Index of drugs

Treatment of major depressive disorders.

1 tabl powl. contains 20 mg or 40 mg of citalopram in the form of hydrobromide. The preparation contains lactose.

A strong serotonin reuptake inhibitor (5-HT). Long-term treatment with citalopram does not induce tolerance to inhibition of 5-HT uptake. Citalopram is a very selective serotonin reuptake inhibitor (SSRI) with minimal or no effect on the uptake of noradrenaline (NA), Dopamine (DA) and gamma-aminobutyric acid (GABA). Unlike many tricyclic antidepressants and some of the newer SSRIs, citalopram has no affinity or has very little affinity for many receptors, including 5-HT receptors_1A, 5-HT₂, DA D₁ and D₂, adrenergic a₁, a₂ and b, histamine H₁, muscarinic cholinergic, benzodiazepine and opioid. Like tricyclic antidepressants, other SSRIs and MAO inhibitors, citalopram shortens the REM sleep phase and extends the slow wave phase. Does not significantly affect the parameters of cardiac and vascular function. After oral administration, citalopram is absorbed almost completely, regardless of food intake (oral bioavailability is around 80%). The maximum concentration in the blood occurs after 3 hours after administration. Citalopram 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 group of selective serotonin reuptake inhibitors, but their potency is less than that of citalopram. T_0,5 citalopram is about 1.5 days. Citalopram is excreted mainly in the bile (85%), the rest (15%) in the urine. 12-23% of the daily dose is excreted in the urine in unchanged form. Elderly patients have a longer half-life (1.5-3.75 days) and lower clearance values ​​due to slower metabolism. Citalopram is eliminated more slowly in patients with impaired hepatic function and with mild and moderate renal impairment.

Hypersensitivity to citalopram or other components of the preparation. Citalopram should not be used in patients receiving MAO inhibitors, including selegiline in a daily dose of more than 10 mg. Citalopram should not be used within 14 days after discontinuation of irreversible MAOIs or during the period defined for discontinuation of reversible MAO inhibitors described in the monograph for this class of drugs. MAO inhibitors should not be given to therapy before 7 days after discontinuation of citalopram. Combined treatment with citalopram and linezolid is contraindicated if careful observation and monitoring of blood pressure is not ensured. Combined treatment with pimozide is contraindicated. Patients with known QT prolongation or congenital long QT syndrome. Combination therapy with citalopram with other medicinal products causing QT prolongation.

It should not be used in children and adolescents under 18 years of age (no long-term safety data is available for this population in relation to growth, maturation and cognitive and behavioral development, however, in pediatric and suicidal behavior and behavior, more often in the group receiving antidepressants than in the placebo group); If a decision to treat is made due to clinical indications, the patient should be carefully monitored for signs of suicide. The risk of suicide may increase in the early stages of depression. During treatment, especially at the beginning and in the event of a change in dose, patients should be closely monitored, particularly those at high risk (patients with a history of suicide-related events or patients exhibiting a significant degree of suicidal thoughts).Akathisia may occur during treatment, characterized by a subjectively unpleasant or exhausting anxiety and the need for movement often associated with the inability to sit or stand still; in patients who develop these symptoms, increasing the dose may be harmful. Citalopram may affect glycemic control; it may be necessary to adjust the insulin dose and / or oral antidiabetic medicinal products. If you experience seizures, stop taking the medicine. The use of citalopram should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be closely monitored. If the incidence of seizures increases, treatment with citalopram should be discontinued. Caution should be exercised when using citalopram in patients treated with electroconvulsive therapy and in patients with a history of mania or hypomania (if the disease changes into a mania phase, discontinue use). Citalopram may cause prolonged bleeding time and / or abnormal bleeding, therefore caution should be used when other substances that affect platelet function or increase the risk of haemorrhage are used, as well as in patients with blood coagulation disorders. In the case of the occurrence of serotonin syndrome (manifested by the combined occurrence of agitation, tremor, muscle clonic convulsions and hyperthermia), the drug should be discontinued immediately and symptomatic treatment should be given. Do not use together with serotoninergic preparations, such as other triptans, tramadol, oxytryptan and tryptophan. Treating patients with psychoses and episodes of depression may exacerbate psychotic symptoms. The use of citalopram is not recommended in patients with severe renal impairment (creatinine clearance <30 ml / min). In the event of impaired hepatic function, a dose reduction and careful monitoring of liver function is recommended. Co-administration of citalopram with St. John's wort preparations is not recommended. After the product was placed on the market, cases of ventricular arrhythmias, including type disorders, were foundtorsades de pointes, mainly in female patients, in people with hypokalaemia, and in patients with QT prolongation or other heart conditions. Caution is advised in patients with severe bradycardia or in patients who have recently had a myocardial infarction or decompensated heart failure. Electrolyte abnormalities such as hypokalaemia or hypomagnesaemia increase the risk of malignant arrhythmias, therefore these disorders should be corrected before starting citalopram therapy. In patients with stable cardiac disease, ECG should be considered prior to treatment with citalopram. In the event of arrhythmia during treatment, citalopram should be discontinued and an ECG should be performed. Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The preparation can be used during pregnancy only when it is absolutely necessary. Abrupt discontinuation of the preparation during pregnancy should be avoided (cases of withdrawal symptoms in newborns whose mothers used SSRI at the end of pregnancy). If the mother used SSRI / SNRIs later in pregnancy, the following symptoms may occur in the newborn: respiratory distress syndrome, cyanosis, apnea, convulsions, body temperature instability, difficulty in feeding, vomiting, hypoglycaemia, increased or decreased muscle tone, hyperreflexia, tremors, jittery nerves, irritability, lethargy, constant crying, drowsiness, sleep disorders; these symptoms may be caused by serotoninergic or withdrawal symptoms. Citalopram is excreted in human milk in small amounts; the benefits of breastfeeding should outweigh the potential side effects.

Very often: drowsiness, insomnia, agitation, nervousness; pain and dizziness, tremors; incorrect accommodation; palpitations; orthostatic hypotension, hypotension, hypertension; nausea, dryness of the oral mucosa, diarrhea, constipation; excessive sweating; asthenia.Common: decrease or increase in body weight; sleep disorders, impaired concentration, unusual dreams, amnesia, anxiety, weakness of libido, increased appetite, anorexia, apathy, confusion; migraine, paresthesia; blurred vision; tachycardia; rhinitis, sinusitis; indigestion, vomiting, abdominal pain, flatulence with passing of gases, increased salivation; pruritus, rash; impaired urination, polyuria; ejaculation disorders, menstrual disorders, impotence, anorgasmia in women; fatigue, yawning, disorder of taste. Uncommon: euphoria, increased sex drive; extrapyramidal disorders, convulsions; Tinnitus; bradycardia; cough; increase in liver enzymes; hypersensitivity to light; muscle aches; allergic reactions, fainting, malaise. Rare: haemorrhage (eg from reproductive organs, bruises and other forms of bleeding into the skin or bleeding from mucous membranes); niepokój psychoruchowy / akatyzja; hyponatremia and syndrome of inadequate secretion of antidiuretic hormone, especially in elderly patients; serotonin syndrome in patients using SSRIs. Very rare: hallucinations, mania, depersonalization, anxiety attacks (these symptoms may be caused by the underlying disease); supraventricular and ventricular arrhythmias; angioneurotic edema; arthralgia; galactorrhoea; anaphylactic reactions. Not known: suicidal thoughts, suicidal behavior (which may occur during or soon after treatment). Cases of QT prolongation and ventricular arrhythmias, including type-related disorders, have been reported after the introduction of the producttorsades de pointes. Discontinuation of citalopram (especially abrupt) often results in withdrawal symptoms. Dizziness, sensory disturbances (including paresthesia and feelings like electric shock), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances. Epidemiological studies, mainly in patients aged 50 years and older, show an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants. The mechanism leading to this increased risk is unknown.

Orally, as a single dose, in the morning or evening. Adults: the recommended starting dose is 20 mg daily. If necessary, the dose can be increased to 40 mg daily, depending on the individual patient's response. In elderly patients (over 65 years), the dose should be reduced to half the usual recommended dose, e.g. 10-20 mg per day; depending on the patient's individual response, the maximum recommended dose is 20 mg. No dosage adjustment is required in patients with mild to moderate renal impairment; caution is recommended in patients with severe renal insufficiency due to the lack of clinical data for use in this group of patients. In patients with mild to moderate hepatic impairment, the initial dose of 10 mg per day is recommended during the first two weeks of treatment; the dose can then be increased to 20 mg per day, depending on the individual response; In patients with severe hepatic impairment, special care should be taken when setting the dose. In patients with low metabolism with CYP2C19 for the first 2 weeks of treatment, a 10-mg dose is recommended, the dose may be increased to 20 mg per day, depending on the patient's individual response. After the start of treatment, the antidepressant effect occurs after at least 2 weeks; treatment should be continued for 4-6 months after the symptoms have resolved.
The tablets should be taken with or without food, with liquid.