IPG-QUETIAPINE

). , 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 hypertrophy, hypokalemia, or hypomagnesemia (see

Musculoskeletal- Rhabdomyolysis 09/2022 7 WARNINGS AND PRECAUTIONS – Psychiatric 09/2022 7 WARNINGS AND PRECAUTIONS - Skin 10/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed RECENT MAJOR LABEL CHANGES ..........................................................................................................

2 TABLE OF CONTENTS ............................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................................

4 1. INDICATIONS ........................................................................................................................... 4 2. CONTRAINDICATIONS ...............................................................................................................

4 3. SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................................ 5 4. DOSAGE AND ADMINISTRATION ...............................................................................................

7 5 OVERDOSAGE ........................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................................

8 7 WARNINGS AND PRECAUTIONS ................................................................................................ 19 8 ADVERSE REACTIONS ............................................................................................................

32 9 DRUG INTERACTIONS ............................................................................................................. 35 10 CLINICAL PHARMACOLOGY .....................................................................................................