Index of drugs

Treatment of schizophrenia. Treatment of moderate to severe manic episodes in the course of bipolar disorder. Treatment of episodes of severe depression in the course of bipolar disorder. Prevention of recurrence of bipolar disorder (mixed episodes, mania or depression) in patients who have responded to previous Quetiapine treatment.

1 tabl powl. contains 25 mg, 100 mg or 200 mg of quetiapine in the form of fumarate. The preparation contains lactose.

Quetiapine is an atypical antipsychotic drug that acts on a wide spectrum of receptors. It has affinity for the serotonin receptor (5HT₂) in the brain and to Dopamine receptors in the brain (D.₁ and D₂). Quetiapine also has a high affinity for histamine and α receptors₁-adrenergic and smaller to α receptors₂-renergic and serotonin 5HT₁A. Affinity for benzodiazepine and muscarinic receptors is negligible. In addition, N-dealkylated quetiapine (the main metabolite) has a high affinity for the norepinephrine transporting agent (NET). After oral administration, quetiapine is easily absorbed from the gastrointestinal tract and undergoes significant metabolism. The bioavailability of quetiapine is not significantly changed after co-administration with a meal. It is 83% bound to plasma proteins. Quetiapine is extensively metabolised - 73% are excreted in the urine and 21% in the faeces; less than 5% of the drug is excreted unchanged with faeces and urine T_0,5 is about 7 h for quetiapine and 12 h for its main metabolite. Quetiapine clearance in the elderly is 30-50% lower than in younger people. Clearance of quetiapine in patients with severe renal insufficiency or hepatic insufficiency was approximately 25% lower.

Hypersensitivity to quetiapine or any of the excipients. Concomitant use of inhibitors of the cytochrome P450 3A4 system, such as protease inhibitors used in HIV treatment, azole antifungals, Erythromycin, Clarithromycin and nefazodone.

Due to the increased risk of suicidal thoughts, self-injuries and suicides in depression during bipolar disorder, the patient should remain under strict control until improvement occurs. Patients with bipolar depression who are experiencing drowsiness of severe intensity may require more frequent visits for a minimum of 2 weeks from the onset of somnolence or until symptoms improve; it may be necessary to consider discontinuation of treatment. Caution should be exercised in patients with known cardiovascular disease, cerebrovascular disease and other conditions predisposing to low blood pressure, as well as in patients with a history of epilepsy, risk factors for stroke, diabetes mellitus, impaired liver function (especially at the beginning of treatment) and in elderly patients (safety and efficacy have not been studied in patients> 65 years of age with episodes of depression in the course of bipolar disorder). Quetiapine may cause orthostatic hypotension, especially at the initial dose escalation - a lower dose or a slower increase should be considered. In the event of signs and symptoms of tardive dyskinesia, a dose reduction or discontinuation of treatment should be considered. In addition, treatment with quetiapine should be discontinued and appropriate treatment should be initiated if neuroleptic malignant syndrome occurs and if the neutrophil count is <1.0 x 10⁹/ l (you should follow the patient to detect early signs of infection and control the number of neutrophils until their number increases over 1.5 x 10⁹/ L). Data from clinical studies and the use of quetiapine have not confirmed its association with persistent prolongation of the QT interval, however, caution should be exercised in patients with cardiovascular disease or QT family history prolongation, and if quetiapine is used concomitantly with other drugs that prolong the interval QTc, neuroleptics, especially in elderly patients, patients with congenital long QT syndrome, congestive heart failure, hypertrophy of the heart muscle, hypokalaemia or hypomagnesaemia. It is recommended that the drug be gradually withdrawn for a period of at least 1-2 weeks. Quetiapine is not indicated for the treatment of elderly patients with psychotic symptoms in the course of dementia. The use of quetiapine in children and adolescents is not recommended due to the lack of data on the use of this drug in this group.Due to the lactose content, the drug should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

It can only be used during pregnancy if the benefits to the mother outweigh the potential risk to the fetus. You should avoid breastfeeding while using quetiapine.

Very common: dizziness, drowsiness, headaches; dry mouth; withdrawal symptoms (insomnia, nausea, headache, diarrhea, vomiting, dizziness and irritability); increase in triglycerides (> 200 mg / ml in at least one study), increase in total cholesterol (> 240 mg / ml in at least one study). Common: leukopenia; unpleasant dreams, nightmares; fainting, extrapyramidal symptoms; tachycardia; blurred vision; orthostatic hypotension; rhinitis; constipation, indigestion; mild weakness, peripheral edema; weight gain, ALT and AST increase, decrease in neutrophil counts, increase in Glucose to hyperglycaemia (fasting glucose ≥126 mg / ml, no fasting plasma ≥ 200 mg / ml, at least in one study). Uncommon: eosinophilia, thrombocytopenia; hypersensitivity; epileptic seizures, restless legs syndrome, dysarthria; dysphagia; increased GGTP activity, decreased platelet count (platelet count ≤100 x 10⁹/ l at least in one study). Rare: jaundice; priapism; malignant neuroleptic syndrome; increase in keratin phosphokinase activity. Very rare: anaphylactic reaction; diabetes; tardive dyskinesias; hepatitis; angioneurotic edema, Stevens-Johnson syndrome. Frequency unknown: neutropenia. During treatment with neuroleptics, cases of prolongation of the QTc interval, atrial arrhythmias, sudden unexpected deaths, cardiac arrest, ventricular tachycardia were observed.torsade de pointes. Treatment with quetiapine was associated with a small dose-related decrease in thyroid hormone levels in the blood, particularly T₄ and fT₄, mainly during the first weeks of treatment.

Orally. Adults.Treatment of schizophrenia: the total daily dose for the first 4 days of treatment is: 50 mg - day 1, 100 mg - day 2, 200 mg - day 3, 300 mg - day 4, from day 4 the usually effective daily dose is 300- 450 mg, however, depending on the clinical response and tolerability of the drug, the dose may be modified in the range of 150-750 mg per day; drug administered twice a day.Treatment of manic episodes in the course of bipolar disorder: the total daily dose for the first 4 days of treatment is: 100 mg - day 1, 200 mg - day 2, 300 mg - day 3, 400 mg - day 4, then the dose may be increased by 200 mg daily for 800 mg daily dose on day 6 of treatment; depending on the patient's response and tolerability, the maintenance dose may be 200-800 mg / day, usually effective dose 400-800 mg / day; drug administered twice a day.Treatment of depressive symptoms in the course of bipolar disorder: the total daily dose for the first 4 days of treatment is: 50 mg - day 1, 100 mg - day 2, 200 mg - day 3, 300 mg - day 4, the recommended daily dose is 300 mg, depending on the patient's response it can be increased to 600 mg a day; drug administered once daily, in the evening.Prevention of relapse in bipolar disorder: patients who have had a positive response to quetiapine treatment for a mania, a mixed episode or a depressive episode should continue treatment with the same dose; the dose should be determined individually depending on the clinical response and tolerability of the drug, in the range of 300-800 mg per day, the lowest possible dose should be used. Elderly patients may need to increase the dose more slowly and administer lower daily doses. In patients with hepatic impairment, treatment should start with a daily dose of 25 mg and increase the daily dose by 25-50 mg to achieve a therapeutic dose. No dosage adjustment is necessary for patients with impaired renal function.