Index of drugs

Depression and prevention of recurrent depressive disorders and in the treatment of panic disorders with agoraphobia or without agoraphobia.

1 tabl powl. contains 10 mg or 20 mg or 40 mg of citalopram.

A strong, selective inhibitor of serotonin reuptake. It does not show or has minimal effect on the reuptake of norepinephrine, Dopamine and GABA. It has low affinity (or does not have it at all) in relation to many receptors, including: 5-HT_1A, 5-HT₂, DA-D₁ and DA-D₂, α receptors₁, α₂, β, H₁, muscarinic, cholinergic, benzodiazepine and opioid. During the long-term treatment, there is no development of the drug tolerance. It does not interfere with intellectual or psychomotor functions, shows minimal action or does not show any sedative effects. Almost completely absorbed from the gastrointestinal tract, regardless of the food being taken; the bioavailability is 80%. The plasma concentration is reached after about 1-2 weeks. It is 80% bound to plasma proteins. Metabolism occurs in the liver (all active metabolites are also selective serotonin reuptake inhibitors, although weaker than the parent drug), and biliary excretion (85%) and urine (15%). Approx. 12-35% of the daily dose is excreted in the urine in unchanged form. T_0,5 in the elimination phase is approx. 36 h. In elderly patients T_0,5 it is elongated. citalopram is more slowly eliminated in patients with impaired hepatic function (T_0,5 it is about 2 times longer and steady-state concentration after a given dose about 2 times higher than in patients with normal liver function).

Hypersensitivity to the components of the preparation. Concomitant treatment with MAO inhibitors - should be min. 14 days from discontinuation of treatment with non-selective MAO inhibitors and at least one day with moclobemide. Isohbitors MAO can be included in therapy after at least 7 days after discontinuation of citalopram. Simultaneous treatment with linezolid (unless strict clinical observation and monitoring of blood pressure is possible). Patients with known QT prolongation or congenital long QT syndrome. Simultaneous treatment with medicinal products that cause QT prolongation.

Due to the increased risk of suicidal thoughts and attempts, as well as self-injury, patients should be carefully monitored for a clear remission of depressive symptoms and in the initial stages of the healing process (increased risk of suicide). Patients with a history of suicidal behavior or thoughts should be closely monitored, patients who have demonstrated significant suicidality and patients under 25 years of age prior to initiation of therapy. In diabetic patients, treatment with citalopram may make it difficult to control blood Glucose, most likely due to relief from depression - adjustments of insulin and / or oral antidiabetic medicinal products may be necessary. Caution should be exercised in patients with narrow-angle glaucoma or history of glaucoma. In the event of epileptic seizures, the drug should be discontinued immediately. It should not be used in patients with unstable epilepsy, and patients with well-controlled epilepsy should be carefully monitored. The preparation should be discontinued if the frequency of epileptic seizures increases. Special care should be taken in the case of simultaneous electroconvulsive therapy. Citalopram should be used with caution in patients with a history of mania or hypomania. It should be discontinued if the patient enters the mania phase. Caution should be exercised in patients with coagulation disorders and those taking medications that may affect the function of platelets. In some patients with panic disorder (panic attacks), increased anxiety symptoms are observed at the beginning of treatment. Starting treatment at a low initial dose reduces the likelihood of anxiety. Elderly patients are particularly at risk of experiencing hyponatraemia.There are no data on the medicine for severe renal impairment (creatinine clearance <20 ml / min). The drug should not be used to treat children and adolescents under 18 years of age. In clinical trials, suicidal behavior and hostility (aggression, rebellious behavior, anger) were more frequently observed 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 studies on the safety of children and adolescents regarding growth, maturation, cognitive development and behavioral development. Caution is advised in patients with severe bradycardia or in patients who have recently had an acute myocardial infarction or with decompensated heart failure. Electrolyte disturbances, such as hypokalaemia and hypomagnesaemia, increase the risk of severe arrhythmias and should be compensated before starting treatment with citalopram. If symptoms of cardiac arrhythmia occur during treatment with citalopram, treatment should be discontinued and an ECG should be performed. The preparation contains lactose - patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose should not use this preparation.

Available data on the use in pregnant women indicate a lack of toxicity causing defects in the fetus or newborn. However, citalopram should not be used during pregnancy unless clearly necessary and after careful consideration of the risk / benefit ratio. Citalopram is excreted in breast milk. It has not been determined how treatment can affect a child being fed. If treatment is necessary, discontinuation of breast-feeding should be considered.

Very common: sleep disorders, drowsiness, insomnia, headache, dry mouth, nausea, increased sweating, weakness. Common: reduced appetite, weight loss, agitation, decreased libido, nervousness, confusion, inhibition of orgasm (in women), unusual dreams, apathy, tremors, paresthesia, dizziness, attention disorders, migraine, memory loss, tinnitus, palpitations, yawning, rhinitis, diarrhea, vomiting, constipation, indigestion, abdominal pain, flatulence, increased salivation, pruritus, muscle pain, arthralgia, impotence, ejaculation problems, inability to ejaculate, fatigue. Uncommon: increased appetite, weight gain, aggression, depersonalization, hallucinations, mania, increased libido, syncope, mydriasis (which may lead to acute narrow-angle glaucoma), bradycardia, tachycardia, urticaria, alopecia, rash, purpura , hypersensitivity to light, urinary retention, menorrhagia in women, edema. Rare: hyponatraemia, grand mal seizures, dyskinesia, taste disturbances, haemorrhages, cough, hepatitis, fever, malaise. In addition: 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, prolonged QT interval, ventricular arrhythmia, including cardiac arrhythmiastorsade de pointes,orthostatic hypotension, epistaxis, gastrointestinal bleeding (including rectal bleeding), abnormal liver function tests, ecchymosis, angioneurotic edema, galactorrhea, uterine haemorrhage in women, priapism in men. Epidemiological studies conducted mainly in patients aged 50 years and older indicate an increased risk of bone fractures in patients receiving concomitant SSRIs and tricyclic antidepressants. Abrupt discontinuation leads to withdrawal symptoms such as dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and blurred vision.

Orally.Depression: the preparation is given as a single daily dose of 20 mg.Depending on the patient's response to treatment, the dose can be increased up to a maximum daily dose of 40 mg. The preparation can be taken in the morning or in the evening, regardless of the meals you eat. Treatment should be continued for 6 months to prevent recurrence.Panic disorder syndrome: initially 10 mg per day, then 20 mg per day. The dose may be increased up to a maximum dose of 40 mg daily, depending on the patient's response to treatment. The maximum effectiveness of treatment is observed after about 3 months of treatment.Special groups of patients. Elderly patients: the dose should be reduced to half of the recommended dose, e.g. 10-20 mg; the maximum dose is 20 mg. No dose adjustment is required in patients with mild or moderate renal impairment. There are no data on the use of this drug in patients with severe renal impairment (creatinine clearance below 20 ml / min). In the first 2 weeks of treatment, an initial dose of 10 mg is recommended daily in patients with mild or moderate hepatic impairment. 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. Patients who are slow metabolizing drugs with CYP2C19 is recommended for an initial dose of 10 mg daily for the first 2 weeks of treatment. Depending on the patient's response, the dose can be increased up to 20 mg a day.