Oprah (Opra)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceCitalopramCitalopram
Similar drugsTo uncover
  • Oprah
    pills inwards 
    AKTAVIS, LTD.     Russia
  • PRAM®
    pills inwards 
    Lannacher Heilmittel GmbH     Austria
  • Siozam
    pills inwards 
    VEROPHARM SA     Russia
  • Uorop®
    pills inwards 
    Laboratorios Bago S.A.     Argentina
  • Cipramil
    pills inwards 
    H. Lundbeck A / S     Denmark
  • Citalift
    pills inwards 
    Ranbaxy Laboratories Limited     India
  • Citalon®
    pills inwards 
    Sandoz d.     Slovenia
  • Citalopram
    pills inwards 
    ALSI Pharma, ZAO     Russia
  • Citalopram
    pills inwards 
    Aurobindo Pharma Co., Ltd.     India
  • Citol®
    pills inwards 
    NANOLEC, LTD.     Russia
    • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    Tablet dosage of 20 mg:

    active substance: citalopram hydrobromide 24.99 mg, equivalent to citalopram base 20.00 mg;

    Excipients: mannitol 132.55 mg, microcrystalline cellulose 17.885 mg, silicon dioxide colloid 0.625 mg, magnesium stearate 3.95 mg;

    film coating: hypromellose 2.19 mg, titanium dioxide (E171) 0.88 mg, macrogol-6000 0.53 mg.

    Tablet dosage of 40 mg:

    active substance: citalopram hydrobromide 49.98 mg, equivalent to citalopram base 40.00 mg;

    Excipients: mannitol 265.10 mg, microcrystalline cellulose 35.77 mg, silicon dioxide colloid 1.25 mg, magnesium stearate 7.90 mg;

    film coating: hypromellose 4.38 mg, titanium dioxide (E171) 1.76 mg, macrogol-6000 1.06 mg.

    Description:

    Round biconvex tablets, film-coated, white or almost white with a risk on both sides of the tablet and lateral risks.

    Pharmacotherapeutic group:Antidepressant
    ATX: & nbsp

    N.06.A.B.04   Citalopram

    Pharmacodynamics:

    Citalopram is a highly selective serotonin reuptake inhibitor.

    With long-term treatment of resistance to the inhibitory effect of citalopram with respect to the capture of serotonin does not occur.

    The antidepressant effect of citalopram is probably associated with a specific inhibition of the capture of serotonin in neurons of the brain.

    Citalopram has virtually no effect on the neuronal capture of noradrenaline, dopamine and gamma-aminobutyric acid. Has no affinity or weak affinity for cholinergic, histaminergic, various types of adrenergic, serotonergic and dopaminergic receptors.

    Citalopram is a bicyclic derivative of isobenzofuran, which is not chemically related to tricyclic and tetracyclic antidepressants, as well as to other groups of antidepressants.The main metabolites of citalopram are selective inhibitors of serotonin uptake, but their activity is lower compared to citalopram, on the whole they do not make a significant contribution to the antidepressant effect of citalopram.

    Pharmacokinetics:

    Suction

    Citalopram is rapidly absorbed after oral administration. The maximum concentration in blood plasma is achieved on average in 4 (1-7) hours. Absorption is not dependent on food intake. Bioavailability of citalopram with oral administration is about 80%.

    Distribution

    The apparent volume of distribution is 12-17 l / kg. The binding of citalopram and its metabolites to blood plasma proteins is below 80%.

    Metabolism

    Metabolized with the formation of demethylcitalopram, didemethylcitalopram, citalopram-Nand deaminated derivatives of propionic acid. The derivatives of propionic acid are pharmacologically inactive. Demethylcitalopram, didemethylcitalopram, citalopram-N-Oxide are selective inhibitors of the capture of serotonin with less pharmacological activity than citalopram.

    Metabolized mainly with the participation of isoenzyme CYP2C19, also this process proceeds with some participation of isoenzymes CYP3A4 and CYP2D6.

    Excretion

    The half-life of the drug is 1.5 days. Plasma clearance for oral administration is about 0.4 l / min.

    Citalopram is mainly excreted by the liver (85%) and partly by the kidneys (15%). In unchanged form through the kidneys, 12-23% of citalopram are excreted. Hepatic clearance is about 0.3 l / min, renal clearance - 0.05-0.08 l / min.

    The equilibrium concentration is achieved after 1-2 weeks. A linear relationship between the equilibrium concentration of citalopram and its accepted dose was demonstrated. When taking a dose of 40 mg per day, the average concentration of citalopram in blood plasma is approximately 300 nmol / l. There is no association between citalopram concentration in blood plasma, the magnitude of the therapeutic response, or the intensity of adverse reactions.

    Elderly patients

    As a result of delayed metabolism, elderly patients experience a longer half-life and low clearance values.

    Dysfunction of the liver

    In patients with impaired liver function citalopram output slower.The half-life of citalopram and its equilibrium concentrations in blood plasma is almost twice as high as in patients with normal liver function.

    Renal impairment

    In patients with mild and moderate renal insufficiency citalopram is slower, it has no significant effect on the pharmacokinetics of citalopram. Currently, the experience of treating patients with severe impaired renal function (creatinine clearance less than 30 ml / min) is insufficient.

    Indications:

    - Depressive episodes of moderate to severe severity;

    - panic disorder with or without agoraphobia.

    Contraindications:

    - Hypersensitivity to citalopram or to any component included in the preparation;

    - simultaneous administration of monoamine oxidase (MAO) inhibitors, including selegiline, in a daily dose exceeding 10 mg / day;

    - centnersitalopram should not be taken within 14 days after stopping the intake of irreversible MAO inhibitors, and also after the reversal of reversible MAO, which is specified in their instructions for medical use;

    - treatment with MAO inhibitors can be initiated no earlier than 7 days after discontinuation of citalopram;

    - joint acceptance of linezolid in the event that there are no conditions for careful monitoring of the patient and control of blood pressure;

    - citalopram is contraindicated in patients with an elongated interval QT or with the syndrome of congenital lengthening interval QT;

    - joint taking of drugs that extend the interval QT;

    - joint administration with pimozide;

    - children's age (under 18 years).

    Carefully:

    Impaired liver and / or kidney function, insufficient isoenzyme activity CYP2C19; hypomania, mania, depression with suicidal ideation and attempts, diabetes mellitus, severe bradycardia, recently suffered myocardial infarction, compensated heart failure, water-electrolyte balance disorders, propensity to bleed; simultaneous reception with selegiline (dose <10 mg per day), serotonergic drugs and lithium preparations, herbal preparations on the basis of St. John's wort, by drugs affecting the blood coagulation system; drugs that cause hypokalemia / hypomagnesemia; neuroleptics, cimetidine, inhibitors CYP2C19, CYP2D6; electroconvulsive therapy, the presence of convulsive attacks in the anamnesis, as well as drugs that reduce the threshold of convulsive readiness; elderly age; pregnancy and the period of breastfeeding.

    Pregnancy and lactation:

    Pregnancy

    The use of Oprah is possible during pregnancy only if the potential benefit to the mother exceeds the possible risk to the fetus.

    It should be carefully monitored the newborn if the mother took the drug on late pregnancy, especially in the third trimester. Avoid sudden discontinuation of the drug during pregnancy.

    In the case of mothers receiving selective serotonin / norepinephrine reuptake inhibitors in late pregnancy, the following symptoms can occur in a newborn: respiratory distress syndrome, cyanosis, apnea, convulsions, unstable body temperature, difficulty feeding, vomiting, hypoglycemia, hypertension, lowering blood pressure, hyperreflexia, tremor, trembling, irritability, lethargy, incessant crying, sleep disturbances, including drowsiness.These symptoms can be observed both because of the developed serotonergic syndrome, and because of the "withdrawal" syndrome.

    In most cases complications begin immediately after birth (less than 24 hours).

    Epidemiological data confirm that the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, especially in later life, may increase the risk of developing persistent pulmonary hypertension in newborns.

    PeBreastfeeding rate

    Citalopram is excreted in breast milk. It has been established that a baby with breastfeeding will receive about 5% of the dose taken by the lactating mother, calculated on the basis of body weight (mg / kg). During the reception of citalopram during the breast-feeding period, neonatal side reactions were not observed or they proceeded in mild form. However, the available information is insufficient to assess the possible harm to the health of the child, therefore, in the period of breastfeeding, the drug Oprah should be used with caution.

    Dosing and Administration:

    Inside, once a day (morning or evening), regardless of food intake, washing down with liquid.

    Depressive episodes

    The recommended daily dose is 20 mg once a day. Depending on the patient's individual response to treatment and the severity of the disease, the dose can be increased to 40 mg per day. The maximum daily dose is 40 mg.

    The effect of antidepressant medication should not be expected at least two weeks after the initiation of treatment, which should be continued 4-6 weeks before the resolution of the symptoms of the disease. Patients with recurrent unipolar depression may need continued supportive therapy for a long period to avoid depressive episodes thereafter.

    Panic disorders

    The recommended daily dose during the first week of treatment is 10 mg once a day, after which the dose is increased to 20 mg per day. Depending on the patient's individual response to treatment and the severity of the disease, the dose can be increased to 40 mg per day. The maximum daily dose is 40 mg.

    Treatment of panic disorders is long. Supportive clinical effect was achieved during long-term treatment (1 year). In the case of insomnia or a strong anxiety in the acute period of the disease, additional sedation is recommended.If a decision is made to discontinue treatment, the dose of the drug should be reduced gradually, in order to minimize the severe symptoms of the "withdrawal" syndrome.

    Patients of advanced age (over 65 years)

    In elderly patients, it is recommended to reduce the dose twice (10-20 mg per day). The recommended maximum daily dose for elderly patients is 20 mg.

    Renal impairment

    In patients with impaired renal function of mild and moderate severity, dose adjustment is not required. There is no evidence of citalopram treatment in patients with severe renal insufficiency (creatinine clearance less than 20 mL / min).

    Dysfunction of the liver

    In patients with impaired liver function of mild or moderate severity, the recommended initial dose for the first two weeks of treatment is 10 mg. Depending on the patient's individual response to treatment and the severity of the disease, the dose can be increased to 20 mg per day. Patients with severe impairment of liver function titrate the dose of the drug should be cautious.

    Insufficient isoenzyme activity CYP2C19

    In patients with reduced isoenzyme activity CYP2C19 The recommended initial dose for the first two weeks of treatment is 10 mg.Depending on the patient's individual response to treatment and the severity of the disease, the dose can be increased to 20 mg per day.

    The "cancellation" syndrome

    Avoid abrupt discontinuation of the drug. In order to reduce the likelihood of reactions from the body as a result of the evolving syndrome of "withdrawal", it is necessary to gradually abolish the drug, lowering its dose within 1-2 weeks. If as a result of a reduction in the dose of the drug or if it is canceled, poorly tolerated reactions of the "withdrawal" syndrome develop, the last adjusted dose of the drug should be resumed, then its gradual cancellation can be resumed, lowering the dose at longer intervals.

    Side effects:

    The side effects that occur when taking citalopram are usually mild and transient. Most often they occur in the first or second week of treatment, then usually become less intense and occur less frequently with continued therapy. The following dose-dependent reactions were revealed: increased sweating, dry mouth, insomnia, drowsiness, diarrhea, nausea and fatigue.

    The frequency of adverse reactions is presented in accordance with the following gradation: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10 000, <1/1000); very rarely (<1/10 000), the frequency is unknown (can not be determined from available data).

    From the lymphatic and circulatory system: frequency is not known - thrombocytopenia.

    From the immune system: frequency is not known - hypersensitivity reactions, anaphylactic reactions.

    From the endocrine system: frequency is not known - inadequate secretion of antidiuretic hormone.

    Metabolic and nutritional disorders: often - decreased appetite, weight loss; infrequently - increased appetite, weight gain; rarely - hyponatremia, the frequency is not known - hypokalemia.

    Disorders from the psyche: often - agitation, decreased libido, anxiety, nervousness, confusion, violations of orgasm (women), sleep disorders; infrequently - aggression, depersonalization, hallucinations, mania; frequency is not known - panic attacks, bruxism, anxiety, suicidal thoughts, suicidal behavior2.

    From the nervous system: very often - drowsiness, insomnia, headache; often - tremor, paresthesia, dizziness, violation of attention; rarely - a syncope; rarely - large convulsive seizures,dyskinesia, taste disorders; frequency is not known - seizures, serotonin syndrome, extrapyramidal disorders, akathisia, motor disorders.

    From the side of the organ of vision: infrequently - mydriasis (which can lead to the development of closed-angle glaucoma); frequency unknown - impaired vision.

    From the side of the hearing organ and labyrinthine disorders: often - tinnitus.

    From the cardiovascular system: infrequently bradycardia, tachycardia; rarely - hemorrhages; frequency not known - lengthening interval QT1, ventricular arrhythmia, including arrhythmia of the type "pirouette", orthostatic hypotension.

    From the respiratory and thoracic and mediastinal organs: often - yawning; frequency unknown - epistaxis.

    From the gastrointestinal tract: very often - dry mouth, nausea; often - diarrhea, vomiting, constipation; frequency not known - gastrointestinal bleeding (including rectal bleeding).

    From the liver and bile ducts: rarely - hepatitis; frequency is unknown - deviation of the results of laboratory tests of liver function.

    From the skin and subcutaneous tissues: very often - increased sweating; often itching; infrequently - hives, alopecia, rash, purpura, photosensitivity reactions; frequency is not known - ecchymosis,angioedema.

    From the side of musculoskeletal and connective tissue: often - myalgia, arthralgia.

    From the side of the kidneys and urinary tract: infrequently urinary retention.

    From the genitals and breast: often - impotence, ejaculation, inability to ejaculate; infrequently - menorrhagia (women); frequency is unknown - metrorrhagia (women), priapism (men), galactorrhea.

    General disorders and disorders at the site of administration: often - apathy; infrequent peripheral edema; rarely - hyperthermia.

    1 - Interval lengthening messages QT and ventricular arrhythmias, including arrhythmias of the "pirouette" type, were obtained during post-marketing surveillance of drugs containing citalopram, mainly in female patients with hypokalemia or with risk factors predisposing to the development of lengthening of the interval QT, or with other diseases of the heart.

    2 - During the therapy with citalopram or shortly after the cessation of its administration, reports of suicidal thoughts and behavior were received.

    Fractures of bones

    Epidemiological studies, mainly involving patients aged 50 years and older, have revealed an increased risk of bone fractures with SSRIs and tricyclic antidepressants. The mechanism of this action is not known.

    The "cancellation" syndrome

    The cessation of citalopram therapy (especially severe) often leads to the development of the "withdrawal" syndrome. As a rule, reports of dizziness, impaired sensitivity (including paresthesia), sleep disturbances (including insomnia and deep sleep), agitation or anxiety, nausea and / or vomiting, tremor, confusion, increased sweating, headache, diarrhea, a feeling of severe heartbeat , emotional lability, irritability and visual impairment. Typically, these symptoms are mild to moderate, but in some patients they can be severe and prolonged, and therefore, when citalopram treatment is discontinued, it is recommended to gradually reduce the dose of the drug (see "Method of administration and dose " and "Special instructions").

    Overdose:

    Symptoms: convulsions, tachycardia, drowsiness, lengthening interval QT, coma, vomiting, tremor, lowering of arterial pressure, cardiac arrest, nausea, serotonin syndrome, agitation, bradycardia, dizziness, bundle branch blockade, lengthening interval QRS, arterial hypertension, mydriasis, arrhythmia of the type "pirouette", stupor, increased sweating, cyanosis, hyperventilation of the lungs, hyperthermia, atrial and ventricular arrhythmias.

    Treatment: recommended supportive and symptomatic therapy. It is recommended to use activated carbon, osmotic laxatives (such as sodium sulfonate) and gastric lavage. It requires ECG monitoring and vital body functions.

    In the case of an ECG overdose, monitoring is primarily necessary for patients with congestive heart failure / bradyarrhythmia, patients taking co-drugs, lengthening the interval QT, or patients with metabolic disorders, for example, a dysfunction of the liver. There is no specific antidote.
    Interaction:
    Pharmacodynamic interaction

    It was reported about the development of serotonin syndrome when taking citalopram with moclobemide and buspirone.

    Contraindicated combinations

    MAO inhibitors

    Simultaneous administration of MAO inhibitors and citalopram can lead to the development of serious adverse reactions, including serotonin syndrome (see section "Contraindications ").

    There have been reports of the development of serious adverse reactions, sometimes with a fatal outcome, if the patient has taken the SSRI-group preparation in combination with MAO inhibitors, including an irreversible MAO inhibitor selegiline and a reversible MAO inhibitor linezolid and moclobemide, as well as in patients who have recently stopped taking SSRIs and started taking MAO inhibitors.

    Some cases of interaction resembled the symptoms of serotonin syndrome. Symptoms of interaction include the following symptoms: agitation, tremor, myoclonus, and hyperthermia.

    Interval lengthening QT

    Pharmacokinetic and pharmacodynamic studies of the interaction between citalopram and other drugs increasing the range QT, were not conducted. It is impossible to exclude the additive effect when they are taken together. Therefore, the joint administration of citalopram is contraindicated with drugs that extend the interval QT, such as antiarrhythmic drugs of class IA and III, antipsychotic agents (eg, derivatives of fentiazine, pimozide, haloperidol), tricyclic antidepressants, some drugs with antimicrobial effect (for example, sparfloxacin, moxifloxacin, erythromycin (intravenous dosage form), pentamidine, preparations for the treatment of malaria, especially halofantrine), some antihistamines (astemizole, misolastine), etc.

    Pimozide

    The simultaneous administration of pimozide in a single dose of 2 mg by patients receiving citalopram at 40 mg / day for 11 days, led to an increase in the area under the concentration-time curve of pimozide and an increase in its maximum concentration in the blood plasma. Joint intake of pimozide and citalopram leads to an increase in the interval QTc approximately 10 msec. In view of the presence of this interaction when taking low doses of pimozide, the joint administration of citalopram and pimozide is contraindicated.

    Combinations that require caution when applying

    Selegiline (selective MAO-B inhibitor)

    Pharmacokinetic / pharmacodynamic studies of the interaction of citalopram with a dose of 20 mg per day and selegiline at a dose of 10 mg per day showed no clinically significant interaction. It is not recommended to take citalopram and selegiline in a dose exceeding 10 mg per day.

    Serotonergic drugs

    Lithium and tryptophan

    In clinical trials with the simultaneous administration of citalopram and lithium, no pharmacodynamic interaction was found. However, there have been reports of increased serotonergic effects when taking SSRI with lithium or tryptophan, so caution should be exercised when taking these medications with citalopram.Regularly monitor the level of lithium in blood plasma. Joint use with serotonergic drugs (eg, tramadol, sumatriptan) can lead to increased effects of serotonin.

    Before finding out information regarding the joint administration of citalopram and agonists of 5-HT-receptors, such as sumatriptan and other triptans, it is not recommended to take these drugs in combination.

    Preparations of plant origin on the basis of St. John's Wort

    Simultaneous reception of SSRIs and preparations containing St. John's Wort (Hypericum perforatum), can lead to increased side effects. This pharmacokinetic interaction has not been studied.

    Anticoagulants and other drugs that affect blood coagulability

    Citalopram should be taken with caution to patients taking anticoagulants and other drugs that affect blood clotting, such as non-steroidal anti-inflammatory drugs (NSAIDs) acetylsalicylic acid, dipyridamole, ticlopidine or other drugs (eg, atypical antipsychotics) that increase the risk of developing hemorrhages (see section Special instructions).

    Alcohol

    Citalopram does not enter with pharmacodynamic or pharmacokinetic interaction with ethanol. However, simultaneous use of citalopram and alcohol is not recommended.

    Drugs causing hypokalemia / hypomagnesemia

    Caution should be exercised in conjunction with drugs that provoke the development of hypokalemia / hypomagnesemia, as this may cause an increased risk of developing a malignant arrhythmia.

    Drugs that reduce the threshold of convulsive readiness

    Preparations of the SSRI group can reduce the threshold of convulsive readiness. Care should be taken when concomitantly with other drugs that reduce the threshold of convulsive readiness (tricyclic antidepressants from the SSRI group, neuroleptics (derivatives of butyrofenone, thioxanthene), mefloquine, bupropion and tramadol).

    Neuroleptics

    The experience of using citalopram did not reveal any clinically significant interaction with neuroleptics. However, as with other SSRIs, pharmacodynamic interaction can not be ruled out.

    Pharmacokinetic interactions

    Biotransformation of citalopram to demethylcitalopram is regulated by isoenzymes CYP 2С19 (about 38%), CYP 3A4 (about 31%) and CYP 2D6 (about 31%) of the cytochrome P450 system. The fact that citalopram is metabolized by more than one isoenzyme, means an unlikely inhibition of its biotransformation and the absence of the occurrence of pharmacokinetic interaction when used with other drugs.

    The influence of other agents on the pharmacokinetics of citalopram

    Combination with ketoconazole (a potent inhibitor CYP 3A4) does not change the pharmacokinetics of citalopram.

    The study of the pharmacokinetic interaction of lithium and citalopram did not reveal pharmacokinetic interactions.

    Cimetidine

    Cimetidine (strong inhibitor CYP 2D6, CYP 3A4 and CYP 1A2) leads to a moderate increase in the mean equilibrium concentration of citalopram. It is recommended that you take care with citalopram concurrently with cimetidine. It may be justified to reduce the dose of citalopram.

    Simultaneous administration of escitalopram (the active enantiomer of citalopram) with omeprazole at a dose of 30 mg 1 time per day (inhibitor CYP2C19) leads to a moderate (approximately 50%) increase in the concentration of escitalopram in blood plasma.Therefore, caution should be exercised when co-administration with inhibitors CYP2C19 (eg, omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. It may be justified to reduce the dose of citalopram.

    Metoprolol

    Escitalopram (the active enantiomer of citalopram) is an inhibitor of the isoenzyme CYP2D6. Caution should be exercised in the simultaneous administration of citalopram and drugs metabolized by this isoenzyme and having a small therapeutic index, for example, flecainide, propafenone and metoprolol (in cases of heart failure) or medications that are mainly metabolized by CYP2D6 and acting on the central nervous system, for example, antidepressants - desipramine, clomipramine, nortriptyline, or antipsychotic agents - risperidone, thioridazine, haloperidol. In these cases, dose adjustment may be required.

    When combined with metoprolol leads to an increase in the concentration in the blood of the latter, but this does not significantly affect the effect of metoprolol on blood pressure and heart rhythm.

    Effect of citalopram on other drugs

    The combination of citalopram with metoprolol leads to an increase in the concentration of metoprolol by a factor of 2, but to a statistically insignificant increase in the effect of metoprolol on blood pressure and heart rate in healthy volunteers.

    Citalopram and demethylcitalopram slightly inhibit isoenzymes CYP2C9, CYP2E1 and CYP3A4, weakly inhibit isoenzymes CYP1A2, CYP2C19 and CYP2D6 in comparison with other SSRIs, which are considered to be potent inhibitors of these isoenzymes.

    Levomepromazine, digoxin, carbamazepine

    There were no interactions that were clinically significant when taking citalopram with isoenzymatic substrates CYP1A2 (clozapine and theophylline), CYP2C9 (warfarin), CYP2C19 (imipramine and mephenytoin), CYP2D6 (sparteine, imipramine, amitriptyline, risperidone) and CYP 3A4 (warfarin, carbamazepine, its metabolite - carbamazepine epoxide, and triazolam).

    There was no pharmacokinetic interaction between citalopram and levomepromazine or digoxin, indicating that there was no induction or inhibition of P-glycoprotein.

    Desipramine, imipramine

    In pharmacokinetic studies, there was no effect on the concentration of citalopram and imipramine in blood plasma, although the concentration of its primary metabolite (desipramine) was increased. When taking desipramine in combination with citalopram, an increase in the concentration of desipramine in the blood plasma is observed, which may require a reduction in the dose of desipramine.

    Special instructions:

    Use in children and adolescents under 18 years of age

    Antidepressants should not be taken to children and adolescents under 18 years of age. In a number of cases, in the course of clinical trials in the treatment of antidepressants in children and adolescents, an increased risk of developing suicidal behavior (suicidal thoughts and suicide attempts) was noted in comparison with placebo, and hostility towards others was observed (with predominance of aggression, high irritability). If a decision is made to prescribe the drug, the patient should be carefully monitored to monitor suicidal manifestations.

    It is also worth noting that there are no data on the safety of the drug in relation to the effect on growth, physical, mental and mental development with prolonged use in children and adolescents.

    Paradoxical anxiety

    At the beginning of treatment with antidepressants, in some patients with panic disorders there may be an increase in anxiety symptoms. This paradoxical reaction, as a rule, takes place during the first two weeks of treatment. To prevent the development of an anxiogenic effect, it is recommended to start treatment with low doses of the drug.

    Hyponatremia

    When SSRI was taken, there were cases of hyponatremia, which may be due to inadequate secretion of antidiuretic hormone. This adverse reaction is reversible after discontinuation of treatment. The risk of hyponatremia in elderly female patients is especially high.

    Suicidal attempts / suicidal thoughts or worsening of clinical symptoms

    The risk of committing suicide is inherent in depression, and it can persist until the onset of a state of persistent remission. Since improvement in the patient's condition may not be achieved during the first weeks of treatment and for longer, careful monitoring of the patients before the onset of improvement is necessary. There is a general clinical experience with regard to increasing the risk of suicide in the early stages of the recovery period during the treatment.

    The same recommendations should be followed in the treatment of other mental disorders, other than depression, because they can also be accompanied by suicidal manifestations, including these diseases can be accompanied by depression.

    Patients with suicidal manifestations in the anamnesis, as well as patients who clearly express suicidal thoughts before starting therapy, are at increased risk of suicidal intentions and suicidal attempts, so they should be carefully observed during treatment.

    A meta-analysis of placebo-controlled clinical trials in the treatment of antidepressants revealed an increased risk of suicidal ideation and behavior in adults younger than 25 years compared with placebo.

    Care should be taken to monitor patients, especially those at risk, especially at the beginning of the course of treatment and when changing the dose of the drug. Patients, staff and relatives caring for patients should be warned about the need to monitor the deterioration of the clinical picture of the disease, suicidal attempts and thoughts, as well as unusual changes in the behavior of the patient.If any of the above abnormalities are detected, the doctor should be informed immediately about this.

    Akathisia / psychomotor agitation

    When selective serotonin / norepinephrine reuptake inhibitors are taken, akathisia can develop, characterized by the appearance of an unpleasant feeling of internal motor anxiety or an internal need to make movements, often accompanied by an inability to sit or stand motionless for a long time. This phenomenon usually occurs in the first few weeks of treatment. Do not increase the dose to patients who developed these symptoms.

    Mania

    In patients with manic-depressive illness, a phase change from depressive to manic may occur. When developing a manic condition, the drug should be discarded.

    Convulsions

    Taking antidepressants increases the risk of seizures. Citalopram should be discontinued in patients with convulsive seizures. Citalopram should be avoided in patients with unstable epilepsy. It should be carefully monitored for patients with controlled epilepsy, with an increase in the frequency of seizures, the drug should be discontinued.

    Diabetes

    In patients with diabetes mellitus, the intake of SSRIs can affect the level of glucose in the blood. It may be necessary to adjust the dose of insulin and / or oral hypoglycemic agents.

    Serotonin syndrome

    In the treatment of SSRIs, in rare cases, the development of serotonin syndrome was reported. Clinical manifestations of the syndrome include agitation, tremor, myoclonus, hyperthermia. In such cases citalopram should be immediately withdrawn and symptomatic treatment started.

    Hemorrhage

    When taking SIOZ drugs, there were reports of prolonged bleeding time and the development of subcutaneous hemorrhages (ecchymoses), hemorrhages in the mucous membranes, pelvic organs, gastric bleeding. It is necessary to use caution citalopram in patients with a tendency to bleeding, and also taking indirect anticoagulants and other drugs that affect blood coagulability, as well as patients with a history of bleeding (see the section "Interaction with other medicinal products ").

    Electroconvulsive therapy

    Clinical experience with the use of SSRIs and electroconvulsive therapy is limited, and care must be taken when combining these treatment methods.

    The "cancellation" syndrome

    In patients, especially after a sharp cancellation, after discontinuation of treatment with SSRIs, the syndrome of "withdrawal" is often observed.

    The risk of withdrawal may depend on various factors, including the duration of therapy, the dose of the drug, and the magnitude of the dose reduction. Dizziness, sensitivity disorder (including paresthesia), sleep disturbances (including insomnia and deep sleep), agitation or anxiety, nausea and / or vomiting, tremor, confusion, increased sweating, headache, diarrhea, a feeling of severe heartbeat have been reported. , emotional lability, irritability and visual impairment. Typically, these symptoms are mild to moderate, but in some patients they can be severe. Symptoms of the "cancellation" syndrome usually appear in the first days of drug withdrawal, they were reported very rarely when the patient missed taking the medication by negligence.

    In general, these symptoms pass independently for two weeks, although in some patients they can be observed for 2-3 months or more. Citalopram it is recommended to cancel gradually over several weeks or months, depending on the patient's well-being (see "Method of administration and dose ").

    Psychosis

    The treatment of patients with psychoses associated with depressive episodes can enhance psychotic symptoms.

    Interval lengthening QT

    It was found that citalopram causes a dose-dependent increase in the interval QT. Cases of lengthening the interval QT and ventricular arrhythmias, including arrhythmias of the "pirouette" type, were reported mainly in female patients with hypokalemia or with the presence of factors affecting the lengthening of the interval QT or in the presence of other heart diseases.

    Caution should be exercised in patients with severe bradycardia or in patients with recent myocardial infarction or compensated heart failure.

    Violations of the water-electrolyte balance, such as hypokalemia and hypomagnesemia, increase the risk of developing a malignant arrhythmia.These conditions should be adjusted before treatment with citalopram.

    Patients with stable heart diseases should undergo ECG analysis before starting treatment.

    If there are signs of arrhythmia that occurred during treatment with citalopram, stop taking it and perform an ECG test.

    Closed-angle glaucoma

    SSRIs, including citalopram, can affect the size of the pupil of the eye, which can lead to mydriasis. The effect of mydriasis causes a narrowing of the angle of view, which is the result of increased intraocular pressure and the development of angle-closure glaucoma, especially in patients who are predisposed to the disease. Concerning citalopram should be used with caution in patients with closed-angle glaucoma or closed-angle glaucoma in history.

    Fertility of men

    Studies in animals have shown that citalopram can affect the quality of sperm. Notices of the effect on the quality of sperm in men with the intake of SSRIs showed that the effect on sperm quality is reversible.

    The effect of citalopram on human fertility has not been noted at this time.

    Effect on the ability to drive transp. cf.and fur:

    Citalopram affects the ability to drive vehicles and mechanisms. Patients should take into account possible violations and refrain from engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Tablets, film-coated, 20 mg and 40 mg.
    Packaging:

    10 tablets per blister. For 1, 2 or 3 blisters together with instructions for use in a cardboard box.

    For 10, 30, 60 blisters together with instructions for use in a cardboard box (for hospitals).

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000866
    Date of registration:21.10.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:AKTAVIS, LTD. AKTAVIS, LTD. Russia
    Manufacturer: & nbsp
    Representation: & nbspAktavis, Open Company Aktavis, Open Company
    Information update date: & nbsp09.06.2017
    Illustrated instructions
      Instructions
      Up