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APO-TICAGRELOR is a brand name for Ticagrelor, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Acute Coronary Syndrome APO-TICAGRELOR (ticagrelor tablets), co-administered with low-dose acetylsalicylic acid (ASA: 75 to 150 mg), is indicated for the secondary prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) (see 14 CLINICAL TRIALS). History of Myocardial Infarction (at least…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 05/2023 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............................................................................................................... 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................
4 Administration ....................................................................................................... 5 Missed Dose ..........................................................................................................
7 5 OVERDOSAGE ............................................................................................................. 8
and 14 CLINICAL TRIALS). 2 CONTRAINDICATIONS APO-TICAGRELOR is contraindicated in: • Patients who are hypersensitive to this medication or to any ingredient in the APO-TICAGRELOR (Ticagrelor Tablets) Page 5 of 72 Unclassified / Non classifié formulation.
For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS COMPOSITION AND PACKAGING. • Patients who have active pathological bleeding such as peptic ulcer or intracranial hemorrhage (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
• Patients with a history of intracranial hemorrhage (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). • Patients with moderate to severe hepatic impairment (see 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY). g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir) (see 7 WARNINGS AND PRECAUTIONS and
3 Pediatrics 05/2023 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............................................................................................................... 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................
4 Administration ....................................................................................................... 5 Missed Dose ..........................................................................................................
7 5 OVERDOSAGE ............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS ..................................................................................
APO-TICAGRELOR is contraindicated in: • Patients who are hypersensitive to this medication or to any ingredient in the APO-TICAGRELOR (Ticagrelor Tablets) Page 5 of 72 Unclassified / Non classifié formulation. For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS COMPOSITION AND PACKAGING.
• Patients who have active pathological bleeding such as peptic ulcer or intracranial hemorrhage (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). • Patients with a history of intracranial hemorrhage (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
• Patients with moderate to severe hepatic impairment (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ticagrelor 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.
1 Special Populations.............................................................................................. 1 Pregnant Women ............................................................................................. 2 Breast-feeding .................................................................................................
3 Pediatrics ......................................................................................................... 4 Geriatrics .........................................................................................................
14 8 ADVERSE REACTIONS ................................................................................................ 1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ..........................................................................................................
5 Post-Market Adverse Reactions .......................................................................... 29 9 DRUG INTERACTIONS ................................................................................................ 1 Serious 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 Tests Interactions .....................................................................
35 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ..........................................................................................
3 Pharmacokinetics ............................................................................................. 38 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 42 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................
42 PART II: SCIENTIFIC INFORMATION ....................................................................................... 43 13 PHARMACEUTICAL INFORMATION ............................................................................
43 14 CLINICAL TRIALS ........................................................................................................ 1 Clinical Trials by Indication ...............................................................................
2 Comparative Bioavailability Studies ................................................................. 58 15 MICROBIOLOGY ........................................................................................................ 59 16 NON-CLINICAL TOXICOLOGY .....................................................................................
59 17 SUPPORTING PRODUCT MONOGRAPHS […]