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Citalopram 20 mg;
Excipients: microcrystalline cellulose 46.90/93.80/187, 60 mg, pregelatinized starch 20.20/40.40/80.80 mg, magnesium stearate 0.40/0.80/1.60 mg, Opadry II [polyvinyl alcohol (1.28/2.56/5.12 ) mg, macrogol (0.65/1.30/2.60) mg, talc (0.47/0.94/1.88) mg, titanium dioxide (0.80/1.60/3.20) mg] 3.20 mg/6.40 mg/12.80 mg.
Citalopram is an antidepressant belonging to the group of selective serotonin reuptake inhibitors (SSRIs). It has a pronounced ability to inhibit the reuptake of serotonin, has no or very weak ability to bind to a number of receptors, including gamma-aminobutyric acid (GABA), H1-histamine, D1- and D2-dopamine receptors; alpha1-, alpha2-, beta-adrenergic; benzodiazepine and m-cholinergic receptors, which leads to the almost complete absence of such undesirable effects as negative chrono-, dromo- and inotropic effects, orthostatic hypotension, sedation and dry mouth. Citalopram inhibits the CYP2D6 isoenzyme only to a very small extent, and, therefore, practically does not interact with drugs metabolized by this enzyme. Thus, side effects and toxic effects are much less pronounced.
The antidepressant effect usually develops after 2-4 weeks of treatment.
Citalopram has no effect on serum levels of prolactin and growth hormone.<
Citalopram does not impair cognitive/intellectual function and psychomotor function and has virtually no sedative effect.
Citalopram in doses exceeding 40 mg per day can cause abnormal changes in the electrical activity of the heart (prolongation of the QT interval on the ECG) .
The bioavailability of citalopram is 80% and is practically independent of food intake. The maximum concentration (Cmax) in plasma is reached after an average of 3 hours. Pharmacokinetics is linear dose-dependent in single and multiple doses (doses in the range of 10-60 mg per day). When taken once a day, the equilibrium plasma concentration is established after 7-14 days of therapy. The volume of distribution is about 12-17 l / kg. Plasma protein binding - no more than 80%. It is present in plasma unchanged. Penetrates into breast milk.
Metabolized by demethylation, deamination and oxidation with the participation of cytochrome P450 (isoenzymes CYP3A4 and CYP2C19, to a lesser extent CYP2D6) with the formation of pharmacologically less active metabolites. Inhibition of one of these enzymes can be compensated by other enzymes. The half-life (T1 / 2) of citalopram is 1.5 days (36 hours). Excretion is carried out by the kidneys (15%) and the liver (85%). 12-23% of citalopram is excreted unchanged through the kidneys. Hepatic clearance - about 0.3 l / min, renal clearance - 0.05-0.08 l / min.
The following adverse reactions may occur:
Allergic reactions: infrequently - hypersensitivity; very rarely - anaphylactic reactions.
From the side of the central nervous system: very often - drowsiness, headache, tremor, dizziness; often - migraine, paresthesia, sleep disorder; infrequently - extrapyramidal disorders, convulsions; rarely - serotonin syndrome (combination of agitation, tremor, myoclonus and hyperthermia); frequency unknown - psychomotor agitation, akathisia.
On the part of the mental sphere: very often - agitation, nervousness; often - decreased libido, impaired orgasm (in women), anxiety, confusion, drowsiness, impaired concentration, strange dreams, amnesia; infrequently - aggression, depersonalization, hallucinations, mania, euphoria, increased libido; frequency unknown - panic attacks, bruxism, suicidal thoughts.
On the part of the digestive system: very often - dry mouth, nausea, constipation; often - vomiting, flatulence, diarrhea, abdominal pain, hepatitis; frequency unknown - gastrointestinal bleeding.
From the side of the cardiovascular system: very often - a feeling of palpitations; often - tachycardia, arterial hypertension, orthostatic hypotension; rarely - bradycardia, lowering blood pressure, arrhythmia; frequency unknown - prolongation of the QT interval on the ECG.
On the part of the hematopoietic organs: rarely - hemorrhages (for example, gynecological bleeding, bleeding of the gastrointestinal tract,
Depressive episodes of moderate and severe Panic Disorders
Hypersensitivity to citalopram or to any of the excipients that make up this drug.
· Citalopram should not be used in combination with monoamine oxidase inhibitors (MAO ), including selegiline, moclobemide, linezolid (an antibiotic), as well as within 14 days after stopping their intake.Treatment with MAO inhibitors can be started no earlier than 7 days after stopping taking citalopram.
· Citalopram is contraindicated when used concomitantly with medicinal products. drugs that prolong the QT interval on the ECG (in particular, with pimozide), as well as with congenital prolongation of the QT interval. this age is not set.
Combined use is contraindicated:
With MAO inhibitors.
Concomitant treatment with MAO inhibitors is contraindicated (both non-selective and selective) due to the risk development of serious side effects, including serotonin syndrome. Citalopram should not be used in combination, including with selegiline, moclobemide, linezolid (antibiotic), etc., and also within 14 days after stopping their use. Treatment with MAO inhibitors can be started no earlier than 7 days after discontinuation of citalopram.
With drugs that prolong the QT interval.
Use with drugs that prolong the QT interval, such as antiarrhythmics (procainamide, amiodarone, etc.), antipsychotics/neuroleptics (eg, phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants and SSRIs (fluoxetine), antimicrobials (macrolide antibiotics and their analogs, eg, erythromycin,
Children under 18 years of age is a contraindication for the use of citalopram, since the effectiveness and safety of its use at this age has not been established.
Due to the possibility of suicidal attempts, patients with depression require careful monitoring of patients at the beginning treatment and the appointment of minimum effective doses to reduce the risk of overdose. This precaution should also be observed in the treatment of other psychiatric disorders due to the possibility of concomitant depressive episodes.
Severe depressions are characterized by a risk of suicidal acts, which may persist until a significant remission is achieved. In this regard, at the beginning of treatment, a combination with drugs from the benzodiazepine group or neuroleptic drugs and constant medical supervision (entrust trusted persons with the storage and issuance of drugs) may be indicated. In the treatment of panic disorders with the appointment of antidepressants and / or benzodiazepines, in some patients, in response to the initiated treatment, anxiety or anxiety increases significantly. This condition (called by specialists "pathological disinhibition" or simply "paradoxical anxiety", the term itself has not yet been approved) is considered a rare phenomenon, although this pathological reaction has been repeatedly documented in the scientific literature. This "paradoxical anxiety" usually subsides within the first few weeks of starting treatment. It is recommended to start with a low dose to reduce the risk of paradoxical anxiety. Discontinuation of the drug in this case is recommended if such a paradoxical reaction does not disappear for a long time, and if such complications of therapy outweigh the benefits of the treatment.
In children, adolescents and young adults (under 24 years of age) with depression and other psychiatric disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing citalopram or any other antidepressants in this category of patients, the risk of suicide should be correlated with the benefits of their use. In short-term studies, the risk of suicide did not increase in people over 24 years of age, and slightly decreased in people over 65 years of age. During treatment with antidepressants, all patients should be monitored for early detection of suicidal tendencies.
Citalopram should be used with caution in renal failure (creatinine clearance below 30 ml / min), hypomania, mania, pharmacologically uncontrolled epilepsy, depression with suicidal attempts, diabetes mellitus, cirrhosis of the liver, bleeding tendency; concomitant use with drugs that reduce the seizure threshold and cause hyponatremia, with ethanol, as well as with drugs metabolized by the CYP2C19 isoenzyme.
Citalopram can cause a dose-dependent prolongation of the QT interval, which can lead to cardiac arrhythmias.
The drug is available by prescription
This drug information is intended for physicians and healthcare professionals,