Rexetin - instructions for use, reviews, analogs and forms of release (20 mg and 30 mg tablets) antidepressant medications for the treatment of depression, panic disorders and phobias in adults, children and pregnancy. Withdrawal syndrome and alcohol

In this article, you can read the instructions for using the drug Rexetin. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of antidepressant Rexetin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Rexetin analogues in the presence of existing structural analogues.Use for the treatment of depression, panic disorders and phobias in adults, children, as well as in pregnancy and lactation. Abolition of the drug and its interaction with alcohol.

Rexetin antidepressant. Inhibits reverse neuronal seizure of serotonin in the central nervous system. Little affects the neuronal seizure of norepinephrine and dopamine. It also has anxiolytic and psychostimulating action.

Composition

Paroxetine hydrochloride hemihydrate (Paroxetine) + auxiliary substances.

Pharmacokinetics

After oral administration, Rexetin is well absorbed from the digestive tract. Simultaneous food intake does not affect the absorption and pharmacokinetics of paroxetine. Paroxetine binds to plasma proteins by 93-95%. The equilibrium state is achieved 7-14 days after the initiation of therapy, in the future the pharmacokinetics do not change with prolonged therapy. Metabolized mainly in the liver with the formation of predominantly inactive metabolites. About 64% of paroxetine is excreted in the urine (2% in unchanged form, 62% in the form of metabolites); approximately 36% is released through the intestine, mainly in the form of metabolites, less than 1% - unchanged with feces.

The concentration of paroxetine in the blood plasma increases with the violation of the liver and kidneys, as well as in the elderly.

Indications

• depression of various etiology, incl. states accompanied by anxiety;
• obsessive-compulsive disorder (obsessive-compulsive disorder);
• panic disorders, incl. with fear of being in the crowd (agoraphobia);
• social phobia;
• generalized anxiety disorder (GAD);
• posttraumatic stress disorders.

It is also used in the context of anti-relapse treatment.

Forms of release

Tablets coated with 20 mg and 30 mg.

Instructions for use and dosage

Tablets should be taken 1 time per day, preferably in the morning, while eating, without chewing.

As 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.

With 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 can be increased by 10 mg per week until the therapeutic effect is achieved; the maximum daily dose is 50 mg per day.

In obsessive-compulsive disorders (obsessive-compulsive disorder), the initial dose is 20 mg per day.The dose may be increased by 10 mg until a therapeutic response is obtained. The maximum daily dose is usually 40 mg, but should not exceed 60 mg.

In panic disorders, the recommended therapeutic dose is 40 mg per day. Therapy should be started with a small (10 mg per day) dose, with a weekly increase of 10 mg per week to achieve the desired effect. 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.

With social phobia therapy can be started with a dose of 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 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 per day.

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

In post-traumatic stress disorders, the recommended therapeutic dose is 20 mg per day. Depending on the patient's response to therapy, the daily dose can be increased by 10 mg, the maximum daily dose is 50 mg.

Depending on the clinical condition of the patient, maintenance therapy is necessary to prevent the possibility of relapses. The course of maintenance therapy after the disappearance of symptoms of depression can be 4-6 months, and with obsessive and panic disorders and more. As with other psychotropic drugs, the drug should be abruptly discontinued.

In weakened patients and the elderly, the serum paroxetine concentration may increase faster than usual, so the recommended initial dose is 10 mg per day. This dose can be increased by 10 mg weekly depending on the patient's condition. The maximum dose should not exceed 40 mg per day.

Children due to lack of clinical experience, the drug is not shown.

Side effect

• nausea;
• constipation;
• diarrhea;
• decreased appetite;
• abnormal liver function;
• drowsiness;
• tremor;
• general weakness;
• increased fatigue;
• insomnia;
• headache;
• increased irritability;
• paresthesia;
• dizziness;
• somnambulism;
• decreased concentration of attention;
• extrapyramidal disorders;
• orofacial dystonia;
• epileptiform seizures;
• increased intracranial pressure;
• increased sweating;
• dry mouth;
• impaired vision;
• an attack of acute glaucoma;
• tachycardia;
• ECG changes;
• lability of blood pressure;
• fainting;
• ejaculation disorder;
• change in libido;
• difficulty urinating;
• hyperemia of the skin;
• subcutaneous hemorrhage;
• edema in the face and limbs;
• anaphylactic reactions (urticaria, bronchospasm, angioedema);
• itching;
• Myopathy, myalgia, myasthenia gravis, myoclonia;
• hyperprolactinemia;
• galactorrhea;
• increase in temperature and development of the influenza-like state;
• change in taste;
• thrombocytopenia.

Sudden abolition of the drug may cause dizziness, impaired sensation (eg, paresthesia), a sense of fear, sleep disturbance, agitation, tremor, nausea, increased sweating and confusion, so stopping therapy with the drug should be gradual (it is advisable to reduce dosages every second day).

The frequency of manifestation and the intensity of side effects in the therapy process is reduced, so when they develop in most cases it is possible to continue taking the drug.

Contraindications

• simultaneous administration of MAO inhibitors and a period of 14 days after their cancellation;
• pregnancy;
• lactation (breastfeeding);
• children and adolescents under 18 years of age (due to lack of clinical experience);
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

The safety of the use of Rexetin during pregnancy and during lactation has not been studied, so the drug should not be used during pregnancy and lactation, except when, from a medical point of view, the potential benefit of treatment exceeds the potential risk associated with taking the drug.

Women of childbearing age are recommended contraception during paroxetine therapy.

Use in children

Contraindicated in children and adolescents under the age of 18 (due to lack of clinical experience).

special instructions

Contraindicated taking Rexetin simultaneously with MAO inhibitors and within 14 days after their withdrawal.In the future, paroxetine should be used with extreme caution, starting a course of treatment with small doses and gradually increasing dosages until the desired therapeutic effect is achieved. After the end of paroxetine therapy for 14 days, treatment with MAO inhibitors should not be started.

If the patient was previously manic, during the reception of paroxetine, the possibility of relapse (as with other antidepressants) should be considered.

There is insufficient experience of simultaneous use of electroconvulsive therapy and paroxetine.

In connection with the predisposition to suicidal attempts in patients with depression and patients with drug abuse during the period of withdrawal, this category of patients requires careful monitoring during treatment.

In many cases, hyponatremia has been noted, especially in elderly patients who receive diuretics. After the withdrawal of paroxetine, the level of sodium in the blood is normalized.

In some cases, against the background of paroxetine treatment, increased bleeding occurred (mainly ecchymosis and purpura).

Against the background of paroxetine, hyperglycemic conditions were rarely noted.

Suicidal / Suicidal Thinking

Depression is associated with an increased risk of suicidal thoughts, autoaggression and suicide. This risk persists until a remission occurs. Because the improvement may not occur within the first few weeks or more from the start of treatment, patients should be carefully monitored until such an improvement occurs. The current clinical experience indicates that when treating with antidepressants, the risk of suicide may increase in the early stages of recovery.

Other psychiatric conditions in which Rexetin is administered may also be associated with an increased risk of suicidal behavior. In addition, these conditions can be associated with a major depressive disorder. The same precautions as for the treatment of patients with major depressive disorder should be observed when it comes to treating patients with other psychiatric disorders. Patients with an anamnesis of suicidal behavior or thoughts, or exhibiting a significant degree of suicidal thinking before starting treatment, are at greater risk of suicidal thoughts or suicide attempts, and should be carefully observed during treatment.Such patients aged 18-29 years have an increased risk of suicide, so treatment with the drug should be carefully monitored.

Patients (and those who provide care to patients) should be prepared for the need for monitoring in emergencies - suicidal intent / behavior or thoughts about autoaggression, in order to seek medical help immediately if these symptoms are present.

Impact on the ability to drive vehicles and manage mechanisms

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

Drug Interactions

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

Like other serotonin reuptake inhibitors, undesirable interactions between MAO inhibitors and paroxetine have been observed in animal experiments.

The simultaneous use of paroxetine with tryptophan leads to the onset of headache, nausea, increased sweating and dizziness, therefore, this combination should be avoided.

Between paroxetine and Warfarin is assumed pharmacodynamic interaction (with unchanged prothrombin time marked increased bleeding); The use of such a combination requires caution.

With the combined use of Rexetin with sumatriptan, general weakness, hyperreflexia, and coordination disorders are noted. If they need to be used together, special care should be taken (medical control is required).

With simultaneous use of paroxetine can inhibit the metabolism of tricyclic antidepressants (by inhibiting the isoenzyme CYP2D6), so the use of this combination requires caution and reduced doses of tricyclic antidepressants.

Drugs that enhance or inhibit the activity of liver enzyme systems can affect the metabolism and pharmacokinetics of paroxetine. When combined with inhibitors of liver metabolic enzymes, the lowest effective dose of paroxetine should be used.Co-administration with hepatic enzyme inducers does not require correction of the initial dose of paroxetine; further changes in dosage depend on the clinical effect (efficacy and tolerability).

Rexetin significantly inhibits the activity of the isoenzyme CYP2D6. Therefore, special caution requires the simultaneous use of paroxetine with drugs, the metabolism of which occurs with the participation of this isoenzyme, including. with some antidepressants (for example, nortriptyline, amitriptyline, imipramine, desipramine and fluoxetine), phenothiazines (eg thioridazine), antiarrhythmic drugs of class 1C (for example, propafenone, flecainide and enkainide) or with those drugs that block its action (eg, quinidine , cimetidine, codeine).

There are no reliable clinical data on the inhibition of the isoenzyme CYP3A4 by paroxetine, so it is possible to use with drugs inhibiting this enzyme (for example, terfenadine).

Cimetidine inhibits certain cytochrome P450 isoenzymes. Because of this, when paroxetine is used together with cimetidine, the level of paroxetine in the blood plasma increases at the stage of the equilibrium state.

Phenobarbital increases the activity of certain cytochrome P450 isoenzymes. When paroxetine is used together with phenobarbital, the concentration of paroxetine in the blood plasma decreases, and its T1 / 2 is shortened.

With the combined use of paroxetine and phenytoin, the concentration of paroxetine in the blood plasma decreases and the frequency of side effects of phenytoin may increase. 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; increased paroxysmal convulsive readiness was not noted.

Paroxetine is largely associated with blood plasma proteins. With simultaneous use with drugs that also bind to plasma proteins, against the background of increased concentrations of paroxetine in the blood plasma may increase the side effects.

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

Diazepam for course use does not affect the pharmacokinetics of paroxetine.

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

In clinical trials, paroxetine did not affect the level of Propranolol in the blood.

In some cases, increased the concentration of theophylline in the blood. Despite the fact that during clinical trials the interaction between paroxetine and theophylline is not proven, regular monitoring of the level of theophylline in the blood is recommended.

Strengthening of the action of ethanol (alcohol) with simultaneous application with paroxetine is not revealed. However, due to the effect of paroxetine on the enzyme system of the liver, it is necessary to exclude the use of alcoholic beverages during treatment with paroxetine.

Analogues of the drug Rexetin

Structural analogs for the active substance:

• Adress;
• Aktaparoxetine;
• Apo Paroxetine;
• Paxil;
• Paroxetine;
• Plizil;
• Sirestill.

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