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 (episodes of mania, depression or mixed episodes) in patients who have responded to previous Quetiapine treatment.

1 tabl powl. contains 25 mg, 100 mg, 200 mg or 300 mg quetiapine (as fumarate). The preparation contains lactose.

Atypical antipsychotic drug. Quetiapine and its pharmacologically active metabolite, norkwetiapine, act on many receptors of neurotransmitters. The antipsychotic effect is mainly due to the blocking of serotonin (5-HT) receptors in the brain₂) and Dopamine (D.₁ and D₂). In addition, norcorapine has a strong affinity for the norepinephrine transporter (NET). Quetiapine and norquetiapine also have high affinity for histamine and α receptors₁-adrenergic and lower affinity for α receptors₂-renergic and serotonin 5-HT₁. Affinity to muscarinic and benzodiazepine cholinergic receptors is negligible. Quetiapine is well absorbed from the gastrointestinal tract (food does not affect its bioavailability). It binds to plasma proteins in 83%. It is extensively metabolised in the liver, mainly involving CYP3A4. Less than 5% of the drug is excreted unchanged with faeces and urine. About 73% of the metabolites of quetiapine are excreted in the urine, 21% in the faeces. T_0,5 quetiapine in the elimination phase is about 7 h, norewetiapine - 12 h.

Hypersensitivity to quetiapine or other components of the preparation. Do not use together with CYP3A4 inhibitors such as HIV protease inhibitors, azole antifungal preparations, Erythromycin, Clarithromycin, nefazodone.

It is not advisable to use quetiapine in children and adolescents. Quetiapine is not approved for the treatment of elderly patients with psychosis associated with dementia. Use with caution in patients with cardiovascular disease, cerebrovascular disease or other conditions predisposing to hypotension; with risk factors for stroke; with history of epileptic seizures; with diabetes or risk factors for developing diabetes (regularly monitor these patients for deterioration in blood Glucose control and weight control); with risk factors for neutropenia (with an earlier low white blood cell count and a history of drug-induced neutropenia); with hepatic impairment; in the elderly; in patients using medicines that strongly induce hepatic enzymes (these medicines significantly reduce the amount of quetiapine in the blood). Caution should be exercised in patients with cardiovascular disease or family history of QT prolongation, and if quetiapine is co-administered with other QT prolonging or neuroleptic drugs, particularly in elderly patients with congenital long QT syndrome, congestive heart failure heart, cardiac hypertrophy, hypokalaemia or hypomagnesaemia. Quenching disorders have been observed with quetiapine - caution should be used in patients at risk of aspiration pneumonia. Before and during treatment with the preparation, all possible risk factors for venous thromboembolism should be identified and appropriate preventive measures should be taken. All patients treated with the product should be monitored for signs of suicidal ideation and behavior (especially during early recovery, after a change in the dose, as well as after abrupt quetiapine discontinuation); this applies especially to patients under the age of 25 years and patients with a history of suicidal behavior or thoughts. When treating patients with other mental disorders, the same precautions should be taken as when treating patients with major depressive episodes. All patients treated with quetiapine should be monitored for signs of hyperglycaemia (excessive thirst and hunger, polyuria and weakness).During treatment with Quetiapine, body weight and lipid profile should be monitored. In case of deterioration of the metabolic profile (changes in body weight, glucose concentration, blood lipids), follow the clinical guidelines and apply appropriate treatment. If hypotension develops during treatment with quetiapine, a dose reduction or slower titration should be considered. In patients with akathisia, increasing the dose of quetiapine may be harmful. If tardive dyskinesia occurs, consideration should be given to reducing the dose or stopping quetiapine treatment. Quetiapine treatment should be discontinued in case of symptoms of malignant neuroleptic syndrome. QUetiapine should be discontinued in patients with neutrophil counts <1 x 10⁹/ L; patients should be monitored for signs of infection, and neutrophil counts should be monitored until they exceed 1.5 x 10⁹/ L. Patients with bipolar depression who are experiencing drowsiness of severe intensity may require more frequent visits during the first 2 weeks after the onset of sleepiness or until improvement; it may be necessary to consider discontinuation of treatment. Data on the use of quetiapine in combination with valproate or lithium in acute moderate to severe manic episodes are limited, although the combination therapy was well tolerated (the data shows that the treatment has an additive effect in the third week). Due to the lactose content, the preparation should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

During pregnancy, apply only if the benefits for the mother outweigh the potential risk to the fetus. Extrapyramidal disturbances and / or withdrawal symptoms were observed in newborns whose mothers used the drug during pregnancy (especially in the third trimester) - therefore newborns should be carefully monitored. Women taking the drug should not breastfeed.

Very common: decrease in hemoglobin, increase in triglycerides, total cholesterol (mainly LDL), decrease in HDL cholesterol, weight gain, dizziness, drowsiness, headache, dry mouth, withdrawal symptoms (insomnia, nausea, pain) headache, diarrhea, vomiting, dizziness and irritability). Common: leukopenia, decreased neutrophil count, increased eosinophils, hyperprolactinemia, decreased total T4, decreased free T4 concentration, reduced total T3, increased TSH, increased appetite, increased blood glucose up to hyperglycemic levels, unpleasant dreams and nightmares sleepy, suicidal thoughts and behavior, syncope, extrapyramidal symptoms, dysarthria, tachycardia, palpitation, blurred vision, orthostatic hypotension, rhinitis, dyspnoea, constipation, indigestion, vomiting, ALT, AST, GGT, weakness, peripheral edema, irritability , fever. Uncommon: thrombocytopenia, anemia, hypersensitivity reactions (including cutaneous allergic reactions), decrease in free T3 concentration, hypothyroidism, hyponatremia, diabetes, seizures, restless leg syndrome, tardive dyskinesia, QT prolongation, dysphagia, sexual dysfunction. Rarely: agranulocytosis, metabolic syndrome, somnambulism and related reactions (such as sleep telling and eating disorder related to sleep), venous thromboembolism, pancreatitis, jaundice, hepatitis, priapism, galactorrhea, breast swelling, menstrual disorders , neuroleptic malignant syndrome, hypothermia, elevation of creatine phosphokinase. Very rare: anaphylactic reaction, inappropriate vasopressin secretion syndrome, angioneurotic edema, Stevens-Johnson syndrome, rhabdomyolysis. Not known: neutropenia, toxic epidermal necrolysis, erythema multiforme. In addition, during the use of neuroleptics observed: QT prolongation, ventricular arrhythmias, cardiac arrest,torsades de pointes and cases of sudden unexpected deaths.Side effects that are more common in children and adolescents (10-17 years) than in adults and side effects that were not seen in adults: very common: increased appetite, increased prolactin, increased blood pressure, extrapyramidal symptoms; common: irritability - the drug is not recommended for use in children.

Orally. Adults.Treatment of schizophrenia: drug administered twice a day. 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 dose should be increased to an effective dose usually 300-450 mg per day. Depending on the clinical response and tolerability, the dose can be adjusted in the range of 150-750 mg per day.Treatment of manic episodes in the course of bipolar disorder: drug administered twice a day. 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 a maximum of 200 mg per day to 800 mg daily dose on day 6 of treatment. Depending on the clinical response and tolerability, the dose can be adjusted between 200-800 mg / day; the usual effective dose is 400-800 mg per day.Treatment of depressive episodes in the course of bipolar disorder: drug administered once a day, before bedtime. 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. Some patients benefit from a 600 mg dose per day. Doses greater than 300 mg should be administered by a physician experienced in the treatment of bipolar disorder. In some patients who have problems tolerating the drug, a dose reduction of up to 200 mg per day may be considered.Prevention of relapse in bipolar disorder: in patients who have experienced a reaction to quetiapine for the treatment of an acute phase of bipolar disorder, quetiapine should be continued at the same dose to prevent recurrence of manic, mixed or depressive episodes. The dose can be modified depending on the clinical response and tolerability of the patient, in the 300-800 mg range, administered twice daily. The lowest effective dose should be used.Special groups of patients. In elderly patients, the mean plasma clearance of quetiapine is 30-50% lower; depending on the patient's response and tolerability, dose escalation should be slowed down and the daily therapeutic dose should be reduced in relation to the dose used in younger patients; the efficacy and safety of the medicine has not been studied in patients> 65 years with episodes of depression in the course of bipolar disorder. In patients with impaired hepatic function, the starting dose should be 25 mg a day; the dose should be increased daily by 25-50 mg per day until an effective dose is obtained, depending on the patient's clinical response and tolerability. In patients with impaired renal function, there is no need to change the dosage.
The drug can be taken with or without food. Table. 300 mg can be divided into halves.