Loading…
TRANEXAMIC ACID is a brand name for Tranexamic Acid, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tranexamic Acid Injection, USP (tranexamic acid) is indicated for: Increased local fibrinolysis when the diagnosis is indicative of hyperfibrinolysis, as with dental extraction in patients with coagulopathies (in conjunction with antihaemophilic factor). 1.1 Pediatrics No data are available to Health Canada for…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 07/2022 7 WARNINGS AND PRECAUTIONS 07/2022 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....................................................
3 Reconstitution .................................................................................................. 4 Administration.................................................................................................. 6 5 OVERDOSAGE ............................................................................................................
7
1 Adverse Reaction Overview Gastrointestinal Disorders: Gastrointestinal symptoms (nausea, vomiting, diarrhea) occur but disappear when the dose is reduced. Immune System Disorders: allergic dermatitis has been reported less commonly.
Tranexamic Acid Injection, USP (tranexamic acid) Page 11 of 22 Nervous System Disorders: Isolated cases of dizziness or reduced blood pressure have been reported. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Eye Disorders:
No retinal changes have been reported or observed at ophthalmic check-ups of patients treated with tranexamic acid for several weeks or months. This is despite experimental findings in animals (dog and cat) where retina changes have been observed after long-term administration of large doses of tranexamic acid.
1 Adverse Reaction Overview). 1. 1 Adverse Reaction Overview). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data No data is available regarding abnormal laboratory findings and tranexamic acid therapy.
5 Post-Market Adverse Reactions Rare cases of adverse events have been reported with the use of tranexamic acid. Eye Disorders: impaired vision, blurred vision or colour vision impairment (chromatopsia) Immune System Disorders: Cases of allergic reaction with use of intravenous tranexamic acid, including anaphylaxis or anaphylactoid reaction have been reported that are suggestive of a causal relationship.
07/2022 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....................................................
3 Reconstitution .................................................................................................. 4 Administration.................................................................................................. 6 5 OVERDOSAGE ............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations...........................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tranexamic Acid in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
Nervous System Disorders: dizziness and seizures Vascular Disorders: thromboembolic events (acute myocardial infarction, thrombosis, arterial thrombosis limb, carotid artery thrombosis, cerebral infarction, cerebrovascular accident, deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction).
Hypotension may occur after fast injection. Tranexamic Acid Injection, USP (tranexamic acid) Page 12 of 22
1 Pregnant Women ........................................................................................ 2 Breast-feeding........................................................................................... 3 Pediatrics ..................................................................................................
4 Geriatrics .................................................................................................. 10 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 .................................................
1 Less Common Clinical Trial Adverse Reactions – Pediatrics ......................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .....................................................................................................
5 Post-Market Adverse Reactions....................................................................... 11 9 DRUG INTERACTIONS............................................................................................... 2 Drug Interactions Overview.............................................................................
4 Drug-Drug Interactions ................................................................................... 5 Drug-Food Interactions ................................................................................... 6 Drug-Herb Interactions ...................................................................................
7 Drug-Laboratory Test Interactions ................................................................... 12 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action.................................................................................
2 Pharmacodynamics ................................................................................... 3 Pharmacokinetics...................................................................................... 13 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
14 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 14 PART II: SCIENTIFIC INFORMATION ..................................................................................... 15 13 PHARMACEUTICAL INFORMATION...........................................................................
15 14 CLINICAL TRIALS....................................................................................................... 1 Clinical Trials by Indications ....................................................................... 2 Comparative Bioavailability Studies ...........................................................
3 Immunogenicity ........................................................................................ 4 Clinical Trials - Reference Biologic Drug ...................................................... 15 15 MICROBIOLOGY .......................................................................................................
15 16 NON-CLINICAL TOXICOLOGY .................................................................................... 16 General Toxicology: ............................................................................................................
16 17 SUPPORTING PRODUCT […]