Description
Release form
Coated tablets
Packing
30 pcs.
Pharmacological Action
Antidepressant. Selective serotonin reuptake inhibitor (5-HT). Serenate has a weak effect on the reuptake of norepinephrine and dopamine. At therapeutic doses, sertraline blocks the uptake of serotonin by human platelets. Sertraline does not have an affinity for muscarinic, serotonin, dopamine, adrenergic, histamine, GABA or benzodiazepine receptors. It does not have a stimulating, sedative or anticholinergic effect.
Indications
– depression of various etiologies (treatment and prevention)
– obsessive-compulsive disorder (OCD)
– panic disorder (with or without agoraphobia)
– post-traumatic stress disorder (PTSD).
Contraindications
– unstable epilepsy
– children under 6 years of age
– pregnancy
– lactation period
– combined use of sertraline and MAO inhibitors (when replacing one drug with another, you should refrain from taking antidepressants for 14 days) sertraline with tryptophan or fenfluramine
– hypersensitivity to Serenate components.
Use during pregnancy and lactation
Adequate and strictly controlled clinical studies of the safety of the drug Serenata during pregnancy have not been conducted. Prescribing the drug to pregnant women is contraindicated.
Special instructions
Sertraline should not be prescribed within 14 days after discontinuation of treatment with MAO inhibitors. MAO inhibitors are not prescribed within 14 days after the cancellation of sertraline.
Patients receiving electroconvulsive therapy lacked sufficient experience with the use of Serenate. The possible success or risk of such a combination treatment has not been studied.
Patients with depression are at risk for suicidal attempts. This danger persists until the development of remission. Therefore, from the beginning of treatment to the achievement of the optimal clinical effect, patients should be constantly monitored.
With the simultaneous use of the drug Serenate and drugs that have a depressing effect on the central nervous system, special care and careful monitoring of the patient’s condition are required.
Pediatric use
Caution is advised to use the drug in children over the age of 6 years.
During treatment, drinking alcohol is prohibited.
Influence on the ability to drive vehicles and control mechanisms
The appointment of sertraline, as a rule, is not accompanied by a violation of psychomotor functions. However, its use simultaneously with other drugs can lead to impaired attention and coordination of movements. Therefore, during treatment with sertraline, it is not recommended to drive vehicles, special equipment or engage in activities associated with increased risk.
Composition
1 tablet contains sertraline (in the form of hydrochloride) 100 mg
Dosage and Administration
Inside. For adults, Serenate is prescribed in an initial dose of 50 mg 1 time / day. in the morning or evening. The daily dose can be gradually increased, not earlier than a week later, from 50 mg to a maximum daily dose of 200 mg.
For children, the initial dose is 25 mg 1 time / day. in the morning or evening. After a week, the dose can be increased to 50 mg 1 time / day.
Side effects of the
From the digestive system: dry mouth, decreased appetite (rarely increased), up to anorexia, dyspeptic disorders (flatulence, nausea, vomiting, diarrhea), abdominal pain with prolonged use in 0.8% of cases – asymptomatic increased activity of transaminases in the blood serum (upon discontinuation of the drug, enzyme activity normalizes).
From the side of the central nervous system and peripheral nervous system: drowsiness, headache, dizziness, tremor, insomnia, anxiety, agitation, hypomania, mania, impaired gait, weakness, During treatment with sertraline, extrapyramidal disorders, dyskinesias, tremors, convulsions, and visual impairment were noted. Movement disorders were more often observed in patients with indications of their presence in the anamnesis or with the concomitant use of antipsychotic drugs.
From the endocrine system: ejaculation disorders, decreased libido, menstrual irregularities, hyperprolactinemia, galactorrhea.
From the side of metabolism: increased sweating, weight loss 0.8% (more often in elderly patients, as well as when taking diuretics or some other drugs) – transient hyponatremia (this side effect is associated with inadequate secretion of ADH).
Dermatological reactions: redness of the skin, skin rash rarely – erythema multiforme.
Drug interaction
With the simultaneous use of the drug Serenate and MAO inhibitors, both selectively acting (selegiline) and with a reversible type of action (moclobemide), serious complications, including serotonin syndrome, can develop. Similar complications, sometimes fatal, occur when prescribing MAO inhibitors during treatment with antidepressants that inhibit the neuronal uptake of monoamines or immediately after they are canceled. With the simultaneous use of selective serotonin reuptake inhibitors and MAO inhibitors, hyperthermia, rigidity, myoclonus, lability of the autonomic nervous system (rapid fluctuations in the parameters of the respiratory and cardiovascular systems), changes in mental status, including increased irritability, severe agitation, confusion, which in some cases can go into a delirious state or coma.
With the joint administration of coumarin and sertraline derivatives, a significant increase in prothrombin time is noted (it is recommended to control prothrombin time at the beginning of treatment with Serenat and after its withdrawal).
Pharmacokinetic interaction
Sertraline binds to plasma proteins. Therefore, it is necessary to take into account the possibility of its interaction with other drugs that bind to proteins (for example, with diazepam, tolbutamide and ivarfarin).
With simultaneous use with cimetidine, a significant decrease in sertraline clearance is observed. With prolonged treatment with sertraline at a dose of 50 mg / day in case of simultaneous use, an increase in the concentration in the blood plasma of desipramine is observed, which is metabolized with the participation of the CYP2D6 isoenzyme.
In experimental studies of the drug interaction in vitro, it was shown that metabolic processes involving CYP3A3 / 4 isoenzymes – beta-hydroxylation of endogenous cortisol and the metabolism of carbamazepine and terfenadine – do not change with prolonged administration of sertraline at a dose of 200 mg / day. The plasma concentration of tolbutamide, phenytoin and warfarin with long-term administration of sertraline in the same dose also does not change. Thus, we can conclude that sertraline does not inhibit the activity of the CYP2C9 isoenzyme.
Sertraline does not affect the concentration of diazepam in serum, which indicates the absence of inhibition of the CYP2C19 isoenzyme.
According to in vitro studies, sertraline has virtually no effect or minimally inhibits the CYP1A2 isoenzyme.
The pharmacokinetics of lithium does not change with the simultaneous use of sertraline, however, in such cases tremor is more often observed. As well as the appointment of other selective serotonin reuptake inhibitors, the combined use of sertraline with drugs that affect serotonergic transmission (e.g., lithium) requires increased caution. When replacing one inhibitor of neuronal uptake of serotonin with another, there is no need for a washing period. However, caution is required when changing the course of treatment.
Avoid co-administration of tryptophan or fenfluramine with sertraline.
Sertraline induces minimal induction of microsomal liver enzymes. The simultaneous administration of sertraline and antipyrine at a dose of 200 mg leads to a significant decrease in T1 / 2 of antipyrine, although this occurs in only 5% of cases.
With the simultaneous use of sertraline does not alter the beta-adrenergic blocking effect of atenolol.
With the simultaneous use of sertraline at a dose of 200 mg / day with glibenclamide or digoxin, drug interaction was not detected.
overdose
Symptoms: Severe symptoms of sertraline overdose have not been detected even with high doses. However, severe poisoning may occur when used with other drugs or ethanol. Overdose can cause serotonin syndrome with nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, psychomotor agitation, diarrhea, sweating, myoclonus and hyperreflexia.
Treatment: There are no specific antidotes. Intensive supportive therapy and constant monitoring of vital body functions are required. Causing vomiting is not recommended. The introduction of activated carbon may be more effective than gastric lavage. It is necessary to maintain the airway. Sertraline has high Vd, so increasing diuresis, dialysis, hemoperfusion, or blood transfusions may be ineffective.
Storage Conditions
In a dry, dark place at a temperature not exceeding 20 ° C.
Shelf life
2 years.
Deystvuyushtee substance
Sertraline
Terms and conditions
prescription
dosage form
tablets
Possible product names
SERENATE 0.1 N30 TABLE P / O
Serenate 100mg tab. p / o X30 (R)
Serenate 100mg tab. poststation X30 (R) /! until 01. 13g /
SERENATE TAB P / O 100 MG 30
SERENATE TAB P / O 100 MG 30 (02.12)
Torrent, India
