Qtipine 25/Qtipine 100/Qtipine 300

Treatment of schizophrenia; moderate to severe manic episodes or 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.

Adult Schizophrenia Initially 25 mg bid (day 1), 50 mg bid (day 2), 100 mg bid (day 3) & 150 mg bid (day 4). Total daily dose for 1st 4 days: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) & 300 mg (day 4). Dose may then be adjusted to 300-450 mg daily in 2 or 3 divided doses. Max: 750 mg daily. Moderate to severe manic episodes in bipolar disorder Initially 50 mg bid (day 1), 100 mg bid (day 2), 150 mg bid (day 3) & 200 mg bid (day 4). Total daily dose for 1st 4 days: 100 mg (day 1), 200 mg (day 2), 300 mg (day 3) & 400 mg (day 4). Dose may then be adjusted to 400-800 mg daily. Dose increment should not be >200 mg daily. Major depressive episodes in bipolar disorder Administer 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). Dose may then be adjusted to 400 mg on day 5 up to 600 mg by day 8. Preventing recurrence of manic, mixed or depressive episodes in bipolar disorder Patient who has responded for acute treatment of bipolar disorder should continue therapy at same dose administered at bedtime. Adjust dose depending on response & tolerability w/in 300-800 mg daily administered bid. Use lowest effective dose for maintenance therapy. Patient w/ hepatic impairment Initially 25 mg daily. Can be increased in increments of 25-50 mg daily to an effective dose depending on response & tolerability. Qtipine 25/Qtipine 300 Childn & adolescent 13-17 yr Schizophrenia associated w/ bipolar disorder Administer bid; may be administered tid based on response & tolerability. Total daily dose for 1st 5 days: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3), 300 mg (day 4) & 400 mg (day 5). Dose should be adjusted w/in 400-800 mg daily based on response & tolerability. Dose increment should not be >100 mg daily. Childn & adolescent 10-17 yr Manic episodes associated w/ bipolar disorder Administer bid; may be administered tid based on response & tolerability. Total daily dose for 1st 5 days: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3), 300 mg (day 4) & 400 mg (day 5). Dose should be adjusted w/in 400-800 mg daily based on response & tolerability. Dose increment should not be >100 mg daily.

May be taken with or without food: Swallow whole, do not split/chew/crush.

Hypersensitivity. Co-administration w/ CYP3A4 inhibitors eg, HIV-PIs, azole antifungals, erythromycin, clarithromycin & nefazodone.

Carefully monitor patients w/ a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement, during treatment. Monitor for any clinical worsening, suicidal behavior or thoughts & unusual changes in behavior. Assess metabolic parameters (eg, wt, blood glucose & lipids) at time of treatment initiation & regularly control changes in these parameters during course of treatment. Use has been associated w/ development of akathisia; somnolence & related symptoms eg, sedation; orthostatic hypotension & related dizziness; NMS. Consider dose reduction or discontinuation if signs & symptoms of tardive dyskinesia appear. Caution in patients w/ known CV disease, cerebrovascular disease, or other conditions predisposing to hypotension; history of seizures; CV disease or family history of QT prolongation, or when quetiapine is prescribed either w/ medicines known to increase QT interval, or w/ concomitant neuroleptics, especially in the elderly; congenital long QT syndrome, CHF, heart hypertrophy, hypokalaemia or hypomagnesaemia; at risk for aspiration pneumonia. Discontinue use in the event of NMS; neutrophil count <1 x 10⁹/L. Reports of cardiomyopathy & myocarditis; constipation & intestinal obstruction; pancreatitis. Gradual w/drawal over a period of at least 1-2 wk is advisable. False +ve results in enzyme immunoassays for methadone & TCAs in patients who have taken quetiapine. Do not drive or operate machinery until individual susceptibility is known. Caution in patients w/ known hepatic impairment. Use during pregnancy only if potential benefit justifies potential risk. Discontinue nursing or discontinue drug taking into account the importance of drug to the mother's health. Safety & effectiveness in childn <13 yr w/ bipolar mania have not been established. Not recommended in childn & adolescents <18 yr. Caution in the elderly especially during initial dosing period. Increased occurrence of accidental injury (fall), especially in the elderly. Not approved for the treatment of elderly w/ dementia-related psychosis. Qtipine 100 Reports of sleep apnoea syndrome; VTE; misuse & abuse. Caution in patients receiving concomitant CNS depressants & who have a history of or are at risk for sleep apnoea eg, those who are overweight/obese or are male; patients w/ current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, intestinal obstruction or related conditions, increased IOP or narrow angle glaucoma; history of alcohol or drug abuse. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Caution in elderly w/ Parkinson's disease.

Decreased Hb; elevations in serum triglyceride levels & total cholesterol (predominantly LDL-C), decreases in HDL-C, wt gain; dizziness, somnolence, headache, extrapyramidal symptoms; dry mouth, w/drawal (discontinuation) symptoms. Leucopenia, decreased neutrophil count, increased eosinophils; hyperprolactinaemia, decreases in total T₄, free T₄ & total T₃, increases in TSH; increased appetite, increased blood glucose to hyperglycaemic levels; abnormal dreams & nightmares, suicidal ideation & behaviour; dysarthria; tachycardia, palpitations; blurred vision; orthostatic hypotension; dyspnoea; constipation, dyspepsia, vomiting; elevations in serum ALT & γ-GT levels; mild asthenia, peripheral oedema, irritability, pyrexia.

Decreased plasma conc which could affect quetiapine efficacy w/ strong hepatic enzyme inducer eg, carbamazepine or phenytoin. Caution in combination w/ other centrally acting medicinal products & alcohol; medicinal products known to cause electrolyte imbalance or increase QT interval. Increased AUC w/ ketoconazole (CYP3A4 inhibitor). Increased clearance w/ thioridazine. Qtipine 100 Caution in treating patients receiving medications having anti-cholinergic (muscarinic) effects.

Antipsychotics

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

Rx