Qutero

Qutero

quetiapine

Manufacturer:

Hetero Labs

Distributor:

Unimed
Concise Prescribing Info
Contents
Quetiapine fumarate
Indications/Uses
Schizophrenia. Depressive & acute manic episodes associated w/ bipolar I disorder as either monotherapy or adjunct to lithium or divalproex. Maintenance treatment of bipolar I disorder as adjunct therapy to lithium or divalproex. Prevention of recurrence in patients w/ bipolar disorder & whose manic or depressive episode has responded to quetiapine treatment.
Dosage/Direction for Use
Schizophrenia Adult Initially 25 mg bd, increased in increments of 25-50 mg bd or tds on day 2 & 3 to reach target dose range: 300-400 mg bd or tds by day 4. Further dose increments or decrements of 25-50 mg bd at intervals not <2 days if necessary. Adolescent 13-17 yr Total daily dose for 1st 5 days of therapy: 50 mg bd-tds (day 1), 100 mg bd-tds (day 2), 200 mg bd-tds (day 3), 300 mg bd-tds (day 4) & 400 mg bd-tds (day 5), may be adjusted w/in 400-800 mg daily after day 5 in increments not >100 mg daily. Acute manic episodes associated w/ bipolar I disorder Adult Total daily dose for 1st 4 days of therapy: 100 mg bd (day 1), 200 mg bd (day 2), 300 mg bd (day 3) & 400 mg bd (day 4), may be increased up to 800 mg daily by day 6 in increments not >200 mg daily. Childn & adolescent 10-17 yr Total daily dose for 1st 5 days of therapy: 50 mg bd-tds (day 1), 100 mg bd-tds (day 2), 200 mg bd-tds (day 3), 300 mg bd-tds (day 4) & 400 mg bd-tds (day 5), may be adjusted w/in 400-600 mg daily after day 5 in increments not >100 mg daily. Depressive episodes associated w/ bipolar disorder 50 mg once daily at bedtime (day 1), 100 mg once daily at bedtime (day 2), 200 mg once daily at bedtime (day 3) & 300 mg once daily at bedtime (day 4), may be titrated to 400 mg on day 5 & up to 600 mg by day 8. Maintenance treatment of bipolar I disorder 400-800 mg bd. Prevention of recurrence in bipolar disorder Dose adjustment should be w/in 300-800 mg bd. Hepatic impairment Initially 25 mg daily, may be increased in increments of 25-50 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ CYP450 3A4 inhibitors eg, HIV PIs, azole antifungals, erythromycin, clarithromycin, nefazodone.
Special Precautions
Discontinue use if tardive dyskinesia or neuroleptic malignant syndrome occur. Increased risk of suicidal thoughts & suicide-related events. Increased incidence of extrapyramidal symptoms (EPS). Hyperglycaemia & DM; somnolence; CV or cerebrovascular disease or other conditions predisposing to hypotension; history of seizures & QT prolongation; preexisting low WBC count & history of drug-induced neutropenia; congenital long QT syndrome, CHF, heart hypertrophy, hypokalaemia or hypomagnesaemia; risk factors of stroke; acute moderate to severe manic episodes. Monitor blood glucose & lipids levels & manage wt changes. Avoid abrupt w/drawal. Concomitant use w/ drugs increasing QTc interval, neuroleptics. May affect ability to drive & use machines. Hepatic impairment. Pregnancy. Avoid use during lactation. Ped <13 yr w/ schizophrenia, <10 yr w/ bipolar mania, <18 yr w/ bipolar depression & in maintenance treatment for bipolar disorder. Not to be used in elderly w/ dementia-related psychosis.
Adverse Reactions
Dizziness, somnolence, headache, EPS; dry mouth; w/drawal symptoms; elevated serum triglyceride levels & total cholesterol, decreased HDL cholesterol & Hb, wt gain. Leucopenia; hyperprolactinaemia; increased appetite; abnormal dreams & nightmares; dysarthria; tachycardia, palpitations; blurred vision; orthostatic hypotension; dyspnoea; constipation, dyspepsia, vomiting; mild asthenia, peripheral oedema, irritability, pyrexia; elevated serum ALT & prolactin, γ-GT, decreased neutrophil count, free T4, total T3 & T4, increased eosinophils, blood glucose & TSH, QT prolongation. Childn 10-17 yr: Increased BP. Syncope; rhinitis.
Drug Interactions
Decreased plasma conc w/ strong hepatic enzyme inducer eg, carbamazepine or phenytoin. Increased AUC w/ ketoconazole. Increased clearance w/ thioridazine. Other centrally-acting drugs, alcohol, drugs causing electrolyte imbalance or increased QTc interval. Not recommended w/ grapefruit juice.
MIMS Class
Antipsychotics
ATC Classification
N05AH04 - quetiapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Presentation/Packing
Form
Qutero FC tab 100 mg
Packing/Price
10 × 10's
Form
Qutero FC tab 200 mg
Packing/Price
10 × 10's
Form
Qutero FC tab 300 mg
Packing/Price
10 × 10's
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