Quetiapine pills 25mg, 60pcs – Ozon

Composition

Composition for 1 tablet of 25 mg: Active ingredient: quetiapine fumarate – 28,780 mg, in terms of quetiapine-25,000 mg. Excipients: microcrystalline cellulose-60.0 mg; lactose monohydrate (milk sugar) – 44.0 mg; povidone (polyvinylpyrrolidone medium molecular weight) – 9.0 mg; croscarmellose sodium (primellose) – 10.5 mg; magnesium stearate-1.5 mg Shell: Opadray II (polyvinyl alcohol, partially hydrolyzed-2.0 mg; macrogol (polyethylene glycol) 3350 -1.01 mg; talc-0.74 mg; titanium dioxide E 171-1.1333 mg; iron oxide (II) yellow dye E 172-0.1167 mg).

Pharmacological action

Pharmacotherapy group

Antipsychotic agent (neuroleptic)

ATX codeN05AH04

Pharmacological action

Quetiapine is an atypical antipsychotic medication. Quetiapine and its active metabolite N-dealkylquetiapine (norquetiapine) interact with a wide range of brain neutrotransmitter receptors. Quetiapine and N-dealkylquetiapine exhibit a high property to 5 HT2-serotonin receptors and D1 and D2 – dopamine receptors, which causes the main clinical antipsychotic properties of the drug and a low frequency of ext-apyramidal side effects.

Quetiapine has no affinity for the norepinephrine transporter and has a low affinity for 5 HT1A, while N-dealkylquetiapine shows a high affinity for both. Inhibition of the norepinephrine transporter and partial agonism against 5 HT1A-serotonin receptors, manifested by the metabolite, may cause the antidepressant effect of the drug. Quetiapine and N-dealkylquetiapine have high affinity for histamine and α1-adrenergic receptors and moderate affinity for α2-adrenergic receptors.

Quetiapine shows no significant affinity for muscarinic receptors, while its metabolite N-dealkylquetiapine shows moderate to high affinity for several subtypes of muscarinic receptors. In standard animal tests, quetiapine exhibits antipsychotic activity. The specific contribution of the N-dealkylquetiapine metabolite to the pharmacological activity of quetiapine has not been established.

The results of the study of extrapyramidal symptoms (EPS) in animals revealed that quetiapine causes mild catalepsy at a dose that effectively blocks D2-dopamine receptors. Quetiapine causes a selective decrease in the activity of mesolimbic A10-dopaminergic neurons in comparison with A9 – nigrostriar neurons involved in motor function. When taking quetiapine with dose titration in schizophrenia, the frequency of EPS and concomitant use of M-holinoblockers was comparable to that of placebo. The drug is well tolerated when taken at the recommended doses, including in elderly patients. In placebo – controlled studies in elderly patients with dementia, the incidence of cerebrovascular complications with quetiapine did not exceed those in the placebo group.

The drug is effective against both positive and negative symptoms of schizophrenia. Quetiapine is effective as a monotherapy for moderate to severe manic episodes. There are no data on long-term use of the drug for the prevention of subsequent manic and depressive episodes. Data on the use of quetiapine in combination with valproates or lithium preparations in moderate to severe manic episodes are limited, but the combination was generally well tolerated, and the frequency of EPS and concomitant use of M-holinoblockers is comparable to that with placebo. Quetiapine is effective at doses of 300 mg and 600 mg in patients with moderate to severe bipolar disorder of type I and II. At the same time, the effectiveness of the drug at a dose of 300 mg and 600 mg is comparable. Quetiapine is effective in patients with schizophrenia and mania when the drug is taken twice a day, despite the fact that the half-life is approximately 7 hours. The effect of quetiapine on 5 HT2 and D2 receptors lasts up to 12 hours after taking the drug. In a clinical study in patients with depressive episodes in the structure of type I and II bipolar disorder, the use of quetiapine at a dose of 300 mg per day was more effective than placebo in reducing the overall score on the MADRS Depression Rating Scale (Montgomery-Asberg Depression Rating Scale. Montgomery-Asberg Depression Rating Scale).

In 4 additional clinical trials of quetiapine lasting 8 weeks in patients with moderate to severe depressive episodes in the structure of bipolar disorder, quetiapine at doses of 300 mg and 600 mg showed greater efficacy compared to placebo: an average improvement in MADRS scores and an improvement in overall MADRS scores (at least 50%) compared to the initial values. In a short-term (9-week) study in non-dementia patients aged 66 to 89 years with major depressive disorder, quetiapine in doses ranging from 50 mg to 300 mg (dose adjusted for clinical response, average daily dose was 160 mg) reduced symptoms of depression compared to placebo. The incidence of EPS and weight gain in stable patients with schizophrenia does not increase with long-term drug therapy. In studies of major depressive disorder according to the DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders (4th ed. )), there was no increase in the risk of suicidal behavior and suicidal thinking when taking the drug compared to placebo. When using quetiapine at a dose of 75-750 mg per day compared with placebo, there were no differences in the frequency of extrapyramidal symptoms and concomitant use of anticholinergic drugs.

Quetiapine does not cause a prolonged increase in the concentration of prolactin in blood plasma. There were no differences in prolactin concentrations when using quetiapine or placebo at a fixed dose. When quetiapine was administered at doses up to 800 mg/day for the treatment of moderate to severe manic episodes, either in monotherapy or in combination with lithium or seminatria valproate, the incidence of EPS and concomitant use of M-holinoblockers was comparable to that of placebo.

In two short-term (6-week) studies, combination therapy of a depressive episode with quetiapine at a dose of 150 mg/day and 300 mg/day with amitriptyline, bupropion, citapopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline or venlafaxine in patients with a suboptimal response to antidepressant monotherapy showed improvement in depression symptoms on the MADRS scale (Montgomery-Asberg Depression Rating Scale. Montgomery-Asberg depression rating scale) (mean square change of 2-3.3 points) compared to antidepressant monotherapy.

Indications

– schizophrenia.

– manic episodes in the structure of bipolar disorder.

– depressive episodes of moderate to severe severity in the structure of bipolar disorder.

Quetiapine is not indicated for the prevention of manic and depressive episodes.

Contraindications

* hypersensitivity to any component•

* lactase deficiency, lactose intolerance, glucose-galactose malabsorption•

* concomitant use with inhibitors of cytochrome P 450 isoenzymes, including antifungal agents – azole derivatives, erythromycin, clarithromycin, nefazodone, HIV protease inhibitors (see the section “Interaction with other drugs”).

* psychoses and elderly patients with dementia.

How to take, course of use and dosage

Inside,2-3 times a day, regardless of food intake, there are different schemes for using the drug, the doctor should give clear instructions to the patient on the dosage regimen.

Adults

Acute and chronic psychoses, including schizophrenia.

The drug is prescribed 2 times a day. The total daily dose for the first 4 days of therapy is 50 mg (day 1),100 mg (day 2),200 mg (day 3),300 mg (day 4). Starting from day 4, the dose should be adjusted to the effective dosage, usually in the range of 300 to 450 mg / day. In the future, if it is necessary to adjust the dose, it is recommended to increase the daily dose by 50-100 mg at intervals of 2 days. Depending on the clinical effect and individual tolerability of the drug, the dose may vary from 150 to 750 mg / day. The maximum daily dose of quetiapine is 750 mg.

Treatment of manic episodes in the structure of bipolar disorder.

Quetiapine is used as monotherapy or in combination with drugs that have a normothymic effect. The drug is prescribed 2 times a day. The daily dose for the first 4 days of therapy is: 100 mg (day 1),200 mg (day 2),300 mg (day 3),400 mg (day 4). In the future, by the 6th day of therapy, the daily dose of the drug can be increased to 800 mg. The increase in the daily dose should not occur faster than 200 mg per day. The daily dose is divided into 2 doses. Depending on the clinical effect and individual tolerability of the patient, the dose may vary from 200 to 800 mg / day. Usually, the effective dose is from 400 to 800 mg / day. The maximum daily dose of quetiapine is 800 mg.

Treatment of moderate to severe depressive episodes in the structure of bipolar disorder.

Quetiapine is prescribed 1 time a day at night. The daily dose for the first 4 days of therapy is: day 1-50 mg, day 2-100 mg, day 3-200 mg, day 4-300 mg. The recommended dose is 300 mg / day. The maximum daily dose is 600 mg. The antidepressant effect of quetiapine was confirmed when used at doses of 300 and 600 mg per day.With short-term therapy, the effectiveness of quetiapine at doses of 300 and 600 mg was comparable.

Elderly patients

In elderly patients, the initial dose of the drug is 25 mg / day. The dose should be increased daily by 25-50 mg until an effective dose is reached, which is likely to be less than in younger patients. In elderly patients, quetiapine (as well as other antipsychotics) should be taken with caution, especially at the beginning of therapy. The selection of the effective dose of the drug in such patients may be slower, and the daily therapeutic dose is lower than in young people. The average plasma clearance of quetiapine in elderly patients is 30-50% lower than in young patients. In addition, patients in this group are more likely to have diseases of the liver, kidneys, nervous and cardiovascular systems, and concomitant treatment is most often prescribed.

Patients with renal insufficiency

No dose adjustment is required. Patients with hepatic insufficiency Quetiapine is extensively metabolized in the liver. Therefore, caution should be exercised when using the drug in patients with hepatic insufficiency, especially at the beginning of therapy. It is recommended to start therapy with quetiapine at a dose of 25 mg / day and increase the dose daily by 25-50 mg until the therapeutic effect is achieved. Maintenance therapy To maintain remission, it is advisable to use the lowest dose. Patients should be periodically evaluated to determine whether maintenance therapy is necessary. Resumption of an interrupted course of treatment in patients previously treated with quetiapine. If therapy is resumed less than 1 week after quetiapine withdrawal, the drug can be continued at a dose adequate for maintenance therapy. When resuming therapy in patients who have not received quetiapine for more than 1 week, follow the rules for initial dose selection and set the effective dose before the patient’s clinical response.

Form of production

Film-coated tablets 25 mg,100 mg,150 mg,200 mg and 300 mg. 10,20,25,30 or 50 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished.

By 10,20,30,40,50,60,70,80,90 or 100 tablets in cans made of polyethylene terephthalate or polyethylene for medicines, sealed with lids made of high-pressure polyethylene with control of the first opening or polypropylene lids with “push-turn” systems or lids made of low-pressure polyethylene with control of the first opening.

One jar or 1,2,3,4,5,6,7,8,8 or 10 contour cell packages together with the instructions for use are placed in a cardboard package (pack).

Active ingredient

Quetiapine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets