Composition
1 coated tablet contains:
Active ingredient:
sertraline hydrochloride 100 mg
Pharmacological action
Sertraline is a powerful and selective serotonin reuptake inhibitor (5 HT). 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-holinoblokiruyushchy and cardiotoxic effects. It 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 undergoes active first-pass metabolism through the liver. The main metabolite, N-desmethylsertraline, is significantly less active than sertraline and has virtually no antidepressant effect. Steady-state concentrations are reached after approximately one week of treatment (once a day), with a twofold accumulation of the drug. Binding to plasma proteins is 98%.
The average half-life of sertraline is 22-36 hours. Sertraline and N-desmethylsertraline are actively biotransformed, the resulting metabolites are excreted in the faeces and urine in equal amounts. Only 0.2% of sertraline is secreted unchanged by the kidneys. The pharmacokinetics of the drug in elderly and young patients do 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 states of varying severity (from mild to severe), including those accompanied by feelings of anxiety and suicidal attempts;
- Neurotic, somatoform depressions;
- Post-traumatic stress disorder (PTSD);
- Obsessive-compulsive disorder (OCD)
- Treatment of panic disorders, whether or not accompanied by agoraphobia and other phobias;
- Treatment of anorexia nervosa, bulimia and chronic pain syndromes.
Use during pregnancy and lactation
Adequate controlled trials of sertraline in pregnant and lactating women have not been conducted, and Serlift may be prescribed when the intended benefit to the mother outweighs the possible risk to the fetus and child.
Contraindications
- Hypersensitivity to the Active ingredient or other ingredients that are part of the Serlift preparation.
- Combined use of sertraline and MAO inhibitors
- Co-use of sertraline with tryptophan or phenylfluramine
- Combined use with pimozide
- Acute epilepsy
- Children under 6 years of age
- Pregnancy and lactation
Side effects
Nervous system and sensory disorders: drowsiness, dizziness, headache, insomnia, confusion, amnesia, ataxia, discoordination, hyper – and paresthesia, hyperkinesis, hypo – and dyskinesia, extrapyramidal disorders, convulsions, mydriasis, nystagmus, ptosis, hyporeflexia, aggressiveness, anxiety, psychosis, amnesia, apathy, depersonalization, emotional lability, euphoria, hallucinations, paranoid reactions, somnambulism.
Cardiovascular and blood disorders (hematopoiesis, hemostasis): arterial hypertension or hypotension, palpitations, chest pain, anemia; rarely-tachycardia, collaptoid conditions.
From the digestive tract: dry mouth, decreased appetite up to anorexia (rarely — increased appetite, possibly as a result of the elimination of depression), dyspeptic disorders (flatulence, nausea, vomiting, diarrhea or unstable stools, constipation), stomach cramps, abdominal pain, pancreatitis, changes in liver tests, hepatitis, jaundice or liver failure, dysphagia, irritation of the gastrointestinal mucosa, glossitis, hypertrophy gums, ulcerative stomatitis.
Respiratory system disorders: chest tightness.
From the genitourinary system: delayed ejaculation, decreased libido, erectile dysfunction, anorgasmia, menstrual disorders, gynecomastia, priapism, dysuria, hyperprolactinemia, galactorrhea.
Allergic reactions: redness of the skin, urticaria; swelling of the face or lips; skin rash, generalized pruritus, erythema multiforme.
Other: edema (including periorbital), arthralgia, lymphadenopathy, increased sweating, weight loss, withdrawal syndrome.
Interaction
Serious side effects have been reported in patients receiving sertraline in combination with MAO inhibitors. Concomitant use of sertraline with diazepam or tolbutamide may cause changes in serum levels of these drugs.
With simultaneous use 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 sertraline treatment and after its cancellation. Cimetidine causes a decrease in sertraline clearance when used together.
Sertraline can inhibit the metabolism of tricyclic antidepressants, so caution should be exercised when using these drugs simultaneously.
How to take, course of use and dosage
The standard initial dose of Serlift is 50 mg once a day, regardless of food intake. The initial effect may appear after 7 days, the full effect of the drug usually appears after 2-4 weeks of treatment. In the absence of an effect, after several weeks of use, the dose can be gradually increased (by 50 mg per week)to a maximum dose of 200 mg per day in one dose.
With prolonged use of Serlift, the minimum effective maintenance dose is individually selected for the patient. It does not require dose adjustment in elderly and somatic patients.
Indications |
Initial daily dosage (mg) |
Effective daily dosage (mg) |
Adults |
||
Depression |
50 |
100-200 |
Obsessive-compulsive disorders |
50 |
75-200 |
Panic disorders |
25 |
50-200 |
Post traumatic stress disorder |
25 |
50-200 |
Generalized anxiety disorder |
50 |
50-200 |
Social phobias |
50 |
50-150 |
Premenstrual syndrome in women |
50 |
50-100 |
Children 6-12 years old |
||
Obsessive-compulsive disorders |
25 |
50-100 |
Teenagers aged 13-17 |
||
Obsessive-compulsive disorders |
50 |
50-150 |
Overdose
Severe symptoms of sertraline overdose were not detected even when the drug was prescribed in large doses.
Symptoms of overdose: tremor, disorientation, restlessness, muscle hypertonia, 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. Gastric lavage and the use of activated charcoal may be used to reduce absorption. It is necessary to ensure normal airway patency, oxygenation and ventilation of the lungs. It is necessary to monitor the functions of vital organs, carry out symptomatic and supportive therapy.
Special instructions
Serlift should not be administered in conjunction with MAOI, or within 14 days of discontinuation of MAOI treatment. After the Serlift is canceled, no MAOIs are prescribed for 14 days. During treatment with Serlift, care should be taken when driving vehicles and potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Film-coated tablets
Storage conditions
In a dry place, at a temperature not exceeding 25 °C
Shelf life
3 years
Active ingredient
Sertraline
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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