Kvetiron of 200 tab. of p/o of 200 mg No. 30

Pharmacological properties

Kvetiapin ― atypical antipsychotic means. kvetiapin and its active plasma metabolite norkvetiapin interact with various types of neuromediator receptors. kvetiapin and norkvetiapin have high selectivity to serotonin receptors (5-nt2) and to receptors of d1 and d2 dopamine in a brain. this combination of receptor antagonism with bigger selectivity to 5-nt2-receptors concerning receptors of d2 is considered to promoting clinical antipsychotic effects and low tendency to extrapyramidal side effects of medicament kvetiron in comparison with typical antipsychotic drugs. kvetiapin and norkvetiapin also have high affinity to gistaminergichesky and α1-адренергическим to receptors, but smaller affinity to α2-адренергическим and to serotoninovy 5-nt1a-receptors.

Kvetiapin has no affinity to cholinergic muskarinovy receptors or benzodiazepine receptors whereas norkvetiapin has moderate or high affinity to several subtypes of muskarinovy receptors that can explain anticholinergic (muskarinovy) effects.

Inhibition norkvetiapiny (NET) and also partial agonistic action on 5-HT ₁ A-receptors can promote therapeutic effectiveness of the medicament Kvetiron as antidepressant.

Pharmacodynamics. It is known that kvetiapin it is active in antipsychotic activity tests, such as conditioned-reflex avoiding.

Kvetiapin blocks agonistic influence on dopamine that is confirmed by results of assessment of behavioural reactions or electrophysiologic researches and also increases concentration of metabolites of dopamine, a neurochemical expression of blocking of receptors of D ₂ .

Knows that during preclinical trials in which the tendency to development of extrapyramidal symptoms was checked kvetiapin the atypical profile of activity had and differed from standard antipsychotic drugs.

Kvetiapin after prolonged use did not result

in excessive sensitivity of dopamine D ₂ - receptors.

Kvetiapin in the doses effective for blockade of dopamine D ₂ - receptors, caused only a weak katalepsy.

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For a kvetiapin after its long introduction showed selectivity for a limbic system which was shown by ability to block depolarization in A10 mesolimbic neurons, but not in A9 nigrostriarny neurons which contain dopamine.

Pharmacokinetics. Absorption. Kvetiapin after intake is well soaked up and actively metabolized. At reception after a meal there is no significant change in bioavailability of a kvetiapin. In an equilibrium state the maximum molar concentration of an active metabolite of a norkvetiapin makes 35% of concentration of a kvetiapin. The pharmacokinetics of a kvetiapin and norkvetiapin within the approved range of doses is linear.

Kvetiron XR reaches the C _max in blood plasma approximately through 6 h after use (T _max ). Kvetiron XR shows dozoproportsionalny pharmacokinetics for doses to 800 mg inclusive at use of 1 times a day. The C _max in blood plasma and AUC for the medicament Kvetiron XR which is applied 1 time a day are comparable to those which are reached for the same general daily dose of a kvetiapin of the fumarat, tablets with immediate release (Kvetiron of a tablet, film coated) which is applied 2 times a day. Food with the high content of fats leads to statistically reliable increase in the C _max and AUC medicament Kvetiron XR.

Distribution. About 83% of a kvetiapin contact proteins of blood plasma.

Metabolism. Kvetiapin is actively metabolized in a liver, use is radioactive a marked kvetiapin revealed that less than 5% of a kvetiapin are not metabolized and removed in not changed view with urine or a stake. During the researches in the conditions of in vitroustanovleno that CYP 3A4 is the main enzyme responsible for the metabolism of a kvetiapin caused by P450 cytochrome. Education and removal of a norkvetiapin happens mainly to participation of CYP enzyme 3A4.

Kvetiapin and some of his metabolites (including norkvetiapin) in the conditions of in vitro have weak inhibiting effect on isoenzymes 1A2, 2C9, 2C19, 2D6 and 3A4 of the system of P450 cytochrome.

Braking of isoenzymes of CYP in the conditions of in vitro happened only at concentration, at 5-50 times of

exceeding concentration which is reached at use of doses for the person in the range of 300-800 mg/days

On the basis of these results in the conditions of in vitro it is improbable that simultaneous introduction of a kvetiapin with other active agents will lead to clinically significant slowing down of metabolism of other active agents caused by P450 cytochrome.

Removal. A kvetiapina and the norkvetiapina makes t _½ according to about 7 and 12 h. About 73% of a radioactive label are removed with urine and 21% ― with a stake.

Average molar fraction of a free kvetiapin and active metabolite of N-dezalkilkvetiapina which is removed with urine makes 5% of the entered dose.

Special populations

Floor. The pharmacokinetics of a kvetiapin at women and men does not differ.

Patients of advanced age. The average clearance of a kvetiapin at patients of advanced age is 30-50% lower, than at patients at the age of 18–65 years.

Patients with a renal failure. At patients with a considerable renal failure (clearance of creatinine of 30 ml/min. / 1.73 m ² ) the average clearance of a kvetiapin in blood plasma decreases approximately by 25%, but individual sizes of clearance remain within the range characteristic of healthy faces.

Patients with an abnormal liver function. At patients with damage of a liver (the compensated alcoholic cirrhosis) the average clearance of a kvetiapin in blood plasma decreases approximately by 25%. As in a liver there is a broad metabolic disintegration of a kvetiapin, at patients with an abnormal liver function the concentration of a kvetiapin in blood plasma can increase and therefore for patients of this group the dose adjustment can be required (see USE).

Children. There are pharmacokinetic data obtained at the children accepting 400 mg of a kvetiapin 2 times a day. When receiving a therapeutic dose the levels of initial connection of a kvetiapin at children and teenagers (10–17 years) were in general similar that at adults though the C _max at children had higher values, than at adults. AUC and C _max were higher than a norkvetiapin, children (10–12 years) have about 62 and 49% and teenagers (13–17 years) have 28 and 14% respectively in comparison with adults.

Indication

Kvetiron's

. schizophrenia; bipolar disorder, including the maniacal episodes connected with bipolar disorders and the big depressive episodes connected with bipolar disorders; prevention of a recurrence at patients with bipolar disorders at which maniacal attacks were exposed to treatment kvetiapiny.

Kvetiron XR is shown to

for treatment:

• schizophrenia, including preventions of a recurrence at the patients with a stable course of schizophrenia receiving maintenance therapy by Kvetiron XR;
• bipolar disorder, in particular: for treatment of moderate and heavy maniacal episodes in bipolar disorder; for treatment of depressive episodes in bipolar disorder; for prevention of the following episode of a disease at patients with bipolar disorder, at patients with maniacal or depressive episodes at which treatment kvetiapiny is effective.

Kvetiron XR is shown to

for the accompanying treatment of depressive episodes at patients with depressive disorder at which the suboptimal response to monotherapy is recorded by antidepressants. Prior to treatment the doctor needs to study a profile of safety Kvetirona XR carefully.

Use

Kvetiron's

— various doses for each indication exist. the dose of medicament and duration of a course of treatment are defined by the doctor individually for each patient depending on indications and disease severity. for oral administration. kvetiapin it is possible to accept irrespective of meal.

Adult

Course treatment of schizophrenia. Kvetiapin it is necessary to accept 2 times a day. In the first 4 days of therapy the daily dose makes: the 1st day — 50 mg, the 2nd — 100 mg, the 3rd — 200 mg, the 4th — 300 mg. Since 4 days the dose is raised to achievement of necessary clinical effect (within 300–450 mg/days). Depending on clinical performance and tolerance of medicament the daily dose of Kvetiron can make 150–750 mg.

Maximum daily dose of Kvetiron for treatment of patients with schizophrenia — 750 mg.

Course treatment of the maniacal episodes associated with bipolar disorders. Kvetiapin it is necessary to accept 2 times a day. The daily dose in the first 4 days of treatment makes: the 1st day — 100 mg, the 2nd — 200 mg, the 3rd — 300 mg, the 4th — 400 mg. Further the dose is increased (but no more than by 200 mg daily) up to 800 mg/days, since 6th day of treatment. Depending on clinical performance and tolerance of medicament the dose can make 200–800 mg/days. The usual effective dose is in range of 400-800 mg/days

Maximum daily dose of Kvetiron for treatment of maniacal episodes — 800 mg.

Treatment of the depressive episodes connected with bipolar disorders. Kvetiapin it is necessary to apply 1 time a day before going to bed.

Daily dose in the first 4 days of treatment makes

: the 1st day — 50 mg, the 2nd day — 100 mg, the 3rd day — 200 mg, the 4th day — 300 mg. The recommended daily dose — 300 mg. It is known that during clinical trials the additional benefit in group of use of 600 mg in comparison with group of 300 mg was not observed. The dose of 600 mg can be effective for some patients. Clinical trials show that for certain patients in case of the problems connected with intolerance of medicament it is possible to consider a question of a dose decline to minimum — 200 mg. The doctor with experience of treatment of bipolar disorder has to appoint treatment of the depressive episodes connected with bipolar disorder.

Prevention of a recurrence at patients with bipolar disorders. For prevention of the maniacal, depressive or mixed episodes in bipolar disorder the patients who had a response to use of a kvetiapin at urgent treatment of bipolar disorder have to continue treatment in the same dose. The dose can be adjusted depending on the clinical answer and shipping for each certain patient within the range of a daily dose of 300-800 mg which is appointed by 2 times a day. It is important that applied the lowest effective doses to maintenance therapy.

Patients of advanced age. To patients of advanced age kvetiapin, as well as other antipsychotic means, it is necessary to appoint with care, especially in an initiation of treatment. Slower titration of a dose of a kvetiapin can be necessary, and the daily therapeutic dose has to be lower, than that that is applied at young patients, depending on the clinical answer and shipping of treatment of each certain patient. The average clearance of a kvetiapin is reduced by 30–50% at patients of advanced age in comparison with young patients.

Efficiency and safety did not estimate

at patients aged 65 years with depressive episodes within bipolar disorder are more senior.

Abnormal liver function and kidneys. For patients with a renal failure the dose adjustment is not obligatory.

Kvetiapin is actively metabolized by

in a liver therefore patients with a liver failure of Kvetiron need to apply with care, especially during an initial stage of treatment.

treatment should begin with

At patients with an abnormal liver function with a dose 25 mg/days. The dose is increased daily by 25–50 mg/days before achievement effective, depending on the clinical answer and tolerance of medicament the patient.

Kvetiron XR should apply

1 time a day on an empty stomach (at least for 1 h before meal). Tablets should be swallowed entirely, without breaking, without crushing and without chewing.

Adult. For treatment of schizophrenia and maniacal episodes from moderated to heavy degree in bipolar disorder medicament Kvetiron XR it is necessary to use at least for 1 h before meal. The daily dose at the beginning of therapy makes 300 mg in the 1st day and 600 mg — for the 2nd day. The recommended daily dose — 600 mg, however, if it is clinically proved, a dose it is possible to increase to 800 mg/days. The dose should be adjusted within the range of effective doses — from 400 to 800 mg/days — depending on the clinical answer and shipping. For maintenance therapy in schizophrenia there is no need for dose adjustment.

For treatment of depressive episodes in bipolar disorder Kvetiron XR should use medicament before going to bed 1 time a day. The general daily dose for the first 4 days of treatment makes 50 mg (1st day), 100 mg (2nd day), 200 mg (3rd day) and 300 mg (4th day). The recommended daily dose — 300 mg. The additional benefit in group of use of 600 mg in comparison with group of 300 mg is noted. The dose of 600 mg can be effective for some patients. The doctor with experience of treatment of bipolar disorder has to appoint doses higher than 300 mg. For some patients in case of the problems connected with intolerance of medicament it is possible to consider a question of a dose decline to minimum — 200 mg.

For prevention of the following episode of a disease in bipolar disorder. For prevention of the following maniacal, mixed or depressive episodes in bipolar disorder the patients at whom the response to Kvetiron XR'S use at urgent treatment of bipolar disorder is received have to continue administration of medicament Kvetiron XR in the same appointed dose in the evening. A medicament dose Kvetiron XR it is possible to adjust within the range of doses 300–800 mg/days depending on the clinical answer and individual shipping of the patient. It is important that minimal effective doses were applied to maintenance therapy.

For the accompanying treatment of depressive episodes in depressive disorders Kvetiron XR should be accepted before going to bed. The daily dose at the beginning of therapy makes 50 mg in the 1st and for the 2nd day and 150 mg — for the 3rd and 4th day. At the accompanying therapy (with amitriptyline, bupropiony, tsitalopramy, duloksetiny, estsitalopramy, fluoxetine, paroksetiny, sertraline and venlafaxiny) the antidepressive effect is noted at doses of 150 and 300 mg/days and at a dose of 50 mg/days. At higher doses there is an increased risk of the undesirable phenomena. Therefore the doctor needs to be convinced that the minimal effective dose, since 50 mg/days is applied to treatment. The need for increase in a dose from 150 to 300 mg/days has to be based on assessment of a condition of the certain patient.

Translation from Kvetiron's drug, a tablet with immediate release of active ingredient. For more convenient dosing of patients who are treated separate doses of medicament of Kvetiron (tablets with immediate release of active ingredient) it is possible to transfer to Kvetiron XR in an equivalent general daily dose which is accepted 1 time a day. For ensuring maintenance of the clinical answer the period of titration of a dose can be required.

Patients of advanced age. As well as other anti-psychotics, Kvetiron XR it is necessary to apply with care at patients of advanced age, especially at the beginning of treatment and selection of a dose. Slower titration of a dose of medicament Kvetiron XR can be required, and the daily therapeutic dose can be lower applied at younger patients. The average plasma clearance of a kvetiapin was reduced by 30–50% at patients of advanced age in comparison with younger patients. Treatment of patients of advanced age it is necessary to begin 50 mg/days with a dose. The dose can be raised gradually on 50 mg/days to achievement of an effective dose depending on the clinical answer and individual shipping of treatment by the patient. Patients of advanced age with depressive episodes in depressive disorders should begin reception with 50 mg/days in the 1-3rd day, raising a dose to 100 mg/days for the 4th day and to 150 mg/days for the 8th day. It is necessary to apply a minimal effective dose, since 50 mg/days. If, proceeding from assessment of a condition of the specific patient, increase in a dose to 300 mg/days is necessary, it is not necessary to do it earlier than in 22 days of treatment.

Renal failure. There is no need for dose adjustment for patients with a renal failure.

Abnormal liver function. Kvetiapin is actively metabolized in a liver. Therefore medicament Kvetiron XR should be used with care at patients with the known abnormal liver functions, especially during an initial stage of selection of a dose. Treatment of patients with abnormal liver functions it is necessary to begin 50 mg/days with a dose. A dose it is possible to increase with a step 50 mg/days to achievement of an effective dose depending on the clinical answer and individual shipping of the patient.

Contraindication

Increased individual sensitivity to any component of drug. simultaneous use of inhibitors of cytochrome r450 za4, such as vich-protease inhibitors, azolny antifungal drugs, erythromycin, klaritromitsin and nefazodon (see interactions).

Side effects

Kvetiron's

. at reception of a kvetiapin most often can be observed: drowsiness, dizziness, dryness in a mouth, a headache, a withdrawal, high level of tenge in blood serum, increase in level of the general hs in blood serum, increase in body weight, decrease in level of hemoglobin and extrapyramidal symptoms.

Other possible side reactions. Frequency of side reactions is determined as follows: very often (≥1/10); often (≥1/100 to 1/10); infrequently (≥1/1000 to 1/100); seldom (≥1/10,000 to 1/1000); single (1/10,000); it is unknown (frequency cannot be determined on the basis of the existing data).

from blood and lymphatic system: very often — decrease in level of ^{22 hemoglobin} ; often — a leukopenia ^1.28 , decrease in quantity of neutrophils, increase in level of eosinophils ²⁷ ; infrequently — a neutropenia ¹ , thrombocytopenia, anemia, decrease in quantity of thrombocytes ¹³ ; seldom — an agranulocytosis ²⁶ .

from the immune system: infrequently — hypersensitivity (including allergic skin reactions); single — anaphylactic reactions ⁵ .

from an endocrine system: often — a giperprolaktinemiya ¹⁵ , decrease in level of the general in T ₄ ²⁴ , decrease in level free T ₄ ²⁴ , decrease in level of the general in T ₃ ²⁴ , increase in ^{24 TSH} ; infrequently — decrease in level free T ₃ ²⁵ , a hypothyroidism; hypothyroidism ²¹ ; single — disturbance of secretion of ADG.

from a metabolism and metabolism: very often — increase in the TG level in ^{10.30 blood serum} , increase in the general in XC (especially the XC LDL) ^11.30 , decrease in the LPVP ^{7.30 level} , increase in the body weight ^8.30 ; often — increase in appetite, increase in level of glucose to the sizes characteristic of a hyperglycemia ^6.30 ; infrequently — a hyponatremia ¹⁹ , diabetes ^1.5 , exacerbation of diabetes, is rare — a metabolic syndrome ²⁹ .

from mentality: often — unusual dreams, nightmares, suicide thoughts and behavior ²⁰ ; seldom — a sleep-walking and the related reactions, such as talk in a dream and the food disorders connected with a dream.

from nervous system: very often — dizziness ^4.16 , drowsiness ^2.16 , a headache, extrapyramidal symptoms ^1.21 ; often — a dysarthtia; infrequently — spasms ¹ , restless legs syndrome, tardivny dyskinesia ^1.5 , a loss of consciousness ^4.16 .

from heart: often — tachycardia ⁴ , the strengthened heartbeat ²³ ; infrequently — lengthening of an interval of Q-T ^1,12,18 , bradycardia ³² .

from vessels: often — orthostatic hypotension ^4.16 ; seldom — a venous thrombembolia ¹ .

from an organ of sight: often — illegibility of sight.

from a respiratory system: often — an asthma ²³ ; infrequently — rhinitis.

from digestive system: very often — dryness in a mouth; often — a constipation, dyspepsia, vomiting ²⁵ ; infrequently — a dysphagy ⁷ ; seldom — pancreatitis ¹ , intestinal impassability.

from a gepatobiliarny system: often — increase in level of transaminases (AlAT ³ ), GGT ³ ; infrequently — increase in the AsAT ^{3 level} ; seldom — jaundice ⁵ , hepatitis.

from skin and hypodermic fabrics: single — a Quincke's disease ⁵ , Stephens's syndrome — Johnson ⁵ ; frequency is unknown — a toxic epidermal necrolysis, a multiformny erythema.

from the musculoskeletal system: single — a rhabdomyolysis.

from kidneys and urinary tract: infrequently — an urination delay.

Pregnancy, puerperal period and perinatal states: frequency is unknown — a medicament withdrawal at newborn ³¹ .

from a reproductive system and mammary glands: infrequently — sexual dysfunction; seldom — a priapism, a galactorrhoea, swelling of mammary glands, disturbance of a menstrual cycle.

General disturbances: very often — symptoms of cancellation ^1.9 ; often — a slight asthenia, peripheral hypostases, irritability, a hyperthermia; seldom — a malignant antipsychotic syndrome ¹ , a hypothermia.

Laboratory indicators: seldom — increase in the KFK ^{7 level} .

Note

¹ See. Special INSTRUCTIONS.

Drowsiness can be noted by

² in the first 2 weeks of treatment and, as a rule, disappears at prolonged use of a kvetiapin.

Asymptomatic increase (shift from norm to 3 upper U UU (UUU) at any time) the level of transaminases (AlAT, AsAT) or GGT observed

³ at some patients at use of a kvetiapin. Such increase was usually reversible at treatment continuation kvetiapiny.

⁴ As well as other antipsychotic medicines blocking α ₁ - adrenoceptors, kvetiapin can often cause orthostatic hypotension that is followed by dizziness, tachycardia and (at some patients) a faint, especially during selection of an initial dose (see. SPECIAL INSTRUCTIONS).

Calculation of frequency of these side reactions was carried out by

⁵ only on the basis of post-marketing data of use of a kvetiapin, in a dosage form with fast release.

⁶ glucose Level in blood on an empty stomach ≥126 mg/dl (≥7.0 mmol/l) or glucose level in blood after meal of ≥200 mg/dl (≥11.1 mmol/l) at least in one case.

⁷ Increase in frequency of cases of a dysphagy at use of a kvetiapin in comparison with placebo was observed only during clinical trials of a bipolar depression.

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⁸ It is based for 7% increase in body weight in comparison with initial. Arises mainly within the first weeks of therapy at adults.

⁹ cancellation Symptoms which were observed more often during short-term placebos - controlled clinical trials of monotherapy at whom estimated cancellation symptoms: insomnia, nausea, headache, diarrhea, vomiting, dizziness and irritability. Frequency of these reactions significantly decreased in 1 week after the treatment termination.

¹⁰ TG Level is ≥200 mg/dl (≥2.258 mmol/l) (patients at the age of ≥18 years) or ≥150 mg/dl (≥1.694 mmol/l) (patients at the age of 18 years), at least in one case.

¹¹ Level is XC ≥240 mg/dl (≥6.2064 mmol/l) (patients at the age of ≥18 years) or ≥200 mg/dl (≥5.172 mmol/l) (patients at the age of 18 years) at least in one case. Increase in the LDL level XC of ≥30 mg/dl (≥0.769 mmol/l) was noted very often. The average value among patients with such increase was 41.7 mg/dl (1.07 mmol/l).

¹² See the text below.

¹³ Thrombocytes of ≤100·10 ⁹ / l at least in one case.

According to messages of clinical trials about side reactions the increase in the KFK level in blood is not connected by

¹⁴ with a malignant antipsychotic syndrome.

¹⁵ prolactin Level (patients at the age of 18 years) 20 mkg/l (869.56 pkmol/l) at men; 30 mkg/l (1304.34 pkmol/l) are at women — at any time.

Can lead

¹⁶ to falling.

¹⁷ Level is XC LPVP of 40 mg/dl (1.025 mmol/l) at men; Women have 50 mg/dl (1.282 mmol/l) — at any time.

¹⁸ Number of patients at whom duration of an interval of Q-T _C from 450 ms to ≥450 ms with increase on ≥30 ms changed. In placebo - controlled researches of a kvetiapin average change and the number of patients at which the shift of clinically significant level was noted are similar in groups of a kvetiapin and placebo.

¹⁹ Shift is from 132 to ≤132 mmol/l at least at one inspection.

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²⁰ About cases of suicide thoughts and suicide behavior it was reported during therapy kvetiapiny or right after the treatment termination (see. Special INSTRUCTIONS and PHARMACOLOGICAL PROPERTIES).

²¹ See. Pharmacological PROPERTIES.

²² Decrease in level of hemoglobin to ≤13 g/dl (8.07 mmol/l) at men, ≤12 g/dl (7.45 mmol/l) are at women, at least at one inspection, was observed at 11% of the patients receiving treatment kvetiapiny in all researches, including open. For these patients the average maximum decrease in level of hemoglobin was 1.50 g/dl at any time.

These events often noted

²³ against the background of tachycardia, dizziness, orthostatic hypotension and/or the basic heart/respiratory diseases.

²⁴ on the basis of a deviation from normal initial to potentially clinically importance at any time after initial in all researches. The deviation of values of the general of T ₄ , free T ₄ , the general T ₃ and free made T ₃ 0.8 VGN (pkmol/l) and the deviation of TSH made 5 mME/l at any time.

²⁵ According to increase in frequency of cases of vomiting at patients of advanced age (≥65 years).

²⁶ Deviations of quantity of neutrophils from ≥1,5·10 ⁹ / l from basic to 0,5·10 ⁹ / l at any time during treatment.

by

²⁷ It is based on a deviation from normal initial to potentially clinically importance after initial in all researches at any time. The deviation of quantity of eosinophils made 1·10 ⁹ / l at any time.

by

²⁸ It is based on a deviation from normal initial to potentially clinically importance after initial in all researches at any time. The deviation of quantity of leukocytes made ≤3·10 ⁹ / l at any time.

²⁹ According to messages about side reactions concerning a metabolic syndrome from all clinical trials of a kvetiapin.

³⁰ during clinical trials at some patients more than 1 time observed strengthening of the metabolic factors having negative effect on the body weight, glucose level in blood and lipids (see. Special INSTRUCTIONS).

³¹ See Use during pregnancy or feeding by a breast.

³² Can arise in time or soon began therapies and to be associated with hypotension and/or a faint. Frequency of emergence is based on messages about side reactions (bradycardia) and the phenomena connected with it which were observed in all clinical trials of a kvetiapin.

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At use of neuroleptics it was very seldom reported about cases of lengthening of an interval of Q-T on the ECG, ventricular arrhythmia, polymorphic ventricular tachycardia (torsade de pointes), a sudden not clear lethal outcome, cardiac arrest, and such effects are klassospetsifichesky.

Children. The side reactions stated above which were observed at adults, note also at children. Side reactions with high frequency of emergence in this age group of patients or which did not observe at adult patients are provided below.

Frequency of side reactions is determined by

as follows: very often (≥1/10); often (≥1/100 to 1/10); infrequently (≥1/1000 to 1/100); seldom (≥1/10,000 to 1/1000) and it is very rare (1/10,000).

from an endocrine system: very often — increase in level of ^{1 prolactin} .

from a metabolism and metabolism: very often — increase in appetite.

from nervous system: very often — extrapyramidal symptoms ³ ; often — a syncope.

Vascular disorders: very often — increase in the ABP ² .

from a respiratory system: often — rhinitis.

from digestive system: very often — vomiting.

General disturbances: often — irritability ³ .

Note

¹ prolactin Level (patients at the age of 18 years) 20 mkg/l (869.56 pkmol/l) at men; 26 mkg/l (1130.428 pkmol/l) are at women at any time; at 1% of patients noted increase in level of prolactin of 100 mkg/l.

² on the basis of a deviation above clinically significant borders (the criteria adapted by National Institute of health care) or increase in 20 mm Hg. for systolic arterial blood pressure or 10 mm Hg. for the diastolic arterial blood pressure at any time received from short-term (3–6 weeks) placebo - controlled researches with participation of children and teenagers.

Frequency corresponds to

³ observed at adults, but irritability can be connected with various clinical manifestations at children and teenagers in comparison with adults.

Kvetiron XR. At reception of a kvetiapin it was most often reported about such undesirable reactions: drowsiness, dizziness, dryness in a mouth, an asthenia of easy degree, a constipation, tachycardia, orthostatic hypotension and dyspepsia.

As well as concerning other antipsychotic means, use of a kvetiapin was followed by increase in body weight, a syncope, a malignant antipsychotic syndrome, a leukopenia and peripheral hypostases.

Disturbance from blood and lymphatic system: leukopenia ¹ , eosinophilia, thrombocytopenia, neutropenia ¹ , anemia, agranulocytosis.

Disturbance from the immune system: hypersensitivity, anaphylactic reaction ⁶ .

Disturbance from an endocrine system: giperprolaktinemiya ¹⁶ , hypothyroidism ²² , inadequacy of secretion of ADG.

Disturbance of metabolism and trophicity: strengthening of appetite, hyponatremia ²⁰ , diabetes ^{1, 5, 6} , metabolic syndrome.

Disturbance from mentality: unusual dreams and nightmares, suicide thoughts and suicide behavior ²¹ , a sleep-walking and the reactions connected with it, such as talk in a dream, disorders of feeding behavior in a dream.

Disturbance from nervous system: dizziness ¹⁷ , drowsiness ^{2, 17} , headache, syncopal state ^{4, 17} , extrapyramidal symptoms ^{1, 22} , dysarthtia, spasms ^{1, 17} , epilepsy ¹ , syndrome