Universal reference book for medicines
Product name: QUENTIAX В® (KVENTIAX В® )

Active substance: quetiapine

Type: Antipsychotic drug (antipsychotic)

Manufacturer: KRKA-RUS (Russia) manufactured by KRKA-RUS (Russia)
Composition, form of production and packaging
Tablets covered with a film coat of
brownish-red color, round, biconvex, with a facet;
the cross-sectional view is a white rough surface with a brownish-red shell.
1 tab.

quetiapine fumarate 28.78 mg,

which corresponds to the content of quetiapine 25 mg

Excipients: lactose monohydrate 4.5 mg, calcium hydrogen phosphate dihydrate 2.5 mg, microcrystalline cellulose 18.97 mg, povidone 1.25 mg, sodium carboxymethyl starch (type A) 5 mg, magnesium stearate 1.5 mg.

The composition of the membrane: hypromellose 1.25 mg, titanium dioxide (E171) 0.425 mg, macrogol 4000 0.2 mg, iron iron oxide yellow (E172) 0.075 mg, iron oxide red (E172) 0.05 mg.

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (6) - packs of cardboard.
10 pieces.
- blisters (9) - packs of cardboard.
The tablets covered with a film cover of light yellow color, round, biconcave;
a cross-sectional view is a white rough surface with a light yellow shell.
1 tab.

quetiapine fumarate 115.13 mg,

which corresponds to the content of quetiapine 100 mg

Excipients: lactose monohydrate - 18 mg, calcium hydrophosphate dihydrate - 10 mg, microcrystalline cellulose - 75.87 mg, povidone - 5 mg, sodium carboxymethyl starch (type A) - 20 mg, magnesium stearate - 6 mg.

Composition of the film coat: hypromellose - 5 mg, titanium dioxide (E171) - 1.85 mg, macrogol 4000 - 1 mg, iron oxide oxide yellow (E172) - 0.15 mg.

10 pieces.
- blisters (6) - packs of cardboard.
The tablets covered with a film membrane of white color, round, biconcave, with a facet;
the cross-sectional view is a white rough surface with a white sheath.
1 tab.

quetiapine fumarate 172.69 mg,

which corresponds to the content of quetiapine 150 mg

Excipients: lactose monohydrate - 27 mg, calcium hydrophosphate dihydrate - 15 mg, microcrystalline cellulose - 113.81 mg, povidone - 7.5 mg, sodium carboxymethyl starch (type A) - 30 mg, magnesium stearate - 9 mg.

The composition of the membrane: hypromellose - 7.5 mg, titanium dioxide (E171) - 3 mg, macrogol 4000 - 1.5 mg.

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (6) - packs of cardboard.
10 pieces.
- blisters (9) - packs of cardboard.
The tablets covered with a film cover of white color, round, biconcave;
the cross-sectional view is a white rough surface with a white sheath.
1 tab.

quetiapine fumarate 230.26 mg,

which corresponds to the content of quetiapine 200 mg

Excipients: lactose monohydrate 36 mg, calcium hydrophosphate dihydrate 20 mg, microcrystalline cellulose 151.74 mg, povidone 10 mg, sodium carboxymethyl starch (type A) 40 mg, magnesium stearate 12 mg.

The composition of the film membrane: hypromellose - 10 mg, titanium dioxide (E171) - 4 mg, macrogol 4000 - 2 mg.

10 pieces.
- blisters (6) - packs of cardboard.
The tablets covered with a film shell of white color, oval, biconcave;
the cross-sectional view is a white rough surface with a white sheath.
1 tab.

quetiapine fumarate 345.39 mg,

which corresponds to the content of quetiapine 300 mg

Excipients: lactose monohydrate - 54 mg, calcium hydrophosphate dihydrate - 30 mg, microcrystalline cellulose - 227.61 mg, povidone - 15 mg, sodium carboxymethyl starch (type A) - 60 mg, magnesium stearate - 18 mg.

Sheath composition: hypromellose - 15 mg, titanium dioxide (E171) - 6 mg, macrogol 4000 - 3 mg.

10 pieces.
- blisters (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Antipsychotic drug (antipsychotic).
Quetiapine is an atypical antipsychotic drug that exhibits a higher affinity for serotonin 5HT 2 receptors than for dopamine D 1 and D 2 receptors in the brain. Quetiapine has an affinity for histamine and? 1- adrenoreceptors, and a lower affinity for? 2- adrenoreceptors. There was no significant affinity for quetiapine for cholinergic muscarinic and benzodiazepine receptors.
In standard tests, quetiapine displays antipsychotic activity.

The results of the study of extrapyramidal symptoms in animals revealed that quetiapine causes a weak catalepsy in a dose effectively blocking dopamine D 2receptors.
Quetiapine causes a selective decrease in the activity of mesolimbic A10-dopaminergic neurons, compared to A9-nigrostriate neurons involved in motor function.
There was no difference between quetiapine (75-750 mg / day) and placebo in the incidence of extrapyramidal symptoms and concomitant use of anticholinergic drugs.
Do not cause a prolonged increase in the concentration of prolactin in the blood plasma.
Quetiapine has long maintained clinical improvement in those patients who had a positive effect at the very beginning of treatment.

The duration of action of quetiapine on serotonin 5HT 2 receptors and dopamine and D 2 receptors is less than 12 hours after administration of the drug.

PHARMACOKINETICS

Suction and distribution

Absorption is high, food intake does not affect bioavailability.
Binding to plasma proteins - 83%.
The pharmacokinetics of quetiapine is linear and does not differ between men and women.

Metabolism

It is actively metabolized in the liver with the formation of pharmacologically inactive metabolites under the influence of the isoenzyme CYP3A4.
Quetiapine and some of its metabolites are weak inhibitors of human isozymes 1A2, 2C9, 2C19, 2D6 and 3A4 cytochrome P450, but only in concentrations at least 10-50 times higher than the drug concentration when applied in the effective dose range of 300 to 450 mg / day.
Based on in vitro results, the simultaneous administration of quetiapine to other drugs should not be expected to result in clinically significant inhibition of cytochrome P450 mediated metabolism of other drugs.

Excretion

T 1/2 is approximately 7 hours. It is excreted by the kidneys approximately 73% and through the intestine - 21%.
Less than 5% of quetiapine is not metabolized and is excreted unchanged.
Pharmacokinetics in special clinical cases

The average clearance of quetiapine in elderly patients is 30-50% less than in patients aged 18 to 65 years.

The average clearance of quetiapine plasma in patients with severe renal insufficiency (CK <30 mL / min / 1.73 m 2 ) and in patients with liver damage (stabilized alcoholic cirrhosis) is reduced by approximately 25%.

INDICATIONS

- treatment of acute and chronic psychoses, including schizophrenia;

- treatment of manic episodes in bipolar disorder.

DOSING MODE

The drug is administered orally, 2 times / day, regardless of food intake.

In the treatment of acute and chronic psychoses, including schizophrenia, the daily dose in the first 4 days is: 1st day - 50 mg;
The second day - 200 mg; The third day - 200 mg and the 4th day - 300 mg. Starting from the 4th day, the daily dose is 300 mg. Depending on the clinical effect and the tolerability of the drug, its dose can individually vary from 150 mg / day to 750 mg / day. The maximum daily dose for the treatment of schizophrenia is 750 mg.
In the treatment of manic episodes with bipolar disorder, quetiapine is recommended as a monotherapy or as an adjuvant therapy for mood stabilization.

The daily dose for the first 4 days is: 1st day - 100 mg;
The second day - 200 mg; The third day - 300 mg and the 4th day - 400 mg. An increase in the daily dose in the future is possible at 200 mg / day and by the 6th day of therapy is 800 mg. Depending on the clinical effect and the tolerability of the drug, its dose can individually vary from 200 mg / day to 800 mg / day. Typically, the effective dose is from 400 mg to 800 mg / day. The maximum daily dose is 800 mg.
Because
the plasma clearance of quetiapine in elderly patients is reduced by 30-50%, the drug should be administered with caution, especially at the beginning of therapy. The starting dose is 25 mg / day, followed by an increase of 25-50 mg until the effective dose is reached.
In patients with renal and hepatic insufficiency, it is recommended to start therapy with 25 mg / day.
Further it is recommended to increase the dose daily by 25-50 mg until the effective dose is reached.
SIDE EFFECT

Classification of the incidence of adverse events (WHO): very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000), very rarely (<1/10 000, including individual messages).

From the hematopoietic system: often - leukopenia;
infrequently - eosinophilia; very rarely - neutropenia.
From the central and peripheral nervous system: very often - dizziness, drowsiness, headache;
often syncopal states; infrequently - anxiety, agitation, insomnia, akathisia, tremor, convulsions, depression, paresthesia; rarely - malignant neuroleptic syndrome (hyperthermia, impaired consciousness, muscle rigidity, vegetative-vascular disorders, increased concentration of CK); very rarely - tardive dyskinesia.
From the cardiovascular system: often - tachycardia, orthostatic arterial hypotension, prolongation of the QT interval on the ECG.

On the part of the respiratory system: rhinitis, pharyngitis.

On the part of the digestive system: often - dry mouth, constipation, diarrhea, dyspepsia, increased serum transaminase (ACT or ALT);
rarely - jaundice, nausea, vomiting, abdominal pain; very rarely - hepatitis.
Allergic reactions: infrequent - skin rash, hypersensitivity reactions;
very rarely - angioedema, Stevens-Johnson syndrome.
On the part of the reproductive system: rarely - priapism.

From the endocrine system: often - weight gain (mainly in the first weeks of treatment);
very rarely - hyperglycemia or decompensation of diabetes mellitus.
Laboratory indicators: infrequently - increase of serum GGT level and triglyceride content (not on an empty stomach), hypercholesterolemia;
decrease in the level of thyroid hormones (total T4 and free T4 / in the first 4 weeks), as well as general T3 and reversible T3 (only with high doses of quetiapine).
Other: often - peripheral edema, asthenia;
rarely - back pain, chest pain, subfebrile condition, myalgia, dry skin, weak eyesight.
CONTRAINDICATIONS

- the period of breastfeeding;

- children and adolescents under 18 years of age (effectiveness and safety not established);

- Hypersensitivity to quetiapine or other components of the drug.

Caution should be given to patients with cardiovascular and cerebrovascular diseases or other conditions predisposing to arterial hypotension, with a congenital increase in the QT interval on the ECG, or in the presence of conditions potentially capable of causing an increase in the QT interval (simultaneous administration of drugs prolonging the QT interval, congestive heart failure , hypokalemia, hypomagnesemia), with hepatic insufficiency, epilepsy, convulsive fits in the anamnesis, pregnancy,
of the residential age.
PREGNANCY AND LACTATION

The safety and effectiveness of quetiapine in pregnant women have not been established.
Therefore, in pregnancy, quetiapine can only be used if the expected benefit justifies the potential risk.
The degree of excretion of quetiapine with mother's milk is not established.
Women should be advised to avoid breastfeeding while taking quetiapine.
APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with renal insufficiency, it is recommended to start therapy with 25 mg / day.
Further it is recommended to increase the dose daily by 25-50 mg until the effective dose is reached.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with hepatic insufficiency, it is recommended to start therapy with 25 mg / day.
Further it is recommended to increase the dose daily by 25-50 mg until the effective dose is reached.
APPLICATION FOR CHILDREN

Contraindications: children and adolescents under 18 years of age (efficacy and safety not established).

APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients.

SPECIAL INSTRUCTIONS

With a sharp cancellation of high doses of antipsychotic drugs, the following acute reactions (withdrawal syndrome) can occur: nausea, vomiting, and rarely insomnia.
Cases of exacerbation of psychotic symptoms and the appearance of involuntary motor disorders (akathisia, dystonia, dyskinesia) have been reported. In connection with which, it is recommended to cancel the drug gradually.
When prescribing quetiapine concomitantly with drugs that extend the QT interval, care should be taken, especially in elderly patients, with congestive heart failure, hypokalemia, and hypomagnesemia.

Given that quetiapine affects the central nervous system, the drug should be used with caution in combination with other drugs that have a depressant effect on the central nervous system.
It is recommended to refrain from drinking alcohol.
When symptoms of tardive dyskinesia appear, reduce the dose or stop using quetiapine.

In controlled clinical trials, there was no difference in the incidence of seizures between quetiapine and placebo.
However, as with other antipsychotics, caution should be exercised in the treatment of patients with a history of seizures.
Malignant neuroleptic syndrome can be associated with ongoing antipsychotic treatment.
Clinical manifestations of the syndrome include: hyperthermia, altered mental status, muscle rigidity, instability of the autonomic nervous system, an increase in the level of CK. With the development of this syndrome, quetiapine should be withdrawn and treated accordingly.
Impact on the ability to drive vehicles and manage mechanisms

During treatment with quetiapine, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

OVERDOSE

Data on quetiapine overdose are limited.
Cases of quetiapine administration in a dose exceeding 30 g are described. In most patients, side effects were not noted, but in cases of their development, side effects were treated independently. A case of a lethal outcome was recorded with the administration of 13.6 g quetiapine. Very rarely reported cases of quetiapine overdose, resulting in prolongation of the QT interval, coma or death. In patients with severe cardiovascular disease in history, the risk of side effects in overdose may increase.
Symptoms: excessive sedation, drowsiness, tachycardia, lowering blood pressure.

Treatment: conduct symptomatic therapy, activities aimed at maintaining the function of respiration, cardiovascular system, adequate oxygenation and ventilation of the lungs.
There are no specific antidotes.
DRUG INTERACTION

Quetiapine does not induce the induction of liver enzyme systems involved in the metabolism of phenazone and lithium.

The simultaneous administration of quetiapine with drugs potentially inhibiting hepatic enzymes such as carbamazepine or phenytoin, as well as with barbiturates, rifampicin, may reduce the plasma concentrations of quetiapine, which may require an increase in the Quentiax dose, depending on the clinical effect.
This should also be taken into account when removing phenytoin or carbamazepine, or other inducer of the liver enzyme system, or by substituting for a drug that does not induce microsomal liver enzymes (eg , valproic acid).
The main enzyme responsible for the metabolism of quetiapine is the isoenzyme CYP3A4.
The pharmacokinetics of quetiapine does not change with simultaneous use of cimetidine (inhibitor P450), fluoxetine (inhibitor CYP3A4 and CYP2D6) or an antidepressant imipramine (inhibitor of CYP2D6).
It is advisable to use caution while using quetiapine and systemic use of CYP3A4 inhibitors (antifungal agents of the azole group and macrolide antibiotics),
plasma concentrations of quetiapine may increase. Therefore, lower doses of quetiapine should be used. Particular attention should be paid to elderly and weakened patients.
The pharmacokinetics of quetiapine did not change significantly when administered concomitantly with antipsychotic agents, risperidone or haloperidol.
However, simultaneous administration of quetiapine with thioridazine led to an increase in the clearance of quetiapine.
Drugs that depress the central nervous system, and ethanol increase the risk of side effects.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children, at a temperature of no higher than 30 В° C.
Shelf life - 2 years. Do not use the drug after the expiration date.
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