Seroquel XR

Seroquel XR

quetiapine

Manufacturer:

AstraZeneca
Concise Prescribing Info
Contents
Quetiapine fumarate
Indications/Uses
Acute & maintenance treatment of schizophrenia. Bipolar disorder including manic episodes associated w/ bipolar I disorder & depressive episodes associated w/ bipolar disorder. Add-on treatment of major depressive episodes in patients w/ major depressive disorder (MDD) who have had inadequate response after 6 wk treatment of antidepressant monotherapy.
Dosage/Direction for Use
Adult Schizophrenia & manic episodes associated w/ bipolar disorder Daily dose: 300 mg (day 1), 600 mg (day 2) & up to 800 mg (after day 2). Adjust dose w/in the effective dose range of 400-800 mg daily. Depressive episodes associated w/ bipolar disorder Total daily dose for first 4 days: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) & 300 mg (day 4). Recommended daily dose: 300 mg. Doses are to be taken once daily at bedtime. Add-on treatment of major depressive episodes in MDD Daily dose: Initially, 50 mg on days 1 & 2, & 150 mg on days 3 & 4. Increase the dose from 150-300 mg daily based on individual patient evaluation. Administer prior to bedtime. Switching from Seroquel immediate-release (IR) tab Treatment w/ divided doses of Seroquel IR may be switched to Seroquel XR at an equiv total daily dose taken once daily. Individual dosage adjustment may be necessary. Elderly Initially Seroquel IR 25 mg daily then increase dose in 25-50 mg daily increments. May be switched to Seroquel XR at an equiv total daily dose when effective dose is reached. Dosing should begin w/ 50 mg daily (day 1-3) increasing to 100 mg daily (day 4) & 150 mg daily (day 8). Hepatic impairment Initially 50 mg daily. May be increased in increments of 50 mg daily to an effective dose.
Administration
May be taken with or without food: Swallow whole, do not split/chew/crush.
Contraindications
Hypersensitivity. Concomitant administration w/ CYP450 3A4 inhibitors eg, HIV-PIs, azole antifungals, erythromycin, clarithromycin & nefazodone.
Special Precautions
Increased risk of suicidal thoughts, self-harm & suicide-related events. Increased incidence of extrapyramidal symptoms. Tardive dyskinesia. Somnolence & dizziness, orthostatic hypotension. Sleep apnea syndrome, overwt/obese, male patients. Venous thromboembolism. Constipation & intestinal obstruction. Pancreatitis. Patients concomitantly taking anticholinergic medications; carbamazepine or phenytoin; medicines that increase QT interval; CNS depressants. CV & cerebrovascular disease or other conditions predisposing to hypotension. Patients w/ suspected cardiomyopathy or myocarditis. History of seizures; urinary retention, prostatic hypertrophy, intestinal obstruction or related conditions, increased IOP or narrow angle glaucoma; QT prolongation; alcohol or drug abuse. NMS. Severe neutropenia (<0.5 x 109/L), agranulocytosis. Patients at risk for aspiration pneumonia. Monitor wt; blood glucose & lipid levels. Avoid abrupt cessation. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Patients should be advised not to drive or operate machinery. Pregnancy & lactation. Young adult <25 yr w/ major depressive episodes in bipolar disorder. Newborn. Elderly patients w/ dementia-related psychosis.
Adverse Reactions
Decreased Hb; elevated serum triglyceride, LDL & total cholesterol, decreased HDL, wt gain; dizziness, somnolence, headache, extrapyramidal symptoms; dry mouth; withdrawal symptoms. Leucopenia, decreased neutrophil, increased eosinophil; hyperprolactinaemia, decreased total T4, free T4 & total T3, increased TSH; increased appetite, blood glucose to hyperglycaemic levels; abnormal dreams & nightmares, suicidal ideation & behaviour; dysarthria; tachycardia, palpitations; blurred vision; orthostatic hypotension; dyspnoea; constipation, dyspepsia, vomiting; elevated ALT & γ-GT levels; mild asthenia, peripheral oedema, irritability, pyrexia.
Drug Interactions
Caution in combination w/ other centrally-acting drugs, anticholinergic medications & alcohol. Increased AUC w/ CYP3A4 inhibitors (eg, ketoconazole). Increased clearance w/ carbamazepine, thioridazine & phenytoin. Drugs causing electrolyte imbalance or increase QT interval. Grapefruit juice. False +ve results in enzyme immunoassays for methadone & TCAs.
MIMS Class
Antipsychotics
ATC Classification
N05AH04 - quetiapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Presentation/Packing
Form
Seroquel XR tab 150 mg
Packing/Price
10's (Rp542,319/pak)
Form
Seroquel XR tab 200 mg
Packing/Price
10's (Rp577,990/pak)
Form
Seroquel XR tab 300 mg
Packing/Price
10's (Rp623,510/pak)
Form
Seroquel XR tab 400 mg
Packing/Price
10's (Rp770,656/pak)
Form
Seroquel XR tab 50 mg
Packing/Price
10's (Rp506,649/pak)
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