Rexetine, 30 mg, film-coated tablets, 30 pcs., Gedeon Richter buy in Moscow at a low price

Rexetine, 30 pcs., 30 mg, film-coated tablets

Inside,

1 time per day, preferably in the morning, during meals, without chewing.

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

For depression:

The recommended daily dose is 20 mg. As with other antidepressants, the effect in most cases develops gradually. Some patients may require an increase in the dose of the drug. Depending on the patient’s response to therapy, the daily dose can be increased by 10 mg at intervals of 1 week until a therapeutic effect is achieved; the maximum daily dose is 50 mg.

For obsessive-compulsive disorders (obsessiveness syndrome):

the initial dose is 20 mg/day. The dose may be increased by 10 mg weekly until the desired therapeutic response is achieved. The maximum daily dose is usually 40 mg, but should not exceed 60 mg.

For panic disorders:

The recommended therapeutic dose is 40 mg/day. Therapy should begin with a small dose (10 mg/day), with a weekly increase in dosage by 10 mg/day 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.

For social phobias:

Therapy can be started with a dose of 20 mg/day. If after a 2-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, a daily dose of 20 mg is usually sufficient.

For generalized anxiety disorder:

The recommended therapeutic dose is 20 mg/day. Depending on the patient’s response to therapy, the daily dose can be increased gradually by 10 mg; the maximum daily dose is 50 mg.

For post-traumatic stress disorder:

The recommended therapeutic dose is 20 mg/day. Depending on the patient's response to therapy, the daily dose can be increased periodically by 10 mg, the maximum daily dose is 50 mg.

Depending on the clinical condition of the patient, maintenance therapy must be carried out to prevent possible relapses. This course, after the symptoms of depression disappear, can last 4–6 months, and for obsessive and panic disorders, even more. As with other psychotropic drugs, abrupt cessation of treatment should be avoided. In weakened and elderly patients, the level of the drug in the blood serum may increase above normal, so the recommended initial dose is 10 mg/day. This dose can be increased by 10 mg weekly, depending on the patient's condition.

The maximum dose should not exceed 40 mg/day.

The drug is not indicated for children due to lack of clinical experience.

In case of renal (Cl creatinine <30 ml/min) or liver failure, 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 patient's condition, but one should strive to maintain it at the lowest possible level.

Rexetine 20 mg, 30 film-coated tablets

Registration Certificate Holder

GEDEON RICHTER (Hungary)

Dosage form

Medicine - Rexetin® (Rexetin®)

Description

Film-coated tablets

white or almost white, round, biconvex, with a mark on one side and with an engraving “X20” on the other.

1 tab.

paroxetine hydrochloride hemihydrate 22.76 mg, which corresponds to the content of paroxetine 20 mg

Excipients

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

Film shell composition:

polysorbate 80, macrogol 400, macrogol 6000, titanium dioxide, hypromellose.

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

Indications

depression of various etiologies, incl. states accompanied by anxiety;
obsessive-compulsive disorder (obsessiveness syndrome);
panic disorders, incl. with fear of being in a crowd (agoraphobia);
social phobia;
generalized anxiety disorder (GAD);
post-traumatic stress disorders.

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

Contraindications for use

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

Rexetine should not be used in combination with thioridazine because, like other drugs that inhibit CYP2D6, paroxetine may increase plasma concentrations of thioridazine. Administration of thioridazine alone may result in ECG QT prolongation with associated serious ventricular arrhythmias such as torsade de pointes (TdP) and sudden death.

Carefully

The drug should be used for disorders of the cardiovascular system, liver failure, chronic renal failure, prostatic hyperplasia, as well as in elderly patients.

Paroxetine should be used with caution if there is 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 exhibit such disorders.

Like other selective serotonin reuptake inhibitors (SSRIs), paroxetine causes mydriasis, so if you have glaucoma, the drug should be used with caution.

When paroxetine is used together with benzodiazepines (oxazepam), barbiturates, and antipsychotics, there is no evidence of an increase in their inherent 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 with the combined use of lithium with paroxetine or with other serotonin reuptake inhibitors has not yet been accumulated, so this combination should be used with caution, with regular monitoring of lithium blood levels.

pharmachologic effect

Antidepressant. Inhibits the reverse neuronal uptake of serotonin into the central nervous system. Has little effect on the neuronal uptake of norepinephrine and dopamine. It also has anxiolytic and psychostimulating effects.

Drug interactions

Food and antacids

do not affect the absorption and pharmacokinetics of paroxetine.

Similar to other serotonin reuptake inhibitors, undesirable interactions 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 warfarin

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

In the few cases where paroxetine has been used with sumatriptan

general weakness, hyperreflexia, and coordination problems are noted. If their simultaneous use is necessary, extreme caution should be exercised (medical supervision is required).

When used concomitantly, paroxetine may inhibit the metabolism of tricyclic antidepressants.

(due to inhibition of the CYP2D6 isoenzyme), therefore the use of this 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 concomitantly with inhibitors of metabolic liver enzymes, the lowest effective dose of paroxetine should be used. Combined 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, special caution requires the simultaneous use of paroxetine with drugs whose metabolism occurs with the participation of this isoenzyme, incl. with some antidepressants (for example, nortriptyline, amitriptyline, imipramine, desipramine and fluoxetine), phenothiazines (for example, thioridazine), class 1 C antiarrhythmic drugs (for example, propafenone, flecainide and encainide) or with those drugs that block its action (for example, quinidine, cimetidine, codeine).

Reliable clinical data on the inhibition of the CYP3A4 isoenzyme

no, therefore it can be used with drugs that inhibit this enzyme (for example, terfenadine).

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 steady-state stage.

Phenobarbital

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

When 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 incidence of their side effects may also increase. In patients with epilepsy treated for a long time with carbamazepine, phenytoin or sodium valproate, 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 highly bound to plasma proteins. When used simultaneously with drugs that also bind to plasma proteins,

against the background of increased concentrations of paroxetine in the blood plasma, side effects may increase.

Due to the lack of sufficient clinical experience with the concomitant use of digoxin

with paroxetine, the use of this combination requires caution.

Diazepam

When used in a course, it does not affect the pharmacokinetics of paroxetine.

Paroxetine significantly increases the concentration of procyclidine

in blood plasma, therefore, if anticholinergic side effects occur, it is necessary to reduce the dose of procyclidine.

In clinical studies, paroxetine had no effect on propranolol

in blood.
In some cases, an increase in the concentration of theophylline
in the blood was noted. Although the interaction between paroxetine and theophylline has not been proven in clinical studies, regular monitoring of theophylline blood levels is recommended.

Increased effects of alcohol

When used simultaneously with paroxetine, it was not detected. However, due to the effect of paroxetine on the liver enzyme system, it is necessary to avoid drinking alcohol during treatment with paroxetine.

Dosage regimen

Rexetine® should be taken 1 time/day, preferably in the morning, with meals, do not chew the tablets.

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

For depression

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

For 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.

For panic disorders

The recommended therapeutic dose is 40 mg/day. Therapy should begin with a small dose (10 mg/day), 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.

For 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.

For generalized anxiety disorder

The recommended therapeutic dose is 20 mg/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.

For post-traumatic stress disorders

The recommended therapeutic dose is 20 mg/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 to prevent the possibility of relapse

maintenance therapy is necessary.
of depression
disappear can be 4-6 months, and for
obsessive and panic disorders,
even more. As with other psychotropic drugs, abrupt withdrawal of the drug should be avoided.

In frail and elderly patients

Paroxetine serum concentrations may increase faster than usual, so the recommended starting dose is 10 mg/day. This dose can be increased by 10 mg weekly depending on the patient's condition.

The maximum dose should not exceed 40 mg/day.
for children
due to lack of clinical experience.

In case of renal (creatinine clearance<30 ml/min) or liver failure

the concentration of paroxetine in the blood plasma increases, so the recommended daily dose of the drug in these cases is 20 mg. This dose can be increased depending on the patient's condition, but one should strive to maintain the dose at the lowest possible level.

Overdose

Symptoms:

Paroxetine therapy is safe over a wide range of doses. Signs of overdose appeared when paroxetine was used simultaneously 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 facial skin. No coma or seizures were noted. Fatal outcomes have been reported rarely, usually with simultaneous overdose of paroxetine and another drug causing adverse interaction effects.

Treatment:

gastric lavage, 20-30 g of activated carbon every 4-6 hours during the first 24-48 hours; The airways should be cleared and oxygenation administered if necessary. Carry out monitoring of 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 entered the tissues from the blood.

Side effect

The frequency and intensity of side effects decreases during therapy, so if they develop, in most cases it is possible to continue taking the drug.

Adverse reactions are presented as percentages of the identified ratio from the total number of patients receiving this treatment.

From the digestive system:

nausea (12%); sometimes - constipation, diarrhea, loss of appetite; rarely - increased liver function tests; in some cases - severe liver dysfunction. A cause-and-effect relationship has not been proven between taking paroxetine and changes in liver enzyme activity, but discontinuation of paroxetine is recommended in case of liver dysfunction.

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 previous intensive use of antipsychotics. Epileptiform seizures were rarely observed (which is also typical for therapy with other antidepressants); increased intracranial pressure.

From the autonomic nervous system:

increased sweating (9%), dry mouth (7%).

From the side of the organ of vision:

in some cases - blurred vision, mydriasis; rarely - an attack of acute glaucoma.

From the cardiovascular system:

in some cases - tachycardia, ECG changes, blood pressure lability, fainting.

From the reproductive system:

ejaculation disorder (13%), in some cases - changes in libido.

From the urinary system:

rarely - difficulty urinating.

From the side of water-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 normalizes. In some cases, this condition developed due to overproduction of antidiuretic hormone. Most of these cases were observed in elderly people who, in addition to paroxetine, received diuretics and other drugs.

Allergic reactions:

rarely - skin hyperemia, subcutaneous hemorrhages, swelling in the face and limbs, anaphylactic reactions (urticaria, bronchospasm, angioedema), itching.
Other:
in isolated cases - myopathies, myalgia, myasthenia gravis, myoclonus, hyperglycemia; rarely - hyperprolactinemia, galactorrhea, hypoglycemia, fever and development of a flu-like state, change in taste. Thrombocytopenia has rarely developed (a cause-and-effect 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, compared with tricyclic antidepressants, is less likely to cause dry mouth, constipation and drowsiness. Sudden discontinuation of the drug may cause dizziness, sensory disturbances (for example, paresthesia), fear, sleep disturbance, agitation, tremor, nausea, increased sweating and confusion, so discontinuation of drug therapy should be done gradually (it is advisable to reduce the dose every second day).

special instructions

Taking paroxetine simultaneously with MAO inhibitors and within 14 days after their discontinuation is contraindicated.

In the future, paroxetine should be used with extreme caution, starting treatment with small doses and gradually increasing the dosage until the desired therapeutic effect is achieved. After completing paroxetine therapy, treatment with MAO inhibitors should not be started for 14 days.

If the patient was previously in a manic state

, while taking paroxetine, the possibility of relapse should be taken into account (as with other antidepressants).

There is insufficient experience with the simultaneous use of electroconvulsive therapy

and paroxetine.

Due to predisposition to suicide attempts

in patients with depression and patients with drug addiction during the abstinence period, this category of patients requires careful monitoring during the treatment process.

Hyponatremia was observed in many cases

, especially in elderly patients receiving diuretics. After stopping paroxetine, blood sodium levels return to normal.

, increased bleeding occurred during treatment with paroxetine.

(mainly ecchymosis and purpura).

Hyperglycemic conditions have rarely been reported with paroxetine use.

Suicide/Suicidal ideation

Depression is associated with an increased risk of suicidal ideation, self-injury, and suicide. This risk persists until remission occurs. Because improvement may not occur within the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. Current clinical experience suggests that during treatment with antidepressants, the risk of suicide may increase in the early stages of 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 that are taken when treating patients with major depressive disorder should be observed when it comes to treating patients with other psychiatric disorders. Patients with a history of suicidal behavior or thoughts, or who demonstrate a significant degree of suicidal ideation before treatment, are at greater risk for suicidal ideation or suicide attempts and should be closely monitored during treatment. There is an increased risk of suicide in such patients aged 18-29 years, so treatment with the drug should be carefully monitored.

Patients (and those who provide care to patients) should be prepared for the need to monitor in emergency situations - the emergence of suicidal intentions/behavior or thoughts of self-aggression, in order to seek medical help immediately if these symptoms are present.
Effect on the ability to drive vehicles and operate machinery.
Controlled studies have not revealed a negative effect of paroxetine on psychomotor or cognitive function. Despite this, at the beginning of the course of therapy, for an individually determined period, you should not drive a car or work in high-risk conditions that require quick reactions. The degree of restriction is determined individually.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C.

Best before date

Shelf life: 5 years.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

The safety of paroxetine during pregnancy and lactation has not been studied, therefore the drug should not be used during pregnancy and lactation, except in cases where, from a medical point of view, the potential benefits of treatment outweigh the possible risks associated with taking the drug.
For women of childbearing potential,
contraception is recommended during therapy with paroxetine.

Use for renal impairment

Restrictions for impaired renal function - With caution.

For renal (creatinine clearance<30 ml/min)

Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

For liver failure

Use in elderly patients

Restrictions for elderly patients - Use with caution.

In elderly patients

Paroxetine serum concentrations may increase faster than usual, so the recommended starting dose is 10 mg/day. This dose can be increased by 10 mg weekly depending on the patient's condition.

Use in children

Restrictions for children - Contraindicated.

Contraindication: children and adolescents under 18 years of age (due to lack of clinical experience).

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

GEDEON RICHTER JSC (Hungary)

Organization accepting complaints from consumers Moscow representative office of JSC Gedeon Richter 119049 Moscow, 4th Dobryninsky lane, 8 Tel. Email