Serenata - description of the drug, instructions for use, reviews

There are restrictions during pregnancy

Has restrictions when breastfeeding

Has restrictions for children

Can be taken by older people

Has limitations for liver problems

Can be taken for kidney problems

When neuroses and depressive states reach a severe stage, it is impossible to cope with this problem on your own. To speed up the recovery process, specialists prescribe antidepressant medications. Today, Serenata is especially popular - it is a sertraline-containing drug (hereinafter referred to as the drug), which has pronounced antidepressant properties. According to the instructions for use, Serenata can be used both in adult practice and in pediatrics.

Packaging of the drug Serenata

General information about Serenata

Serenate is a selective serotonin reuptake inhibitor. The active substance of the medication affects chemical processes that lead to the development of depression, anxiety, and panic attacks.

It should be remembered that this drug affects the nervous system. In medical practice, there have been cases when young patients (18-24 years old) experienced suicidal thoughts when taking Serenata. The medication has a high degree of effectiveness and has a beneficial effect on the patient’s condition, provided that he follows all the recommendations of the attending physician.

Drug group, INN, scope of application

Serenata belongs to the pharmacotherapeutic group of antidepressants. INN – sertraline. In therapeutic doses, the active component of the drug has an inhibitory effect on the uptake of serotonin in platelets.

Used in diagnosing severe or prolonged depressive conditions. As a rule, it is prescribed to adults, but sometimes pediatricians use the drug to treat children over 6 years of age with obsessive-compulsive disorder.

Release forms and prices for the drug, average in Russia

Manufacturers produce the medicine in tablet form. The tablets are oval in shape and coated with a special soluble film coating.

The cost of a medicinal product (MP) depends on the dosage of the active substance. You can buy it at any pharmacy in your city.

The antidepressant is available with a doctor's prescription.

Compound

The mechanism of action of the tablets is determined by the main active ingredient – ​​sertraline. The substance is a white crystalline powder. It dissolves poorly in water and well in ethanol. Sertraline is a derivative of tametraline. Under its influence, the influence of the neurotransmitter on the nervous system increases.

The drug also contains auxiliary components:

• microcrystalline cellulose;
• anhydrous calcium hydrogen phosphate;
• sodium carboxymethyl starch;
• hyprolose;
• magnesium stearate;
• polysorbate-80.

The film shell consists of titanium dioxide, hypromellose, propylene glycol.

Pharmacodynamics and pharmacokinetics

A powerful antidepressant has little effect on the reuptake of dopamine and norepinephrine. Blocks the uptake of serotonin by the presynaptic membrane of neurons in the brain. When used for a long period, a decrease in the number of adrenergic receptors in the central nervous system is observed.

According to the results of many clinical studies, LP does not have sedative, anticholinergic or stimulant properties. Does not cause psychological or physical dependence.

Penetrating into the body, it is absorbed completely, but slowly. The level of maximum concentration in blood plasma is recorded after 4.5-8 hours. The presence of food in the stomach slows down the absorption process.

Approximately 98% of the active component binds to proteins. Active biotransformation occurs in the liver. The half-life is 62-104 hours. An equal amount of the substance is released with feces and urine. About 13% remains in its original form.

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Release form and composition

The dosage form of Serenata is film-coated tablets: biconvex, capsule-shaped, with a dividing line on one side, the color of the shell and the color at the break - from white to almost white (in blisters of 10 pcs., in a cardboard pack of 3 or 5 blisters).

Composition per 1 tablet:

• active ingredient: sertraline (in the form of hydrochloride) – 50 or 100 mg;
• auxiliary components: microcrystalline cellulose, sodium carboxymethyl starch, calcium hydrogen phosphate dihydrate, polysorbate, hydroxypropylcellulose, magnesium stearate;
• shell: propylene glycol, hypromellose, titanium dioxide.

Indications and contraindications

The need to take pills is determined by a qualified specialist after an examination. The list of indications includes:

1. Social phobia (fear of large crowds of people).
2. Panic disorders.
3. Post-traumatic stress disorders.
4. Long-term depression.
5. Obsessive-compulsive disorders (OCD) in adults and children.

Before starting treatment, you should familiarize yourself with the contraindications. Conditions under which it is prohibited to take this drug include:

• hypersensitivity to the main component;
• unstable form of epilepsy.

It is not recommended to take the drug simultaneously with tryptophan, pimozide, fenfluramine and monoamine oxidase inhibitors.

With increased caution, tablets are prescribed to patients with mental retardation and other brain pathologies, liver/renal failure, epilepsy, and low body mass index.

To date, the issue of the drug’s effect on fetal development has not been fully studied. In this regard, doctors recommend avoiding the use of Serenata. If a woman is of reproductive age and there is a need to undergo treatment, contraception should be taken during this period to avoid conception.

Research results have shown that a small amount of the active substance passes into breast milk. To protect the newborn from negative effects, you need to stop using the medication or interrupt lactation. In pediatrics, the drug is prescribed from the age of 6 years.

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Instructions for use of Citalopram, reviews of the drug from patients and doctors, its analogues

Use during pregnancy and lactation

Adequate, strictly controlled clinical studies on the safety of Serenata during pregnancy have not been conducted. It is contraindicated to prescribe the drug to pregnant women.

Patients of childbearing age who are to be treated with sertraline are required to use effective contraception.

There is no reliable data on the safety of Serenata during lactation. Sertraline is known to be excreted in breast milk. If you need to take the drug, you should stop breastfeeding.

Instructions for use of Serenata tablets

The treatment plan is drawn up by the doctor for each patient separately. It depends on the characteristics of his body, age and severity of the disease.

The tablets are intended to be taken orally once daily, with or without food. According to the standard instructions, for OCD or major depression, treatment should begin with 50 mg, in other cases - with 25 mg.

Once a week, it is allowed to increase the dose by 50 mg, provided that the medicine is well tolerated by the patient. The maximum allowable amount should not exceed 200 mg/24 hours.

The therapeutic effect appears approximately a week after the start of treatment. The duration of the course can be up to 6 months. It depends on the type and severity of the disease.

In childhood and adolescence, the recovery process should take place under the supervision of a doctor. Children 6-12 years old can take 25 mg of LP per day, from 12 to 17 - 50 mg once a day.

It is recommended to take the tablets at the same time every day. This will help avoid accumulation of the substance in the body. For patients of retirement age, a pediatric dosage is also suitable.

Upon completion of the therapeutic course, the dosage should be reduced gradually. Otherwise, there is a risk of withdrawal syndrome.

special instructions

Since this antidepressant has a strong effect, its use has its own characteristics. You need to familiarize yourself with them in the first stages of treatment.

The list of special recommendations for the use of the drug includes the following:

1. It is strictly forbidden to take tablets less than 14 days after completing MAOI treatment.
2. It is necessary to regularly check the level of concentration of tricyclic antidepressants in the blood to determine the need to adjust the daily dose.
3. The use of the drug may cause slight dilation of the pupils, as a result, patients may develop angle-closure glaucoma.
4. If you have diabetes, you should regularly check your blood sugar levels.
5. The medication may affect the ability to drive. In this regard, it is advisable not to drive and avoid activities that require maximum concentration immediately after taking the pill.
6. It is prohibited to take alcoholic beverages at the same time as medication.
7. If a depressive state is accompanied by suicidal thoughts, the patient should be under the supervision of a doctor until positive dynamics appear.
8. In case of liver or kidney dysfunction, the general condition of the patient should be monitored. If necessary, the dose is adjusted.

Possible side effects and overdose

If drugs are poorly tolerated, negative reactions from internal organs or systems may occur. The most common side effects include:

• flatulence;
• disruptions in the functioning of the nervous system, accompanied by drowsiness, fatigue, changes in gait, numbness of the limbs or tongue, hearing loss, speech impairment, dizziness;
• pain in muscles and joints;
• change in the frequency of contractions of the heart muscle;
• disruptions of the menstrual cycle;
• sudden weight loss;
• increased sweating;
• hiccups;
• dyspnea;
• bronchospasm;
• rashes on the skin;
• exacerbation of infections.

These conditions are grounds for stopping taking Serenata.

Using medications for a long time or taking too large doses can cause an overdose. Intoxication is accompanied by nausea, arrhythmia, diarrhea, sweating, irritability, and rapid heartbeat.

First aid methods for overdose include gastric lavage. After this, the patient needs to take a sorbent (Enterosgel, Activated carbon, Atoxil, Polysorb).

To determine further actions, the patient should be taken to a medical facility. If necessary, forced diuresis or hemodialysis is performed in a hospital setting.

Drug interactions

Experts pay special attention to issues of Serenata’s interaction with other drugs. When used in combination, they can enhance or neutralize the therapeutic effect of each other.

It is strictly forbidden to combine an antidepressant with non-selective or selective monoamine oxidase inhibitors. This combination can cause vomiting, tremors, confusion, and mood swings.

Features of interaction with various medications:

• Serenate leads to increased concentrations of pimozide;
• in combination with drugs that contain lithium, tremor increases;
• sertraline concentration increases under the influence of clarithromycin, erythromycin, verapamil, diltiazem, nefazodone;
• cimetidine affects drug clearance;
• the substance does not react with digoxin;
• sertraline in combination with indirect anticoagulants causes an increase in prothrombin time.

If a person is already taking any medications, he should inform the doctor. This will help protect the body from unwanted consequences.

special instructions

There is insufficient data from studies of the use of Serenata in patients receiving ECT (electroconvulsive therapy), and therefore the possible success or risk of such a combination has not been studied.

Patients with depression represent a risk group for suicidal intentions and attempts. This danger persists until the remission phase and requires constant medical monitoring of patients from the start of the course until an acceptable clinical effect is achieved.

The simultaneous use of Serenata and drugs that depress the central nervous system should be carried out with extreme caution and under careful monitoring of the patient's condition.

Drinking alcohol during treatment is prohibited.

Impact on the ability to drive vehicles and complex mechanisms

Sertraline, as a rule, does not cause impairment of psychomotor functions. However, when used in combination with other drugs, concentration and coordination of movements may be impaired. In this regard, engaging in potentially hazardous activities and driving vehicles and special equipment are not recommended.

Analogues of Serenata

Analogs of Serenata can be divided into two large groups. The first includes drugs with a similar composition, and the second - with an identical mechanism of action.

The most optimal medications to replace Serenata are:

1. Zoloft (350 rubles). Available in the form of tablets that contain sertraline. The medicine has antidepressant properties. Indications for use are similar to the original. Helps block the uptake of serotonin into platelets.
2. Fluxen (from 36 rubles). Capsules containing fluoxetine hydrochloride (

pharmachologic effect

The essence of the drug's action is to selectively inhibit the reuptake of serotonin.
The active element sertraline hydrochloride has a negligible effect on the reverse blocking of dopamine and norepinephrine. The antidepressant effect appears after two weeks of systematic use of the medication. The greatest effect is observed only after six weeks of regular use. Sertraline does not develop drug dependence.

Medicinal doses of the active component provoke blocking the uptake of serotonin by blood bodies. The medication does not have a sedative, stimulating or anticholinergic effect. Constant use of Serenate does not provoke weight gain (unlike antidepressants with a tricyclic structure).

Sertraline hydrochloride formula

Reviews from doctors and patients about Serenate

In addition to instructions for use, before starting treatment, you can read reviews from specialists and patients. They will help form an idea of ​​the effectiveness and safety of the medicine.

Alexey, 29 years old: “I went to the doctor with signs of social phobia. I work remotely, but sometimes I have to go on business trips. This is a real test for me. Even a banal exit to the market or to the store ends in a panic attack. The psychotherapist prescribed Serenata and drew up a treatment regimen. Gradually I began to notice an improvement in my condition. Now the course is coming to an end, and the doctor is preparing a regimen for discontinuing the medication. Over the past six months I have only had one panic attack. I can freely go shopping and travel on public transport. I was afraid of suicidal thoughts, fortunately, they did not arise. Anxiety and neuroses have subsided.”

Irina, 36 years old: “In the first couple of days of treatment with the pills, I developed dizziness, nausea, and headache, but after a week they went away. It seemed to me that the drug helps me fight neuroses and irritability. After 6 months, I noticed that, in addition to negative ones, positive emotions also disappeared. Nothing made me happy, not even my son’s victory in the regional Olympiad. A strange inner emptiness appeared.”

Dmitry Lykov, psychiatrist: “I prescribe Serenata for conditions where weaker drugs do not give the desired effect. The fact is that this drug is quite aggressive and is best used in extremely severe cases. To eliminate mild symptoms, I prescribe less powerful medications. The only disadvantage I can think of is the cost. Not everyone can afford such an expensive medicine.”

Serenata has a high degree of effectiveness. When used correctly, it does not cause negative reactions. It is characterized by a mild antidepressant effect, thanks to which patients do not experience sudden mood swings and changes in condition.

Drug interactions

Contraindicated combinations:

• MAO inhibitors: sertraline is contraindicated to be used simultaneously, 1 week before and 2 weeks after the end of treatment with MAO inhibitors; MAO inhibitors can be prescribed 2 weeks after discontinuation of sertraline;
• pimozide: combined use of sertraline (200 mg per day) and pimozide (2 mg once) led to an increase in pimozide concentrations; Due to insufficient data on the mechanism of this interaction and the narrow therapeutic index of pimozide, their simultaneous use is contraindicated.

Possible interaction of Serenata with other substances/drugs:

• haloperidol, carbamazepine, ethanol, other CNS depressants: despite the fact that no enhancement of their effect on psychomotor and cognitive functions was observed in healthy people, use with sertraline requires caution;
• fenfluramine, tryptophan, 5-HT agonists, tramadol, St. John's wort preparations, other drugs/substances affecting serotonergic neurotransmission: given the risk of pharmacodynamic interaction with sertraline, their combined use should be avoided if possible or caution should be exercised when prescribed concomitantly with Serenata;
• fentanyl, other serotonergic agents (including serotonergic antidepressants), other opioids: caution should be used when used concomitantly with sertraline;
• lithium preparations: the pharmacokinetics of lithium does not change, but there is an increase in tremor, which indicates a possible pharmacodynamic interaction with sertraline; constant monitoring of plasma lithium concentration is required for the purpose of dose adjustment, as well as monitoring of patients;
• phenytoin: with long-term use of sertraline (200 mg per day), the metabolism of phenytoin is not clinically significantly inhibited; in some episodes, an increase in the concentration of phenytoin was observed, and therefore monitoring of its plasma concentration is recommended, especially in patients with concomitant diseases who are/are not receiving other therapy at the same time, and adjustment of the dosage regimen, if necessary; phenytoin can reduce plasma concentrations of sertraline;
• carbamazepine, phenobarbital, St. John's wort preparations, rifampicin, other inducers of the CYP 3A4 isoenzyme: may reduce the plasma concentration of sertraline;
• Triptans: Sumatriptan, when used with sertraline, caused weakness, hyperreflexia, incoordination, confusion, anxiety and agitation. Serotonergic syndrome may also develop when sertraline is used in combination with other triptans; if it is necessary to use sertraline and triptans simultaneously for medical reasons, it is important to ensure appropriate monitoring of the patient’s condition;
• warfarin, other indirect anticoagulants: use with sertraline (200 mg per day) slightly but statistically significantly increases prothrombin time, which can lead to a violation of the INR (international normalization ratio). Therefore, at the beginning of therapy with sertraline and when discontinuing it, careful monitoring of prothrombin time is required;
• atenolol: β-adrenergic blocking properties are not affected by sertraline;
• digoxin: no interaction with sertraline was detected when taken at a dose of 200 mg per day;
• cimetidine: significantly reduces the clearance of sertraline, the clinical significance of such changes is unknown;
• other SSRIs (selective serotonin reuptake inhibitors), including drugs containing sertraline; drugs that affect platelet function, such as NSAIDs (non-steroidal anti-inflammatory drugs), acetylsalicylic acid, ticlopidine; drugs that may increase the risk of bleeding: when taken with Serenata, the risk of bleeding increases;
• drugs that increase the QTc interval: the risk of prolongation of the QTc interval and the likelihood of developing a tachysystolic form of ventricular arrhythmia increases;
• diazepam, tolbutamide, warfarin, other drugs that are highly bound to plasma proteins: their interaction with sertraline is possible due to its high degree of binding to plasma proteins, the effect must be taken into account when used together;
• desipramine (a marker of the activity of the CYP 2D6 isoenzyme), other CYP 2D6 substrates with a narrow therapeutic index, such as class 1C antiarrhythmics (propafenone, flecainide), tricyclic antidepressants, typical antipsychotics: clinically significant interaction with sertraline is possible, especially against the background of its use in high doses and/or prolonged treatment;
• drugs metabolized by other cytochrome P450 isoenzymes (CYP 1A2, CYP 2C9, CYP 2C19, CYP 3A4): sertraline does not inhibit these isoenzymes in a clinically significant manner;
• grapefruit juice: drinking 3 glasses of juice daily increases the plasma concentration of sertraline by 2 times, so this combination should be avoided;
• potent inhibitors of the CYP 3A4 isoenzyme, such as itraconazole, ketoconazole, posaconazole, voriconazole, protease inhibitors, telithromycin, clarithromycin, nefazodone; moderate inhibitors of the CYP3A4 isoenzyme, such as aprepitant, erythromycin, fluconazole, verapamil, diltiazem: theoretically (based on data from studies of the interaction of sertraline with grapefruit juice), a significant increase in the exposure of sertraline can be expected, and therefore it is recommended to avoid its simultaneous use with potent inhibitors of the CYP isoenzyme 3A4;
• tolbutamide (CYP 2C9 isoenzyme): sertraline does not appear to inhibit cytochrome P450 CYP 2C9 isoenzymes;
• diazepam (CYP 2C19 isoenzyme): sertraline does not affect its serum concentration, indicating the absence of inhibition of the CYP 2C19 isoenzyme;
• lansoprazole, omeprazole, pantoprazole, other potent inhibitors of the CYP 2C19 isoenzyme: their effect on sertraline cannot be excluded, since patients with slow metabolism of the CYP 2C19 isoenzyme have a more than 50% increase in its plasma concentration compared to patients with rapid metabolism;
• CYP1A2 isoenzyme: according to the results of in vitro studies, sertraline has virtually no effect on this isoenzyme or minimally inhibits it;
• antipyrine: sertraline (200 mg per day) slightly (up to 5%), but significantly reduces the T1/2 index of antipyrine.

MAO inhibitors and other types of antidepressant drugs

1. Aurorix (the active ingredient is moclobemide).
2. Pyrazidol (the main component is pirlindol).

When using such drugs, you must completely abstain from alcoholic beverages. Taking antidepressants and alcohol in almost 100% of cases provokes the development of dangerous conditions - tyramine or serotonin syndrome, difficulty breathing. In addition, treatment with MAO must be accompanied by a strict diet, consumption of foods and medications indicated in the instructions for use.

Among the medications that are representatives of less popular medications, patients with depression may be prescribed:

1. Monoamine receptor agonists – Trazadone, Remeron, Calixta. Such products belong to the modern class of medications that have minor side effects.
2. Agomelatine, which stimulates melatonin receptors while simultaneously blocking serotonin receptors.

New generation antidepressants are popular in developed countries. The list of these includes Sertraline, Opipramol, Zoloft, Toloxatone, Cymbalta. Most of these products cause a weak stimulating effect and do not exhibit anticholinergic or cardiotoxic properties.

Overdose and additional instructions

There were no documented cases of negative symptoms from overdose. But parallel use with ethanol or other drugs can cause serious poisoning. When using the drug in a dose of more than 200 mg, serotonin syndrome occurs, which is manifested by vomiting, nausea, drowsiness, diarrhea, restlessness and excessive sweating.

There are no special antidotes to eliminate such symptoms. In this case, symptomatic supportive treatment and stable monitoring of body functions are used. You also need to monitor the airway patency. Instead of gastric lavage, it is recommended to administer activated carbon, which will be more effective.

Side effects include dry mouth, headache, lethargy, hypomania, decreased appetite and weight loss. During treatment, dyskinesia, spontaneous secretion of milk (in women), skin rash, convulsions and tremor were noted. If the medication is discontinued, decreased sensitivity, hallucinations, symptoms of depression and aggressive reactions very rarely occur.

During the therapeutic course it is prohibited to drink alcohol. Also, you should not take the medicine during pregnancy or lactation. Not prescribed until the age of six years.