Instruction for use: Citol

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

Composition and release form

Tablets, coated with a coating.

citalopram 20 mg; 40 mg

auxiliary substances: corn starch; lactose; PVP; avicel PH200; magnesium stearate; hydroxypropylmethylcellulose; polyethylene glycol 40, titanium dioxide

in the package contour cell 28 pcs .; in a pack of cardboard 1 (Table 20 and 40 mg) or 2 (Table 20 mg) packaging.

Description of dosage form

White elliptical tablet-shaped tablets, with the logo "Ai" - on one side and the dividing risk - on the other.

Characteristic

Antidepressant, from the group of selective serotonin reuptake inhibitors (SSRIs).

Pharmachologic effect

Pharmacological action - antidepressant.

Pharmacodynamics

Has a strong ability to inhibit the reuptake of serotonin, has no or has a very weak ability to bind to a variety of receptors, including histamine, muscarinic and adrenoreceptors. To a very small extent inhibits cytochrome P450 2D6 and, therefore, does not interact with drugs metabolized by this enzyme. Thus, side effects and toxic effects are manifested to a much lesser degree.

The antidepressant effect usually develops after 2-4 weeks of treatment.

Has 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.

Pharmacokinetics

When administered, the bioavailability of citalopram is about 80% and is virtually independent of food intake. Cmax in plasma is achieved 2-4 hours after administration. Binding to plasma proteins is below 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. Css with a daily one-time reception 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.

Indication for the Citol

Depressive disorders of various etiologies.

Contraindications

hypersensitivity;

simultaneous administration with MAO inhibitors (including the period within 14 days after their cancellation), sumatriptan and other serotonergic drugs;

children's age (efficacy and safety of use not established).

Carefully:

hepatic and / or renal insufficiency;

convulsive seizures (including in the anamnesis);

pregnancy;

lactation period;

elderly age.

Side effects

The undesirable effects of Citol ® have a transient character and are poorly expressed. As a rule, they are observed during the first 1-2 weeks of treatment and usually significantly weaken as the patients improve. In very rare cases, convulsions were observed.

Side effects can be systematized as follows.

From the cardiovascular system: often - bradycardia, postural hypotension, arterial hypotension; rarely - arterial hypertension, tachycardia, puffiness, angina, extrasystole, arrhythmia, heart failure, myocardial infarction; in exceptional cases - transient ischemic attacks, phlebitis.

From the nervous system: rarely - asthenia, excessive fatigue, drowsiness or insomnia, anxiety, tremor, impaired concentration, agitation, amnesia, apathy, extrapyramidal effects, mood reduction, aggressive behavior, hallucinations, depersonalization, confusion, emotional lability, euphoria , manic disorders, panic behavior, suicidal attempts, paranoid reaction, psychosis, serotonin syndrome (agitation, confusion, diarrhea, hyperthermia, hyperreflexia, ataxia, tremor, increased sweating, agitation, uncontrolled behavior), rarely - drug dependence, catatonic reactions.

On the part of the digestive tract: rarely - dry mouth, nausea, vomiting, hypersalivation, flatulence, diarrhea, abdominal pain, anorexia, gastritis, gastroenteritis, stomatitis, hemorrhoids, dysphagia, gingivitis, esophagitis, an increase in "liver" transaminases and alkaline phosphatase; in exceptional cases - colitis, stomach ulcer, cholecystitis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulitis, hiccough.

From the hemopoietic system: thrombocytopenia, purpura, bleeding disorders, bleeding.

From the musculoskeletal system: rarely - arthritis, muscle weakness; in exceptional cases - bursitis, osteoporosis.

From the endocrine system: in exceptional cases - hypothyroidism, gynecomastia.

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

On the part of the reproductive system: often - violation of sexual function (violation of ejaculation, decreased libido, impotence, menstrual irregularities); galactorrhea, breast augmentation, vaginal bleeding.

On the part of the respiratory system: often - cough; rarely - bronchitis, rhinitis; sinusitis; shortness of breath, pneumonia; in exceptional cases - asthma, laryngitis, bronchospasm.

From the genitourinary system: often - polyuria, dysuria; in exceptional cases - hematuria, oliguria, pyelonephritis, kidney pain.

Skin reactions: often - skin rash, hair loss, itching; rarely - increased reaction to light, hives, acne, eczema, alopecia, dermatitis, psoriasis epidermal necrolysis, in exceptional cases - hypertrichosis, decreased sweating, keratitis, cellulitis, itching of the anus.

Other: rarely - mastodynia, hyponatremia, yawning, gnashing of teeth, increase or decrease in body weight, dyspnea.

If side effects develop, immediately consult a doctor.

Interaction

Strengthens the effect of sumatriptan and other serotonergic drugs. Does not affect the effects of ethanol, drugs Li +, benzodiazepines, antipsychotic drugs (neuroleptics), narcotic analgesics, beta-blockers, phenothiazines, tricyclic antidepressants, antihistamines and hypotensive drugs.

To an insignificant degree inhibits cytochrome CYP2D6, and therefore weakly interacts with drugs 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. At simultaneous appointment with warfarin PV increases by 5%.

Dosing and Administration

Inside, 1 time per day, regardless of meals, at any time of the day. The initial dose is 20 mg / day, if necessary, increase the dose. The maximum daily dose is 60 mg.

The recommended daily dose for the elderly is 20 mg. Depending on the individual reaction and severity of depression, the dose can be increased to a maximum of 40 mg / day.

In case of liver failure, the drug intake should be limited to the minimum recommended doses. With a mild to moderate degree of chronic renal failure, correction of the dosing regimen is not required.

Overdose

Symptoms: dizziness, drowsiness, dysarthria, sinus tachycardia, nodal rhythm on the ECG, prolongation of the QT interval, pirouette arrhythmia, ventricular arrhythmia, increased sweating, vomiting, cyanosis, hyperventilation of the lungs, tremor, amnesia, confusion, rhabdomyolysis, seizures, coma.

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

Special instructions

There is very little clinical experience with the use of Citol® in the conduct of electroconvulsive therapy.

When developing manic state the drug should be canceled.

Treatment with MAO inhibitors can be initiated no earlier than 7 days after stopping citalopram.

Care should be taken when prescribing during breastfeeding because of the risk of drowsiness in infants, a reduction in the sucking reflex, and weight loss.

In elderly patients, the area under the concentration / time curve (AUC) and T1 / 2 citalopram increases, which requires a reduction in its dose.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, as well as when taking alcohol.

Storage conditions for Citol

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Citol

2 years.

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