Maximum dose: 200 mg/day 12 years or older: 100 mg orally every 12 hours for 5 to 10 days There are insufficient data to establish efficacy in the subsequent prophylaxis of rheumatic fever. (10) Triglycerides ≥200mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L) (patients <18 years of age) on at least one occasion.

Shifts in total T25. Neither low dose (400 mg/day) nor high dose regimen (800 mg/day) quetiapine was superior to placebo with respect to the percentage of patients achieving response, defined as ≥30% reduction from baseline in PANSS total score.

The bioavailability of quetiapine is not significantly affected by administration with food.Steady-state peak molar concentrations of the active metabolite norquetiapine are 35% of that observed for quetiapine.The pharmacokinetics of quetiapine and norquetiapine are linear across the approved dosing range.Quetiapine is approximately 83% bound to plasma proteins.Quetiapine is extensively metabolised by the liver, with parent compound accounting for less than 5% of unchanged drug-related material in the urine or faeces, following the administration of radiolabelled quetiapine.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. General Dosage Range. (5) Calculation of frequency for these ADRs has been taken from post-marketing data only. Both in mania and schizophrenia higher doses resulted in numerically lower response rates.In a third short-term placebo-controlled monotherapy trial with quetiapine prolonged release in children and adolescent patients (10-17 years of age) with bipolar depression, efficacy was not demonstrated.No data are available on maintenance of effect or recurrence prevention in this age group.In the short-term pediatric trials with quetiapine described above, the rates of EPS in the active arm vs. placebo were 12.9% vs. 5.3% in the schizophrenia trial, 3.6% vs. 1.1% in the bipolar mania trial, and 1.1% vs. 0% in the bipolar depression trial. A retrospective study of children and adolescents who received valproate, quetiapine, or both, found a higher incidence of leucopenia and neutropenia in the combination group versus the monotherapy groups.Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.Caution should be exercised when quetiapine is used concomitantly with medicinal products known to cause electrolyte imbalance or to increase QT intervalThere have been reports of false positive results in enzyme immunoassays for methadone and tricyclic antidepressants in patients who have taken quetiapine. The use of quetiapine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. Effects related to elevated prolactin levels were seen in rats, although these are not directly relevant to humans (see section 5.3).Given its primary central nervous system effects, quetiapine may interfere with activities requiring mental alertness. The pharmacokinetics of sodium valproate and quetiapine were not altered to a clinically relevant extent when co-administered. The mechanism for this increased risk is not known. (5) Calculation of frequency for these ADRs has been taken from post-marketing data only. Quetiapine should be used with caution in patients with risk factors for stroke.In a meta-analysis of atypical antipsychotics, it has been reported that elderly patient with dementia-related psychosis are at an increased risk of death compared to placebo. The administration of activated charcoal should be considered.In cases of quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents. The data showed an additive effect at week 3. (7) An increase in the rate of dysphagia with quetiapine vs. placebo was only observed in the clinical trials in bipolar depression. Individual patients may benefit from a 600 mg dose. The same ADRs described above for adults should be considered for children and adolescents. Cardiomyopathy and myocarditis have been reported in clinical trials and during the post-marketing experience, however, a causal relationship to quetiapine has not been established. akathisia, extrapyramidal disorder, tremor, dyskinesia, dystonia, restlessness, muscle contractions involuntary, psychomotor hyperactivity and muscle rigidity) did not exceed 4% in any treatment group.In short term, fixed dose (50mg/d to 800 mg/d), placebo-controlled studies (ranging from 3 to 8 weeks), the mean weight gain for quetiapine-treated patients ranged from 0.8 kg for the 50 mg daily dose to 1.4 kg for the 600 mg daily dose (with lower gain for the 800 mg daily dose), compared to 0.2 kg for the placebo treated patients.

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