Qtipine 25/Qtipine 300

Qtipine 25/Qtipine 300

quetiapine

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Quetiapine fumarate
Indications/Uses
Schizophrenia, manic & depressive episodes associated w/ bipolar disorder. Prevent recurrence in bipolar disorder.
Dosage/Direction for Use
Adult Schizophrenia Initially 25 mg bid (day 1), 50 mg bid (day 2), 100 mg bid (day 3) & 150 mg bid (day 4). Adjust dose to 300-450 mg daily in 2 or 3 divided doses. Max: 750 mg daily. Manic episodes associated w/ bipolar disorder Initially 50 mg bid (day 1), 100 mg bid (day 2), 150 mg bid (day 3) & 200 mg bid (day 4). Adjust dose 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). 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 w/in 300-800 mg/day. Lowest effective dose used for maintenance therapy. Childn & adolescent 13-17 yr Schizophrenia associated w/ bipolar disorder Administer bid, may be administered tid base on response. 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). Adjust dose w/in 400-800 mg/day based on response. Increments should not be >100 mg daily. Childn & adolescent 10-17 yr Manic episodes associated w/ bipolar disorder Administer bid, may be administered tid base on response. 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). Adjust dose w/in 400-800 mg/day base on response. Increments should not be >100 mg daily. Patient w/ hepatic impairment Initially 25 mg/day. Can be increased in increments of 50 mg/day to an effective dose depending on response.
Administration
May be taken with or without food: Swallow whole, do not split/chew/crush.
Contraindications
Hypersensitivity. Co-administration w/ cytochrome P450 3A4 inhibitors eg, HIV-PIs, azole antifungals, erythromycin, clarithromycin & nefazodone.
Special Precautions
Increased risk of suicidal thoughts, self-harm & suicide. Risk of worsening metabolic profile. Reports of severe neutropenia; pancreatitis; orthostatic hypotension & related dizziness; NMS; development of akathisia. Consider dose reduction or discontinuation if signs & symptoms of tardrive dyskinesia appear. Caution in patients w/ risk for aspiration pneumonia; history of seizures. Avoid abrupt cessation of therapy. False +ve results in enzyme immunoassays for methadone & TCAs in patients who have taken quetiapine. Somnolence; may affect ability to drive or use machines. Caution in patients w/ known hepatic impairment. Safety & efficacy during pregnancy have not been established. Discontinue nursing or discontinue therapy; considering importance of the drug to the mother. Caution in the elderly especially during initial dosing period. Not approved in dementia-related psychosis in the elderly. Not recommended for use in childn & adolescent <18 yr. Safety & effectiveness in childn <13 yr w/ bipolar mania have not been established.
Adverse Reactions
Decreased Hb; elevations in serum triglyceride levels & in total cholesterol, decreases in HDL-C, wt gain; dizziness, somnolence, headache, extrapyramidal symptoms; dry mouth, withdrawal symptoms. Leucopenia, decreased neutrophil count, increased eosinophils; hyperprolactinaemia, decrease in total T4, free T4 & total T3, increase 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.
Drug Interactions
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. Increased AUC w/ ketoconazole (CYP3A4 inhibitor). Increased clearance w/ thioridazine. Exercise caution when used concomitantly w/ medicinal products known to cause electrolyte imbalance or increase QT interval.
MIMS Class
Antipsychotics
ATC Classification
N05AH04 - quetiapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Presentation/Packing
Form
Qtipine 25 film-coated tab 25 mg
Packing/Price
100's (P2,946.43/box)
Form
Qtipine 300 film-coated tab 300 mg
Packing/Price
100's (P11,812.5/box)