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JAMP QUETIAPINE FUMARATE 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).
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 JAMP Quetiapine Fumarate Product Monograph Page 11 of 68 hypertrophy, hypokalemia, or hypomagnesemia (see
Musculoskeletal - Rhabdomyolysis 01/2023 7 WARNINGS AND PRECAUTIONS - Psychiatric 01/2023 7 WARNINGS AND PRECAUTIONS - Skin 01/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed RECENT MAJOR LABEL CHANGES ............................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................... 4 1. INDICATIONS ...................................................................................................................
1 Pediatrics ................................................................................................................ 2 Geriatrics .................................................................................................................
4 2. CONTRAINDICATIONS ...................................................................................................... 4 3. SERIOUS WARNINGSAND PRECAUTIONS BOX .................................................................. 5 4.
DOSAGE AND ADMINISTRATION...................................................................................... 1 Dosing Considerations .............................................................................................. 2 Recommended Dose and Dosage Adjustment............................................................
4 Administration ......................................................................................................... 5 Missed Dose ............................................................................................................
7 5. OVERDOSAGE .................................................................................................................. 7 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 8 7. WARNINGS AND PRECAUTIONS .......................................................................................
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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1 Special Populations ................................................................................................. 1 Pregnant Women .................................................................................................
2 Breast-feeding..................................................................................................... 3 Pediatrics .............................................................................................................
4 Geriatrics ........................................................................................................... 21 8. ADVERSE REACTIONS .....................................................................................................
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................... 1 Clinical Trial Adverse Reactions - Pediatrics ...........................................................
3 Less Common Clinical Trial Adverse Reactions......................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...........................................................................................................
5 Post-Market Adverse Reactions ............................................................................. 35 JAMP Quetiapine Fumarate Product Monograph Page 3 of 68 9. DRUG INTERACTIONS.....................................................................................................
2 Drug Interactions Overview .................................................................................... 3 Drug-Behavioural Interactions ................................................................................. 4 Drug-Drug Interactions ...........................................................................................
5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Interactions .................................................................................
39 10. CLINICAL PHARMACOLOGY .......................................................................................... 1 Mechanism of Action ............................................................................................
2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics ................................................................................................. 41 11.
STORAGE, STABILITY AND DISPOSAL ............................................................................ 42 12. SPECIAL HANDLING INSTRUCTIONS .............................................................................. 42 PART II: SCIENTIFIC INFORMATION ......................................................................................
43 13. PHARMACEUTICAL INFORMATION ............................................................................... 43 14. CLINICALTRIALS............................................................................................................
1 Clinical Trials by Indication ..................................................................................... 3 Comparative Bioavailability Studies ......................................................................... 45 15.
MICROBOLOGY ............................................................................................................ 46 16. NON-CLINICAL TOXICOLOGY […]