Instruction for use: Opra

Dosage form: coated tablets

Active substance: Citalopram*

ATX

N06AB04 Citalopram

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F33 Recurrent depressive disorder: Major depressive disorder; Secondary depression; Double Depression; Depressive pseudodement; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive syndrome; Depressed masks; Depression; Depression is smiling; Involutional depression; Involutional depression; Masked Depression; Melancholic Attack; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F34.1 Dysthymia: Dysthymic state within the framework of psychopathic disorders in children and adolescents

F41.0 Panic disorder [episodic paroxysmal anxiety]: Panic state; Panic attack; Panic; Panic disorders

F41.2 Mixed anxiety and depressive disorder: Depression with anxiety-depressive components; Mixed anxiety-depressive conditions; Anxiety Depression; Anxious and depressing mood; Anxiety-depressive state; Anxious-depressive conditions; Anxiety-depressive syndrome; Anxious-Neurotic Conditions

F42 Obsessive-compulsive disorder: Obsessive-compulsive syndrome; Obsessive compulsive states; Obsessive-compulsive syndrome; The Obsession Syndrome; The obsession neurosis; Obsessive-compulsive neurosis; Obsessions

Composition and release form

Tablets, coated with a coating.

citalopram hydrobromide (equivalent to citalopram base) 20 mg; 40 mg

auxiliary substances: mannitol; ICC; silicon oxide colloidal anhydrous; magnesium stearate; hypromellose; titanium dioxide; macrogol 6000

in a blister of 10 pcs .; in a pack of cardboard 1 blister.

Description of dosage form

Biconvex round tablets covered with a white or almost white coating, with a risk on one side.

Characteristic

Citalopram is an antidepressant from the group of selective serotonin reuptake inhibitors (SSRIs).

Pharmachologic effect

Pharmacological action - antidepressant.

Pharmacodynamics

Citalopram, possessing a pronounced ability to inhibit the reuptake of serotonin, has or has little ability to bind to a variety of receptors, including histamine, muscarinic and adrenoreceptors. Inhibits cytochrome P4502D6 only to a small extent and, therefore, does not interact with drugs metabolized by this enzyme. Thus, side effects and toxic effects are manifested to a much lesser extent. The antidepressant effect usually develops after 2-4 weeks of treatment. Citalopram has practically no effect on the conduction system of the heart and blood pressure, on hematologic indices, liver and kidney function, does not cause an increase in body weight. Citalopram does not interfere with human cognitive function, does not cause sedation. In experimental studies, the drug did not show teratogenic effects, effects on reproductive function and perinatal development of offspring.

Pharmacokinetics

Bioavailability of citalopram with oral intake is about 80% and is practically independent of food intake. Cmax in plasma is achieved 2-4 hours after administration. Binding to plasma proteins is less than 80%. The plasma is present unchanged. At doses of 10-60 mg / day pharmacokinetic parameters have a linear dependence. The volume of distribution is 12 l / kg. The equilibrium concentration with a daily single dose is established after 7-14 days. Penetrates into breast milk. Metabolized by demethylation, deamination and oxidation involving cytochrome P450 (isozymes CYP3A4 and CYP2C19) with the formation of less pharmacologically active metabolites. T1 / 2 of the drug is 1.5 days. Excretion is performed by the kidneys and with feces.

Patients over the age of 65 years. There is a longer biological half-life (1.5-3.75 days) and lower clearance values (0.08-0.3 l / min). Concentrations that were observed in the equilibrium state in elderly patients were almost 2 times higher than those observed in younger patients who received the same dose.

Lack of liver function. In patients with reduced liver function, citalopram is withdrawn more slowly. The biological half-life of citalopram is almost doubled and the equilibrium concentrations of citalopram in plasma are almost 2 times higher than in patients with normal liver function after administration of the same dose.

Lack of kidney function. The excretion of citalopram proceeds more slowly in patients with a small and moderate degree of renal dysfunction without a significant effect on the pharmacokinetics. Currently, the experience of treating patients with severe renal function deficiency (Cl creatinine <20 ml / min) is insufficient.

Indications for the Opra

treatment of depressive diseases and prevention of relapses;

treatment of panic disorder with or without fear of open space;

treatment of obsessive-compulsive disorder (obsessive-compulsive disorder).

Contraindications

hypersensitivity to citalopram or to any component included in the formulation;

children's age (up to 18 years);

the drug should not be used in combination with MAO inhibitors, and also within 14 days after discontinuation of their administration. Treatment with MAO inhibitors can be initiated no earlier than 7 days after stopping citalopram.

Carefully:

insufficiency of liver and / or kidney function;

convulsive seizures in the anamnesis;

elderly age.

Application in pregnancy and lactation

Citalopram should not be given to pregnant and breast-feeding women unless the potential clinical benefit prevails over theoretical risk, because the safety of the drug during pregnancy and breastfeeding in humans is not established. During breastfeeding, it may cause drowsiness in infants, a reduction in the sucking reflex, and loss of body weight.

Side effects

From the side of the nervous system: rarely - asthenia, fatigue, drowsiness or insomnia, anxiety, tremor, agitation, amnesia, apathy, extrapyramidal effects, mood changes, aggressive behavior, hallucinations, depersonalization, emotional lability, euphoria, mania, hypomania, panic behavior , paranoid reaction, psychosis, serotonin syndrome (agitation, confusion, diarrhea, hyperthermia, hyperreflexia, ataxia, unusual fatigue, tremor, increased sweating, agitation, uncontrolled my behavior).

From the digestive tract: rarely - dry mouth, nausea, vomiting, hypersalivation, flatulence, diarrhea, abdominal pain, anorexia.

From the cardiovascular system: rarely - bradycardia, lowering blood pressure, orthostatic hypotension, arrhythmia.

On the part of the organs of hematopoiesis: rarely - thrombocytopenia, bleeding.

From the senses: rarely - mydriasis, paresis of accommodation, a taste disorder.

On the part of the reproductive system: violation of sexual function (violation of ejaculation, decreased libido, impotence), menstrual cycle disorders.

Allergic reactions: skin rash, rarely - epidermal necrolysis, rhinitis, sinusitis.

Interaction

Strengthens the effect of sumatriptan and other serotonergic drugs. Does not affect the effects of ethanol, lithium drugs, benzodiazepines, antipsychotics (neuroleptics), narcotic analgesics, beta-adrenoblockers, phenothiazines, tricyclic antidepressants, antihistamines and hypotensive drugs. To an insignificant degree inhibits cytochrome CYP2D6, due to which it weakly interacts with drugs that are metabolized with its participation. With simultaneous administration with MAO inhibitors, the development of hypertensive crisis (serotonin syndrome) is possible. Cimetidine increases the concentration in the blood and increases the effect of citalopram. With a simultaneous appointment with warfarin, prothrombin time increases by 5%.

Dosing and Administration

Inside, 1 time per day at any time, either with meals, or on an empty stomach.

Depression. The recommended daily dose is 20 mg of citalopram. Depending on the patient's individual response to treatment and the severity of the disease, the dose can be increased to a maximum of 60 mg / day.

Panic disorders. It is recommended to use 10 mg of citalopram 1 time per day during the first week of treatment, after which the dose is increased to 20 mg / day. Depending on the patient's individual response to treatment and the severity of the disease, the dose can be increased to a maximum of 60 mg / day.

Obsessive-compulsive disorder. The recommended daily dose is 20 mg once a day. Depending on the individual response of the patient to treatment, the dose can be increased by 20 mg to a maximum of 60 mg / day.

Patients aged 65 years and over. The recommended initial dose can be increased to 40 mg / day.

Impaired renal function. Patients with mildly or moderately impaired renal function may apply the drug in normal doses. Information on citalopram treatment in patients with severe renal insufficiency (Cl creatinine up to 20 ml / min) is not available.

Dysfunction of the liver. Patients with impaired liver function should not be administered more than 30 mg / day.

Duration of treatment. Usually, the antidepressant effect of the drug is observed after 2-4 weeks of treatment. Treatment with antidepressants is symptomatic and should be carried out for a long time. Usually, to prevent recurrence, treatment should be performed for 6 months or even longer. In the case of patients with recurrent depression, maintenance treatment should be carried out for several years to prevent the onset of subsequent phases of the disease. If the treatment is completed, the drug should be withdrawn gradually within a few weeks. In the treatment of panic disorder, the maximum effect of citalopram is observed after 3 months of treatment and persists throughout the period of maintenance therapy. In the treatment of obsessive-compulsive disorder, the effect of the drug appears after 2-4 weeks of treatment; With continued treatment, further improvement may be observed.

Overdose

Symptoms: nausea, dizziness, drowsiness, dysarthria, sinus tachycardia, nodal rhythm, increased sweating, cyanosis, tremor, amnesia, confusion, cardiac rhythm and conduction (prolongation of the QT interval), rhabdomyolysis, seizures, coma.

Treatment: gastric lavage, symptomatic and maintenance therapy; there is no specific antidote.

Precautionary measures

When developing manic state the drug should be canceled. Patients with drug dependence (including history) need supervision and control over the use of the drug. Treatment with MAO inhibitors can be initiated no earlier than 7 days after stopping citalopram. In elderly patients, a dose reduction of citalopram is required. Citalopram does not affect the intellectual and psychomotor functions and abilities. However, it is recommended that patients who take psychotropic medications are informed that their ability to concentrate and show attention may be somewhat disturbed as a result of their illness or the action of the drugs taken, or as a result of a combination of these two factors

Storage conditions for Opra

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Opra

3 years.

Do not use after the expiry date printed on the package.