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BIO-QUETIAPINE is a brand name for Quetiapine, supplied as a tablet (immediate release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). , dehydration, hypovolemia and treatment with antihypertensive medications) (see
). 4% (2/527) on active control drugs. The risk of hypotension and syncope may be reduced by more gradual titration to the target dose (see 4 DOSAGE AND ADMINISTRATION). , dehydration, hypovolemia and treatment with antihypertensive medications) (see 5 OVERDOSAGE).
Bio-QUETIAPINE Product Monograph Page 11 of 66 QT Prolongation:
In clinical trials, quetiapine was not associated with a persistent increase in absolute QT intervals. However, the QT effect was not systematically evaluated in a thorough QT study. In post-marketing experience, there have been cases reported of QT prolongation at therapeutic doses in patients with concomitant illness and in patients taking medicines known to cause electrolyte imbalance or increase QT interval, and with overdose (see 5 OVERDOSAGE).
As with other antipsychotics, caution should be exercised when quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation. , the elderly, patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalemia, or hypomagnesemia (see
3 Pharmacokinetics, Special Populations and Conditions).
Renal Impairment:
As clinical experience is lacking, caution is advised (see 7 WARNINGS AND PRECAUTIONS - Renal). 4 Administration Bio-QUETIAPINE is for oral use only. 3 Pharmacokinetics). 5 Missed Dose If a dose is missed by only a few hours, take it as soon as possible.
If most of the day has passed since the missed dose, skip that dose and wait until next scheduled dose. Never take two doses at once. Bio-QUETIAPINE Product Monograph Page 8 of 66 5.
OVERDOSAGE Experience Clinical Trials:
One death has been reported in a clinical trial following an overdose of 13,600 mg of quetiapine alone, however, survival has also been reported in acute overdoses of up to 30,000 mg of quetiapine. Most patients who overdosed reported no adverse events or recovered fully from the reported events.
Post-Marketing:
In post-marketing experience, there have been cases of coma and death in patients taking a quetiapine fumarate immediate release overdose. The lowest reported dose associated with coma has been in a patient who took 5,000 mg and had a full recovery within 3 days.
The lowest reported dose associated with a death was in a patient who took 6,000 mg. In post-marketing experience, there were cases reported of QT prolongation with overdose. Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose (see 7 WARNINGS AND PRECAUTIONS -Hypotension and Syncope).
, drowsiness and sedation, tachycardia, hypotension and anticholinergic effects). Treatment There is no specific antidote to quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Quetiapine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In this context, published reports in the setting of anticholinergic symptoms describe a reversal of severe central nervous system effects, including coma and delirium, with administration of intravenous physostigmine (1-2 mg), under continuous ECG monitoring.
If physostigmine salicylate is used, atropine sulfate should be available to reverse excessive cholinergic effects such as bradycardia, marked salivation, emesis and bronchospasm. In cases of quetiapine overdose refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of quetiapine- induced alpha blockade).
For management of a suspected drug overdose, contact your regional poison control centre. Bio-QUETIAPINE Product Monograph Page 9 of 66 Close medical supervision and monitoring should be continued until the patient recovers. 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging.
Route of Administration Dosage Form / Strength /Composition Non-medicinal Ingredients Oral Use Immediate-Release Tablet 25 mg, 100 mg, 150 mg, 200 mg and 300 mg Cellulose microcrystalline, di basic calcium phosphate dihydrate, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate type A.
The coating of the tablet contains hypromellose, iron oxide red (25 mg tablets), iron oxide yellow (25 mg, 100 mg and 150 mg tablets), polyethylene glycol 400 (macrogol 400) and titanium dioxide. Bio-QUETIAPINE is available as film-coated tablets containing quetiapine fumarate equivalent to 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine free base as follows: 25 mg Bio-QUETIAPINE Tablets are pink coloured, round, biconvex, debossed ‘25’ on one side and plain on the other side, available in bottles of 100 and 500 tablets.
100 mg Bio-QUETIAPINE Tablets are yellow coloured, round, biconvex, debossed ‘100’ on one side and plain on the other side, available in bottles of 100 and 500 tablets. 150 mg Bio-QUETIAPINE Tablets are pale yellow coloured, round, biconvex, debossed ‘150’ on one side and plain on the other side, available in bottles of 100and 500 tablets.
200 mg Bio-QUETIAPINE Tablets are white to off white, round, biconvex, debossed ‘200’ on one side and plain on the other, available in bottles of 100 and 500 tablets. 300 mg Bio-QUETIAPINE Tablets are white to off white, capsule shaped, biconvex, debossed ‘300’on one side and plain on the other, available in bottles of 100 and 500 tablets.
Bio-QUETIAPINE Product Monograph Page 10 of 66 7.
WARNINGS AND PRECAUTIONS General Body Temperature Regulation:
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents (including quetiapine fumarate). , exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
2 Clinical Trial Adverse Drug Reactions, Pyrexia.
Dependence / Tolerance:
There have been reports of quetiapine misuse, abuse, tolerance, and/or physical dependence. These cases include adult and adolescent patients using quetiapine alone or with other substances of abuse. Caution is needed when prescribing quetiapine to patients with a history of alcohol or drug abuse.
g. development of tolerance, increases in dose, drug-seeking behavior), particularly if they have a history of alcohol or drug abuse.
Acute Withdrawal (discontinuation) Symptoms:
Acute […]