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*Demonstrated efﬁcacy in psychotic, mood and depressive disorders.1
PBS Information: Authority required (STREAMLINED). Maintenance treatment of bipolar I disorder. Monotherapy,
for up to 6 months, of an episode of acute mania associated with bipolar I disorder. Treatment of schizophrenia. This
product is not listed on the PBS for bipolar depression, major depressive disorder or generalised anxiety disorder.
MINIMUM PRODUCT INFORMATION SEROQUEL XR® (quetiapine fumarate). INDICATIONS: Bipolar
disorder: Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium
valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes • Treatment of
depressive episodes associatedwithbipolardisorder •Treatmentofacute mania associatedwithbipolarIdisorder
as monotherapy or in combination with lithium or sodium valproate. Schizophrenia: Treatment of schizophrenia,
prevention of relapse and maintenance of clinical improvement during continuation therapy. Major depressive
disorder (MDD): Treatment of recurrent major depressive disorder in patients who are intolerant of, or who have
an inadequate response to alternative therapies. Generalised anxiety disorder (GAD): Treatment of generalised
anxiety disorder. DOSAGE: Once daily, without food. Tablets should be swallowed whole and not split, chewed
or crushed. Maintenance treatment of bipolar I disorder: SEROQUEL XR responders for acute treatment should
continue therapy at the same dose. Usual effective dose 300 to 800 mg/day. Bipolar depression: Treatment
should be initiated either by psychiatrist or by general practitioner after consulting the psychiatrist. 50 mg (Day
1), 100 mg (Day 2), 200 mg (Day 3), and 300 mg (Day 4). May be titrated to 400 mg (Day 5) and up to 600 mg
(Day 8). Acute mania: 300 mg (Day 1), 600 mg (Day 2), up to 800 mg after Day 2, alone or in combination with
a mood stabiliser. Usual effective dose 400-800 mg/day. Schizophrenia: 300 mg (Day 1), 600 mg (Day 2), up
to 800 mg after Day 2. Usual effective dose 400-800 mg/day. MDD: 50 mg (Day 1 & 2), 150 mg (Day 3 & 4),
up to 300 mg/day. Treatment should be administered in the evening and be initiated either by psychiatrist or by
general practitioner after consulting the psychiatrist. GAD: 50 mg (Day 1 & 2), 150 mg (Day 3 & 4), adjusted
within 50-150mg/day. Switching from SEROQUEL immediate release: Divided doses of SEROQUEL immediate
release may be switched to SEROQUEL XR at equivalent total daily dose taken once daily. Elderly: Caution,
slower titration recommended. CONTRAINDICATIONS: Hypersensitivity
to any component of SEROQUEL XR. PRECAUTIONS: Concomitant
cardiovascular illness; orthostatic hypotension; QT prolongation risk; history
of seizures or low seizure thresholds; high suicide risk patients; EPS; tardive dyskinesia; NMS; elevated core
body temperature; neutropenia; withdrawal; hyperglycaemia and diabetes mellitus; *lipid increases, monitoring
recommended; *worsening of > one metabolic factor observed in clinical trials, monitoring recommended;
elderly patients with dementia-related psychosis; aspiration pneumonia; lactose intolerance. *Pregnancy
(Category C) Non-teratogenic class effect: Neonates exposed to antipsychotics during the 3rd trimester at
risk of extrapyramidal neurological disturbances and/or withdrawal symptoms. Use in lactation. Use in children
and adolescents. Interacts with: thioridazine; lorazepam; levodopa & dopamine agonists; CYP3A4 inhibitors
e.g. ketoconazole, grapefruit juice; hepatic enzyme inducers; cardiovascular medicines; ADHD medicines.
ADVERSE REACTIONS: Common adverse events in controlled clinical trials -- Adults: sedation & somnolence;
dry mouth; insomnia; dizziness; orthostatic hypotension; syncope; constipation; dyspepsia; nausea; *vomiting;
abdominal pain; diarrhoea; increased appetite; tachycardia; headache; *pyrexia; back pain; vision blurred;
irritability; myalgia; nasopharyngitis; rhinitis; dyspnoea; fatigue; weight gain; withdrawal symptoms; leukopenia/
neutropenia; increases in: lipids *(decreases in fasting HDL levels observed), blood glucose, liver enzymes &
serum prolactin levels; decreases in haemoglobin levels; *decreases in total T4, free T4 & total T3, increases in
TSH; EPS; dysarthria; mild asthenia; peripheral oedema; abnormal dreams & nightmares. Children & adolescents:
increased appetite; increases in serum prolactin, blood pressure; EPS; weight gain. For all other adverse
events, see full PI. Date of TGA approval: 20 September 2010. Date of most recent amendment: 30 March 2011. .
REFERENCE: 1. Seroquel XR Approved Product Information. ® Seroquel XR is a registered
trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd.
ABN 54 009 682 311. 5 Alma Road, North Ryde, NSW 2113. AstraZeneca Medical Information:
1800 805 342. www.astrazeneca.com.au. AU-SXR000331. TCA AZ/SXR232-O AP.
*Please note changes in Product Information.
BEFORE PRESCRIBING PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA.
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