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 in the form of hydrobromide. The preparation contains lactose.

Antidepressant - a selective serotonin reuptake inhibitor (SSRI). It practically does not affect the uptake of norepinephrine, Dopamine and GABA by neurons. 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. After oral administration, they are almost completely absorbed from the gastrointestinal tract. The maximum plasma concentration is reached on average after 3 hours of administration. Bioavailability is about 80%. The drug and its major metabolites bind to plasma proteins in less than 80%. Citalopram is metabolised to the active metabolites: demethyl citalopram, didemethylcitalopram, citalopram N-oxide and inactive deaminated propionic acid derivative. All active metabolites also belong to the SSRI group, but their potency is less than that of citalopram. Metabolism is mediated by CYP2C19, CYP3A4 and CYP2D6. T_0,5 in the elimination phase, it is about 1.5 days. The drug is excreted mainly in bile (85%) and kidney (15%). 12-23% of the dose is excreted unchanged in urine. Steady state concentrations are reached after 1-2 weeks of drug administration.

Hypersensitivity to citalopram or to any of the excipients. It must not be used in combination with an MAO inhibitor, including selegiline above 10 mg daily. Treatment may be started 14 days after discontinuation of irreversible MAO inhibitors or at such time after discontinuation of reversible MAO inhibitors as described in the drug information. Treatment with MAO inhibitors can be initiated 7 days after discontinuation of citalopram. Combination therapy with citalopram with linezolid is contraindicated unless there is the possibility of close clinical observation and monitoring of blood pressure. Citalopram must not be used together with pimozide. Patients with known QT prolongation, congenital long QT syndrome or other concomitant treatment for QT prolongation.

It should not be used in children and adolescents under 18 years of age. Suicidal behaviors (suicide attempts and suicidal thoughts) and hostility (especially aggression, rebel behavior, anger symptoms) were more frequently observed in clinical trials in children and adolescents treated with antidepressants than in the placebo group. If a decision to treat is made based on an existing clinical need, the patient should be carefully monitored for signs of suicide. There are no long-term data on the safety of the medicine in children and adolescents regarding the impact on growth, maturation and cognitive development and behavioral development. Depression is associated with an increased risk of suicidal thoughts, self-injury and suicide. This risk persists until full remission occurs. The patient should be closely monitored until the appearance of improvement and in the early stages of recovery (increased risk of suicide). In patients treated for other psychiatric disorders, the same precautions should be taken as in patients with major depression. Patients with a history of suicide-related events or patients exhibiting intense suicidal thoughts before commencing treatment are considered to be at increased risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment, particularly in patients below 25 years of age. For patients with panic disorder, a low initial dose is recommended to reduce the likelihood of paradoxical anxiety symptoms during the initial treatment period. In patients with symptoms of akathisia, increasing the dose may be harmful.In patients with bipolar disorder, a manic phase may occur - in this case citalopram should be discontinued. The use of the drug should be discontinued if seizures occur. In patients with unstable epilepsy, use of SSRIs should be avoided, and patients with pharmacologically mastered epilepsy should remain under close medical supervision. SSRIs should be discontinued if the incidence of seizures increases. In diabetic patients, treatment with SSRIs may affect blood Glucose - you may need to adjust your insulin dose and / or oral hypoglycemic agents. If symptoms of serotonin syndrome occur, the drug should be discontinued and symptomatic treatment initiated. Because of the risk of abnormal bleeding, caution is advised in patients taking SSRIs, especially when co-administered with medicinal products that affect the function of platelets or other substances that increase the risk of hemorrhage, as well as in patients with a history of bleeding. Clinical experience in the concurrent use of SSRIs and electroconvulsive therapy is limited - caution is advised. The drug causes dose-dependent QT interval prolongation; there is a risk of ventricular arrhythmia, includingtorsade de pointes (mainly in female patients, in people with hypokalemia and in patients with QT prolongation or other heart diseases). Caution should be exercised in patients with bradycardia or in patients who have recently had a myocardial infarction or congestive heart failure. Electrolyte abnormalities, such as hypokalaemia and hypomagnesaemia, increase the risk of malignant arrhythmias and should be compensated before treatment with citalopram. Before starting treatment for patients with stable heart disease, an ECG should be performed. If heart rhythm abnormalities occur during treatment, the medicine should be discontinued and ECG must be performed. Caution is advised in patients with severe renal impairment (creatinine clearance below 30 ml / min). Particular care should be taken in patients with severe hepatic impairment. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

The drug can be used during pregnancy if necessary, provided that the newborn baby is observed if the mother continues to use citalopram in the later stages of pregnancy, especially in the third trimester. During pregnancy, sudden discontinuation of the preparation 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 later stages, may increase the risk of persistent pulmonary hypertension syndrome (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: decreased appetite, weight loss, agitation, decreased libido, anxiety, nervousness, confusion, orgasmic disorders (women), unusual dreams, tremors, paresthesia, dizziness, attention disorders, tinnitus, yawning, diarrhea, vomiting, constipation, pruritus, muscle pain, arthralgia, impotence, ejaculation problems, inability to ejaculate, fatigue, fever.Uncommon: increased appetite, weight gain, aggression, depersonalization, hallucinations, mania, syncope, mydriasis, bradycardia, tachycardia, urticaria, alopecia, rash, purpura, photosensitivity, urinary retention, menorrhagia, edema. Rare: hyponatraemia, grand mal seizures, dyskinesia, dysgeusia, haemorrhage, hepatitis. Not known: thrombocytopenia, hypersensitivity, anaphylactic reaction, abnormal secretion of antidiuretic hormone, hypokalemia, panic attacks, bruxism, anxiety, suicidal thoughts, suicidal behavior, seizures, serotonin syndrome, extrapyramidal disorder, akathisia, movement disorders, visual disturbances, QT interval prolongation in the ECG, ventricular arrhythmias, including type disorderstorsade de pointes, orthostatic hypotension, nosebleeds, gastrointestinal bleeding (including rectal bleeding), abnormal liver function tests, ecchymosis, angioneurotic edema, uterine haemorrhage, priapism, and menstrual discharge (men). After the introduction of the medicine, cases of QT prolongation and ventricular arrhythmias, including type disorders, were foundtorsade de pointes, mainly in women, in patients with hypokalemia and in patients with pre-existing QT prolongation or other cardiac diseases. Epidemiological studies indicate an increased risk of bone fractures in patients aged 50 years and older receiving SSRIs and tricyclic antidepressants.
Withdrawal of the drug (especially abrupt) may lead to withdrawal symptoms: dizziness, sensory disturbances (including paraesthesia), sleep disorders (insomnia, intense dreams), agitation, anxiety, nausea, vomiting, tremor, confusion, excessive sweating, pain headache, diarrhea, palpitations, emotional instability, irritability, blurred vision.

Orally. Adults.Treatment of depression: 20 mg daily in a single dose. Depending on the patient's individual response to treatment, the dose may be increased up to a maximum of 40 mg per day.Treating an anxiety disorder with anxiety attacks. During the first week, a single dose of 10 mg per day is recommended, followed by an increase in the daily dose to 20 mg. Depending on the patient's individual response to treatment, the dose may be increased up to a maximum of 40 mg per day. In elderly patients, the 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. No dose reduction is required in patients with mild or moderate renal impairment; in patients with severe renal impairment (creatinine clearance less than 30 ml / min) caution is recommended. In patients with mild or moderate hepatic impairment, the initial 10 weeks of treatment is recommended for the initial 10 mg daily. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg per day. Severe caution is recommended in patients with severe hepatic impairment, including during dose adjustment. For patients known to be slow metabolizing CYP2C19 medication, an initial dose of 10 mg per day is recommended for the first 2 weeks of treatment. Depending on the patient's response, the dose may be increased up to a maximum of 20 mg per day. The antidepressant effect of the drug is usually obtained after 2-4 weeks of use. Treatment should be continued long enough to prevent the recurrence of depression. The duration of treatment is usually 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. The maximum effectiveness of citalopram in the treatment of anxiety disorder with anxiety attacks is achieved after about 3 months, and this response persists during continued treatment.
Table. You can be taken at any time of the day, with or without food.