Siozam
Siozam: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Siozam
ATX code: N06AB04
Active ingredient: citalopram (Citalopram)
Manufacturer: JSC "VEROPHARM" (Russia)
Description and photo updated: 2018-29-11
Siozam is an antidepressant.
Release form and composition
Dosage form - film-coated tablets: round, biconvex, scored, white (10 or 14 pieces in a blister contour packaging, in a cardboard box 1, 2 or 4 packages; 14, 28 or 56 pieces in a polymer can / vial or in a can of light-protective glass, in a cardboard box 1 can / bottle; each pack also contains instructions for the use of Siozam).
Composition of 1 film-coated tablet:
- active substance: citalopram (in the form of hydrobromide) - 20 or 40 mg;
- auxiliary components: glycerol (glycerin), sodium carboxymethyl starch (primogel), povidone (polyvinylpyrrolidone 25,000), lactose monohydrate (milk sugar), magnesium stearate, microcrystalline cellulose, corn starch;
- film shell: Opadray II containing lactose monohydrate, hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol (polyethylene glycol 4000).
Pharmacological properties
Pharmacodynamics
The active substance of Siozam, citalopram, is an antidepressant from the group of selective serotonin reuptake inhibitors (SSRIs). It has a pronounced ability to suppress the reuptake of serotonin, while it binds very little or does not bind at all to a number of receptors, including muscarinic, histamine and adrenergic receptors.
The drug suppresses cytochrome P450IID6 to a very low degree, therefore it does not interact with drugs that are metabolized with the participation of these enzymes. Accordingly, the risk of developing toxic effects and side effects is reduced.
Citalopram practically does not affect blood pressure and the cardiac conduction system, renal and liver function, hematological parameters. Does not have a sedative effect. Does not impair human cognitive functions. Does not cause weight gain. In experimental studies, the drug did not have a teratogenic effect, did not affect the reproductive function and perinatal development of the child.
The antidepressant effect develops within 2-4 weeks of regular intake of Siozam.
Pharmacokinetics
The time to reach the maximum concentration is 2-4 hours after taking Siozam. Bioavailability - about 80%, almost does not depend on the simultaneous intake of food. No more than 80% of the received dose binds to plasma proteins. The volume of distribution is 12 l / kg. In plasma, citalopram is found unchanged. Penetrates into breast milk.
When taking the drug in daily doses of 10-60 mg, the pharmacokinetic parameters of citalopram have a linear relationship.
With a daily intake of the drug once a day, the equilibrium concentration (C ss) is established after 7-14 days.
It is metabolized with the participation of cytochrome P450 isoenzymes (CYP3A4 and CYP2C19) by oxidation, demethylation and deamination with the formation of less pharmacologically active metabolites.
The half-life (T ½) is 36 hours. It is excreted by the kidneys and through the intestines.
In elderly patients (over 65 years old), T ½ increases (36–90 h), the clearance value decreases (0.08–0.3 l / min). When taking the same doses, C ss is almost 2 times higher than in younger patients.
With a decrease in liver function, a slower excretion of the drug from the body is observed, an increase in T ½ and C ss is almost 2 times compared with the same parameters in patients with normal liver function.
In patients with mild to moderate renal insufficiency, excretion of the drug is slowed down, but no significant change in pharmacokinetic parameters is observed.
Indications for use
- depression of various etiologies (treatment and prevention);
- obsessive-compulsive disorder (obsessive compulsive disorder);
- panic disorder (including with agoraphobia).
Contraindications
Absolute:
- age up to 18 years;
- simultaneous use of MAO (monoamine oxidase) inhibitors, as well as a period of 14 days after their cancellation;
- hypersensitivity to any component of the drug.
Relative:
- a history of seizures;
- mania and hypomania;
- drug dependence, including a history;
- renal / hepatic impairment;
- pregnancy and lactation (provided that the expected benefits of therapy for the mother definitely outweigh the potential risks to the fetus);
- age over 65.
Siozam, instructions for use: method and dosage
Siozam film-coated tablets should be taken orally. Time of meals and time of day do not matter.
Recommended dosage regimens:
- depression, obsessive-compulsive disorder: the initial daily dose is 20 mg. In case of insufficient effect and in more severe clinical cases, it is possible to increase the daily dose up to 60 mg;
- panic disorder: the initial daily dose is 10 mg, after a week it is increased to 20 mg. If the effect is insufficient, a further increase in the dose is possible, but not more than up to 60 mg per day.
For patients over 65 years of age, the maximum daily dose should not exceed 40 mg.
For mild to moderate renal impairment, the dose is not adjusted.
In liver failure, the maximum permissible daily dose is 30 mg.
The antidepressant effect usually develops within 2–4 weeks of regular use of the drug. The duration of taking Siozam is long. To avoid relapses, treatment is recommended for at least 6 months. Maintenance therapy for periodic (recurrent) depression is carried out for several years to prevent the onset of the development of subsequent phases of the disease.
At the end of therapy, Siozam should be canceled gradually, over several weeks.
In the treatment of panic disorders, the maximum therapeutic effect develops after 3 months, obsessive-compulsive disorders - after 2-4 weeks (with longer treatment, further improvement is possible).
Side effects
- allergic reactions: skin rash; rarely - sinusitis, rhinitis, epidermal necrosis;
- from the nervous system: rarely - insomnia / drowsiness, euphoria, agitation, asthenia, apathy, tremor, anxiety, amnesia, depersonalization, panic reactions, aggressive behavior, mood changes, extrapyramidal effects, emotional lability, manic and / or psychotic disorders (in including hallucinations), serotonin syndrome (confusion, agitation, hyperreflexia, hyperthermia, ataxia, diarrhea);
- on the part of the cardiovascular system: rarely - a decrease in blood pressure, arrhythmia, bradycardia, orthostatic hypotension;
- from the senses: rarely - a violation of taste, paresis of accommodation, mydriasis;
- from the digestive tract: rarely - abdominal pain, nausea, hypersalivation, dry mouth, diarrhea, flatulence, vomiting, anorexia;
- from the hematopoietic organs: rarely - bleeding, thrombocytopenia;
- from the reproductive system: menstrual irregularities, decreased libido, impaired ejaculation, impotence;
- others: rarely - grinding teeth, yawning, hyperthermia, urinary disorders, galactorrhea, mastodynia, polyuria, hyponatremia, weight gain or loss, myalgia, arthralgia, dyspnea.
Overdose
Symptoms: drowsiness, dizziness, confusion, dysarthria, cyanosis, increased sweating, tremor, amnesia, cardiac arrhythmias and conduction disturbances (sinus tachycardia, lengthening of the QT interval, junctional rhythm), convulsions, nausea, rhabdomyolysis, coma.
Treatment: gastric lavage, symptomatic and supportive therapy. The specific antidote is unknown.
special instructions
Patients with drug dependence (currently or in history) should be under special control during the period of therapy in order to avoid drug abuse.
In case of development of a manic state, Siozam should be discontinued.
Influence on the ability to drive vehicles and complex mechanisms
The components of Siozam, as a rule, do not cause the development of disorders of intellectual and psychomotor functions in humans. However, patients should take into account that their ability to concentrate may be reduced to some extent due to the disease itself, the action of the drugs used, or a combination of these two factors.
Application during pregnancy and lactation
Siozam is contraindicated during pregnancy and lactation, unless the expected benefits of therapy to the mother clearly outweigh the potential risks to the fetus. The limitation is due to the lack of sufficient data on the safety of the use of citalopram in women during these periods.
When taking the drug during lactation, citalopram can reduce the sucking reflex in infants, cause drowsiness and weight loss.
Pediatric use
Siozam is not used in pediatrics.
With impaired renal function
Renal failure is a relative contraindication to the appointment of Siozam (i.e., the drug can be used, but with extreme caution and under the close supervision of a physician). For mild to moderate functional disorders, the usual dose is prescribed. Experience in treating patients with severe functional renal failure (creatinine clearance <20 ml / mol) is limited.
For violations of liver function
Liver failure is a relative contraindication to the appointment of Siozam (i.e., the drug can be used, but with extreme caution and under the close supervision of a physician). A dose reduction is required.
Use in the elderly
Siozam tablets are used with caution in patients over 65 years of age. A decrease in the daily dose of the drug is required.
Drug interactions
Siozam does not interact with the following drugs: tricyclic antidepressants, narcotic analgesics, antipsychotics (neuroleptics), benzodiazepines, beta-blockers, antihistamines and antihypertensive drugs, lithium drugs, phenothiazines.
Citalopram enhances the effect of sumatriptan and other serotonergic drugs.
Cimetidine, with simultaneous use, increases the concentration of citalopram in the blood and enhances its effect.
Siozam weakly interacts with drugs that are metabolized with the participation of cytochrome CYP2D6.
Cimetidine, used in combination with warfarin, increases prothrombin time by 5%.
If MAO inhibitors are used during antidepressant therapy, a hypertensive crisis (serotonin syndrome) may develop.
Analogs
Analogues of Siozam are: Adepress, Alventa, Amitriptyline, Anafranil, Asentra, Valdoxan, Venlaxor, Duloxenta, Calixta, Lerivon, Mirzaten, Noxibel, Oprah, Paxil, Paroxetine, Prozac, Sancipam, Selektra, Serlifteva, Flexetrin, Trittico Tsitol, Eisipe, Efevelon, etc.
Terms and conditions of storage
Store in a dry, dark place, out of the reach of children, at temperatures up to 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Siozam
Basically, patients leave positive reviews about Siozam, noting the effectiveness of this antidepressant drug.
In rare negative messages, there are complaints about the development of side effects, due to which the treatment had to be interrupted, including drowsiness, lethargy, lack of appetite, mood lability, tremors, palpitations, weakness.
Price for Siozam in pharmacies
The approximate price for Siozam in a dosage of 20 mg (20 pcs. In a package) is 336-360 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
