A-Depresin - instructions for use of the drug, structure, Contraindications

A-Depressin is an antidepressant drug.

A-Depressin: indications and dosage

Indications of the drug A-Depressin:
The main purpose of the drug – severe depression
A-Depresin is intended for daily use, once a day, in the morning or before bed. Eating does not affect the properties of the drug.

A-Depressin: dosage

The standard adult dose is 50 mg. Taking into account the habituation and therapeutic effect, the dose can be gradually increased.. Changing the dosage of the drug is recommended not earlier than, than a week after the start of the course and no more than once a 7 days, taking into account the period of partial elimination of the main component of the drug - sertraline (1 once a day). The degree of increase in the dose is 50 mg.

The maximum dose per day, no more 200 mg. In the course of a long course of use, it is necessary to gradually reduce the dose while monitoring the reaction of the patient's body..

The use of the drug by the elderly.

In elderly patients, the period of partial elimination of substances from the body is longer, therefore, the minimum dosage of A-Depresin is recommended for admission.
The use of the drug by people with impaired liver function.
Precautions to be taken in patients with liver problems. In such cases, you need to take the minimum dose or increase the maximum interval between doses..
The use of the drug by people with impaired renal function.
Patients with impaired renal function and the excretory system need a dosage adjustment by the attending physician..

A-Depressin: overdose

A-Depresin has a high overdose threshold. Cases of an overdose of A-Depresin have been recorded when taking a dose up to 13,5 g. Deaths from increasing the dose of the drug were most often observed in conjunction with other drugs and / or alcoholic drinks. Therefore, during an overdose, intensive care is necessary..

Overdose symptoms include side effects indirect to serotonin, such as drowsiness, disorders of the gastrointestinal tract (eg, nausea and vomiting), tachycardia, tremor, agitation and dizziness. Sometimes coma developed. There is no specific treatment, as there are no specific antidotes for sertraline. It is necessary to ensure the patency of the airways, proper oxygenation and ventilation. Activated carbon, which can be used together with sorbitol, may be less effective., than vomiting or flushing, and should be considered for its use in the treatment of overdose. Monitoring of vital signs and cardiac activity is recommended along with general symptomatic and supportive measures.. Due to the large volume of distribution of sertraline, forced diuresis, dialysis, hemoperfusion and exchange transfusion will not be effective.

A-Depressin: side effects

Adverse reactions of A-Depresin are classified by organ systems and frequency of occurrence. (very common: ≥1 / 10; common: ≥1 / 100 – <1/10; infrequently: ≥1 / 1000 – <1/100; rarely: ≥1 / 10 000 – <1/1000, rarely <1/10 000).

mental disorders: Very common: insomnia, drowsiness, anorexia. Often: pathological yawning, ažitaciâ, anxiety. Rarely: euphoria, depressive symptoms, hallucinations, craze, hypomania. Rarely: decreased libido (men and women), nightmares, aggressive reactions, psychoses, suicidal thoughts (behavior).

Gastrointestinal tract: Very common: nausea, diarrhea, dry mouth. Often: dyspepsia, vomiting, abdominal pain. Rarely: pancreatitis, increased appetite.

urinary system: Rarely: urinary incontinence. Rarely: urinary retention, swelling of the face.

Blood and lymphatic system: Often: purpura, Platelet dysfunction, changed hemorrhagic diathesis (For Example, with nosebleeds, gastrointestinal bleeding or hematuria). Rarely: leukopenia, thrombocytopenia.

endocrine system: Rarely: galactorrhea, gynecomastia, hyperprolactinemia, gipotireoidizm, hypoaldosteronism syndrome.

metabolism: Rarely: giponatriemiya.

nervous system: Very common: headache, movement disorders (including extrapyramidal symptoms, such as hyperkinesia, increased muscle tone, teeth grinding and gait disturbance), paresthesia, gipesteziya, tremor, dizziness. Rarely: migraine. Rarely: psychomotor agitation / akathisia, involuntary muscle contractions, coma, seizures, signs and symptoms, associated with serotonin syndrome: ažitaciâ, confusion, sweating, diarrhea, fever, arterial hypertension, rigidity and tachycardia. In some cases, these symptoms arose in connection with the combined use of serotonergic drugs.

organ of vision: Often: blurred vision. Rarely: midriaz.

The organ of hearing / vestibular apparatus: Often: tinnitus.

Cardiovascular system: Often: chest pain, heartbeat. Rarely: arterial hypertension, fainting, tachycardia.

respiratory system: Rarely: bronchospasm.

hepatobiliary system: Rarely: severe liver (hepatitis, jaundice, hepatic failure) and asymptomatic elevation of plasma transaminases (ATL and AST).

Skin and subcutaneous tissue: Often: rash. Infrequently: itch, baldness, erythema multiforme. Rarely: skin photosensitivity reactions, hives, angioedema, severe cases of exfoliative skin lesions, e.g. Stevens-Johnson syndrome and epidermal necrolysis).

Musculoskeletal system: Rarely: arthralgia.

reproductive system: Very common: sexual dysfunctions (primarily, delayed ejaculation in men), menstrual irregularities Rarely: priapism.

general disorders: Often: desudation, asthenia, fatigue, hot flushes. Infrequently: malaise, weight gain, weight loss, fever. Rarely: anaphylactoid reactions, allergic reactions, allergy.

laboratory parameters: Rarely: pathological indicators of laboratory tests.

Other: withdrawal reactions with sertraline. Avoid abrupt discontinuation of sertraline treatment. Most symptoms, that occur when sertraline is discontinued, are mild and disappear after discontinuation of the drug.

A-Depressin: Contraindications

Contraindications to the drug A-Depressin:

• Hypersensitivity to sertraline and other components of the drug
• concomitant use with a monoamine oxidase inhibitor (MAOI) and with pimozide.

A-Depressin: interactions with other drugs and alcohol

Interaction of A-Depressin:

Drugs, acting on the central nervous system: caution is advised when sertraline is co-administered with another medicinal product, acting on the central nervous system. In particular, serotonin reuptake inhibitors have the potential to interact with tricyclic antidepressants, leading to increased plasma levels of tricyclic antidepressants. A possible mechanism for this interaction is the inhibitory effect of serotonin reuptake inhibitors on the CYP 2D6 isoenzyme.. Serotonin reuptake inhibitors show variability in terms of severity of inhibition of CYP 2D6 activity. Its clinical significance depends on the severity of inhibition and the therapeutic index of the drug., injectable concomitant. In practical interaction studies, long-term use 50 mg of sertraline per day showed a minimal increase (on average 23-37%) plasma levels of desipramine in the plateau phase (marker of CYP 2D6 enzyme activity).

Alcohol: The concomitant use of sertraline and alcohol in patients with depression is not recommended..

lithium and tryptophan: combined administration of sertraline and lithium leads to increased tremor, indicating a possible pharmacodynamic interaction. Other cases of increased effects have also been reported., when serotonin reuptake inhibitors were administered with lithium or tryptophan, therefore, the simultaneous use of serotonin reuptake inhibitors with these drugs should be carried out with caution.

Drugs, affect platelet function, such as non-steroidal anti-inflammatory drugs.

Because sertraline binds to plasma proteins, Consideration should be given to the possibility of interactions with other medicinal products., that bind to plasma proteins.

Co-administration of sertraline (200 mg per day) and diazepam or tolbutamide causes minor, a statistically significant change in some pharmacokinetic parameters. Simultaneous administration with cimetidine causes a significant decrease in the clearance of sertraline. The clinical significance of these changes is not known. Sertraline does not affect the ability of atenolol to block beta-adrenergic receptors.. No interaction of glibenclamide or digoxin with sertraline was observed. (200 mg per day).

Co-administration of sertraline (200 mg per day) and warfarin leads to a small, but a statistically significant increase in prothrombin time, the clinical significance of which is unknown. Prothrombin time should be carefully monitored when starting or stopping treatment with sertraline..

Sertraline (200 mg per day) does not potentiate the action of carbamazepine, haloperidol or phenytoin on cognitive and psychomotor function in healthy individuals.

A-Depressin: composition and properties

active substance : 1 tablet, coated liner, It contains 50 mg or 100 mg sertraline (as hydrochloride)

Excipients:

core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, povidone, sodium croscarmellose, magnesium stearate

shell:

tablets 50 mg opadri 12F20984 blue (gipromelloza, Titanium dioxide, macrogol, polysorbate, indigo)

tablets 100 mg Opadry 12F22609 yellow (gipromelloza, Titanium dioxide, macrogol, polysorbate, iron oxide yellow, iron oxide black).

A-Depressin: release form

Pills, Film-coated.

A-Depressin: pharmachologic effect

Pharmacological

Sertraline is a potent specific neuronal serotonin reuptake inhibitor. (5-HT) in vitro which leads to increased effects of 5-HT in animals. Sertraline also has little effect on serotonin reuptake in human platelets.. The drug does not stimulate, sedative, anticholinergic activity or cardiotoxicity in animals. In controlled studies in healthy individuals, sertraline did not cause sedation and does not affect psychomotor functions.. Due to its selectivity for inhibition of serotonin reuptake, sertraline does not stimulate catecholaminergic activity. Besides, sertraline does not show affinity for muscarinic, serotonergic, dopaminergic, histaminergic, benzodiazepine, GABA or adrenergic receptors. Long-term use of sertraline leads to a decrease in the activity of adrenergic receptors in the brain..

Pharmacokinetics

Sertraline has a dose-dependence of pharmacokinetic parameters in the range 50-200 mg. After oral administration of sertraline for 14 day dose 50-200 mg once daily, peak blood levels are reached through 4,5-8,4 hours after admission.

With daily administration of sertraline, a plateau phase is reached after one week.. The plasma half-life of sertraline is approximately 26 hours with an average elimination half-life in young people and the elderly from 22 to 36 hours. Sertraline about 98% bound to plasma proteins. The major metabolite, N-desmethylsertraline, is inactive on models of depression live and exhibits a half-life of approximately 62-104 o'clock. Sertraline and N-desmethylsertraline are extensively metabolized in men, with metabolites, formed are excreted in feces and urine in equal amounts. Only a small amount (<0,2%) sertraline is excreted in the urine in unchanged form.

Displaying, that the pharmacokinetics of sertraline in pediatric patients with OCD is similar to that in adults (although sertraline is metabolized somewhat more efficiently in pediatric patients).

But, lower doses may be recommended for pediatric patients due to low body weight (especially aged 6-12 years), to prevent too high plasma levels.

The pharmacokinetics of sertraline in elderly patients is similar to that in younger patients.. Food does not significantly affect the bioavailability of sertraline tablets., coated.

Storage conditions: A-Depresin should be stored at a temperature no higher than 25 ° C out of the reach of children.

A-Depressin: general information

• Sales form: on prescription
• Current in-about: Sertraline
• Manufacturer: TEVA Pharmaceutical Industries Ltd, Israel