Reksetin

Description overdue on 07/11/2014

• Latin name: Rexetin
• ATC code: N06AB05
• Active substance: Paroxetine (Paroxetine)
• Manufacturer: JSC «Gedeon Richter» («Gedeon Richter»), Hungary

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• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications Reksetina
• Contraindications
• Side effects
• Reksetin, instructions for use (method and dosage)
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Cautions
• Analogs
• Synonyms
• Babies
• With alcohol
• During pregnancy (and lactation)
• Reviews
• Price, where to buy

Composition

1 tablet pharmaceutical preparation may contain either 22, 76 mg, or 34 and 14 mg of the essential active substance - Paroxetine hydrochloride hemihydrate .

Dosage aids equivalent to the amount of the main active ingredient:

• calcium hydrogen phosphate dihydrate - 244, 24/366, 36 mg;
• Valium - 15/22, 5 mg;
• sodium carboxymethyl - 15/22, 5 mg;
• magnesium stearate - 3/4 5 mg.

Components of the film-coated tablet calculated based on the amount of active substance:

• Hypromellose - 7, 2/10, 8 mg;
• titanium dioxide - 1, 1.3, 545 mg;
• macrogol 400 - 0, 07/0, 105 mg;
• polysorbate 80 - 0 044/0, 066 mg.

Product form

Tablets of white color, with a longitudinal groove on the top are designed for 20 or 30 mg of the main active ingredient, based on this figure and the corresponding marked with a cross on its back. Film-coated tablets, packed in blisters. Contour-stripes package of aluminum or PVC of 10 pieces each. The cardboard package - 3 blisters.

Pharmacological action

Reksetin - Pharmaceutical antidepressant Which refers to a group of election reuptake inhibitors Serotonin . That is the main active component paroxetine , A complex organic compound having a bicyclic structure inhibits the presynaptic membrane vesicles opportunity to replenish the loss of active neurotransmitter serotonin, whereby it remains in the synaptic cleft. Thus, on the background of the main pharmacological action carries a pronounced activating effect on the central nervous system, because of the nerve impulse transmitter has its impact far more long-lasting (stimulation serotonergic system ).

It should be noted that paroxetine As the main chemical component of the drug also has anxiolytic , so how anxiety Primarily due to the increased excitability of the subcortical structures of the brain, which are the active ingredient Reksetina extends its influence. Because of the oppression of the central nervous system as limbic formation . thalamus   and hypothalamus   reduces symptoms of anxiety syndrome.

In the application of the pharmaceutical preparation, a decrease obsessive-compulsive disorders . This mental pathology, described the constant appearance of various obsessions or fears, from which the patient is trying to get rid of with the help of an equally obsessive thoughts and tiring. Severe illness, which has its place in the International Classification of Diseases, 10th revision.

The active component has high antidepressant specificity of the pharmacological action . Paroxetine has no effect on muscarinic, opioids, nicotine, or adrenergic receptors, because does not cause generalized addiction and drug addiction. Also, the intensity does not change the reuptake of neurotransmitters such as norepinephrine   and dopamine .

Pharmacodynamics and pharmacokinetics

Upon receiving the pill by mouth (orally), the pharmacological drug is rapidly absorbed in the gastrointestinal tract. Food intake did not significantly affect the ability Reksetina to suction. The medicament has a high degree of plasma protein binding   (about 93-95 percent paroxetine ) That ensures continuous circulation of the active components in the main bloodstream.

It is metabolized in the liver of pharmacological agents with the formation of active metabolites. After conversion of the drug in the form of metabolites derived primarily by the kidneys in urine composition. The half-life   It ranges from 15 to 24 hours, depending on the individual exchange rate. For short conservative course of treatment significantly accumulates, the equilibrium concentration is reached within one week of regular admission tablets Reksetina. Chronic administration of pharmaceuticals loses the ability to cumulation.

Indications Reksetina

• depression   various etiologic origin (particularly pathological conditions that are complicated by constant anxiety);
• episodes Bipolar Disorder   or depression in the background Schizophrenia ;
• Treatment and Prevention obsessive-compulsive disorder   (drug capable of preventing relapses active even after prolonged therapeutic course);
• organic lesions of the central nervous system (including deep brain stimulation);
• sanitation episodic flow manic-depressive syndrome   in the depressive phase;
• state or generalized social anxiety symptoms Syndrome of constant anxiety ;
• post-traumatic mental disorders Which typically occur when a disaster or extremely life-threatening situations;
• neuro-psychiatric disorders, accompanied by attacks agoraphobia   and panic .

In recent years, there is clinical evidence that the indications for use of medication can be extended social phobia . So pharmaceutical research have confirmed that the active conservative treatment can achieve the same positive results as from the continuous use of a psychiatrist, because previously it was the only scheme of reorganization insane social phobia.

Contraindications

• Hypersensitivity, idiosyncrasy , Hereditary or acquired intolerance to the constituent components of the pharmaceutical formulation;
• application drugs that inhibit the enzyme monoamine oxidase   (drug only be used after three weeks after treatment with antidepressants);
• conservative therapy tryptophan   or derivatives thereof;
• long QT syndrome ;
• hepatic impairment;
• abandoned coal glaucoma   (It can lead to excessive increase in intraocular pressure);
• Arrhythmia   ventricular origin;
• prostatic hyperplasia   men;
• Children age category up to 18 years of age or older age.

Side effects Reksetina

When conservative treatment of active pharmaceutical product may develop the following adverse reactions:

• On the side central and peripheral nervous system : dizziness   or headache , Violation of the waking and sleeping, tremor   and trembling of the limbs, fatigue, paresthesia , Irritability, dry mouth , Irregularities in the visual apparatus of nervous origin, enhanced sweating . Also described by experienced clinicians extrapyramidal state   and orofacial dystonia But they occur very rarely.
• Digestive system : dyspeptic syndrome , Violations of the chair (still possible, as constipation And diarrhea ), Decreased appetite,   increase in liver enzymes and as a consequence of dysfunction of the liver.
• On the side Cardiovascular : cardiac arrhythmias work . hypertension   or hypotension Starting from primary predisposition of the patient, the electrocardiogram changes, vasodilatation , up to fainting as a result of acute circulatory failure.
• On the side genitourinary system : decreased libido , Violations of the active Ejaculation   (ejaculation), difficulty urinating.
• In the other systems of the body: erubescence As a manifestation of congestion of the vascular bed, hematoma , Electrolyte imbalance ( hyponatremia ), Increased production and excretion vasopressin   (antidiuretic hormone) thrombocytopenia , Flu-like symptoms (fever, rhinorrhea and so forth), hyper- or hypoglycemia, muscle pain and even myopathy.
• Also can be observed allergic reactions Which manifest themselves in the form of hives , Skin rash, or itching , Edema of the upper half of the body (face and extremities) bronchospasm . angioneurotic angioedema .

It should be noted that the side effects from the use of pharmacological treatment is much more pronounced at the beginning of a course of drug therapy. During treatment, typically that undesirable reactions greatly reduced.

In a sudden discontinuation of the drug may occur withdrawal Which is usually described by symptoms:

• strong tremor ;
• nausea . vomiting ;
• violation of peripheral sensitivity;
• confusion ;
• violation of physiological sleep and wakefulness.

To avoid withdrawal symptoms and manifestations withdrawal   the drug should be withdrawn gradually after the passage of a full therapeutic course.

Reksetin, instructions for use (method and dosage)

Tablets Rexetin is recommended in the morning, orally   during the meal, but they should not be chewed, because doing so can damage the shell. Depending on the clinical condition, the dosage may be changed after 2-3 weeks after initiation of therapy.

Instructions for use Reksetina largely varies according to the patient's diagnosis:

• With depression   daily dosage of the drug is 20 mg. The pharmacological effect develops gradually, because in the most severe clinical cases, you may need to increase the amount of drug. At intervals of 1 week the dosage may be increased to 10 mg to achieve a therapeutic effect. The maximum daily amount Reksetina - 50 mg.
• The initial dosage for the treatment of obsessive-compulsive disorder is 20 mg per day. As in the case of depressions, if the therapeutic effect is not immediately possible to increase the amount of medication received 10 mg at intervals of a week, however, the maximum daily dose should not exceed 60 mg.
• Therapy for panic disorder   It should start with a small daily dose (10 mg), and then on a weekly basis to improve until the necessary remedial effect. Low initial dose due to possible increase in the intensity of the symptoms of underlying pathology because of side effects (adverse reactions occur at the beginning of the most conservative of the course). The maximum dosage is as in obsessive-compulsive, 60 mg.
• Treatment of social phobia usually begin with 20 mg per day. If, after two weeks of drug therapy patient's condition does not improve quality, it is possible to increase the number of weekly Reksetina 10 mg to achieve the desired effect and a maximum dose of 50 mg daily intake. Typically, for supporting readjustment sufficient dosage - is 20 mg.
• Driving conservative treatment of post-traumatic stress disorder   or generalized anxiety syndrome   similar to that in the treatment of social phobia.

After passing through the active phase of conservative readjustment when leading manifestation of the basic pathology of the central nervous system greatly reduce the need to carry out supportive therapy   to prevent relapse. This course is usually from 4 to 6 months. Also, at the end of treatment should be aware of the possible withdrawal syndrome Because stop taking the tablets should be gradual.

With hepatic or renal insufficiency If creatinine clearance less than 30 mL / min, the body's ability to metabolise paroxetine , The main active ingredient of the pharmaceutical preparation, is sharply reduced because the maximum daily dose should not exceed 20 mg. In absolute life-saving dose can be increased, however, should seek, if possible, keep it to a minimum.

Overdose

Generally, treatment Reksetinom well tolerated, as it has quite a wide margin of safe use, but with a single dose of 2,000 mg, or in combination with drugs that contain paroxetine possible manifestation of toxicity of the main active component and the development of acute poisoning with the following symptoms:

• nausea, vomiting;
• intense shivering limbs ;
• Dry mouth;
• dilated pupils;
• state of excitement or drowsiness;
• headache   or dizziness ;
• redness of the upper body, especially the facial skin.

Specific antidote for overdose Reksetinom relief does not exist, because only applies symptomatic treatment   manifestations of increased concentration of pharmacological agents. It is necessary to carefully monitor vital functions, provide a free airway. It is recommended gastric lavage as soon as possible, and receive enterosorbents . Well-behaved showed further conduct oxygen therapy   Reksetinom an overdose.

Cooperation

Reksetin categorically can not be combined with monoamine oxidase inhibitors Because such a complex therapy leads to mutual reinforcement of side effects. Failure to follow this strict rule may be a fatal.

The simultaneous use of the pharmaceutical and biological drugs or supplements containing Tryptophan   may increase the force that undesirable consequences of treatment. As a rule, there are intense headaches, frequent dizziness, nausea and vomiting. Similarly, the act antiepileptic drugs . antidepressants   different groups ( Nortriptyline . Amitriptyline . Fluoxetine   and others), when applied simultaneously with Reksetinom.

The combination Sumatriptan   and Reksetina necessarily require constant monitoring by qualified medical personnel, since the combination of these pharmaceutical drugs cause fatigue, increase strength reflexes ( hyperreflexia ), The coordination of movements. If the scheme of medical treatment consists of these drugs, it is recommended to carry out treatment in a hospital.

When used together, tablets and Reksetin oral anticoagulants   may increase the prothrombin time and the development of bleeding, as potentiates the effect of the latter.

Formulations pharmacological effect of which is directed to activation of liver enzymes   (e.g., inductor microsomal oxidation such as Phenytoin ), May change the metabolic capacity paroxetine . It is increasing its rate of decay into inactive metabolites, increasing half-life, which is manifested in the absence of therapeutic effects even with gradual increase in dosage of medication.

Adversely affect the metabolism of drugs and Reksetina group phenobarbital . However, the components of the pharmaceutical subunit not accelerate hepatic and renal link exchange cycle. That is, the bioactive components Reksetina displayed at a higher rate, which greatly contributes to reduction in their concentration in the blood plasma.

Reksetin increases plasma concentrations of Protsiklidina and Theophylline But in clinical studies the mechanism of this interaction is not revealed. Because the combined use of pharmaceuticals is recommended control of the plasma concentrations of the active components.

Terms of sale

The tablets are released only after the presentation of the certified form of the receptor.

Storage conditions

Store in a dry place out of reach of young children, at a constant temperature range of 15 to 30 degrees Celsius.

Shelf life

From 2 to 4 years.

Cautions

Admission may be accompanied Reksetina akathisia Which is characterized by an inner restlessness, problems with concentration and inability is in one position long period of time, because in the period of treatment with this pharmaceutical preparation should give up driving or other potentially dangerous devices.

Patients with diabetes Who are being treated Reksetinom should properly adjust the dose insulin   and / or other oral hypoglycemic agents have been among the adverse therapeutic effects observed hyper- or hypoglycemia, depending on the predisposition.

If conservative treatment scheme, in addition Reksetina include lithium preparations , Their co-administration is carried out under mandatory supervision concentration of active substances in the blood plasma.

Analogs Reksetina

Match code ATC 4th level:

• Paxil
• Luvox
• Tsipraleks
• Fluoxetine

ATC code of the pharmaceutical formulation coincides with such drugs as: Csete . Lyuksotil . Parelaks . One can not say which antidepressants are more justified in the application. Of course, not rely on the opinion of a qualified person, and the individual characteristics of the organism when choosing a treatment for such an important organ systems as nervous.

It should be noted that a pharmacy counterparts Reksetina not differ greatly in value, because the base drug selection on the price of the drug should not be.

Synonyms

Adepress . Paroxetine . Pliz . Paxil .

Babies

The drug is strictly contraindicated for use in children, as up to 18 years can affect the development of the internal organs and the personality.

Alcohol and Reksetin

Strengthening actions ethanol   while the use of paroxetine not detected in clinical trials, however, as in the case with antidepressants other groups, alcohol use during medical treatment is not recommended, as this may lead to unforeseen circumstances (known clinical cases of exacerbation of the underlying disease of the central nervous system and even deaths in the background suicidal disorders).

During pregnancy and lactation

Rexetin pharmacological agents used during pregnancy only if absolutely vital readings, since the use of the drug may a significant impact on fetal development . For example, in the first trimester dramatically increases the risk of   miscarriage   cyanosis . epilepsy . .

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