Siozam - instructions for use, dose, side effects, contraindications

Excipients: corn starch, lactose monohydrate (sugar milk), povidone (polyvinylpyrrolidone 25000), microcrystalline cellulose, sodium carboxymethyl starch (primogel), glycerol (glycerin), magnesium stearate;

composition of the shell: Opadrai II (hypromellose (hydroxypropylmethylcellulose), lactose monohydrate, macrogol (polyethylene glycol 4000), titanium dioxide).

Description:

The tablets covered with a film cover, white color, round, biconcave form, with a risk.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.04 Citalopram

Pharmacodynamics:

Citalopram is an antidepressant belonging to the group of selective serotonin reuptake inhibitors (SSRIs). Possessing a pronounced ability to inhibit serotonin reuptake, does not have or has a very weak ability to bind to a variety of receptors, including histamine, muscarinic and adrenoreceptors. Citalopram to a very small extent inhibits cytochrome P450IID6 and, therefore, does not interact with drugs metabolized by this enzyme (the risk of side effects and toxic effects is lower).

The antidepressant effect usually develops after 2-4 weeks of treatment. Citalopram practically has no effect on the conduction system of the heart and blood pressure, on haematological parameters, liver and kidney function, does not cause an increase in body weight.

Citalopram does not interfere with the cognitive functions of a person, does not cause sedation, in experimental studies, the drug does not show teratogenic effects, effects on reproductive function and perinatal development of offspring.

Pharmacokinetics:

Bioavailability of citalopram is about 80% and practically does not depend on food intake.

Maximum concentration (TFROM_max) in plasma is achieved in 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 (C_ss) 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 (isoenzymes CYP3A4 and CYP2C19) with the formation of less pharmacologically active metabolites.

Half-life (T_1/2) 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 twice as high as those observed in younger patients who received the same dose.

Lack of liver function

In patients with reduced liver function citalopram output more slowly. The biological half-life of citalopram is almost doubled and the equilibrium concentrations of citalopram in plasma are almost twice as high as 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.

Indications:

- Depression of various etiologies, treatment and prevention;

- panic disorder (including with agoraphobia);

- obsessive-compulsive disorder (obsessive-compulsive disorder).

Contraindications:

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

- simultaneous use with monoamine oxidase (MAO) inhibitors, and also within 14 days after discontinuation of their intake;

- Children's age (effectiveness and safety of use are not established).

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

Carefully:

With insufficient liver and / or kidney function, with convulsive seizures in the anamnesis, patients older than 65 years, with drug dependence (including history), mania, hypomania.

Pregnancy and lactation:

Do not assign citalopram pregnant and breastfeeding women, if the potential clinical benefit does not prevail over the theoretical risk, because the safety of the drug during pregnancy and lactation in humans is not established.

Dosing and Administration:

Inside, once a day, at any time of the day, regardless of food intake.

Depression

The recommended daily dose of Siozam is 20 mg. Depending on the patient's individual response to treatment and the severity of the disease, the dose may be increased. The maximum daily dose is 60 mg.

Panic disorders

The recommended daily dose of Siozam is 10 mg during the first week of treatment, after which the dose is increased to 20 mg per day. The maximum daily dose is 60 mg.

Obsessive-compulsive disorder

The recommended daily dose of Siozam is 20 mg. Depending on the patient's individual response to treatment and the severity of the disease, the dose may be increased. The maximum daily dose is 60 mg.

Patients aged 65 years and over

The maximum daily dose is not more than 40 mg.

Impaired renal function

Patients with mildly or moderately impaired renal function may apply the drug in normal doses. Currently, the experience of treating patients with severe renal failure is insufficient (creatinine clearance below 20 ml / mol) is insufficient.

Disturbed liver function

Patients with impaired liver function should not be prescribed more than 30 mg per day.

Duration of treatment

Usually, the antidepressant effect of the drug is observed after 2-4 weeks of treatment. Treatment with antidepressants should be carried out for a long time. Usually, to prevent recurrence, treatment should be carried out for 6 months or even a longer period of time. 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 Siozam should be canceled gradually within a few weeks.

In the treatment of panic disorder, the maximum effect of citalopram is observed after 3 months of treatment. This effect persists throughout the period of maintenance therapy.

In the treatment of obsessive-compulsive disorder, the effect of the drug manifests itself after a 2-4 weeks of treatment; With further continuation of treatment, further improvement can be observed.

Side effects:

From the nervous system: rarely asthenia, drowsiness or insomnia, anxiety, tremor, agitation, amnesia, apathy, extrapyramidal effects, mood changes, aggressive behavior, depersonalization, emotional lability, euphoria, manic and / or psychotic (including hallucinations) disorders, panic reactions, serotonin syndrome (agitation, confusion, diarrhea, hyperthermia, hyperreflexia, ataxia).

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

From the side of the cardiovascular system: rarely - bradycardia, lowering blood pressure (BP), orthostatic hypotension, arrhythmia.

From the hematopoiesis: rarely - thrombocytopenia, bleeding.

From the sense organs: 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 irregularities.

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

Other: rarely - hyperthermia, polyuria, mastodonia, galakroteia, hyponatremia, urination disorder, arthralgia, myalgia, yawning, gnashing of teeth, increase or decrease in body weight, dyspnea.

Overdose:

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

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

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, in connection with which, weakly interacts with drugs that are metabolized with his 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 simultaneous administration with warfarin, prothrombin time increases by 5%.

Special instructions:

When developing a manic condition, the drug should be discarded.

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.

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, a dose reduction of citalopram is required.

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

Citalopram usually does not affect the intellectual and psychomotor functions and abilities.Nevertheless, it is recommended that patients who receive psychotropic medications are informed that their ability to concentrate and show attention may be impaired to some extent as a result of their illness or the action of the medication taken, or as a result of a combination of these two factors.

Form release / dosage:

Tablets, film-coated, 20 mg and 40 mg.

Packaging:

For 10 or 14 tablets in a planar cell package.

14, 28 or 56 tablets in a can of light-protective glass or a can of polymeric, or a polymer bottle.

Each jar or bottle, 1, 2 or 4 contour squares, together with the instruction for use, is placed in a bundle.

Storage conditions:

In a dry place, protected from light and inaccessible to children, at a temperature not youwe 25 ° C.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002009/07

Date of registration:08.08.2007

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Representation: & nbspVEROPHARM, AO VEROPHARM, AO Russia

Information update date: & nbsp27.09.2015

Illustrated instructions

Instructions

Siozam (Siozam)