Reksetin: reviews of doctors, the correct dosage, the effect of the drug and a lot of useful information. Reksetin®: instructions for use

Reksetin is a Hungarian drug of the group, which has gained great popularity in our country. But like any other medicine, it suits some people perfectly, while others are rather difficult to tolerate. How to take Reksetin correctly, and how can it be replaced if necessary?

Characteristics of the drug Reksetin

The product is available in the form of round convex tablets coated with a white coating. The main active ingredient is paroxetine hydrochloride hemihydrate. Reksetin goes on sale in blisters, each of which contains ten tablets of 20 or 30 mg. Each package contains three blisters.

The drug is prescribed to people with mental disorders under the following conditions:

• various kinds (postpartum, masked, deep, etc.) In most cases, the daily dosage of Reksetin is 20 mg, the maximum allowable is 50 mg.
• For the treatment of social phobia, stress conditions and prolonged syndrome baseless anxiety, the initial dose is 20 mg per day and is increased by 10 mg weekly at the discretion of the attending physician.
• With panic disorders and obsessive-compulsive disorder, stably acting daily dose 40mg, maximum allowable 60mg.
• In cases of impaired liver and kidney function, the concentration of the drug in the human body increases significantly. Therefore, patients with renal or hepatic insufficiency, as well as all the elderly, are recommended to start treatment with a dosage not exceeding 10 mg under the constant supervision of specialists.

Rexetin is highly effective and has a number of side effects on the part of the digestive, nervous, autonomic, cardiovascular and reproductive systems. In most cases this is:

• and vomiting, stool disorders.
• Tremor of the limbs, irritability, excitability, or, on the contrary, weakness and drowsiness.
• Dizziness, temporal pain, increased pressure.
• Excessive perspiration and salivation.
• Ejaculatory disorders and libido disorders.
• Allergic reactions.

Often the human body reacts negatively to the drug in the first two to three weeks of treatment, after which the discomfort associated with severe tolerance disappears, and the symptoms of the underlying disease gradually recede. Most patients note an improvement in their general condition on the twentieth day of taking Reksetin.

The treatment of mental disorders is a long and painstaking process that takes months, and sometimes even years, requiring constant medical supervision. Under no circumstances should you start or stop taking antidepressant drugs without permission.

Analogues and substitutes

Reksetin is a potent and by no means cheap drug, depending on the region, its cost ranges from 750 to 1100 rubles. As a more affordable alternative, its analogues from Russian and foreign manufacturers can be used. Some of them are available both in the form of tablets and drops, which is much more preferable for many patients.

Adepress is considered the most successful of all existing copies of Reksetin, produced in Russia. It has a relatively low cost (from 420 to 580 rubles), a wide range clinical action, a small amount side effects, easily portable to initial stage, and completely absent afterwards. Available in the form of tablets and drops for oral administration.

Plizil is a Croatian drug, available in tablets and drops. Actions, indications for use and contraindications are identical to Reksetin, but the price is more attractive 380-480 rubles.

Paxil is an antidepressant similar to Rexetine. Produced on the basis of the same active substance and in the same dosage form. Used to treat mental disorders and prolonged depression, its cost in Russian pharmacies is 700-800 rubles per pack of 30 tablets. Producing countries: Romania, Poland, Great Britain, France.

Actaparoxetine is produced in Iceland and Malta, in the form of tablets of 20 mg or 30 mg. Unlike many identical drugs, Actaparoxetine does not contribute to the deterioration and inhibition of cognitive and psychomotor functions. Its cost is 480 rubles for 30 tablets of 20 mg, and 600-650 rubles for a pack of 30 mg tablets.

Cyrestill is an Italian analogue of Reksetin, available in the form of tablets, capsules and drops with a pronounced anise flavor. The most common and accessible form is drops in darkened bottles of 30 ml or 60 ml. The retail price of one bottle of 30 ml ranges from 800 to 1100 rubles.

All analogues of Reksetin are produced on the basis of the active substance Paroxetine, have identical properties, side effects and contraindications. However, before replacing the prescribed drug with an analogue, a mandatory consultation with the attending physician is required.

Experts consider Reksetin a potent drug and recommend taking it only in case of severe mental disorders that last for a long time. Mild depressive and anxiety states it can be cured by more gentle means.

Taking antidepressants should begin with minimal doses, gradually increasing them, according to the scheme drawn up by the doctor. In the first 15-20 days of taking the drug, 85% of patients have a relatively severe tolerability of the drug, it is very important to survive this period and continue treatment.

During treatment, doctors recommend that you stop driving a car and other dangerous forms of activity that require concentration and quick reactions. In a severe protracted state, many people are prone to impulsive acts and are at risk of suicide. Therefore, they need the support of loved ones and psychotherapy sessions.

A sharp rejection of antidepressants is not acceptable, treatment is stopped by gradually reducing the dosage according to the scheme drawn up by the doctor. Data medicines dispensed in pharmacies by prescription, contraindicated in women during pregnancy and lactation, children under 18 years of age. Accordingly, they should be used strictly according to the doctor's prescription, and stored in safe places inaccessible to children.

Antidepressant

Active substance

Release form, composition and packaging

white or almost white, round, biconvex, with a risk on one side and engraved "X 20" on the other.

Shell composition:

Film-coated tablets white or almost white, round, biconvex, with a risk on one side and engraved "X30" on the other.

Excipients: hypromellose, calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch, magnesium stearate.

Shell composition: hypromellose, macrogol 400, macrogol 6000, polysorbate 80, titanium dioxide.

10 pieces. - blisters (3) - packs of cardboard.

pharmachologic effect

Antidepressant. Inhibits reverse neuronal uptake in the CNS. It has little effect on the neuronal uptake of norepinephrine and dopamine. It also has an anxiolytic and psychostimulant effect.

Pharmacokinetics

Suction

After oral administration, paroxetine is well absorbed from the gastrointestinal tract. Simultaneous food intake does not affect the absorption and pharmacokinetics of paroxetine.

Distribution

Paroxetine binds to blood proteins by 93-95%. The equilibrium state is reached within 7-14 days after the start of therapy, in the future, the pharmacokinetics during long-term therapy does not change.

Metabolism

It is metabolized mainly in the liver with the formation of predominantly inactive metabolites.

breeding

T 1/2 of paroxetine ranges from 6 to 71 hours, but averages 24 hours. About 64% of paroxetine is excreted by the kidneys (2% - unchanged, 62% - in the form of metabolites); approximately 36% is excreted through the intestines, mainly in the form of metabolites, less than 1% - unchanged.

Pharmacokinetics in special clinical situations

The concentration of paroxetine in the blood plasma increases with impaired liver and kidney function, as well as in the elderly.

Indications

- depression of various etiologies, incl. conditions accompanied by anxiety;

- obsessive-compulsive disorders (compulsive disorder);

- panic disorders, incl. with the fear of being in a crowd (agoraphobia);

- social phobia;

- generalized anxiety disorder (GAD);

- post-traumatic stress disorder.

It is also used as part of anti-relapse treatment.

Contraindications

- hypersensitivity to the components of the drug;

- simultaneous reception of MAO inhibitors and a period of 14 days after their cancellation;

- pregnancy;

- lactation ( breast-feeding);

- children under 18 years of age (due to lack of clinical experience).

Rexetin should not be used in combination with thioridazine because, like other drugs that inhibit the CYP2D6 isoenzyme, paroxetine may increase plasma concentrations. Administration of thioridazine alone may result in QT prolongation on the ECG with concomitant serious ventricular arrhythmias such as ventricular tachycardia pirouette type, and cause sudden death.

Carefully the drug should be used in violation of the functions of cardio-vascular system, liver failure, chronic kidney failure, prostatic hyperplasia, as well as in elderly patients.

Paroxetine should be used with caution in the presence of a history of epilepsy. According to clinical observations, paroxetine causes epileptiform seizures in 0.1% of patients. It is necessary to interrupt the course of treatment of patients who have manifested such disorders.

Like other selective serotonin reuptake inhibitors (SSRIs), paroxetine causes mydriasis, so in the presence of glaucoma, the drug should be used with caution.

With the combined use of paroxetine with benzodiazepines (oxazepam), barbiturates, neuroleptics, there was no evidence of an increase in their sedative effect (drowsiness). There is little experience with the combined use of paroxetine with antipsychotics, so in these cases the drug should be used with caution.

Sufficient experience of the joint use of lithium with paroxetine or other serotonin reuptake inhibitors has not yet been accumulated, therefore this combination should be used with caution, under regular monitoring of the level of lithium in the blood.

Dosage

Reksetin should be taken 1 time / day, preferably in the morning, during meals, do not chew the tablets.

As with therapy with other antidepressants, depending on the clinical condition of the patient, after 2-3 weeks of therapy, the dose of the drug can be changed.

At depression the recommended daily dose is 20 mg. The effect in most cases develops gradually. In some patients, an increase in the dose of the drug is possible. The daily dose may be increased by 10 mg per week until a therapeutic effect is achieved; the maximum daily dose is 50 mg / day.

At obsessive-compulsive disorders(obsession syndrome) the initial dose is 20 mg / day. The dose may be increased by 10 mg per week until a therapeutic response is achieved. The maximum daily dose is usually 40 mg, but should not exceed 60 mg.

At panic disorder the recommended therapeutic dose is 40 mg/day. Therapy should be started with a small (10 mg/day) dose, with a weekly increase of 10 mg per week until the desired effect is achieved. The maximum daily dose should not exceed 60 mg. The recommended low initial dose of the drug is due to the possibility of a temporary increase in the intensity of the symptoms of the disease at the beginning of therapy.

At social phobias therapy can be started with a dose of 20 mg / day. If after a two-week course of treatment there is no significant improvement in the patient's condition, the dose of the drug can be increased weekly by 10 mg until the desired effect is achieved. The maximum daily dose should not exceed 50 mg. For maintenance therapy, the drug is used at a dose of 20 mg / day.

At generalized anxiety disorder the recommended therapeutic dose is 20 mg/day. Depending on the patient's response to therapy, the daily dose may be increased gradually by 10 mg per week; the maximum daily dose is 50 mg.

At post-traumatic stress disorder the recommended therapeutic dose is 20 mg/day. Depending on the patient's response to therapy, the daily dose may be increased by 10 mg, the maximum daily dose is 50 mg.

Depending on the clinical condition of the patient, prevent the possibility of relapse supportive therapy is necessary. Maintenance therapy after symptoms disappear depression can be 4-6 months, and with obsessive and panic disorders and more. As with other psychotropic drugs, abrupt discontinuation of the drug should be avoided.

At debilitated patients and the elderly the concentration of paroxetine in the blood serum may increase faster than usual, so the recommended initial dose is 10 mg / day. This dose can be increased by 10 mg weekly depending on the condition of the patient.

The maximum dose should not exceed 40 mg/day.

children due to lack of clinical experience, the drug is not indicated.

At renal (CC< 30 мл/мин) или печеночной недостаточности the concentration of paroxetine in the blood plasma increases, therefore the recommended daily dose of the drug in these cases is 20 mg. This dose can be increased depending on the condition of the patient, but it is necessary to strive to maintain the dose at the lowest possible level.

Side effects

The frequency of manifestation and intensity of side effects during therapy decreases, therefore, with their development, in most cases, it is possible to continue taking the drug.

Adverse reactions are presented with the percentage of the identified ratio of the total number of patients receiving this treatment.

From the side digestive system: nausea (12%); sometimes - constipation, diarrhea, loss of appetite; rarely - an increase in liver function tests; in some cases - a severe violation of liver function. A causal relationship has not been proven between paroxetine and changes in liver enzyme activity, but discontinuation of paroxetine is recommended in case of impaired liver function.

From the side of the central nervous system: drowsiness (9%); tremor (8%); general weakness and increased fatigue (7%), insomnia (6%); in some cases - headache, increased irritability, anxiety, paresthesia, dizziness, somnambulism, decreased concentration; rarely - extrapyramidal disorders, orofacial dystonia. Extrapyramidal disorders are observed mainly with the previous intensive use of antipsychotics. Rarely, epileptiform seizures have been observed (which is also characteristic of therapy with other antidepressants); increased intracranial pressure.

From the vegetative nervous system: increased sweating (9%), dry mouth (7%).

From the side of the organ of vision: in some cases - visual impairment, mydriasis; rarely - an attack of acute glaucoma.

From the side of the cardiovascular system: in some cases - tachycardia, ECG changes, blood pressure lability, fainting.

From the reproductive system: ejaculation disorder (13%), in some cases - a change in libido.

From the urinary system: rarely - difficulty urinating.

From the side of water and electrolyte balance: in some cases - hyponatremia with the development of peripheral edema, impaired consciousness or epileptiform symptoms. After discontinuation of the drug, the sodium level in the blood returns to normal. In some cases, this condition developed due to overproduction of antidiuretic hormone. Most of these cases were observed in elderly people who received other drugs in addition to paroxetine.

Allergic reactions: rarely - skin flushing, subcutaneous hemorrhages, swelling in the face and limbs, anaphylactic reactions (urticaria, bronchospasm, angioedema), pruritus.

Others: in isolated cases - myopathy, myalgia, myasthenia gravis, myoclonus, hyperglycemia; rarely - hyperprolactinemia, galactorrhea, hypoglycemia, fever and the development of a flu-like state, a change in taste. Thrombocytopenia has rarely developed (a causal relationship with the drug has not been proven). Taking paroxetine may be accompanied by an increase or decrease in body weight. Several cases of increased bleeding have been described.

Paroxetine is less likely to cause dry mouth, constipation, and drowsiness than tricyclic antidepressants. Sudden discontinuation of the drug can cause dizziness, sensory disturbances (eg, paresthesia), anxiety, sleep disturbance, agitation, tremor, nausea, increased sweating and confusion, so stopping drug therapy should be done gradually (it is advisable to reduce the dose every second day).

Overdose

Symptoms: paroxetine therapy is safe over a wide range of doses. Signs of an overdose were manifested with the simultaneous use of paroxetine at a dose of 2000 mg or more with other drugs, or with alcohol: nausea, vomiting, tremor, dilated pupils, dry mouth, general agitation, increased sweating, drowsiness, dizziness, redness of the skin of the face. No coma or convulsions were noted. Fatal outcome in this case was observed rarely, usually with a simultaneous overdose of paroxetine and another drug that causes adverse interaction effects.

Treatment: gastric lavage, 20-30 g of activated charcoal every 4-6 hours for the first 24-48 hours; should be released Airways, if necessary, carry out oxygenation. They monitor the vital functions of the body and general measures aimed at maintaining them. Continuous monitoring of cardiac and other vital functions is recommended. There is no specific antidote. Forced diuresis, hemodialysis, or hemoperfusion are ineffective if a large dose of paroxetine has passed from the blood to the tissues.

drug interaction

Food and antacids do not affect the absorption and pharmacokinetics of paroxetine.

Like other serotonin reuptake inhibitors, an undesirable interaction between MAO inhibitors and paroxetine.

Concomitant use of paroxetine with tryptophan leads to headache, nausea, increased sweating and dizziness, so this combination should be avoided.

between paroxetine and pharmacodynamic interaction is expected (with unchanged prothrombin time, increased bleeding is noted); the use of such a combination requires caution.

In a few cases, the use of paroxetine with sumatriptan there is general weakness, hyperreflexia, impaired coordination. If it is necessary to use them simultaneously, special care should be taken (medical supervision is required).

Paroxetine may inhibit metabolism when used concomitantly. tricyclic antidepressants(due to inhibition of the CYP2D6 isoenzyme), therefore, the use of such a combination requires caution and a reduction in the dose of tricyclic antidepressants.

Drugs that induce or inhibit the activity of liver enzyme systems may affect the metabolism and pharmacokinetics of paroxetine. When used together with inhibitors of metabolic liver enzymes, the lowest effective dose of paroxetine should be used. Joint use with liver enzyme inducers does not require adjustment of the initial dose of paroxetine; further dose changes depend on the clinical effect (efficacy and tolerability).

Drugs whose metabolism is carried out with the participation of the CYP2D6 isoenzyme. Paroxetine significantly inhibits the activity of this isoenzyme. Therefore, the simultaneous use of paroxetine with drugs whose metabolism occurs with the participation of this isoenzyme, incl. with certain antidepressants (eg, nortriptyline, amitriptyline, imipramine, desipramine, and fluoxetine), phenothiazines (eg, thioridazine), class 1C antiarrhythmics (eg, propafenone, flecainide, and encainide), or those that block its action (eg, quinidine, cimetidine, codeine).

Reliable clinical data on paroxetine inhibition isoenzyme CYP3A4 no, therefore, use with drugs that inhibit this enzyme (for example, terfenadine) is possible.

Cimetidine inhibits some cytochrome P450 isoenzymes. As a result, the combined use of paroxetine with cimetidine increases the level of paroxetine in the blood plasma at the stage of the equilibrium state.

Phenobarbital increases the activity of some cytochrome P450 isoenzymes. With the combined use of paroxetine with phenobarbital, the concentration of paroxetine in the blood plasma decreases, and its T 1/2 is also shortened.

With the combined use of paroxetine and phenytoin the concentration of paroxetine in the blood plasma decreases and an increase in the frequency of side effects of phenytoin is possible. When using other anticonvulsants, the frequency of their side effects may also increase. In patients with epilepsy treated for a long time with carbamazepine, phenytoin or sodium valproate, the additional administration of paroxetine did not cause changes in the pharmacokinetic and pharmacodynamic properties of anticonvulsants; there was no increase in paroxysmal convulsive readiness.

Paroxetine is largely bound to plasma proteins. When used simultaneously with drugs that also bind to plasma proteins, against the background of an increase in the concentration of paroxetine in the blood plasma, an increase in side effects is possible.

Due to the lack of sufficient clinical experience with the combined use digoxin with paroxetine, the appointment of such a combination requires caution.

Diazepam at exchange application does not affect the pharmacokinetics of paroxetine.

Paroxetine significantly increases the concentration procyclidine in plasma, therefore, if anticholinergic side effects appear, it is necessary to reduce the dose of procyclidine.

V clinical research paroxetine did not affect the concentration propranolol in blood.

In some cases, an increase in the concentration theophylline in blood. Despite the fact that in the course of clinical studies the interaction between paroxetine and theophylline has not been proven, regular monitoring of the level of theophylline in the blood is recommended.

Strengthening the action alcohol with simultaneous use with paroxetine was not detected. However, due to the effect of paroxetine on the liver enzyme system, it is necessary to avoid the use of alcoholic beverages during treatment with paroxetine.

special instructions

It is contraindicated to take paroxetine simultaneously with MAO inhibitors and within 14 days after their cancellation. In the future, paroxetine should be used with extreme caution, starting the course of treatment with small doses and gradually increasing the dosage until the desired therapeutic effect is achieved. After the end of therapy with paroxetine for 14 days, you can not start a course of treatment with MAO inhibitors.

If the patient has previously been manic state, while taking paroxetine, the possibility of relapse should be considered (as with other antidepressants).

There is not enough experience of simultaneous use electroconvulsive therapy and paroxetine.

Due to the predisposition to suicide attempts in patients with depression and patients with drug addiction during the withdrawal period, this category of patients must be carefully monitored during treatment.

In many cases it was noted hyponatremia especially in elderly patients receiving diuretics. After the abolition of paroxetine, the level of sodium in the blood returns to normal.

In some cases, during treatment with paroxetine, there was increased bleeding(mainly ecchymosis and purpura).

Rarely observed during the use of paroxetine hyperglycemic conditions.

Suicide/suicidal ideation

Depression is associated with an increased risk of suicidal thoughts, auto-aggression, and suicide. This risk persists until remission occurs. Since improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. Current clinical experience suggests that when treated with antidepressants, the risk of suicide may increase by early stages recovery.

Other psychiatric conditions for which Rexetine is prescribed may also be associated with an increased risk of suicidal behavior. In addition, these conditions may be comorbid with major depressive disorder. The same precautions as in the treatment of patients with major depressive disorder should be observed when it comes to the treatment of patients with other psychiatric disorders. Patients with a history of suicidal behavior or thoughts, or who demonstrate a significant degree of suicidal ideation prior to treatment, are at greater risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment. In these patients aged 18-29 years, there is an increased risk of suicide, so treatment with the drug should be carefully monitored.

Patients (and those caring for patients) must be prepared for the need for monitoring in emergency situations- the appearance of suicidal intentions / behavior or thoughts of auto-aggression, in order to apply for medical care immediately if these symptoms are present.

Influence on the ability to manage vehicles and mechanisms

Controlled studies have not shown a negative effect of paroxetine on psychomotor or cognitive function. Despite this, at the beginning of the course of therapy, for an individually set period, you can not drive a car or work in conditions increased danger requiring fast response. The degree of restriction is determined individually.

Pregnancy and lactation

The safety of paroxetine during pregnancy and lactation has not been studied, therefore, the drug should not be used during pregnancy and lactation, unless, from a medical point of view, the potential benefit of treatment outweighs the possible risk associated with taking the drug.

Women of childbearing age during therapy with paroxetine, contraception is recommended.

Application in childhood

Contraindication: children and adolescence up to 18 years (due to lack of clinical experience).

With impaired renal function

At renal (CC< 30 мл/мин) the concentration of paroxetine in the blood plasma increases, therefore the recommended daily dose of the drug in these cases is 20 mg. This dose can be increased depending on the condition of the patient, but it is necessary to strive to maintain the dose at the lowest possible level.

For impaired liver function

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life - 5 years.

Navigation

The drug "Reksetin" is included in an extensive group of antidepressants. Unlike barbiturates and benzodiazepines, it does not cause drug dependence and is well tolerated by patients. If necessary, the product can be administered to patients simultaneously with antihypertensive, hypoglycemic and other drugs necessary to maintain vitality. important indicators. Despite the presence of "Rexetin" detailed instructions according to the application, drug-based therapy should be carried out with the permission of the doctor and under his supervision.

Compound

The active ingredient in the drug is paroxetine in the form of hydrochloride hemihydrate. "Rexetin" is the international trade name of the drug. Also in the main part of the product are magnesium stearate, sodium carboxymethyl starch, hypromellose and calcium hydrogen phosphate dihydrate. The film shell is represented by hypromellose, titanium dioxide, polysorbate 80 and macrogol 400. The dosages of all excipients are calculated taking into account the volume of the main substance.

Release form

In pharmacies, you can buy Reksetin tablets of 20 mg and 30 mg of the active ingredient. These are round, biconvex white elements with a dividing line and embossed in the form of a number corresponding to the content of paroxetine. They are film-coated, packaged in blisters of 10 pieces, laid out in cardboard boxes.

pharmachologic effect

The principle of operation of the antidepressant "Reksetin" is based on the ability of its active substance to influence the process of serotonin circulation in the brain. An organic formation with a complex chemical structure starts a cycle of reactions. Their result is the stimulation of certain parts of the central nervous system. At the same time, in other parts of the brain, their functions are suppressed, and hyperexcitability decreases. Such a complex effect on the central nervous system leads to the formation of a number of therapeutic effects.

Pharmacodynamics and pharmacokinetics

A distinctive feature of the drug is its selectivity pharmacological action. Its influence does not affect receptors, the irritation of which can cause drug dependence or general addiction. Also, its entry into the body does not affect the level of norepinephrine and dopamine.

"Rexetin" helps to achieve the following results:

• elimination of manifestations of depressive disorders as a result of psychostimulating action;
• removal of anxiety by reducing the level of excitability of the subcortex of the brain;
• decrease in severity clinical picture characteristic of obsessive-convulsive pathologies. The patient ceases to be tormented by obsessive thoughts, fears or ideas. The general psycho-emotional background improves.

After taking the tablet, the active substance is rapidly absorbed in the digestive tract and enters the bloodstream. Eating does not affect this indicator. The connection of the main component with blood proteins is up to 95%. After 1-2 weeks after the start of therapy, the content of the substance reaches an equilibrium state, providing a well-functioning effect of the drug. With subsequent long-term therapy, the indicators do not change.

Processing of paroxetine occurs in the liver. The chemical compound decomposes into a number of metabolites, most of which do not have pharmacological activity. The half-life of a substance is on average a day, but the figure can reach almost 3 days. Up to 64% of the component is excreted by the kidneys, the rest - by the intestines. About 3% of the drug comes out unchanged. In the elderly, against the background of problems in the work of the liver and / or kidneys, the concentration of the drug in the blood exceeds the standard values. To prevent negative effects, dose adjustment is required.

Indications for the use of "Rexetin"

An antidepressant can be used alone or as part of complex therapy. The decision on its use is made by the attending physician. The scheme of therapy is selected in accordance with the diagnosis, the characteristics of the patient's condition, his physiological parameters.

Indications for the use of the drug:

• various forms of depression. The drug shows particular effectiveness in the fight against a disease of a pathological nature, which is accompanied by a feeling of anxiety;
• depression against the background of schizophrenia, periods of exacerbation of bipolar disorder;
• fight against clinical signs obsessive-convulsive disorder, relapse prevention. Even with prolonged treatment courses, the product can prevent active exacerbations;
• neurological and mental manifestations of organic pathologies of the brain, even with damage to the deep tissues of the organ;
• some stages of manic-depressive syndrome in its episodic course;
• general manifestations of the syndrome of constant anxiety;
• mental disorders that appeared after suffering a shock, life-threatening situation, moral trauma;
• neuropsychiatric disorders associated with panic attacks, agoraphobia.

In recent years, with the help of "Rexetin", the treatment of social phobia has been successfully carried out. A few more back the only effective method sessions with a psychotherapist or psychiatrist were admitted to combat fear of people. With the help of the drug, the severity of positive dynamics from the classical approach can be strengthened and consolidated.

Contraindications

The manufacturer warns of the need to be careful when taking an antidepressant, start therapy only with the permission of the doctor. In a number of conditions, the use of the remedy will have to be abandoned. In some cases, drug treatment is allowed only in a hospital setting.

The list of absolute contraindications to the use of the drug includes:

• any period of bearing a child and breastfeeding;
• taking MAO inhibitors and a period of 2 weeks after completion of therapy;
• childhood;
• individual intolerance to the components of the product;
• the use of "Thioridazine" - there is a risk of developing ventricular arrhythmia and sudden death of the patient.

Relative prohibitions include diseases of the heart and blood vessels, liver, kidneys, prostatic hyperplasia. For these conditions, treatment is heightened attention by a doctor or replacing the antidepressant with a less dangerous analogue in this case. With caution, the medicine should be taken by the elderly, with a history of epilepsy and glaucoma.

Side effects of "Rexetin"

According to statistics, a negative response of the body to the ingestion of drugs occurs in 10-20% of cases. The frequency of occurrence and severity of symptoms usually decrease during therapy. For this reason, in most situations side effects do not become a reason for refusing Reksetin. Final decision on whether to continue drug treatment accepted by the attending physician.

Potential side effects of taking an antidepressant:

• neurological - pathological fatigue and severe weakness, hand tremor, daytime sleepiness, sleep problems. Sometimes there is a headache, dizziness, irritability, a drop in concentration. In rare situations, epileptic seizures occur, signs of intracranial hypertension appear. Adverse reactions from the vegetative NS are manifested in the form of dry mouth, increased sweating;
• dyspeptic - nausea, problems with stool, loss of appetite. V rare cases there are signs of impaired liver function;
• cardiovascular - increased heart rate, changes in the ECG pattern, drops blood pressure, fainting against the background of circulatory failure, heart rhythm disturbance;
• immune - an allergic response in the form of reddening of the skin, subcutaneous hemorrhages, swelling of the limbs or pastosity of the face, itching. In rare cases, there is a risk of developing anaphylaxis;
• on the part of the sense organs - decreased visual acuity, exacerbation of glaucoma;
• from the genitourinary system - a decrease in sexual desire, problems with ejaculation, difficulty urinating;
• the state of water and electrolyte balance - a decrease in the level of sodium in the blood, which is accompanied by swelling of the tissues of different parts of the body, a disorder of consciousness. In difficult cases, a clinical picture of epilepsy is possible. The reaction is especially common among older people who additionally take diuretic drugs;
• other – increase or decrease in body weight, decrease muscle strength, muscle soreness, drop in blood sugar levels. Some patients report an increase in body temperature and the appearance of symptoms characteristic of the flu. Such situations are rare, the connection of many of them with the reception of "Rexetin" has not yet been proven.

Violation of the rules for stopping therapy can cause a withdrawal syndrome. A sharp rejection of the medication is often accompanied by dizziness, impaired sensitivity of the limbs, sleep problems, excessive arousal, attacks of fear. Some patients note against such a background nausea, twitching of the limbs, confusion, increased sweating. To prevent such consequences, the abolition of the drug is carried out according to the scheme selected by the doctor. It usually involves a slow decrease in dosage every other day.

"Rexetin": instructions for use - method and dosage

The annotation to the medication contains universal recommendations for taking it, but the pledge effective treatment antidepressants - an individual approach to each patient. Features of the basis of the therapy regimen depend on what the treatment is for, the age and general condition of the patient. Tablets should be taken orally, without violating the integrity of the film membrane. A change in the clinical picture in the course of taking the drug allows adjustment of dosages.

• depressive disorders - the standard therapeutic daily dose is 20 mg of the active substance. The maximum daily volume of the drug is 50 mg. The increase in dosage is carried out slowly - no more than 10 mg per week, until the therapeutic effect is obvious;
• obsessions and conditions - the starting therapeutic volume of the drug is 20 mg per day. A few weeks later, the patient's condition is assessed. If the therapeutic effect is not achieved, he begins to take 30 mg of the drug per day. The maximum therapeutic dose usually does not exceed 40 mg of the active substance, but in rare cases it can be increased by another 10-20 mg;
• panic attacks - at the beginning of course therapy, the patient is given only 10 mg of the product. The use of higher dosages at the start of treatment threatens to temporarily increase the severity of the clinical picture. Gradually, the volume of the drug is increased by 10 mg per week until a suitable dose is established. The permissible maximum with this diagnosis is 60 mg of paroxetine;
• the clinical picture of social phobia, anxiety, the consequences of trauma and stress - the starting dose is 20 mg of the active ingredient. It is gradually increased according to the standard scheme until a stable result is achieved. The daily maximum is 50 mg "Rexetin". Often such courses are carried out intermittently or use maintenance therapy. In the latter case, the daily dose is 20 mg of the drug.

The starting dose when working with elderly patients is 10 mg of the active substance. Its increase occurs according to the standard scheme, but the maximum should not go beyond the indicator of 40 mg of the component. Persons with a history of renal or hepatic insufficiency need a private approach, regular assessment of the state of the organs with the help of tests. Usually they try not to give more than 20 mg of Reksetin per day, but a slight correction of the data is possible.

Often, after the end of the treatment course, the antidepressant is not completely canceled, but continues to be taken as maintenance therapy. This approach is used from 4-6 months to a year, depending on the diagnosis. Reception allows you to prevent the development of relapses, to achieve the most stable effect.

Overdose

Cases of drug poisoning against the background of exceeding dosages are very rare. The risk of developing a clinical picture characteristic of drug intoxication occurs with a single use of 2000 mg of the active ingredient. Also, the likelihood of negative consequences is high when the drug is mixed with alcohol or combined with other drugs.

An overdose of Reksetin is manifested by the following symptoms:

• nausea and vomiting;
• tremor of the limbs;
• dilated pupils;
• dryness of the oral mucosa;
• pathological arousal, agitation;
• drowsiness;
• increased sweating;
• dizziness, problems with coordination;
• hyperemia of the skin.

Convulsions, coma and other serious complications due to an overdose of the drug were not observed.

Registered deaths associated with taking the medicine simultaneously with other medicines, alcohol. First aid consists in washing the stomach, taking an enterosorbent in accordance with body weight for 2 days. There is no antidote, hemodialysis and other methods of blood purification are not effective. Until the disappearance of all symptoms, it is necessary to monitor the vital signs of the victim, if necessary, carry out symptomatic therapy.

Interaction

The use of the drug does not need to be organized taking into account the dietary schedule or the use of antacids. They do not affect the degree of absorption of the active substance, the rate of manifestation of the therapeutic effect and its severity. If the product is part of complex therapy, or the patient additionally takes any medications, care must be taken.

The drug should be taken taking into account the following points:

• combining the product with MAO inhibitors increases the severity of side effects and can cause death;
• simultaneous administration of the drug with "Tryptophan" often causes headache, dizziness, increased sweating, nausea;
• in combination with "Warfarin" increased bleeding is possible;
• taking "Sumatriptan" against the background of treatment with an antidepressant is accompanied by problems with coordination, exacerbation of reflexes, general weakness;
• combining the reception of "Rexetin" with tetracyclic antidepressants requires a dose reduction of the latter;
• when using drugs that affect the performance of the liver, it may be necessary to adjust the therapeutic dosage of the drug. But in this case, the initial volumes will be standard;
• "Cimetidine" increases the concentration of the product in the blood plasma after 2-3 weeks of therapy;
• "Phenobarbital" reduces the volume of paroxetine in the blood plasma and reduces its half-life;

• combining the product with a number of anticonvulsants can lead to an increase in the side effects of the latter, an increase in the frequency of symptoms;
• at the same time, Digoxin and Reksetin are prescribed with caution due to the lack of accurate data on the consequences of such a combination.

Before using any medications while on an antidepressant, it is recommended that you get your doctor's permission. Any negative reaction of the body to the joint use of medications must be reported to a specialist.

Terms of sale

Rexetine is a prescription drug that must be prescribed by a healthcare professional.

Storage conditions and shelf life

The product should be kept in a dry and dark place out of the reach of children. The air temperature should be between 15-30℃. The expiration date is indicated on the packaging and can be up to 5 years.

special instructions

The increased chemical activity of the drug can cause unexpected reactions in the body. The manufacturer identifies a number of rules, the observance of which allows you to minimize possible risks, to achieve the maximum effect from therapy.

When using an antidepressant, you need to consider the following points:

• the passage of a treatment course requiring the use of MAO inhibitors is a contraindication to the use of the drug. You can switch to an antidepressant only 14 days after giving up biologically active substances;
• if there are signs of a manic state in history, while taking the product, there is a possibility of resuming an attack;
• treatment of patients with severe depression, drug or alcohol addiction should be carried out under medical supervision. These groups of people are predisposed to suicide attempts;
• in older people taking diuretics, taking an antidepressant can cause a decrease in sodium levels in the blood. Cancellation of the drug short time brings everything back to normal;
• at the initial stage of therapy, patients require increased monitoring due to the presence of the risk of suicide attempts. Only after the first signs of positive dynamics appear, the observation can be weakened.

During the treatment course, it is recommended to refrain from driving, performing actions that require attention and increased concentration. Often, an antidepressant causes a feeling of internal agitation, the inability to remain calm, the need to move or do something.

Analogues of "Rexetin"

If for some reason "Rexetin" is not suitable for the patient, only the attending physician can choose an analogue. The list of antidepressants is quite extensive, each of the groups has its own advantages or disadvantages. To combat the pathological conditions listed above, a neurologist or psychiatrist can choose funds based on similar or other active substances with the desired characteristics. The most common include: "Parelax", "Adepress", "Xet", Luxotil. They also contain paroxetine, but it has a different chemical form.

Doctors do not recommend trying to choose cheaper analogues on their own to replace Reksetin, only based on the similarity of pharmacological product groups. Such experiments threaten to increase the severity of the clinical picture, side effects.

Synonyms

In the absence of the opportunity to purchase the drug under this name, you can replace "Reksetin" with its synonyms. These products contain the same active ingredient but are sold under different brand names. This list includes Paroxetine, Paxil, Pleasil. The course of taking these medicines should also be carried out on the recommendation or with the permission of a doctor.

children

The lack of reliable data on clinical trials of the drug in childhood led to a ban on prescribing the product to patients under 18 years of age. According to scientists, a violation of the rule can lead to a change in a person's personality, cause improper development of internal organs.

Alcohol and Reksetin

Reksetin and alcohol are not recommended to be combined, despite the fact that the danger of such a union has not been clinically confirmed. The consequences of the simultaneous use of products can be unexpected, they are difficult to predict and prevent. Collecting information on the compatibility of Reksetin and alcohol, doctors identified cases of exacerbation of the underlying pathology, suicide attempts, and death.

During pregnancy and lactation

There is no reliable information about the effect of the active substance of the drug on the fetus, so officially taking an antidepressant during pregnancy is prohibited. Neurologists recommend that women of childbearing age during the use of the drug additionally discuss contraceptive options with a gynecologist in order to avoid an unplanned pregnancy. The use of the drug after conception is possible only with the permission of a specialist in the presence of serious indications. Theoretically, the ingestion of paroxetine into the body of a pregnant woman in the first trimester threatens the child with heart defects. There are risks in the third trimester premature birth, perinatal complications.

The active substance of the drug and its metabolites enter the breast milk in an amount sufficient to negatively affect the baby. If it is necessary to conduct a treatment course, the baby is transferred to artificial feeding.

Dosage form"type="checkbox">

Dosage form

Film-coated tablets, 20 mg

Compound

One tablet contains

active substance - paroxetine 20 mg (as paroxetine hydrochloride hemihydrate 22.760 mg),

excipients: magnesium stearate, sodium carboxymethyl starch (type A), hypromellose, calcium hydrogen phosphate dihydrate,

composition of the film shell: polysorbate 80, macrogol 400, macrogol 6000, titanium dioxide (E 171), hypromellose.

Description

Tablets round shape, with a biconvex surface, film-coated, white or almost white, scored on one side and engraved with "" on the other, about 9 mm in diameter.

Pharmacotherapeutic group

Psychoanaleptics. Antidepressants. Selective serotonin reuptake inhibitors. Paroxetine

ATX code N06AB05

Pharmacological properties"type="checkbox">

Pharmacological properties

Pharmacokinetics

Absorption: After oral administration, paroxetine is well absorbed and undergoes primary metabolism. Due to the presystemic metabolism of the drug, the amount of the active substance that enters the systemic circulation is less than the amount of the drug that is absorbed in the digestive tract. The use of higher single doses or repeated use leads to partial saturation of the primary metabolism and a decrease in plasma clearance. However, the non-linearity of the kinetics is insignificant and is observed only in those patients who have low concentrations of paroxetine in the blood plasma when taking low doses. Steady-state plasma concentrations are reached 7-14 days after the start of treatment with immediate or controlled release paroxetine preparations, and pharmacokinetic parameters do not appear to change with long-term therapy.

Distribution

Paroxetine is widely distributed in tissues, pharmacokinetic calculations show that only 1% of all paroxetine present in the body remains in the blood plasma. Paroxetine passes into breast milk and through the placenta. At therapeutic concentrations of paroxetine in the blood, plasma protein binding is 95%. No correlation was found between the plasma concentration of paroxetine and the clinical effect (side effects and efficacy).

Biotransformation

Metabolism of paroxetine is carried out mainly in the liver. The main metabolites are polarized and associated products of oxidation and methylation, which are easily eliminated from the body. Given that these metabolites have virtually no pharmacological activity, they are unlikely to influence the therapeutic effects of paroxetine. Metabolism does not affect the selective inhibitory effect of paroxetine on 5-HT reuptake.

Elimination

About 64% of paroxetine is excreted in the urine (2% unchanged, 62% as metabolites); approximately 36% - with feces (presumably with bile), mainly in the form of metabolites,<1% выделяется с калом в неизмененном виде. Выведение метаболитов носит двухфазный характер, сначала в результате метаболизма первого прохождения, а затем из системного кровотока.

The half-life of paroxetine is not constant but is usually around 24 hours.

Pharmacodynamics

Paroxetine, the active ingredient in Rexetin®, is a selective 5-hydroxytryptamine (5-HT, serotonin) reuptake inhibitor. The specific property of paroxetine to inhibit the reuptake of 5-HT in brain neurons determines its antidepressant effect and effectiveness in the treatment of obsessive-compulsive disorders, social anxiety disorders / social phobias, generalized anxiety disorders, post-traumatic stress disorders, panic disorders.

According to the chemical structure, paroxetine does not belong to tricyclic, tetracyclic and other antidepressants.

The drug exhibits low affinity for muscorin-cholinergic receptors.

Due to the selectivity of action, unlike tricyclic antidepressants, paroxetine has a weak affinity for α-1 and α-2-adrenergic receptors, dopamine (D2), 5-HT1-, 5-HT2- and histamine (H1) receptors, in connection with this CNS depression and hypotension are not observed.

Paroxetine does not impair psychomotor function and does not potentiate the inhibitory effects of ethanol. The drug does not have a clinically significant effect on the cardiovascular system (causes minor changes in blood pressure, heart rate and ECG).

Studies show that, compared with antidepressants that inhibit norepinephrine reuptake, paroxetine has a very low ability to inhibit the antihypertensive effect of guanethidine.

In the treatment of depressive disorders, Reksetin® shows comparable efficacy with standard antidepressants.

Taking paroxetine in the morning does not adversely affect the quality or duration of sleep. In addition, patients improve sleep, which is a clinical response to paroxetine therapy.

Indications for use

severe depressive episodes

Obsessive Compulsive Disorders

Panic disorder with and without agoraphobia

social phobia

Generalized Anxiety Disorders

post-traumatic stress disorder

Dosage and administration

Reksetin® is taken once a day in the morning, along with meals.

The tablet is swallowed whole, without chewing.

Treatment of severe depressive episodes

As with all other antidepressants, depending on the clinical condition of the patient, the dosing regimen should be reviewed and, if necessary, adjusted 3-4 weeks after the start of therapy and further depending on the clinical condition of the patient. In patients who do not achieve the desired therapeutic effect with a daily dose of 20 mg, depending on the patient's response to therapy, the daily dose may be increased by 10 mg every week until a therapeutic effect is achieved; the maximum daily dose is 50 mg.

Treatment of patients with depression should be continued for at least 6 months to ensure complete reduction of symptoms.

Obsessive Compulsive Disorders (OCD)

The recommended dose is 40 mg per day. Start with a dose of 20 mg per day, gradually increasing the dose by 10 mg every week to the recommended dose. If after several weeks of treatment the response is insufficient, some patients may need to gradually increase the dose to the maximum (60 mg).

Patients with obsessive-compulsive disorder (OCD) should be treated long enough to ensure complete reduction of symptoms. This period can last several months or even longer (see the section "Pharmacodynamics").

panic disorder

The recommended dose is 40 mg per day. Treatment should begin with 10 mg per day and, depending on the clinical response of the patient, gradually increase the dose by 10 mg to the recommended dose. It is recommended to start with a low dose in order to minimize possible deterioration at the beginning of treatment. If, after several weeks of taking the drug, a sufficient response to treatment is not obtained, for some patients it may be effective to gradually increase the dose to the maximum (60 mg). Patients with panic disorder should be treated long enough for complete reduction of symptoms. This period can last several months or even longer (see the section "Pharmacodynamics").

social phobia

The recommended dose is 20 mg per day. If after a two-week course of treatment there is no significant improvement in the patient's condition, the dose of the drug can be gradually increased by 10 mg to a maximum daily dose of 50 mg. In the case of prolonged use, it is necessary to periodically assess the patient's condition (see the section "Pharmacodynamics").

Generalized anxiety disorder

The recommended dose is 20 mg per day. In case of insufficient response after several weeks of treatment with the recommended dose, gradual (10 mg) dose increases to a maximum (50 mg / day) may be effective for some patients. In the case of prolonged use, it is necessary to periodically assess the patient's condition (see the section "Pharmacodynamics").

post-traumatic stress disorder

The recommended daily dose is 20 mg. In case of insufficient response after several weeks of treatment with the recommended dose, gradual (10 mg) dose increases to a maximum (50 mg / day) may be effective for some patients. In the case of prolonged use, it is necessary to periodically assess the patient's condition (see the section "Pharmacodynamics").

GENERAL INFORMATION

Paroxetine withdrawal symptoms

Abrupt discontinuation of the drug should be avoided. In clinical studies, the dose was reduced by 10 mg weekly. If intolerable symptoms occur after dose reduction or discontinuation of the drug, consideration may be given to resuming treatment at the previously prescribed dose. In the future, the doctor may continue to reduce the dose, but at a slower pace.

Use in patients with renal / hepatic insufficiency

In patients with severe renal insufficiency (creatinine clearance less than 30 ml / min) or hepatic insufficiency, an increase in the concentration of paroxetine in the blood plasma is observed. Therefore, the dosage should be limited to the minimum dose.

Use in elderly patients

Plasma concentrations of paroxetine are increased in elderly patients, but concentration ranges overlap in older and younger patients. Treatment should begin with the starting dose for adult patients. For some patients, it may be beneficial to increase the dose, but the daily dose should not exceed 40 mg.

Pediatric population

Children and teenagers (7-17 years old)

Paroxetine is contraindicated in the treatment of children and adolescents, as controlled clinical trials have shown an association of paroxetine with an increased risk of suicidal behavior and hostility. In addition, these studies did not provide adequate evidence of efficacy.

Children under 7

Paroxetine has not been studied in children under 7 years of age. Paroxetine is contraindicated as safety and efficacy in this age group have not been established.

Impaired liver or kidney function

In patients with severely impaired renal function (creatinine clearance less than 30 ml / min) or liver, the concentration of paroxetine in the blood plasma is increased. Therefore, the dose should be selected from the lower part of the dose range.

Side effects

Very common (≥ 1/10)

Nausea

sexual dysfunction

Often (≥ 1/100 -<1/10)

Drowsiness, insomnia, agitation, abnormal dreams (including nightmares)

Dizziness, headache, tremor, impaired concentration

Blurred vision

Dry mouth, vomiting, constipation, diarrhea

sweating

Asthenia, weight gain

Increased blood cholesterol, decreased appetite

Uncommon (≥ 1/1000 -<1/100)

Abnormal bleeding, predominantly of the skin and subcutaneous tissues (including bruising, as well as gynecological bleeding)

Confusion, hallucinations

Extrapyramidal disorders

Mydriasis

Sinus tachycardia

Transient increase or decrease in blood pressure

(usually seen in patients with underlying hypertension or anxiety), postural hypotension

Skin rash, itching

Urinary retention, urinary incontinence

Glycemic control disorders in patients with diabetes mellitus

Rare (≥ 1/10000 -<1/1000)

Mania, anxiety, depersonalization, panic attacks, akathisia

Hyponatremia (mainly reported in elderly patients, sometimes due to syndrome of inappropriate secretion of antidiuretic hormone (SINASAH)

Convulsions, restless leg syndrome

Bradycardia

Arthralgia, myalgia

Hyperprolactinemia/galactorrhea, menstrual irregularities (such as menorrhagia, metrorrhagia, amenorrhea, delayed menses, irregular periods)

Elevated liver enzymes

Rarely (<1/10000)

Thrombocytopenia

Severe and potentially fatal allergic reactions (including anaphylactoid reactions and angioedema)

Impaired secretion of antidiuretic hormone

Serotonin syndrome (includes: agitation, confusion, sweating, hallucinations, hyperreflexia, myoclonus, chills, tachycardia, and tremor)

Acute glaucoma

Gastrointestinal bleeding

Liver disease (including hepatitis, sometimes accompanied by jaundice and / or liver failure). Increased activity of "liver" enzymes. During the post-marketing period, there have been very rare reports of liver damage (eg, hepatitis, sometimes accompanied by jaundice and / or liver failure). With a prolonged increase in liver tests, consideration should be given to discontinuing the drug.

Severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, photosensitivity reactions

Priapism

Peripheral edema

With unknown frequency:

Suicidal thoughts and suicidal behavior, aggression.

Often: dizziness, sensory disturbances, sleep disturbances, anxiety, headache.

Uncommon: agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhea, irritability.

Withdrawal of paroxetine (especially abruptly) often results in withdrawal symptoms such as dizziness, sensory disturbances (including paresthesias, electric shock and tinnitus), sleep disturbances (including vivid dreams), agitation or restlessness, nausea , tremors, confusion, sweating, headaches, diarrhea, palpitations, emotional instability, irritability, and visual disturbances.

These adverse events are usually classified as mild or moderate, but may be severe and/or prolonged in some patients. Therefore, if treatment is no longer necessary, it is recommended to start a gradual withdrawal of the drug.

Children and teenagers

Adverse events in pediatric clinical trials

The following adverse events were observed: suicidal behavior (including suicidal attempts and suicidal thoughts), self-harm and increased hostility. Suicidal ideation and suicide attempts have mostly been observed in clinical trials in adolescents with major depressive disorder. Hostility has been reported in children with obsessive-compulsive disorder, especially in children under 12 years of age. The following adverse events were also observed: decreased appetite, tremor, sweating, hyperkinesia, agitation and emotional lability (including tearfulness and mood swings), phenomena associated with increased bleeding, mainly hemorrhages in the skin and mucous membranes.

After discontinuation / gradual dose reduction of paroxetine, the following adverse events were reported: emotional lability (including tearfulness, mood swings, self-harm, suicidal thoughts and suicidal attempts), nervousness, dizziness, nausea and abdominal pain (see section "Special instructions ").

Contraindications

Hypersensitivity to paroxetine or any excipient of the drug

Simultaneous administration of monoamine oxidase inhibitors (MAOIs). In exceptional cases, linezolid (an antibiotic that is a reversible non-selective MAO inhibitor) can be used in combination with paroxetine if the patient can be closely monitored for the development of serotonin syndrome and when monitoring blood pressure (see section "Drug interactions"). Treatment with paroxetine can be started:

Two weeks after the end of the use of an irreversible MAOI, or

At least 24 hours after stopping a reversible MAOI, eg moclobemide, linezolid, methylthioninium chloride (methylene blue, which is a reversible non-selective MAOI).

At least a week should elapse between discontinuation of paroxetine and the start of any MAOI paroxetine should not be used in combination with thioridazine because, like other inhibitors of the hepatic CYP450 2D6 isoenzyme, paroxetine can increase plasma concentrations of thioridazine (see section "Drug interactions") .

When taking only thioridazine, prolongation of the QT interval and associated serious ventricular arrhythmia, for example, torsade de pointes, and sudden death are possible.

Paroxetine should not be used in combination with pimozide (see Drug Interactions).

Children and adolescents up to 18 years old

Pregnancy and lactation

Drug Interactions

Serotonergic drugs

The use of paroxetine, as well as other SSRIs, together with serotonergic drugs may increase the frequency of effects associated with 5-HT (serotonin syndrome, see section "Special Instructions"). Caution and close clinical monitoring are required when using paroxetine and serotenergic drugs such as L-tryptophan, triptans, tramadol, linezolid, methylthioninium chloride (methylene blue), SSIA, lithium, pethidine, and St John's wort. Caution must also be exercised when using fentanyl for general anesthesia or for the treatment of chronic pain.

The simultaneous use of paroxetine and MAOIs is contraindicated due to the risk of developing serotonin syndrome (see section "Contraindications").

With the simultaneous use of pimozide and paroxetine, the concentration of pimozide in the blood can increase by an average of 2.5 times, which can be explained by the known property of paroxetine to suppress the activity of the CYP2D6 isoenzyme. Due to the narrow therapeutic index of pimozide and its known ability to prolong the QT interval, the concomitant use of pimozide and paroxetine is contraindicated.

Enzymes involved in drug metabolism

The metabolism and pharmacokinetics of paroxetine may change with the induction or suppression of the activity of enzymes involved in drug metabolism. When prescribing Rexetin® with enzyme inhibitor drugs (anticholinesterase drugs, monoamine oxidase inhibitors, carbonic anhydrase inhibitors), Rexetin® should be administered in low doses.

There is no need to adjust the starting dose of Rexetine when given in combination with enzyme inducers (eg, carbamazepine, rifampicin, phenobarbital, phenytoin) or with fosamprenavir/ritonavir. Any dose adjustments of Reksetin® (both at the beginning of the appointment of an enzyme inducer and after its withdrawal) should be carried out depending on the clinical effect (tolerability and efficacy).

Muscle relaxants

SSRIs reduce the activity of serum cholinesterase, which leads to an increase in the duration of action of muscle relaxants such as mivacurium and succinylcholine.

Fosamprenavir/ritonavir

Co-administration of fosamprenavir/ritonavir with paroxetine significantly reduced paroxetine plasma concentrations by approximately 55%. There are no data on the effects of long-term (more than 10 days) co-administration of paroxetine and fosamprenavir/ritonavir.

Procyclidine

Daily use of paroxetine significantly increases plasma levels of procyclidine. The dose of procyclidine should be reduced if anticholinergic effects occur.

Antiepileptic drugs

The combined administration of antiepileptic drugs (carbamazepine, phenytoin, sodium valproate with Reksetin® does not affect the pharmacokinetic / pharmacodynamic profile of antiepileptic drugs.

Potential ability of paroxetine to inhibit CYP2D6 enzyme activity

Like all antidepressants, Reksetin® inhibits the activity of the CYP2D6 cytochrome P450 enzyme in the liver. Inhibition of CYP2D6 can lead to an increase in plasma concentrations of concomitantly prescribed drugs that are metabolized with the participation of the CYP2D6 enzyme. These drugs include tricyclic antidepressants (clomipramine, nortriptyline, desipramine), neuroleptics, phenothiazine derivatives (perphenazine, thioridazine), risperidone, atomoxetine, group 1C antiarrhythmics (eg propafenone and flecainide), and metoprolol. It is not recommended to use Reksetin® in combination with metoprolol in establishing heart failure due to the narrow therapeutic index of metoprolol in this indication.

Tamoxifen

According to the literature, there have been reports of pharmacokinetic interactions between inhibitors of the CYP2D6 isoenzyme and tamoxifen with a decrease in the concentration of one of the active metabolites of tamoxifen - endoxifen in the blood serum by 65-75%. Some studies have reported a decrease in the effectiveness of tamoxifen when used simultaneously with some antidepressants of the SSRI group. Since a decrease in the effectiveness of tamoxifen cannot be ruled out, if possible, its combined use with potent inhibitors of the CYP2D6 isoenzyme should be avoided (see section "Special Instructions").

Alcohol

As in the case of other psychotropic drugs, during the period of treatment with Reksetin®, patients are advised to exclude the use of alcoholic beverages.

Oral anticoagulants

The combined use of paroxetine and oral anticoagulants may lead to an increase in anticoagulant activity and the risk of hemorrhages. Caution is advised when using paroxetine in patients taking oral anticoagulants.

Non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid, other antiplatelet agents

The simultaneous appointment of paroxetine and NSAIDs / acetylsalicylic acid may lead to an increased risk of hemorrhages.

Caution should be exercised in patients taking SSRIs concomitantly with oral anticoagulants, drugs known to affect platelet function or increase the risk of bleeding (eg, atypical antipsychotics such as clozapine, phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, NSAIDs, COX inhibitors -2), as well as in patients with bleeding disorders or diseases characterized by increased bleeding.

Pravastatin

The combined use of paroxetine and pravastatin can lead to an increase in the concentration of glucose in the blood plasma. Patients with diabetes mellitus receiving paroxetine and pravastatin may require dose adjustment of oral hypoglycemic agents and / or insulin (see section "Special Instructions").

special instructions

Treatment with paroxetine should be started with caution two weeks after the end of an irreversible MAOI or 24 hours after the end of treatment with a reversible MAOI. The dose of paroxetine should be increased gradually until an optimal response is achieved (see sections "Contraindications" and "Drug Interactions").

Children and teenagers

Paroxetine should not be used in children and adolescents under 18 years of age. In clinical studies, suicidal behavior (suicide attempts and suicidal thoughts) and hostility (predominantly in the form of aggression, violent, oppositional behavior and anger) were more frequently observed among children and adolescents taking antidepressants compared with placebo. If, based on clinical need, it is nevertheless decided to prescribe the drug, careful monitoring is necessary for the appearance of suicidal symptoms. In addition, there are no long-term safety data in children and adolescents regarding growth, maturation and cognitive development.

Suicide/suicidal ideation or clinical deterioration

Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). The risk persists until significant remission occurs. Since improvement may not occur in the first weeks of treatment or even longer, close monitoring should be continued until the condition improves. Based on current clinical experience, the risk of suicide may increase in the initial phase of recovery.

Other mental illnesses for which paroxetine is prescribed may also be associated with an increased risk of suicide-related events. In addition, these conditions may coexist with major depressive disorder. Therefore, the same precautions should be followed in the treatment of these diseases as in the treatment of major depressive disorder.

It is known that the risk of suicidal thoughts or suicidal attempts is increased in patients with a history of suicidal events or suicidal ideation before treatment, so they should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behavior during antidepressant treatment compared with placebo in patients younger than 25 years of age (see also Pharmacodynamics section).

Patients with a history of suicidal attempts or suicidal tendencies should be treated with caution, especially at the beginning of therapy and after dose changes. Patients (and their caregivers) should be warned to monitor the dynamics of symptoms in order to promptly detect clinical deterioration, suicidal behavior or suicidal thoughts and unusual changes in behavior and immediately contact a doctor if such symptoms are present.

Akathisia/psychomotor disturbances

The use of Reksetin® is accompanied by the development of akathisia, which is characterized by internal restlessness and psychomotor agitation, for example, the inability to sit or stand still, which is usually associated with a subjective feeling of discomfort. The development of such a condition is most likely in the first few weeks of treatment. In patients with these symptoms, the condition may worsen when the dose is increased.

Serotonin syndrome/Neuroleptic malignant syndrome

In rare cases, when taking paroxetine, especially in combination with other serotonergic drugs and / or antipsychotics, serotonin syndrome or conditions similar to neuroleptic malignant syndrome can rarely develop. These syndromes can evolve into potentially life-threatening conditions characterized by a symptom complex such as hyperthermia, muscle rigidity, myoclonus, autonomic instability with rapid changes in vital signs, changes in mental status, including confusion, irritability, critical progression of anxiety to delirium and coma. Treatment with Reksetin® in such cases should be discontinued and supportive symptomatic therapy should be started.

Reksetin® should not be administered in combination with serotonin precursors such as L-tryptophan due to the risk of serotonergic syndrome.

As with other antidepressants, Rexetine should be used with caution in patients with a history of mania. The drug should be discontinued at the first signs of mania.

Diabetes

In patients with diabetes mellitus, glycemic control may change during treatment with SSRIs. In patients with diabetes mellitus treated with serotonin reuptake inhibitors, it is necessary to adjust the dose of insulin and / or oral hypoglycemic drugs. In addition, data have been obtained indicating the possibility of increasing the concentration of glucose with the combined use of paroxetine and pravastatin (see the section "Drug Interactions").

Epilepsy

As with other antidepressants, Reksetin® should be used with caution in patients with epilepsy.

Seizures

Among patients taking paroxetine, seizures occur at a frequency of less than 0.1%. If convulsions occur, treatment with paroxetine should be discontinued.

Electroconvulsive Therapy (ECT)

There is insufficient clinical experience with the concomitant use of ECT and Reksetin® therapy.

Glaucoma

Paroxetine, like other SSRIs, can cause mydriasis, which requires caution when treating patients with narrow-angle glaucoma.

Cardiovascular disorders

Patients with cardiovascular disorders should be closely monitored.

Hyponatremia

In some cases, hyponatremia was noted, especially in elderly patients who received diuretics. After discontinuation of the drug, the sodium level in the blood returns to normal.

Hemorrhages

Abnormal bruising in the form of ecchymosis and purpura has been reported with serotonin reuptake inhibitors. There are reports of other hemorrhages, such as gastrointestinal and gynecological bleeding. Elderly patients are more at risk for postmenopausal bleeding.

Caution should be exercised in patients taking SSRIs concomitantly with anticoagulants and other drugs that affect platelet function and increase the risk of bleeding (eg, atypical antipsychotics such as clozapine, phenothiazines, most tricyclic antidepressants (TCAs), acetylsalicylic acid, non-steroidal anti-inflammatory drugs drugs (NSAIDs), inhibitors of cyclooxygenase (COX)-2), as well as in patients with bleeding disorders or conditions in which bleeding may be increased (see section "Side Effects").

Interaction with tamoxifen

As a result of the powerful suppression of the CYP2D6 isoenzyme by paroxetine, a decrease in the concentration of the active metabolite of tamoxifen, endoxifen, may occur. For this reason, paroxetine should be avoided whenever possible during therapy with tamoxifen (see the Drug Interactions section).

Withdrawal symptoms when you stop taking paroxetine

Upon discontinuation of therapy, especially with abrupt discontinuation of the drug, withdrawal symptoms may occur. Adverse events on discontinuation of the drug occurred in 30% of patients compared with 20% in the placebo group. Withdrawal symptoms are different from drug dependence states.

The risk of withdrawal symptoms may depend on several factors, including duration of therapy, dose, and rate of dose reduction.

Withdrawal symptoms: dizziness, sensory disturbances (including paresthesias, electric shock and tinnitus), sleep disturbances (including vivid dreams), agitation or restlessness, nausea, tremors, confusion, sweating, headaches, diarrhea , palpitations, emotional instability, irritability and visual disturbances. Some patients have a hard time with these symptoms, but they are usually classified as mild or moderate. Symptoms usually occur in the first few days after discontinuation of the drug, but in very rare cases it is possible after accidentally skipping one dose. As a rule, these symptoms resolve spontaneously and disappear within 2 weeks, but in some patients they may persist for a longer time (2-3 months or more). Therefore, it is recommended to discontinue the drug gradually, reducing the dose over several weeks or months (by 10 mg weekly) depending on the needs of the individual patient. If intolerable symptoms occur after dose reduction or discontinuation of the drug, consideration may be given to resuming treatment at the previously prescribed dose. In the future, the doctor may continue to reduce the dose, but at a slower pace.

Pregnancy and fertility

Pregnancy

Some epidemiological studies indicate a possible increased risk of congenital malformations, in particular of the cardiovascular system (eg, ventricular or atrial septal defects), with the use of paroxetine in the first trimester of pregnancy. The mechanism of this phenomenon is unknown. Data show that the risk of having a child with a congenital malformation of the cardiovascular system after maternal use of paroxetine is less than 2/100 compared to 1/100 in the general population.

Newborns whose mothers used paroxetine later in pregnancy may experience the following symptoms: respiratory distress syndrome, cyanosis, apnea, convulsions, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypertonicity, hypotension, hyperreflexia, tremor, twitching, increased irritability, lethargy, constant crying, drowsiness and difficulty falling asleep. These symptoms may be due to serotonergic effects or be withdrawal symptoms. In most cases, complications occur immediately or shortly after birth (<24 часов).

Fertility

The effect on human fertility has not yet been investigated.

Features of the influence of the drug on the ability to drive vehicles or potentially dangerous mechanisms

Clinical experience shows that treatment with Reksetin® does not impair cognitive and psychomotor functions. However, patients should be careful when driving and operating potentially dangerous machinery.

Overdose

Symptoms: Based on what is known about paroxetine overdose, it has a wide margin of safety. Experience in the treatment of cases of paroxetine overdose indicates that, in addition to the symptoms described in the "Side Effects" section, fever and involuntary muscle contractions are observed. Even with a single dose of up to 2000 mg of paroxetine, the condition of patients usually returns to normal without serious consequences. There have been isolated reports of the development of coma and changes in the ECG, which very rarely led to death. In these cases, patients most often took paroxetine along with other psychotropic drugs, with or without alcohol.

Storage conditions

Store between 15°C and 30°C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription

Manufacturer and holder of the registration certificate

OJSC "Gedeon Richter"

1103 Budapest, st. Djemrei, 19-21, Hungary

Reksetin: instructions for use and reviews

Reksetin - a drug with antidepressant action.

Release form and composition

Produced in the form of film-coated tablets: almost white or white, round, biconvex, on one side - risk, on the other - engraving "X20" or "X30" (10 pieces in blisters, in a carton pack 3 blisters and instructions for use Rexetin).

The composition of 1 tablet includes:

• Active substance: paroxetine - 20 or 30 mg (paroxetine hydrochloride hemihydrate - 22.76 / 34.14 mg);
• Auxiliary components: sodium carboxymethyl starch, hypromellose, calcium hydrogen phosphate dihydrate, magnesium stearate;
• Shell: polysorbate 80, hypromellose, macrogol 6000, macrogol 400, titanium dioxide.

Pharmacological properties

Pharmacodynamics

Paroxetine is an antidepressant. Inhibits the reverse neuronal uptake of serotonin in the central nervous system. The neuronal uptake of dopamine and norepinephrine is little affected.

It also has an anxiolytic and psychostimulant effect.

Pharmacokinetics

Paroxetine after oral administration is well absorbed from the gastrointestinal tract. The absorption and pharmacokinetic parameters of paroxetine are not affected by the simultaneous intake of food.

The substance binds to plasma proteins at a level of 93-95%. The equilibrium state of paroxetine is reached within 7-14 days after the start of treatment, after which the pharmacokinetics during long-term therapy does not change.

Metabolism occurs mainly in the liver, with predominantly inactive metabolites being formed.

T 1/2 (half-life) of paroxetine is in the range of 6-71 hours, but the average is 24 hours. Approximately 64% of the substance is excreted in the urine (unchanged - 2%; as metabolites - 62%). Approximately 36% of the dose is excreted through the intestines, mainly in the form of metabolites, up to 1% in the feces as unchanged substance.

In case of impaired liver and kidney function, as well as in elderly patients, the concentration of paroxetine in the blood plasma increases.

Indications for use

• Depression of various origins, including conditions accompanied by anxiety;
• Obsessive-compulsive disorders (compulsive disorder);
• post-traumatic stress disorder;
• Panic disorders, including those occurring with agoraphobia (fear of being in a crowd);
• Generalized Anxiety Disorders (GAD);
• Social phobia.

Also, Reksetin tablets are prescribed during anti-relapse treatment.

Contraindications

Absolute:

• Simultaneous reception with monoamine oxidase inhibitors and a period of 14 days after their cancellation;
• Combined use with thioridazine (prolongation of the QT interval on the ECG is possible with concomitant serious ventricular arrhythmias, such as torsades de pointes, and sudden death);
• Age up to 18 years (clinical experience with the use of Reksetin in this group of patients is absent);
• Pregnancy and lactation;
• Hypersensitivity to the components of the drug.

Relative (Rexetin is prescribed with caution in the presence of the following diseases / conditions):

• Hyperplasia of the prostate;
• Violations of the function of the cardiovascular system;
• Chronic renal failure;
• Liver failure;
• Epilepsy in history (possible development of epileptiform seizures, in which case treatment is interrupted);
• Combined use with neuroleptics, lithium preparations (due to insufficient clinical experience of combined use);
• Glaucoma (may develop mydriasis);
• Elderly age.

During the period of therapy with Reksetin, women of childbearing age are recommended to use contraceptives.

Reksetin, instructions for use: method and dosage

Reksetin tablets are taken orally (swallowed whole), preferably in the morning, with meals.

Multiplicity of reception - 1 time per day.

Rexetin dose adjustment is usually carried out after 2-3 weeks of therapy, based on the clinical condition of the patient.

• Depression: 20 mg, as a rule, the effect develops gradually. In some cases, it may be necessary to increase the dose of the drug (per week - by 10 mg, until a therapeutic effect is achieved). Maximum - 50 mg per day;
• Social phobias: 20 mg, if after 14 days of therapy there is no improvement, the dose is gradually increased (by 10 mg 1 time per week) until the desired effect is achieved. Maximum - 50 mg per day. As a maintenance therapy, Reksetin is prescribed 20 mg per day;
• Panic disorders: 10 mg (due to the likely temporary increase in the intensity of the symptoms of the disease at the beginning of treatment) with a gradual (10 mg 1 time per week) increase to 40 mg. Maximum - 60 mg per day;
• Obsessive-compulsive disorders (compulsive disorder): 20 mg, a gradual (by 10 mg) dose increase is possible. Maximum - 40-60 mg;
• Generalized anxiety and post-traumatic stress disorder: 20 mg, possibly gradual (by 10 mg once a week) increase to a maximum daily dose of 50 mg.

To prevent the possibility of relapse, depending on the clinical condition of the patient, maintenance therapy should be carried out. After the disappearance of the symptoms of depression, the course of maintenance treatment can be 4-6 months, with panic and obsessional disorders, a longer use of the drug is possible. Abrupt cancellation of Reksetin is recommended to be avoided.

Daily dose for debilitated patients and elderly patients: initial - 10 mg, maximum - 40 mg (with an increase of 10 mg 1 time per week).

The recommended daily dose for patients with hepatic or renal impairment (with creatinine clearance<30 мл/мин) недостаточностью составляет 20 мг (из-за возрастания плазменной концентрации пароксетина). В зависимости от состояния эту дозу можно увеличивать, однако следует стремиться поддерживать дозу на наименьшем возможном уровне.

Side effects

Possible adverse reactions (the intensity and frequency of their manifestation during treatment decreases, therefore, in most cases, the violations described below do not lead to discontinuation of therapy):

• Central and peripheral nervous system: drowsiness, tremor, insomnia, increased fatigue, general weakness; in some cases - increased irritability, headache, paresthesia, somnambulism, dizziness, decreased concentration; rarely - orofacial dystonia, extrapyramidal disorders (in most cases with previous intensive use of antipsychotics); rarely - epileptiform seizures, increased intracranial pressure;
• Digestive system: nausea; sometimes - diarrhea, constipation, loss of appetite; rarely - an increase in liver function tests; in some cases - functional liver disorders in severe course (between taking Reksetin and changes in the activity of liver enzymes, a causal relationship has not been proven, but in cases of impaired liver function, it is recommended to interrupt therapy);
• Cardiovascular system: in some cases - ECG changes, fainting, tachycardia, arterial pressure lability;
• Autonomic nervous system: dry mouth, increased sweating;
• Urinary system: rarely - difficulty urinating;
• Reproductive system: ejaculation disorder; in some cases - a change in libido;
• Organ of vision: in some cases - mydriasis, visual impairment; rarely - an attack of acute glaucoma;
• Allergic reactions: rarely - subcutaneous hemorrhages, skin flushing, swelling in the limbs and face, skin itching, anaphylactic reactions (in the form of urticaria, bronchospasm, angioedema);
• Water and electrolyte balance: in some cases - hyponatremia in combination with peripheral edema, epileptiform symptoms or impaired consciousness (the level of sodium in the blood normalizes after Rexetine is discontinued; sometimes hyponatremia develops due to hyperproduction of antidiuretic hormone, usually in elderly patients taking Reksetin in combination with diuretics and other drugs);
• Others: in isolated cases - hyperglycemia, myoclonus, myopathy, myasthenia gravis, myalgia; rarely - hyperprolactinemia, hypoglycemia, galactorrhea, development of a flu-like state, fever, change in taste; rarely - thrombocytopenia (a causal relationship with Rexetin has not been proven), a change (increase or decrease) in weight, increased bleeding.

Compared with tricyclic antidepressants, Rexetin causes less dry mouth, drowsiness and constipation. Abrupt discontinuation of therapy can lead to the development of dizziness, sensory disturbances (eg, paresthesia), agitation, anxiety, sleep disturbances, nausea, tremors, increased sweating and confusion. In this regard, Reksetin is canceled gradually (it is recommended to reduce the dose every second day).

Overdose

Paroxetine is safe over a wide range of doses. Signs of an overdose appear with the simultaneous use of paroxetine at a dose of 2000 mg in combination with other drugs or alcohol. Symptoms include: redness of the skin of the face, dizziness, drowsiness, tremor, vomiting, nausea, dilated pupils, xerostomia, increased sweating, general arousal. Convulsions or coma were not noted. At the same time, a fatal outcome was observed rarely, usually in cases of simultaneous overdose of paroxetine and another drug, which is due to adverse interactions.

Therapy includes:

• gastric lavage;
• activated charcoal 20–30 g every 4–6 hours for the first 24–48 hours;
• the release of the respiratory tract, if necessary, oxygenation is indicated;
• constant monitoring of cardiac and other vital functions, general measures that are aimed at maintaining them.

The specific antidote is unknown. If a large dose of paroxetine has passed from the blood to the tissues, then forced diuresis, hemoperfusion, or hemodialysis are ineffective.

special instructions

After the abolition of monoamine oxidase inhibitors, Reksetin can be administered with extreme caution (from small doses and their gradual increase until the desired therapeutic effect is achieved) after 14 days. After the end of therapy, monoamine oxidase inhibitors are prescribed at intervals of 14 days.

If manic states were previously observed, the possibility of a relapse should be taken into account while taking Reksetin.

There is no sufficient experience of combined use with electroconvulsive therapy.

Patients with depression and drug addiction during the withdrawal period need careful medical supervision (there is a predisposition to suicidal attempts).

In many cases, the development of hyponatremia is noted, especially in elderly patients when combined with diuretics. The level of sodium in the blood is normalized after the abolition of Reksetin.

Hyperglycemic conditions during therapy are rare.

Sometimes during the period of treatment there is increased bleeding (mainly purpura and ecchymosis).

Patients with depression need to be carefully monitored until remission (because of an increased risk of suicidal ideation, auto-aggression, and suicide). According to clinical experience, the risk of suicide in the treatment of antidepressants may increase in the early stages of recovery.

In other psychiatric conditions that are indications for the appointment of Reksetin, there is also an increased risk of suicidal behavior. These conditions may co-exist with major depressive disorders, so patients also need medical supervision. In addition, patients with a history of suicidal thoughts or behavior, or who demonstrate a significant degree of suicidal ideation before starting treatment, especially patients 18-29 years old, need careful monitoring.

Influence on the ability to drive vehicles and complex mechanisms

At the beginning of the course of treatment and for an individually set period, it is impossible to drive vehicles or work in conditions of increased danger.

Use during pregnancy and lactation

Reksetin during pregnancy / lactation is not prescribed.

Application in childhood

Patients under 18 years of age are not prescribed the drug.

With impaired renal function

Reksetin in chronic renal failure is used under medical supervision.

For impaired liver function

Reksetin in liver failure is used under medical supervision.

Use in the elderly

Elderly patients should be treated with caution.

drug interaction

With the combined use of Reksetin with certain drugs / substances, the following effects may be observed:

• Monoamine oxidase inhibitors: development of an undesirable interaction;
• Tryptophan: the appearance of nausea, headache, dizziness, increased sweating (the combination is not recommended);
• Warfarin: pharmacodynamic interaction (there is increased bleeding with unchanged prothrombin time; the combination requires caution);
• Sumatriptan: development of general weakness, hyperreflexia, impaired coordination (the combination requires caution and medical supervision);
• Tricyclic antidepressants: inhibition of metabolism (the combination requires caution and dose reduction of tricyclic antidepressants);
• Drugs that enhance or inhibit the activity of liver enzyme systems: the effect on the pharmacokinetics and metabolism of paroxetine (recommended the appointment of minimal doses of Reksetin);
• Drugs metabolized by CYP2D6 (certain antidepressants (eg, amitriptyline, nortriptyline, fluoxetine, imipramine, desipramine), phenothiazines (eg, thioridazine), class 1C antiarrhythmics (eg, encainide, flecainide, propafenone), drugs , which block its action (for example, cimetidine, quinidine, codeine)): a decrease in their activity (the combination requires caution);
• Cimetidine: increased plasma levels of paroxetine at the steady state stage;
• Phenobarbital: decrease in plasma concentration of paroxetine, as well as a decrease in its half-life;
• Phenytoin: decrease in plasma concentration of paroxetine, increase in the frequency of adverse reactions of phenytoin;
• Other anticonvulsants: an increase in the incidence of their adverse reactions;
• Drugs that bind to plasma proteins: increased side effects;
• Digoxin: possible development of an interaction (combination requires caution);
• Procyclidine: an increase in its plasma concentration (with the development of anticholinergic side reactions, a dose reduction of procyclidine is necessary);
• Theophylline: increasing its concentration (regular monitoring of its level is recommended).

During therapy, the use of alcohol should be excluded (due to the effect of Reksetin on the liver enzyme system).

Analogues

Analogues of Reksetin are: Adepress, Paxil, Plizil N, Paroxetine.

Terms and conditions of storage

Keep out of the reach of children at a temperature of 15-30 °C.

Shelf life - 5 years.