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Home  Seroquel prescribing information 
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Seroquel Prescribing Information
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INDICATIONS
DOSAGE
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
INTERACTIONS
PREGNANCY AND LACTATION
UNDESIRABLE EFFECTS
Seroquel™, tablets, 25 mg, 100 mg, 150 mg, 200 mg and 300 mg.
Abbreviated Core Data Sheet
See local Prescribing Information for full details, as Prescribing Information may vary from country to country.
INDICATIONS:
Treatment of acute and chronic psychoses, including schizophrenia
Treatment of manic episodes associated with bipolar disorder.
DOSAGE:
Seroquel should be administered twice daily.
Acute and chronic psychoses, including schizophrenia: Titrate over 4 days to 300mg/day and thereafter within the usual effective dose range of 300 to 450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the dose range 150 to 750 mg/day.
Manic episodes associated with bipolar disorder: The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response and tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800 mg/day.
The mean last week median dose of Seroquel in responders was approximately 600 mg/day and approximately 85% of the responders were in the dose range of 400 to 800 mg/day.
Elderly: As with other antipsychotics Seroquel should be used with caution. Dosage titration and therapeutic dose depend on clinical response and tolerability of the individual patient.
Hepatic impairment: Seroquel should be used with caution as quetiapine is metabolised by the liver. Patients with hepatic impairment should start with 25 mg/day.
Children and Adolescents: Safety and efficacy not yet evaluated.
CONTRAINDICATIONS:
Hypersensitivity to Seroquel.
WARNINGS AND PRECAUTIONS:
Caution in patients with known cardiovascular disease, cerebrovascular disease or other conditions predisposing to hypotension. Caution is also recommended in patients with a history of seizures. If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Seroquel should be considered. If clinical symptoms of Neuroleptic Malignant Syndrome appear, Seroquel should be discontinued. Elderly and debilitated patients should be given special considerations.
When Seroquel is discontinued, gradual withdrawal is advisable.
INTERACTIONS:
Caution in combination with other centrally acting drugs and alcohol. Co-administration with thioridazine causes increased clearance of quetiapine. Hepatic enzyme inducers, such as phenytoin, carbamazepine, barbiturates and rifampicin may decrease the effect of Seroquel. Higher doses of Seroquel may be needed. Potent CYP3A4 inhibitors, such as azole antifungals and macrolide antibiotics, may increase the effect of Seroquel. Lower doses of Seroquel may be needed.
The pharmacokinetics of lithium was not altered when co-administered with Seroquel.
The pharmacokinetics of sodium valproate and Seroquel were not altered to a clinically relevant extent when co-administered.
PREGNANCY AND LACTATION:
Seroquel should only be used during pregnancy if the benefits justify the potential risks. Breast-feeding should be avoided.
UNDESIRABLE EFFECTS:
Very common: Dizziness, somnolence.
Common: Leukopenia, tachycardia, dry mouth, constipation, dyspepsia, mild asthenia, peripheral edema, weight gain, elevations in serum transaminases, syncope, rhinitis, orthostatic hypotension. Uncommon: Eosinophilia, hypersensitivity, elevations in gamma-GT levels, elevations in non-fasting serum triglyceride levels, elevations in total cholesterol, seizure.
Rare: Neuroleptic malignant syndrome, priapism.
Very rare: Neutropenia.
Small dose-related decreases in thyroid hormone levels have also been seen.
Presentation: Film-coated tablets containing quetiapine fumarate delivering 25 mg, 100 mg, 150 mg, 200 mg or 300 mg.
Further information is available on request from AstraZeneca or local AstraZeneca Marketing Companies.
Seroquel is a trademark of the AstraZeneca group.
© AstraZeneca 2003. Date of preparation: 03 November 2005
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