** Seroquel® (Quetiapine) 100 mg 30 Tablets. (atypical antipsychotic).
Each Tablet contains:
Quetiapine 100 mg
– Treatment of schizophrenia
– Treatment of manic episodes associated with bipolar disorder
** Posology && Method of Administration:
Seroquel should be administered twice daily, with or without food.
– For the treatment of schizophrenia: the total daily dose for the first 4 days of therapy is 50mg (Day1), 100mg (Day2), 200mg (Day3) && 300mg (Day4). From Day4 onwards, the dose should be titrated to the usual effective dose range of 300 to 450mg/day. Depending on the clinical response && tolerability to the individual patient, the dose may be adjusted within the range 150 to 750mg/day.
– For the treatment of manic episodes associated with bipolar disorder: as monotherapy or as adjunct therapy to mood stabilizers, the total daily dose for the first 4 days of therapy is 100mg (Day1), 200mg (Day2), 300mg (Day3) && 400mg (Day4). Further adjustments up to 800mg per day by Day6 should be in increments of no greater than 200mg per day. The dose may be adjusted depending on clinical response && tolerability to the individual patient, within the range of 200 to 800mg per day. The usual effective dose is in the range of 400 to 800mg per day.
# Elderly: As with other antipsychotics, Seroquel should be used with caution in the elderly, especially during the initial dosing period. Elderly patients should be started on Seroquel 25mg/day. The dose should be increased daily, in increments of 25 to 50mg, to an effective dose, which is likely to be lower than that in younger patients.
# Children && adolescents: the safety && efficacy of Seroquel have not been evaluated in children && adolescents.
** Special Warnings and Precautions for use:
– Cardiovascular disease: Seroquel should be used with caution in patients with known cardiovascular disease, cerebro-vascular disease, or other conditions predisposing to hypotension. Seroquel may induce orthostatic hypotension, especially during the initial dose-titration period; this is more common in elderly patients than in younger patients. In clinical trials, quetiapine was not associated with a persistent increase in QT-c intervals. However, as with other antipsychotics, caution should be exercised when quetiapine is prescribed with drugs known to prolong the QT-c interval, especially in the elderly.
– Seizures: In controlled clinical trials there was no difference in the incidence of seizures in patients treated with Seroquel or placebo. As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
– Tardive dyskinesia: As with other antipsychotics, there is a potential for Seroquel to cause tardive dyskinesia after long-term treatment. If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Seroquel should be considered.
– Neurolpetic malignant syndrome: Neurolpetic malignant syndrome has been associated with antipsychotic treatment, including Seroquel. Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatinine phosphokinase. In such an event, Seroquel should be discontinued and appropriate medical treatment given.
– Acute withdrawal reaction: Acute withdrawal symptoms including nausea, vomiting and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable.
** Pregnancy and lactation:
The safety and efficacy of Seroquel during human pregnancy have not been established. Therefore, Seroquel should only be used during pregnancy if the benefits justify the potential risks.
The degree to which quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Seroquel.
** Effect on ability to drive and use machines:
Because Seroquel may cause somnolence, patients should be cautioned about operating hazardous machines, including motor vehicles.
** Read the enclosed Instruction leaflet carefully.
To be taken as directed by the physician.
** Do not store above 30 degrees C.
Keep all medicines away from children.
** Manufactured by: AstraZeneca-Egypt
Under License of: AstraZeneca UK
Seroquel® is a Trade Mark of AstraZeneca group of companies