Expiration date: 09/2025

The composition and form of issue:

Tablets, film-coated. 1 tablet contains:

of citalopram hydrobromide (calculated as citalopram) 20 or 40 mg

auxiliary substances: starch, corn lactose monohydrate (milk sugar), povidone (PVP 25000) MKC sodium carboximetilkrahmal (primogel) glycerol (glycerin) magnesium stearate 

the shell: Opadry II — hypromellose (hydroxypropyl methylcellulose) lactose monohydrate macrogol (polyethylene glycol 4000) titanium dioxide 

in a contour acheikova packing 10 PCs. in cardboard pack 1 or 2 packs.

Description pharmaceutical form:

Tablets, film-coated, white, round, lenticular forms, with valium.

Pharmacokinetics:

The bioavailability of citalopram is about 80% and is virtually independent of food intake. Cmax in plasma achieved through 2-4 h after administration. Linking blood plasma is less than 80%. Plasma is present in unchanged form. At doses of 10-60 mg/day pharmacokinetic parameters have a linear dependence. The volume of distribution is 12 l/kg. Equilibrium concentration with daily disposable admission are set within 7-14 days. Passes into breast milk.

Metabolized by demethylation, deamination and oxidation with participation of cytochrome P450 (isoenzyme CYP3A4 and CYP2C19) with the formation of pharmacologically less active metabolites.

T1/2 — 1, 5 days. Excretion is by the kidneys and faeces.

Patients over the age of 65 years

There is a more prolonged biological T1/2 (1, 5-3, 75 days) and a lower value of Cl (0, 08-0, 3 l/min). Concentrations were observed when the equilibrium condition in elderly patients is almost 2 times higher than the concentration observed in younger patients receiving the same dose.

Failure of the liver

In patients with reduced hepatic function citalopram is excreted more slowly. The biological half-life of citalopram is almost 2 times increased and the equilibrium concentration of citalopram in plasma is almost 2 times higher compared to patients with normal hepatic function after the administration of the same dose.

Failure of kidney function

The excretion of citalopram occurs more slowly in patients with mild-to-moderate reduction of kidney function without significant effect on the pharmacokinetics.

Description pharmacological action:

Citalopram is an antidepressant belonging to the group of selective inhibitors of serotonin reuptake. Possessing a pronounced ability to inhibit the reuptake of serotonin, has no or a very weak ability to bind to several receptors including histamine, muscarinic and adrenergic receptors. Citalopram to a very small extent inhibits the cytochrome ?4502D6 and therefore does not interact with drugs metabolized by this enzyme (the risk of side effects and toxic effects below).

Antidepressant effect usually develops after 2-4 weeks of treatment. Citalopram has almost no effect on the conduction system and AD on hematological parameters, liver function and kidney, there is an increase in body mass.

Citalopram does not violate the cognitive functions of a person, does not cause sedation, in experimental studies the drug was not detected teratogenicity, effects on reproduction and prenatal development of the offspring.

Indications:

• depression of various etiologies (treatment and prevention)
  
• panic disorder (including with agoraphobia)
  
• obsessive-compulsive disorder (obsessional neurosis).
  

Contraindications:

• hypersensitivity to citalopram or to any component included in the drug
  
• concurrent use with MAO inhibitors and within 14 days after receiving treatment with MAO inhibitors can be started no earlier than 7 days after discontinuation of citalopram
  
• children's age (the efficacy and safety not established).
  

With caution:

• insufficient function of the liver and/or kidney
  
• the presence of seizures in anamnesis
  
• patients older than 65 years
  
• the presence of drug dependence (including history)
  
• mania hypomania.
  

Application of pregnancy and breast-feeding:

Should not be prescribed citalopram for pregnant and nursing women if the potential clinical benefit not prevail over the theoretical risk, since the safety of the drug during pregnancy and breastfeeding in humans is not established.

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 reaction, serotonin syndrome (agitation, confusion, diarrhea, hyperthermia, hyperreflexia, ataxia).

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

Of the cardiovascular system: rarely- bradycardia, decreased blood pressure, orthostatic hypotension, arrhythmia.

Organs of hematopoiesis: rarely — thrombocytopenia, bleeding.

From the sensory organs: rarely — midriaz, paralysis of accommodation, taste disturbance.

From the reproductive system: sexual dysfunction (abnormal ejaculation, decreased libido, impotence, menstrual disorders).

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

Other: rarely — hyperthermia, polyuria, mastodynia, galactorrhea, hyponatremia, impaired urination, arthralgia, myalgia, yawning, teeth grinding, increase or reduction of body weight, dyspnoea.

Drug interactions:

Enhances the effect of sumatriptan and other serotonergic medications. Does not affect the action of ethanol, drugs, lithium, benzodiazepines, antipsychotic drugs (antipsychotics), narcotic analgesics, beta-blockers, phenothiazine, tricyclic antidepressants, antihistamines and antihypertensive drugs.

To a small extent inhibits the cytochrome P4502D6, and therefore interacts weakly with drugs that are metabolized.

While concurrent use with MAO inhibitors may develop a hypertensive crisis (serotonin syndrome).

Zimetidin increases concentration in the blood and enhances the effect of citalopram.

When concomitant administration with warfarin PV increases by 5%.

Method of application and dose:

Inside, at any time, with or without food, once.

Depression: the recommended daily dose of Sisama is 20 mg., depending on the individual response to treatment and severity of the disease dose can be increased to a maximum daily dose of 60 mg. Usually antidepressant drug action is observed after 2-4 weeks of treatment. Antidepressant treatment should be carried out for a long time. Usually to prevent relapse treatment should be for 6 months or even longer period of time. Patients with periodic (recurrent) depression supportive treatment should be for several years to prevent the start of the subsequent phases of the disease. In the case of completion of treatment Siozam should be withdrawn gradually over several weeks.

Panic disorder: the recommended daily dose of 10 mg for the first week of treatment, after dose increase to 20 mg/day maximum daily dose of 60 mg. in the treatment of panic disorder the maximum effect of citalopram was observed after 3 months of treatment. This effect remains for the entire period of maintenance therapy.

Obsessive-compulsive disorder: the recommended daily dose of 20 mg depending on individual patient response to treatment and severity of the disease dose can be increased to a maximum daily dose of 60 mg. in the treatment of obsessive-compulsive disorder effect of the drug is seen after 2-4 weeks of treatment with continued treatment may be further improved.

Patients aged 65 years and older the maximum dose is 40 mg.

Impaired renal function: patients with slightly or moderately impaired renal function can use the drug at usual doses. Currently, the experience of treatment of patients with severe insufficiency of kidney function (Cl creatinine below 20 ml/mol) is negligible.

Impaired liver function: patients with impaired liver function should not assign more than 30 mg/day.