Serlift tablets p / o 50mg, no. 28

• Treatment and prevention of depressive conditions of varying severity (from mild to severe), including those accompanied by anxiety and suicidal attempts;

• Neurotic, somatoform depression;

• Post-traumatic stress disorder (PTSD);

• Obsessive-compulsive disorder (OCD);

• Treatment of panic disorders with or not accompanied by agoraphobia and other phobias;

• Treatment of anorexia nervosa, bulimia, and chronic pain syndromes.

The standard starting dose for Surlift is 50 mg once daily with or without food. The initial effect can appear after 7 days, the full effect of the drug usually appears after 2-4 weeks of treatment. If there is no effect, after a few weeks of admission, the dose can be gradually increased (by 50 mg per week) to a maximum dose of 200 mg per day in one dose.

With long-term use of Surlift, the patient is individually selected the minimum effective maintenance dose.
Does not require dose adjustment in elderly patients and patients with somatic burden.

Each coated tablet contains
sertraline hydrochloride 50 mg.

Auxiliary components: hyprollose -L, microcrystalline cellulose (Avicel PH 101 and Avicel PH 102), calcium hydrogen phosphate, magnesium stearate, sodium carboxymethyl starch, purified water.

Shell composition: purified water, white opadry dye OY-S-58910 (macrogol 400, titanium dioxide, talc, hypromellose).

• Hypersensitivity to the active substance or other ingredients that make up the drug

• Combined use of sertraline and MAO inhibitors

• Concomitant use of sertraline with tryptophan or phenylfluramine

• Combined use with pimozide

• Epilepsy during exacerbation

• Children under 6 years of age

• Pregnancy and lactation

Dosage form:

film-coated tablets.

Composition:

Surlift 50 mg.
Each coated tablet contains
sertraline hydrochloride 50 mg.

Surlift 100 mg.
Each
film- coated tablet contains Sertraline hydrochloride 100 mg.

Auxiliary components: hyprollose -L, microcrystalline cellulose (Avicel PH 101 and Avicel PH 102), calcium hydrogen phosphate, magnesium stearate, sodium carboxymethyl starch, purified water.

Shell composition: purified water, white opadry dye OY-S-58910 (macrogol 400, titanium dioxide, talc, hypromellose).

Pharmacotherapeutic group:

antidepressant

ATX code: No. 06A B06

Pharmacological properties

Pharmacodynamics

Sertraline is a potent and selective serotonin reuptake inhibitor (5HT). In clinical doses, sertraline blocks the uptake of serotonin in human platelets.
Sertraline has no affinity for muscarinic (cholinergic), serotonin, dopamine, histamine, benzodiazepine and adrenergic receptors.

Sertraline does not cause drug dependence, does not have m-anticholinergic and cardiotoxic effects. Does not increase the activity of the sympathetic nervous system.

Unlike tricyclic antidepressants, it does not increase body weight.

Pharmacokinetics

Sertraline is slowly absorbed from the gastrointestinal tract. Food intake does not significantly affect the bioavailability of the drug. Sertraline is actively metabolized by the first pass through the liver. The main metabolite, N-desmethylsertraline, is significantly inferior in activity to sertraline and has practically no antidepressant effect. Equilibrium concentrations are reached after about a week of treatment (once a day), while a two-fold cumulation of the drug is observed. Plasma protein binding is 98%.

The average elimination half-life of sertraline is 22-36 hours. Sertraline and N-desmethylsertraline are actively biotransformed, the resulting metabolites are excreted in the feces and urine in equal amounts. Only 0.2% of sertraline is secreted by the kidneys unchanged. The pharmacokinetics of the drug in elderly and young patients does not differ significantly.

Sertraline passes into breast milk.

There is no data on its ability to pass through the blood-placental barrier.

Sertraline is not dialyzed.

Indications

• Treatment and prevention of depressive conditions of varying severity (from mild to severe), including those accompanied by anxiety and suicidal attempts;

• Neurotic, somatoform depression;

• Post-traumatic stress disorder (PTSD);

• Obsessive-compulsive disorder (OCD);

• Treatment of panic disorders with or not accompanied by agoraphobia and other phobias;

• Treatment of anorexia nervosa, bulimia, and chronic pain syndromes.

Contraindications

• Hypersensitivity to the active substance or other ingredients that make up the drug

• Combined use of sertraline and MAO inhibitors

• Concomitant use of sertraline with tryptophan or phenylfluramine

• Combined use with pimozide

• Epilepsy during exacerbation

• Children under 6 years of age

• Pregnancy and lactation

Pregnancy and lactation

Adequate controlled trials of sertraline in pregnant and lactating women have not been conducted, Surlift can be prescribed in the case when the intended benefit to the mother outweighs the possible risk to the fetus and child.

Method of administration and dosage

The standard starting dose for Surlift is 50 mg once daily with or without food. The initial effect can appear after 7 days, the full effect of the drug usually appears after 2-4 weeks of treatment. If there is no effect, after a few weeks of admission, the dose can be gradually increased (by 50 mg per week) to a maximum dose of 200 mg per day in one dose.

With long-term use of Surlift, the patient is individually selected the minimum effective maintenance dose.
Does not require dose adjustment in elderly patients and patients with somatic burden.

Overdose

Sertraline overdose did not show severe symptoms even when the drug was prescribed in high doses.

Overdose symptoms: tremor, disorientation, restlessness, muscle hypertonicity, hyperreflexia, myoclonic twitching, first in the feet, then spread throughout the body, abdominal cramps, flatulence, diarrhea, nausea, vomiting, dyspepsia.

Overdose treatment: there are no specific antidotes. To reduce absorption, gastric lavage, the use of activated carbon is possible. It is necessary to ensure normal airway patency, oxygenation and ventilation of the lungs. The functions of vital organs should be monitored, symptomatic and supportive therapy should be carried out.

Interaction with other medicinal products

Cases of serious side effects have been reported in patients receiving sertraline in combination with MAO inhibitors. Concomitant use of sertraline with diazepam or tolbutamide may alter the serum levels of these drugs.

With the simultaneous administration of sertraline (200 mg per day) and warfarin, a slight increase in prothrombin time is possible. It is necessary to monitor this indicator at the beginning of treatment with sertraline and after its cancellation. Cimetidine causes a decrease in the clearance of sertraline when used together.

Sertraline can inhibit the metabolism of tricyclic antidepressants, so caution should be exercised when these drugs are used concomitantly.

special instructions

Surlift should not be administered in conjunction with MAOIs, as well as within 14 days after stopping treatment with MAOIs. After the cancellation of Surlift, an MAOI is not prescribed for 14 days. During treatment with Serlift, care must be taken when driving vehicles and potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

Tablets 50 mg and 100 mg.

14 pieces in a blister; 2 blisters with instructions for use in a cardboard box.

Storage conditions

Store in a dry place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

3 years.

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

Vacation conditions

On prescription.