. This paradoxical reaction usually resolves after 2 weeks of uninterrupted treatment; a low initial dose is recommended. During treatment, there is a risk of hyponatraemia; Elderly patients are a special risk group. Depression is associated with an increased risk of suicidal thoughts, acts of autoimmunity and suicides (suicide attempts). This risk persists until significant remission occurs. Patients should be closely monitored until the appearance of improvement and in the initial stages of the recovery process (increased risk of suicide). When treating patients with other mental disorders, the same precautions should be taken as for the treatment of patients with major depression. Patients with a history of suicide-related events or showing intense suicidal thoughts before starting treatment are more likely to think or attempt suicide, and therefore should be closely monitored during therapy. An increased risk of suicidal behavior occurs in patients under 25 years of age.During treatment, especially at the beginning of therapy and when the dose is changed, patients should be carefully observed, especially those at high risk. In patients who develop symptoms of akathisia, increasing the dose may be harmful. In patients with bipolar disorder, a manic phase may occur - in which case the drug should be discontinued. Caution should be exercised in patients with a history of seizures. It may affect the action and / or insulin secretion and the level of Glucose in the blood, so it may be necessary to modify the antidiabetic treatment in patients with diabetes. In addition, the depressive illness itself can affect blood glucose levels. Due to the risk of serotonin syndrome, caution should be exercised when using citalopram in combination with serotoninergic drugs, such as Sumatriptan or other triptans, tramadol and tryptophan. Due to the risk of abnormal skin bleeding (ecchymosis and purpura), caution is advised in patients taking SSRIs, especially when co-administered with oral anticoagulants, preparations known to affect the function of platelets (eg atypical antipsychotic drugs and phenothiazine derivatives, most tricyclic antidepressants, Acetylsalicylic acid and NSAIDs, ticlopidine and dipyridamole) and in patients with a history of coagulation disorder. The clinical experience of concurrent use of SSRIs and electroconvulsive therapy is limited - caution is advised during such combination therapy. Due to the increased risk of QT prolongation and ventricular arrhythmias, caution is advised in patients with severe bradycardia, patients with recent acute myocardial infarction and patients with decompensated heart failure. Electrolyte abnormalities such as hypokalaemia and hypomagnesaemia increase the risk of malignant arrhythmias, therefore these disorders should be compensated before starting treatment with citalopram. In patients with stable cardiac disease, evaluation of the ECG should be considered before starting treatment. If symptoms of arrhythmia occur during treatment with citalopram, treatment should be discontinued and an ECG should be performed. There is no information on the use of the preparation in patients with severe renal dysfunction (creatinine clearance below 20 ml / min). Caution should be exercised in patients known to be slow metabolizing medication with the participation of CYP2C19. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

Clinical experience with the use of citalopram in pregnant women is limited, but so far there have been no reports of concern. Data obtained in reproductive toxicity studies do not indicate the need for particular caution when using citalopram in women of childbearing age. If the mother continues to use the product in the later stages of pregnancy (especially in the third trimester), the newborn should be observed. During pregnancy, sudden withdrawal of the drug should be avoided. In newborns whose mothers in the later stages of pregnancy were taking SSRI / SNRIs, the following adverse reactions have been reported: respiratory disorders, cyanosis, apnea, seizures, body temperature fluctuations, feeding difficulties, vomiting, hypoglycaemia, increased muscle tone, decreased muscle tone, hyperreflexia, tremor, jittery, irritability, lethargy, constant crying, drowsiness and difficulty falling asleep. These symptoms may be the result of both serotoninergic drugs and withdrawal symptoms. In most cases, symptoms appear immediately or soon (<24 hours) after delivery. The results of epidemiological studies indicate that the use of SSRI in pregnant women, especially in the third trimester, may increase the risk of persistent pulmonary hypertension of the newborn (PPHN). Citalopram is excreted in breast milk. It is estimated that a breastfed child receives approximately 5% of the daily dose taken by the mother (in terms of body weight - mg / kg).
In infants, only minor symptoms were observed or not observed at all.However, available data is not sufficient to assess the risk to the child - caution is advised.

Very common: drowsiness, insomnia, dry mouth, nausea, increased sweating. Common: reduced appetite, agitation, decreased libido, anxiety, nervousness, confusion, orgasmic disorder (women), tremor, paresthesia, tinnitus, bradycardia, tachycardia, yawning, diarrhea, vomiting, pruritus, muscle pain, arthralgia, impotence , ejaculation problems, inability to ejaculate, tiredness, weight loss. Uncommon: increased appetite, aggression, depersonalization, hallucinations, mania, syncope, mydriasis, urticaria, alopecia, rash, purpura, urinary retention, edema, weight gain, and women: menorrhagia. Rare: hyponatremia, grand mal seizures, dyskinesia, hepatitis. Not known: thrombocytopenia, hypersensitivity, anaphylactic reaction, inadequate antidiuretic hormone secretion, panic attacks, bruxism, anxiety, suicidal thoughts, suicidal behavior, seizures, serotonin syndrome, extrapyramidal disorder, akathisia, movement disorders, visual disturbances, ventricular arrhythmias, including type disordertorsade de pointes, orthostatic hypotension, nosebleeds, gastrointestinal bleeding (including rectal bleeding), ecchymosis, angioneurotic edema, abnormal liver function test results, women: uterine haemorrhage, men: priapism, mellitus. Cases of QT prolongation and ventricular arrhythmias, includingtorsade de pointes mainly among women, patients with hypokalemia and patients with pre-existing QT prolongation or other heart diseases. Epidemiological studies, mainly in patients ≥50 years of age, have shown that the risk of bone fractures in patients treated with SSRIs and tricyclic antidepressants is increased. 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 blurred vision.

Orally. Adults.Depression: 20 mg daily in a single dose. Depending on the patient's individual response, the dose may be increased to a maximum of 40 mg daily. The antidepressant effect is usually obtained after 2-4 weeks of therapy. Treatment should be continued long enough to prevent the recurrence of depression. It is usually carried out for a period of 6 months after the disappearance of depressive symptoms. In patients with recurrent depression (unipolar) maintenance treatment may take up to several years to prevent new episodes of the disease.Anxiety disorder with anxiety attacks: a single dose of 10 mg is recommended in the first week of treatment followed by an increase in the dose to 20 mg daily. Depending on the patient's individual response, the dose may be increased to a maximum of 40 mg daily. The maximum effectiveness in the treatment of anxiety disorder with anxiety attacks is achieved after about 3 months of use of the drug. This response persists during continued treatment. In elderly patients (> 65 years), the dose should be reduced to half the recommended dose, ie 10-20 mg per day; the maximum recommended daily dose is 20 mg. There is no need to reduce the dose in patients with mild or moderate renal impairment. There is no information on the use of the preparation in patients with severe renal dysfunction (creatinine clearance below 20 ml / min). In patients with mild to moderate hepatic impairment during the first two weeks of treatment, a starting dose of 10 mg per day is recommended. Depending on the patient's individual response, the dose may be increased up to a maximum of 20 mg per day. In patients with severe hepatic impairment, caution and attention should be advised when setting the dosage. Patients with low metabolism with the participation of CYP2C19, the initial dose of 10 mg per day is recommended during the first two weeks of treatment. Depending on the patient's response, the dose can be increased up to 20 mg a day.
The preparation can be taken at any time of the day, with or without food.