Reksetin

Reksetin – drug with antidepressive action.

Form of release and structure

Reksetin release in the form of tablets, film coated: almost white or white color, round, biconvex, on one party – risk, on another – an engraving of "X20" or "X30" (on 10 pieces in blisters, on 3 blisters in a cardboard pack).

Is a part of 1 tablet:

• Active agent: пароксетин – 20 or 30 mg (гемигидрат a hydrochloride of a paroksetin – 22,76/34,14 mg);
• Auxiliary components: carboxymethylstarch of sodium, gipromelloz, calcium hydrophosphate dihydrate, magnesium stearate;
• Cover: polysorbate 80, gipromelloz, macrogoal 6000, macrogoal 400, titanium dioxide.

Indications to use

• Depressions of various genesis, including the states which are followed by alarm;
• Obsessivno-kompulsivnye frustration (obsessional syndrome);
• Posttraumatic stressorny frustration;
• Panic frustration, including proceeding with an agoraphobia (fear of stay in crowd);
• Generalized Alarming Frustration (GAF);
• Sociophobia.

Also Reksetin appoint when performing antirecurrent treatment.

Contraindications

Absolute:

• Concomitant use with monoamine oxidase inhibitors and the period of 14 days after their cancellation;
• The combined use with thioridazine (lengthening of an interval of QT on an ECG with the accompanying serious ventricular arrhythmias, such as piruetny ventricular tachycardia (torsades de pointes), and sudden death is possible);
• Age up to 18 years (clinical experience of use of Reksetin for this group of patients is absent);
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components.

Relative (Reksetin appoint with care in the presence of the following diseases / states):

• Prostate hyperplasia;
• Dysfunctions of cardiovascular system;
• Chronic renal failure;
• Liver failure;
• Epilepsy in the anamnesis (development of epileptiform attacks is possible, in this case treatment is interrupted);
• The combined use with neuroleptics, lithium drugs (because of insufficiency of clinical experience of the combined use);
• Glaucoma (development of a mydriasis is possible);
• Advanced age.

During therapy by Reksetin women of childbearing age are recommended to use contraceptive means.

Route of administration and dosage

Reksetin accept inside, it is more preferable – in the morning, during food. It is not necessary to chew tablets.

Frequency rate of reception – once a day.

Dose adjustment of Reksetin is carried out, as a rule, in 2-3 weeks of therapy, based on a clinical condition of the patient.

The recommended mode of dosing (daily dose):

• Depression: 20 mg, as a rule, effect develop gradually. In certain cases increase in a dose of drug can be required (in a week – on 10 mg, before achievement of therapeutic effect). As much as possible – 50 mg a day;
• Sociophobia: 20 mg if in 14 days of therapy improvement does not step, a dose gradually (on 10 mg once a week) raise to achievement of desirable effect. As much as possible – 50 mg a day. As a maintenance therapy Reksetin appoint 20 mg a day;
• Panic frustration: 10 mg (because of probable temporary increase of intensity of symptoms of a disease in an initiation of treatment) with gradual (on 10 mg once a week) increase up to 40 mg. As much as possible – 60 mg a day;
• Obsessivno-kompulsivnye frustration (obsessional syndrome): 20 mg, perhaps gradual (on 10 mg) increase in a dose. As much as possible – 40-60 mg;
• Generalized alarming and posttraumatic stressorny frustration: 20 mg, perhaps gradual (on 10 mg once a week) increase up to the maximum daily dose – 50 mg.

For prevention of a possibility of a recurrence depending on a clinical condition of the patient it is necessary to carry out a maintenance therapy. After disappearance of symptoms of a depression the course of the supporting treatment can make 4-6 months, at panic and obsessivny frustration perhaps more prolonged use of drug. Sharp cancellation of Reksetin is recommended to be avoided.

Daily dose for the weakened patients and patients of advanced age: initial – 10 mg, maximum – 40 mg (with increase by 10 mg once a week).

The recommended daily dose for patients with hepatic or renal (at clearance of creatinine <30 ml/min.) insufficiency makes 20 mg (because of increase of plasma concentration of a paroksetin). Depending on a state this dose can be increased, however it is necessary to aim to support a dose at the smallest possible level.

Side effects

Probable side reactions (intensity and frequency of their manifestation in the course of treatment decreases therefore in most cases the disturbances described below do not lead to cancellation of therapy):

• Central and peripheral nervous system: drowsiness, tremor, sleeplessness, increased fatigue, general weakness; in some cases – an acrimony, a headache, paresthesias, noctambulation, dizziness, decrease in concentration of attention; seldom – orofatsialny dystonia, extrapyramidal disturbances (in most cases at the previous intensive use of neuroleptics); seldom – epileptiform attacks, increase in intracranial pressure;
• Alimentary system: nausea; sometimes – diarrhea, a lock, a loss of appetite; seldom – increase in indicators of hepatic functional trials; in some cases – functional disturbances of a liver in a heavy current (between Reksetin's reception and changes of activity of enzymes of a liver relationship of cause and effect is not proved, but in cases of an abnormal liver function it is recommended to interrupt therapy);
• Cardiovascular system: in some cases – changes an ECG, unconscious states, tachycardia, lability of arterial pressure;
• Autonomic nervous system: dryness in a mouth, the increased sweating;
• Urinary system: seldom – difficulty of an urination;
• Reproductive system: frustration of an ejaculation; in some cases – change of a libido;
• Organ of sight: in some cases – a mydriasis, a vision disorder; seldom – an attack of acute glaucoma;
• Allergic reactions: seldom – hypodermic hemorrhages, a dermahemia, hypostases in extremities and a face, a skin itch, anaphylactic reactions (in the form of a small tortoiseshell, a bronchospasm, a Quincke's disease);
• Water and electrolytic balance: in some cases – a hyponatremia in combination with peripheral hypostases, epileptiform symptomatology or disturbance of consciousness (sodium level in blood is normalized after drug withdrawal; sometimes the hyponatremia develops because of hyperproduction of antidiuretic hormone, as a rule, at the patients of old age accepting Reksetin in a combination with diuretic and other drugs);
• Others: in isolated cases – a hyperglycemia, a myoclonia, myopathies, a myasthenia, mialgiya; seldom – a giperprolaktinemiya, a hypoglycemia, a galactorrhoea, development of a grippopodobny state, temperature increase, taste change; seldom – thrombocytopenia (relationship of cause and effect with Reksetin's reception is not proved), change (increase or decrease) of weight, the raised bleeding.

In comparison with tricyclic antidepressants, Reksetin dryness in a mouth, causes drowsiness and a lock less often. Sharp cancellation of therapy can lead to development of dizziness, sensitivity disturbance (for example, paresthesias), agitations, sensation of fear, sleep disorders, nausea, a tremor, the increased sweating and confusion of consciousness. In this regard Reksetin cancel gradually (it is recommended to reduce a dose every second day).

Special instructions

After cancellation of monoamine oxidase inhibitors Reksetin it is possible to appoint with extra care (from small doses and their gradual increase up to achievement of desired therapeutic effect) in 14 days. After the end of therapy monoamine oxidase inhibitors are appointed with an interval of 14 days.

If earlier maniacal states were observed, during Reksetin's reception it is necessary to consider a possibility of approach of a recurrence.

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

Patients with a depression and drug addiction in the period of abstinence need careful medical observation (there is a predisposition to suicide attempts).

In many cases development of a hyponatremia, in particular at elderly patients is noted at the combined use with diuretics. Sodium level in blood is normalized after Reksetin's cancellation.

Hyper glycemic states during therapy are noted seldom.

Sometimes during treatment the raised bleeding is observed (generally a purpura and an ecchymoma).

Patients with a depression need careful monitoring of a state before remission (because of the increased risk of suicide thoughts, an autoaggression and suicide). According to clinical experience, the risk of suicide at treatment by antidepressants can increase at early stages of recovery.

At other psychiatric states which are indications for Reksetin's appointment there is also an increased risk of suicide behavior. Such states can accompany big depressive frustration therefore patients also need medical observation. Besides, patients with the anamnesis of suicide thoughts or behavior or the treatments showing before essential degree of suicide thinking, in particular patients of 18-29 years need careful control.

At the beginning of a course of treatment and throughout individually established period it is impossible to manage motor transport or to work in the conditions of the increased danger.

Medicinal interaction

At the combined use of Reksetin with some medicinal means / substances the following effects can be observed:

• Monoamine oxidase inhibitors: development of undesirable interaction;
• Tryptophane: emergence of nausea, headache, dizzinesses, the increased sweating (the combination is not recommended);
• Warfarin: pharmakodinamichesky interaction (the raised bleeding at not changed prothrombin time is noted; the combination demands care);
• Sumatriptan: development of the general weakness, a hyperreflexia, lacks of coordination (the combination demands care and medical observation);
• Tricyclic antidepressants: metabolism inhibition (the combination demands care and decrease in a dose of tricyclic antidepressants);
• The drugs which are strengthening or braking activity of fermental systems of a liver: influence on pharmacokinetics and metabolism of a paroksetin (purpose of the minimum doses of Reksetin is recommended);
• Drugs which metabolism happens with the participation of CYP2D6 isoenzyme (some antidepressants (for example, amitriptyline, нортриптилин, fluoxetine, Imipraminum, desipramine), fenotiazina (for example, thioridazine), antiarrhytmic drugs of a class 1 C (for example, энкаинид, флекаинид, пропафенон), medicines which block its action (for example, Cimetidinum, quinidine, codeine)): decrease in their activity (the combination demands care);
• Cimetidinum: increase in plasma level of a paroksetin at a stage of an equilibrium state;
• Phenobarbital: decrease plasma concentration of a paroksetin, and also reduction of its elimination half-life;
• Phenytoinum: decrease in plasma concentration of a paroksetin, increase in frequency of side reactions of Phenytoinum;
• Other anticonvulsant drugs: increase in frequency of development of their side reactions;
• Drugs which contact proteins of plasma: strengthening of side effects;
• Digoxin: interaction development is possible (the combination demands care);
• Protsiklidin: increase in its plasma concentration (at development of anticholinergic side reactions the dose decline of a protsiklidin is necessary);
• Theophylline: increase in its concentration (regular control of its level is recommended).

During therapy use of alcohol needs to be excluded (because of Reksetin's influence on fermental system of a liver).

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 15-30 °C.

Period of validity – 5 years.