Index of drugs

Treatment of major depressive disorders.

1 tabl powl. contains citalopram as the hydrobromide. The preparation contains lactose.

Antidepressant - a strong and selective serotonin reuptake inhibitor in brain neurons. Citalopram almost does not affect the uptake of norepinephrine, Dopamine and gamma-aminobutyric acid. It has no or very low affinity for cholinergic, histaminergic receptors and various adrenergic, serotoninergic and dopaminergic receptors. After oral administration, it is rapidly absorbed from the gastrointestinal tract, reaching a maximum blood concentration on average after 4 (1-7) h. Food does not affect the absorption of the drug. The bioavailability after oral administration is approximately 80%. Citalopram and its metabolites bind to plasma proteins less than 80%. Citalopram is metabolised to the active metabolites: demethyl citalopram, didemethylcitalopram, citalopram N-oxide and to the inactive deaminated propionic acid derivative. Active metabolites are selective serotonin reuptake inhibitors, but weaker than citalopram. T_0,5 is about 1.5 days. The drug is excreted by the liver (85%) and partly by the kidneys (15%). 12-23% of the dose is excreted unchanged in urine. Steady state concentrations are reached after 1-2 weeks of drug administration. Elderly patients have an increase in T_0,5 drug in the blood and reduced clearance.

Hypersensitivity to citalopram or other components of the preparation. Citalopram should not be used in patients receiving MAO inhibitors, including selegiline in daily doses greater than 10 mg. Citalopram should not be used within 14 days after discontinuation of irreversible MAOIs or during the definitive withdrawal period of reversible MAO inhibitors (RIMA) given in the product characteristics of the RIMA group. MAO inhibitors should not be initiated until 7 days after discontinuation of citalopram.

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. Due to the increased risk of thoughts and events related to suicide and self-injury, patients should be carefully monitored for a clear remission of depressive symptoms and in the early stages of recovery (increased risk of suicide). The group of increased risk of suicidal ideation and attempts include patients with a history of suicidal behavior or patients exhibiting a significant degree of suicidal tendency and patients under 25 years before commencing treatment; they should be subjected to strict control during treatment. In patients with symptoms of akathisia, increasing the dose may be harmful. In diabetic patients, treatment with SSRIs may compromise glycemic control - adjustments of insulin dose and / or oral antidiabetic agents may be required. Citalopram should be discontinued in any patient who has seizures. Avoid use in patients with unstable epilepsy, and patients with controlled epilepsy should be closely monitored. The drug should be discontinued if the incidence of epilepsy increases. Clinical experience with concomitant use of citalopram and electroconvulsive therapy is very limited - caution is advised. Caution should be used in patients with a history of mania or hypomania; the drug should be discontinued at the time of the manic phase.Caution should be exercised in patients concomitantly taking medications that affect platelet function or increase the risk of hemorrhage, as well as in patients with a history of coagulation disorder. If a serotonin syndrome occurs, citalopram should be discontinued immediately and appropriate treatment should be given. Citalopram should not be used concomitantly with serotonergic drugs such as Sumatriptan or other triptans, tramadol, oxytryptan and tryptophan. Treatment of patients with psychoses and episodes of depression may exacerbate psychotic symptoms. It is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml / min) - no data available. In patients with impaired hepatic function, a dose reduction and close monitoring of liver function is recommended. At the same time, citalopram and herbal preparations containing St John's wort should not be used. Consideration should be given to factors that may affect the availability of the metabolite of citalopram (didemethylcitalopram) because the increased concentration of this metabolite may theoretically prolong the QTc interval in susceptible patients, in patients with suspected congenital long QT syndrome or in patients with hypokalaemia / hypomagnesaemia. ECG should be monitored in case of overdose or if the metabolism of the medicine is changed and its concentration increased, for example in the case of liver dysfunction. Insomnia and agitation may occur at the initial stage of treatment; in this case, dose adjustment may help. Due to the lactose content, the preparation should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The preparation can be used during pregnancy only if absolutely necessary. There have been reports of withdrawal symptoms in newborns whose mothers took SSRI at the end of pregnancy. Avoid abrupt use during pregnancy. If the mother used SSRI / SNRIs during the final stage of pregnancy, the following symptoms may occur in the newborn: respiratory failure, cyanosis, apnea, convulsions, body temperature instability, difficulty in sucking, vomiting, hypoglycaemia, increased or decreased muscle tone, hyperreflexia, tremors, 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 risk of side effects in a child.

Very often: drowsiness, insomnia, agitation, nervousness; pain and dizziness, tremor; accommodation disorder; palpitations; nausea, dryness of the oral mucosa, constipation, diarrhea; excessive sweating; asthenia. Common: decrease or increase in body weight; sleep disorders, impaired concentration, abnormal dreams, amnesia, anxiety, decreased libido, increased appetite, anorexia, apathy, confusion; migraine, paresthesia; blurred vision; tachycardia; orthostatic hypotension, hypotension, hypertension; indigestion, vomiting, abdominal pain, flatulence with passing of gases, increased salivation; impaired urination, polyuria, ejaculation disorders, anorgasmia in women, dysmenorrhea, impotence; rash, pruritus; fatigue, yawning, disorder of taste. Uncommon: euphoria, increased sex drive; extrapyramidal disorders, convulsions; Tinnitus; bradycardia; cough; increase in liver enzymes; hypersensitivity to light; muscle pain; allergic reactions, fainting, malaise. Rare: haemorrhage may occur (eg from the genital tract, from the gastrointestinal tract, ecchymosis and other bleeding within the skin or mucous membranes); niepokój psychoruchowy / akatyzja; hyponatremia and syndrome of abnormal secretion of antidiuretic hormone, especially in elderly patients; serotonin syndrome. Very rare: hallucinations, mania, depersonalization, panic attacks (these symptoms may be caused by the underlying disease); supraventricular and ventricular arrhythmias; galactorrhoea; angioneurotic edema; arthralgia; anaphylactic reactions. In addition, suicidal thoughts and behaviors were reported during treatment with citalopram, or shortly after discontinuation of treatment.Withdrawal (especially sudden) often leads to withdrawal symptoms: dizziness, sensory disturbances (including paresthesia and feelings like electric shock), sleep disturbances (insomnia, intense dreams), agitation or anxiety, nausea and / or vomiting, diarrhea , trembling, confusion, sweating, headache, palpitations, emotional instability, irritability and blurred vision. Usually, these symptoms are mild to moderate and disappear spontaneously, although in some patients they may be severe and (or) persist for a long time; therefore, a gradual dose reduction is recommended.

Orally. Adults: the recommended starting dose is 20 mg once a day. The dose can be increased up to a maximum of 40 mg daily, depending on the patient's individual response. The maximum dose is 60 mg / day. 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.
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 dose may be increased to a maximum of 40 mg. No dosage adjustment is required in patients with mild to moderate renal impairment; caution is recommended in patients with severe renal impairment (creatinine clearance <30 ml / min). In patients with mild or moderate hepatic impairment, the recommended dose is 10 mg daily for the first 2 weeks of treatment. Depending on the patient's individual response, the dose can be increased up to 30 mg. In patients with severe hepatic impairment special care should be taken when adjusting the dose. In patients with a low metabolism involving CYP2C19 for the first 2 weeks of treatment, a 10-mg dose is recommended, the dose may be increased to 20 mg daily, depending on the outcome of the treatment. Avoid sudden drug withdrawal. If treatment is to be terminated, it is recommended to gradually reduce the dose at intervals of 1-2 weeks to reduce the risk of withdrawal reactions. If symptoms are not well tolerated by the patient during withdrawal and dose reduction, a return to the previous dose may be considered. Then you can continue to reduce the dose, but more slowly.
The drug should be taken once a day, at any time, regardless of meals. The tablet can be divided into two equal parts.