Emtaq 100/Emtaq 300

Quetiapine fumarate

Schizophrenia. Moderate to severe manic episodes & 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 Administer bid. Total daily dose for 1st 4 days of therapy: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) & 300 mg (day 4). Titrate to usual effective dose of 300-450 mg daily from day 4 onwards. May be adjusted w/in 150-750 mg daily. Moderate to severe manic episodes in bipolar disorder Administer bid. Total daily dose for 1st 4 four days of therapy: 100 mg (day 1), 200 mg (day 2), 300 mg (day 3) & 400 mg (day 4). Further adjustments up to 800 mg daily by day 6 should be in increments of no >200 mg daily. May be adjusted w/in 200-800 mg daily. Usual effective dose is w/in 400-800 mg daily. Major depressive episodes in bipolar disorder Administer once daily at bedtime. Total daily dose for 1st 4 days of therapy: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) & 300 mg (day 4). Recommended daily dose: 300 mg. Preventing recurrence of manic, mixed or depressive episodes in bipolar disorder Patients who have responded to quetiapine for acute treatment of bipolar disorder should continue therapy at same dose. May be adjusted w/in 300-800 mg daily, administered bid. Hepatic impairment Initially 25 mg/day, increased daily w/ increments of 25-50 mg daily until an effective dose.

May be taken with or without food.

Hypersensitivity.

Discontinue use in event of NMS. Increased incidence of extrapyramidal symptoms. Development of akathisia. Somnolence & related symptoms eg, sedation. Potentially increased occurrence of accidental injury (fall) due to orthostatic hypotension & related dizziness. Severe neutropenia & agranulocytosis. Cardiomyopathy & myocarditis. Constipation & intestinal obstruction. VTE. Pancreatitis. Patients w/ history of or at risk for sleep apnoea eg, overweight/obese or male; history of seizures; current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, intestinal obstruction or related conditions, increased IOP or narrow angle glaucoma; CV disease or family history of QT prolongation; at risk for aspiration pneumonia; history of alcohol or drug abuse. Combination w/ divalproex or lithium in acute moderate to severe manic episodes. Concomitant use w/ CNS depressants; medicines known to increase QT interval or w/ concomitant neuroleptics (especially in the elderly, in patients w/ congenital long QT syndrome, CHF, heart hypertrophy, hypokalaemia or hypomagnesaemia). Gradual w/drawal over at least 1-2 wk is advisable. Monitor for any clinical worsening, suicidal behaviour or thoughts & unusual changes in behaviour. Monitor for wt gain & lipid changes & clinically manage as appropriate. Observe for signs & symptoms of hyperglycaemia & regularly monitor for worsening of glucose control in patients w/ DM or w/ risk factors for DM. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Not recommended in childn & adolescents <18 yr of age. Not approved for use in elderly w/ dementia-related psychosis. Elderly, those >65 yr w/ depressive episodes in framework of bipolar disorder & those w/ Parkinson's disease.

Decreased Hb; elevation in serum triglycerides levels & total cholesterol (predominantly LDL-C), decreased HDL-C, wt gain; dizziness, somnolence, headache, extrapyramidal symptoms; dry mouth; w/drawal (discontinuation) symptoms. Leucopenia, decreased neutrophil count, increased eosinophils; hyperprolactinaemia, decreased total & free T₄, total T₃, increased 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.

Combination w/ other centrally-acting medicinal products & alcohol; medications w/ anti-cholinergic effect; medicinal products known to cause electrolyte imbalance or to increase QT interval. Increased AUC w/ ketoconazole. Contraindicated in concomitant administration w/ cytochrome P450 3A4 inhibitors eg, HIV-PIs, azole-antifungal agents, erythromycin, clarithromycin & nefazodone. Not recommended w/ grapefruit juice. Increased clearance w/ carbamazepine, phenytoin; thioridazine. False +ve results in enzyme immunoassays for methadone & TCAs.

Antipsychotics

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

Rx