Seroquel IR/Seroquel XR

Quetiapine fumarate

Seroquel IR Treatment of schizophrenia; moderate to severe manic episodes in bipolar disorder; major depressive episodes in bipolar disorder. Prevention of recurrence of manic or depressed episodes in patients w/ bipolar disorder who previously responded to quetiapine treatment. Seroquel XR Maintenance treatment of bipolar I disorder, as monotherapy or in combination w/ lithium or Na valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. Treatment of depressive episodes associated w/ bipolar disorder. Treatment of acute mania associated w/ bipolar I disorder as monotherapy or in combination w/ lithium or Na valproate. Treatment of schizophrenia, prevention of relapse & maintenance of clinical improvement during continuation therapy. Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies. Treatment of generalised anxiety disorder (GAD).

Seroquel IR Adult Treatment of schizophrenia Administered bd. Total daily dose for 1st 4 days: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3), 300 mg (day 4). From day 4 onwards, titrate up to 300-450 mg/day. Depending on clinical response & tolerability, adjust dose w/in the range 150-750 mg/day. Treatment of moderate to severe manic episodes in bipolar disorder Administered bd. Total daily dose for 1st 4 days: 100 mg (day 1), 200 mg (day 2), 300 mg (day 3), 400 mg (day 4). Further dose adjustments up to 800 mg/day by day 6 should be in increments of no greater than 200 mg/day. Depending on clinical response & tolerability, adjust dose w/in the range 200-800 mg/day. Treatment of major depressive episodes in bipolar disorder Administered once daily at bedtime. Total daily dose for 1st 4 days: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3), 300 mg (day 4). Recommended daily dose: 300 mg. Prevention of recurrence in bipolar disorder Patients who have responded to quetiapine for acute treatment of bipolar disorder should continue therapy at the same dose. Depending on clinical response & tolerability, adjust dose w/in the range 300-800 mg/day, administered bd. Patient w/ hepatic impairment Initially 25 mg/day, increase dose daily w/ increments 25-50 mg/day until effective dose, depending on clinical response & tolerability. Seroquel XR Adult Maintenance treatment of bipolar disorder Patients who have responded to Seroquel XR for acute treatment of bipolar disorder should continue therapy at the same dose. Usual effective dose range for prevention of relapse/recurrence of manic, depressive & mixed episodes in bipolar disorder: 300-800 mg/day. Bipolar depression Dose titration: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) & 300 mg (day 4). May increase to 400 mg (day 5) up to 600 mg by day 8. Acute mania associated w/ bipolar disorder Dose titration: 300 mg (day 1), 600 mg (day 2) & up to 800 mg (after day 2), alone or in combination w/ a mood stabiliser. Depending on clinical response & tolerability, adjust dose w/in the range 400-800 mg/day. Schizophrenia Starting daily dose: 300 mg (day 1), 600 mg (day 2) & up to 800 mg (after day 2). Depending on clinical response & tolerability, adjust dose w/in the range 400-800 mg/day. Maintenance: Same dosage. Recurrent major depressive disorder Once daily in the evening. Starting dose: 50 mg (days 1 & 2), 150 mg (days 3 & 4). Depending on clinical response & tolerability, adjust dose w/in the range 50-300 mg. Maintenance: Continue effective dose during initial treatment. Generalised anxiety disorder Starting dose: 50 mg (days 1 & 2), 150 mg (days 3 & 4). Depending on clinical response & tolerability, adjust dose w/in the range 50-150 mg. Maintenance: Continue effective dose during initial treatment. Elderly Initially 50 mg/day, can be increased in increments of 50 mg/day until effective dose, depending on clinical response & tolerability. MDD Starting dose: 50 mg (days 1-3), can be increased to 100 mg (day 4), 150 mg (day 8) & up to 300 mg depending on clinical response & tolerability. GAD Starting dose: 50 mg (days 1-3), can be increased to 100 mg (day 4), 150 mg on day 8. Depending on clinical response & tolerability, adjust dose w/in the range 50-150 mg. Patient w/ hepatic impairment Initially 50 mg/day, can be increased in increments of 50 mg/day to an effective dose, depending on clinical response & tolerability.

IR FC tab: May be taken with or without food. XR Tab: Should be taken on an empty stomach: Take at least 1 hr before meals. Swallow whole, do not chew/crush.

Hypersensitivity. Seroquel IR Concomitant use w/ CYP3A4 inhibitors eg, HIV PIs, azole antifungals, erythromycin, clarithromycin, nefazodone.

Patients w/ history of suicide-related events or those exhibiting significant degree of suicidal ideation should receive careful monitoring during treatment. Risk of worsening metabolic profile (eg, changes in wt, blood glucose & lipids); extrapyramidal symptoms; tardive dyskinesia; orthostatic hypotension & related dizziness; neuroleptic malignant syndrome; severe neutropenia & agranulocytosis; anticholinergic effects; hyperglycaemia &/or exacerbation of diabetes; increases in triglycerides, LDL & total cholesterol, & decreases in HDL cholesterol; dysphagia; constipation & intestinal obstruction; venous thromboembolism; pancreatitis. Caution in patients w/ known CV disease, cerebrovascular disease or other conditions predisposing to hypotension; history of seizures; risk factors for QT prolongation. Treatment w/ quetiapine should be reassessed in patients w/ suspected cardiomyopathy or myocarditis. Acute w/drawal symptoms w/ abrupt cessation of treatment; gradual w/drawal over a period of at least 1-2 wk is advisable. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. May interfere w/ activities requiring mental alertness (eg, driving, using of machines). Pregnancy & lactation. Seroquel IR Risk of somnolence & related symptoms eg, sedation; sleep apnoea syndrome; wt gain. Not approved for the treatment of dementia-related psychosis in elderly. Reports of cases of misuse, abuse. False positive results in enzyme immunoassays for methadone & TCAs. Concomitant use w/ strong hepatic enzyme inducer eg, carbamazepine or phenytoin. Not recommended for use in childn & adolescent <18 yr. Seroquel XR Discontinue treatment if severe cutaneous adverse reactions occur. Increased risk of mortality in elderly patients w/ dementia-related psychosis. Caution in patients w/ sleep apnoea. Body temp regulation. Reports of cases of misuse, abuse, tolerance &/or physical dependence. Effects on laboratory tests (eg, transient leukopenia &/or neutropenia, asymptomatic elevations in serum transaminase or γ-GT levels; decreases in thyroid hormone levels). Perform standard clinical assessment, including transaminase levels measurement, prior to treatment initiation in patients who have known or suspected abnormal hepatic function. Perform periodic clinical reassessment w/ transaminase levels for such patients, as well as for patients who develop any signs & symptoms suggestive of a new onset liver disorder during quetiapine therapy. Safety & efficacy have not been established in patients <18 yr.

Seroquel IR Somnolence, dizziness, headache, dry mouth, w/drawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, wt gain, decreased Hb, extrapyramidal symptoms. Seroquel XR Sedation, dry mouth, somnolence, dizziness, headache, constipation, nausea. Extrapyramidal symptoms. Schizophrenia: Insomnia, orthostatic hypotension. Bipolar disorder: Increased appetite, wt increased, dyspepsia, fatigue. MDD: Fatigue, vomiting, diarrhoea, increased appetite, wt increased, insomnia, vision blurred, irritability, myalgia, nasopharyngitis. GAD: Fatigue, insomnia, diarrhoea, wt increased, increased appetite, dyspepsia, vomiting, nasopharyngitis.

Caution in combination w/ other centrally-acting medicinal products & alcohol; other medications w/ anticholinergic effects; medicinal products known to cause electrolyte imbalance or to increase QT interval. Increased plasma conc w/ potent CYP3A4 inhibitors (eg, azole antifungals, macrolide antibiotics, PIs). Not recommended to consume grapefruit juice while on quetiapine therapy. Increased clearance w/ carbamazepine & phenytoin (hepatic enzyme inducers). Seroquel XR Increased oral clearance w/ thioridazine. May antagonise the effects of levodopa & dopamine agonists. Not recommended w/ ADHD medication.

Antipsychotics

N05AH04 - quetiapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.

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