Rexetin pills 20mg №30

Coated tablets

Composition

1 coated pill contains: Paroxetine hydrochloride hemihydrate 3414 mg, which corresponds to a paroxetine content of 20 mg.

Auxiliary substances: Calcium hydrogen phosphate dihydrate, sodium starch glycolate (type A), hypromellose, Magnesium stearate, macrogol 400, macrogol 6000, polysorbate 80, titanium dioxide CI 77891, E171.

Packing

In 1 blister 10 tablets. In a cardboard bundle 3 blisters.

Mechanism of action

Rexetin is an antidepressant.

Inhibits the reverse neuronal seizure of serotonin in the CNS. It has little effect on the neuronal uptake of norepinephrine and dopamine. It also has anxiolytic and psychostimulatory effects.

Indications and usage

Depression of various etiologies, incl. conditions accompanied by anxiety.
- Obsessive compulsive disorder (obsessive syndrome).
- Panic disorders, including with 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

Simultaneous administration of MAO inhibitors and a period of 14 days after their withdrawal.
- Pregnancy.
- Lactation (breastfeeding).
- Children and adolescents up to 18 years (due to the lack of clinical experience).
- Hypersensitivity to the drug.

Pregnancy and Breastfeeding

The safety of paroxetine during pregnancy has not been studied, so it should not be used during pregnancy and lactation, except when medically the potential benefits of treatment outweigh the possible risk associated with taking the drug.

If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

During the period of use of the drug, women of childbearing age should avoid conception (use reliable methods of contraception).

Dosage and administration

Tablets should be taken 1 time / day., Preferably in the morning, during meals, 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.

For depression: The recommended daily intake is 20 mg. The effect in most cases develops gradually. May increase the dose of the drug. The daily dose may be increased by 10 mg per week to achieve a therapeutic effect; The maximum daily dose is 50 mg / day.

In obsessive-compulsive disorders (obsessive syndrome): The initial dose is 20 mg / day.The dose may be increased by 10 mg to achieve a therapeutic response. 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 be started with a small (10 mg / 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 symptoms of the disease at the beginning of therapy.

With 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 to achieve the desired effect. The maximum daily dose should not exceed 50 mg. For maintenance therapy, the drug is used in 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 may be increased gradually by 10 mg per week; The maximum daily dose is 50 mg.

For post-traumatic stress disorder: The recommended therapeutic dose is 20 mg / day. The daily dose may be increased by 10 mg / week, the maximum daily dose is 50 mg.

Depending on the clinical condition of the patient, to prevent the possibility of relapse, it is necessary to carry out maintenance therapy.The course of maintenance therapy after the disappearance of the symptoms of depression may be 4-6 months, and in case of obsessional and panic disorders - more. As with the use of other psychotropic drugs, abrupt withdrawal of the drug should be avoided.

Use in weakened patients and elderly people: In weakened patients and elderly people, the concentration of paroxetine in the blood serum can increase faster than usual, therefore the recommended initial dose is 10 mg / day. This dose can be increased by 10 mg with an interval of 1 week depending on the condition of the patient. The maximum dose should not exceed 40 mg / day.

Use in children: For children due to the lack of clinical experience the drug is not shown.

Use in patients with renal or hepatic insufficiency: In renal (CK <30 ml / min) or hepatic insufficiency, 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 keep the dose at the lowest possible level.

Adverse reactions

Side effects are presented with the percentage of the detected ratio of the total number of patients receiving this treatment).

On the part of the digestive system: Nausea (12%); sometimes constipation, diarrhea, loss of appetite; rarely, elevated liver function tests; in some cases - severe liver dysfunction.Between taking paroxetine and a change in the activity of liver enzymes, a causal relationship has not been proven, but in case of abnormal liver function, discontinuation of paroxetine is recommended.

On the part of the central nervous system: and peripheral nervous system: Drowsiness (9%); tremor (8%), general weakness and fatigue (7%), insomnia (6%); sometimes - headache, irritability, paresthesia, dizziness, somnambulism; rarely extrapyramidal disorders, orofacial dystonia. Extrapyramidal disorders occur predominantly in the prior intensive use of neuroleptics. In some cases - epileptiform seizures (which is characteristic of treatment with other antidepressants); increased intracranial pressure.

On the part of the autonomic nervous system: Increased sweating (9%), dry mouth (7%).

On the part of the organ of vision: In some cases, visual impairment, mydriasis; rarely an attack of acute glaucoma.

Cardiovascular: In some cases - tachycardia, ECG changes, blood pressure lability, fainting.

On the part of the reproductive system: Disorder of ejaculation (13%), in some cases - a change in libido.

On the part of 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 is normalized. In some cases, this condition has developed due to overproduction of antidiuretic hormone. Most of these cases were observed in elderly people who, in addition to paroxetine, received diuretic and other drugs.

Allergic reactions: Rarely - skin hyperemia, subcutaneous hemorrhage, swelling in the face and extremities, Anaphylactic reactions (urticaria, bronchospasm, angioedema), pruritus.

Other: In isolated cases - myopathy, myalgia, hyperglycemia; rarely, hyperprolactinemia, galactorrhea, hypoglycemia, fever and the development of influenza-like state; in some cases - thrombocytopenia (a causal relationship with taking the drug has not been proven). Reception of paroxetine may be accompanied by an increase or decrease in body weight. Described several cases of increased bleeding.

Paroxetine, compared with tricyclic antidepressants, is less likely to cause dry mouth, constipation and drowsiness. Sudden withdrawal of the drug can cause dizziness, sensitivity disorders (eg, paresthesia), fear, sleep disturbance, agitation, tremor, nausea, sweating and confusion, therefore, discontinuation of drug therapy should be made gradually (it is advisable to reduce the dosage every second day).

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

Paroxetine is contraindicated at the same time as 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 the dosage to achieve the desired therapeutic effect. After the end of paroxetine therapy for 14 days, you cannot start a course of treatment with MAO inhibitors.

If the patient was previously in a manic state, while taking paroxetine, consider the possibility of a relapse (as with other antidepressants).

In case of violation of the function of the cardiovascular system, the drug should be used with caution.

Paroxetine should be used with caution if there is a history of epilepsy (like other antidepressants). According to clinical observations, 0.1% of patients with paroxetine cause epileptiform seizures. In this case, it is necessary to interrupt the course of therapy.

There is not enough experience with the simultaneous use of ECT and paroxetine.

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

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

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

The drug is prescribed with caution in glaucoma, becauseparoxetine (like other selective serotonin reuptake inhibitors) causes mydriasis.

With the use of paroxetine, hyperglycemic states have rarely been observed.

Application for violations of liver function: When liver failure increases the concentration of paroxetine in the blood plasma, 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 it is necessary to strive to keep the dose at the lowest possible level. Use for renal impairment: When renal (CC <30 ml / min), 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 keep the dose at the lowest possible level.

- Impact on the ability to drive motor vehicles and control mechanisms: At the beginning of the course of therapy with Rexetin, it is not recommended to perform work requiring increased attention and speed of psychomotor reactions. The time limit is determined based on the individual patient's response to the drug. In the course of controlled studies revealed no negative effects of paroxetine on the speed of psychomotor reactions or cognitive function.

Food and antacid drugs do not affect the absorption and pharmacokinetics of paroxetine.

The simultaneous use of paroxetine with tryptophan leads to headache, nausea, sweating and dizziness.

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

With the combined use of paroxetine with Sumatriptan there is a general weakness, hyperreflexia, impaired coordination. If necessary, their simultaneous use should be especially careful (requires medical supervision).

With the simultaneous use of paroxetine and benzodiazepines (oxazepam), barbiturates, neuroleptics, no increase in the sedative effect (drowsiness) was noted.

The experience of joint use of neuroleptics and paroxetine is small, so this combination requires caution.

With simultaneous use of paroxetine can inhibit the metabolism of tricyclic antidepressants (due to inhibition of the CYP2D6 isoenzyme), therefore, the use of this combination requires caution and reduce the dose of tricyclic antidepressants.

There is not enough experience with the simultaneous use of paroxetine and lithium preparations, so the appointment of such a combination requires caution and regular monitoring of the level of lithium in the blood.

Drugs that enhance or inhibit the activity of the enzyme systems of the liver, can affect the metabolism and pharmacokinetics of paroxetine.When combined with inhibitors of metabolic enzymes of the liver, it is necessary to use the lowest effective dose of paroxetine. Combined use with hepatic enzyme inducers does not require correction of the initial dose of paroxetine; further changes in dosages depend on the clinical effect (efficacy and tolerability).

Paroxetine significantly inhibits the activity of CYP2D6 isoenzyme. Therefore, special care 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 (for example, thioridazine), class 1C antiarrhythmic drugs (for example, propafenone, flekainid and enkainid), or with drugs that block its action quinidine, cimetidine, codeine).

There is no reliable clinical data on the inhibition of paroxetine CYP3A4 isoenzyme.

With the combined use of paroxetine with cimetidine increases the level of paroxetine in the blood plasma at the stage of equilibrium.

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 the frequency of side effects of phenytoin may increase.With the use of other anticonvulsants, the frequency of their side effects may also increase. In patients with epilepsy treated with Carbamazepine , phenytoin or sodium valproate for a long time, the additional prescription of paroxetine did not cause changes in the pharmacokinetic and pharmacodynamic properties of anticonvulsants; increase paroxysmal convulsive readiness was not observed.

With simultaneous use of paroxetine with drugs actively binding to plasma proteins , side effects may increase.

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

Diazepam in the course of administration does not affect the pharmacokinetics of paroxetine.

Paroxetine significantly increases the concentration of procyclidine in the blood plasma, therefore, with the appearance of anticholinergic side effects, 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, there has been an increase in theophylline concentration in the blood. Despite the fact that during clinical studies the interaction between paroxetine and theophylline has not been proven, regular monitoring of theophylline levels in the blood is recommended.

Amplification of the action of ethanol with simultaneous use with paroxetine was not detected.

Symptoms: nausea, vomiting, tremor, dilated pupils, dry mouth, general agitation, increased sweating, drowsiness, dizziness, flushing of the skin of the face. No coma or convulsions were observed. The fatal outcome was rarely observed, usually with a simultaneous overdose of paroxetine and another drug that causes adverse interactions. Signs of overdose are manifested with the simultaneous use of 2 g of paroxetine or when taking a large dose of paroxetine with other drugs or with alcohol. Paroxetine therapy is safe in a large dose range.
Treatment: gastric lavage, 20-30 g of Activated carbon every 4-6 hours during the first 24-48 hours; should be clear airway, if necessary, carry out oxygenation. They monitor the vital functions of the body and general measures aimed at maintaining them. There is no specific antidote. Forced diuresis, hemodialysis, or hemoperfusion are ineffective if a large dose of paroxetine comes from the blood into the tissues.

The drug is recommended to be stored at a temperature of 15 ° to 30 ° C.