As with other antipsychotics, caution should be exercised when quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation. (9) The following withdrawal symptoms have been observed most frequently in acute placebo-controlled, monotherapy clinical trials, which evaluated discontinuation symptoms: insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability. In one long-term study (up to 2 years treatment) evaluating recurrence prevention in patients with manic, depressed or mixed mood episodes quetiapine was superior to placebo in increasing the time to recurrence of any mood event (manic, mixed or depressed), in patients with bipolar I disorder. The mean last week median dose of quetiapine in responders was approximately 600 mg/day and approximately 85% of the responders were in the dose range of 400 to 800 mg/day.In 4 clinical trials with a duration of 8 weeks in patients with moderate to severe depressive episodes in bipolar I or bipolar II disorder, quetiapine immediate release 300 mg and 600 mg was significantly superior to placebo treated patients for the relevant outcome measures: mean improvement on the MADRS and for response defined as at least a 50% improvement in MADRS total score from baseline. Luxemburg: Quetiapin-ratiopharm 100 mg Filmtabletten. Approximately 73% of the radioactivity is excreted in the urine and 21% in the faeces.Quetiapine and several of its metabolites (including norquetiapine) were found to be weak inhibitors of human cytochrome P450 1A2, 2C9, 2C19, 2D6 and 3A4 activities The elimination half-lives of quetiapine and norquetiapine are approximately 7 and 12 hours, respectively. A meta-analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Heben Sie die Packungsbeilage auf. (For cataracts/lens opacities see section 5.1).In an embryofoetal toxicity study in rabbits the foetal incidence of carpal/tarsal flexure was increased. Responder rates (YMRS improvement ≥50%) were 64% for quetiapine 400 mg/day, 58% for 600 mg/day and 37% in the placebo arm.In the schizophrenia study, the difference in LS mean change from baseline in PANSS total score (active minus placebo) was –8.16 for quetiapine 400 mg/day and –9.29 for quetiapine 800 mg/day. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur. (20) Cases of suicidal ideation and suicidal behaviours have been reported during quetiapine therapy or early after treatment discontinuation (see sections 4.4 and 5.1). (22) Decreased haemoglobin to ≤13 g/dL (8.07 mmol/L) males, ≤12 g/dL (7.45 mmol/L) females on at least one occasion occurred in 11% of quetiapine patients in all trials including open label extensions. (2) Based on shifts above clinically significant thresholds (adapted from the National Institutes of Health criteria) or increases >20 mm Hg for systolic or >10 mm Hg for diastolic blood pressure at any time in two acute (3-6 weeks) placebo-controlled trials in children and adolescents. It is important that the lowest effective dose is used for maintenance therapy.As with other antipsychotics, quetiapine should be used with caution in the elderly, especially during the initial dosing period. … In patients who develop these symptoms, increasing the dose may be detrimental. It is also not recommended to consume grapefruit juice while on quetiapine therapy.In a multiple dose trial in patients to assess the pharmacokinetics of quetiapine given before and during treatment with carbamazepine (a known hepatic enzyme inducer), co-administration of carbamazepine significantly increased the clearance of quetiapine. Lipid changes should be managed as clinically appropriate.In clinical trials and use in accordance with the SPC, quetiapine was not associated with a persistent increase in absolute QT intervals. 70%.The pharmacokinetics of quetiapine were not altered following co-administration with cimetidine.The pharmacokinetics of lithium were not altered when co-administered with quetiapine. (15) Prolactin levels (patients>18 years of age): >20 µg/L (>869.56 pmol/L) males; >30 µg/L (>1304.34 pmol/L) females at any time. It must therefore be ensured that patients receive clear information on the appropriate dose for their condition.For the treatment of schizophrenia, quetiapine should be administered twice a day. Treatment with quetiapine should be reassessed in patients with suspected cardiomyopathy or myocarditis.Acute withdrawal symptoms such as insomnia, nausea, headache, diarrhoea, vomiting, dizziness and irritability have been described after abrupt cessation of quetiapine. (5) Calculation of frequency for these ADRs has been taken from post-marketing data only. In patients receiving a hepatic enzyme inducer, initiation of quetiapine treatment should only occur if the physician considers that the benefits of quetiapine outweigh the risks of removing the hepatic enzyme inducer. An increase in LDL cholesterol of ≥30 mg/dL (≥0.769 mmol/L) has been very commonly observed. Less than 1% of patients had an increase to a prolactin level >100 ug/L. The rates of suicide related events in the active arm vs. placebo were 1.4% vs. 1.3% in the schizophrenia trial, 1.0% vs. 0% in the bipolar mania trial, and 1.1% vs. 0% in the bipolar depression trial.