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M-TRANEXAMIC ACID is a brand name for Tranexamic Acid, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: M-TRANEXAMIC ACID (tranexamic acid tablet) is indicated for: • Hereditary angioneurotic oedema. • Increased local fibrinolysis when the diagnosis is indicative of hyperfibrinolysis, as with conization of the cervix, dental extraction in patients with coagulopathies (in conjunction with antihaemophilic factor)…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Tranexamic acid blood levels are increased in patients with renal insufficiency. 2 Recommended Dose and Dosage Adjustment) • Hypotension may occur after fast injection. • The risk for thromboembolic events may be increased in patients using hormonal contraceptives.
If M-TRANEXAMIC ACID has to be used in these patients, advise them to use an effective alternative (non-hormonal) contraceptive method. (see 9 DRUG INTERACTIONS). 2 Recommended Dose and Dosage Adjustment • Conization of the cervix: 2-3 tablets (1000-1500 mg) every 8-12 hours, 12 days post operatively • Epistaxis: 2-3 tablets (1000-1500 mg) every 8-12 hours for 10 days • Hyphaema: 2-3 tablets (1000-1500 mg) every 8-12 hours for 7 days • Dental Surgery in Patients with Coagulopathies: 2 hours before the operation, Factor VIII and Factor IX should be given as well as M-TRANEXAMIC ACID, 25 mg/kg orally.
After the operation, 25 mg/kg M-TRANEXAMIC ACID is given orally 3-4 times a day for 6-8 days. After the operation the patient does not generally require further substitution therapy. • Menorrhagia (hypermenorrhea): 2-3 tablets (1000-1500 mg), 3-4 times a day for several days.
M-TRANEXAMIC ACID treatment should only be started when copious bleeding has begun. • Hereditary angioneurotic oedema: Some patients can sense the onset of attacks and are best treated intermittently with 2-3 tablets (1000-1500 mg), 2-3 times a day for several days.
Others should be treated continuously with this dose. • Pediatrics: Dosage should be calculated according to body weight at 25 mg/kg orally 2-3 times a day. Clinical experience with M-TRANEXAMIC ACID in menorrhagic (hypermenorrhea) children under 18 years of age is not available.
• Patients with Impaired Renal Function: In patients with serum creatine concentrations of M-TRANEXAMIC ACID (Tranexamic Acid Tablets, BP) Page 6 of 25 120 to 250 μmol/L, the recommended dose is 15 mg/kg orally tranexamic acid twice daily.
At serum creatine levels of 250 to 500 μmol/L the dosage should be 15 mg/kg orally at 24 hourly intervals, and at serum creatine levels of 500 μmol/L or more, the same dose should be given at intervals of 48 hours between doses. 5 Missed Dose If you forget to take your tablets you should take your next dose as usual.
Do not take extra tablets to make up for the missed dose.
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.
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.
M-TRANEXAMIC ACID (Tranexamic Acid Tablets, BP) Page 11 of 25 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). 1. 1). 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.
General The erroneous administration of tranexamic acid via intrathecal or epidural routes has been reported, resulting in serious adverse reactions including death. Cardiovascular Venous and arterial thrombosis or thromboembolism has been reported in patients treated tranexamic acid.
Patients with a high risk for thrombosis (a previous thromboembolic event and a family history of thromboembolic disease) should use M-TRANEXAMIC ACID only if there is a strong medical indication and under strict medical supervision.
Patients with disseminated intravascular coagulation (DIC), who require treatment with M-TRANEXAMIC ACID, must be under the strict supervision of a physician experienced in treating this disorder. Driving and Operating Machinery Tranexamic acid may cause dizziness and therefore may influence the ability to drive or use machines.
Endocrine and Metabolism Hormonal Contraceptives:
Combination hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction. Because M-TRANEXAMIC ACID is an antifibrinolytic, concomitant use of hormonal contraception and M-TRANEXAMIC ACID may further exacerbate this increased thrombotic risk.
Women using hormonal contraception should use M-TRANEXAMIC ACID only if there is a strong medical need and the benefit of treatment will outweigh the potential increased risk of a thrombotic event. The risk for thromboembolic events may be increased in patients using hormonal contraceptives.
If M-TRANEXAMIC ACID has to be used in these patients, advise them to use an effective alternative (non-hormonal) contraceptive method. (see 9 DRUG INTERACTIONS). The following patients should consult their doctor prior to initiating treatment with M-TRANEXAMIC ACID: obese and diabetic, with polycystic ovary syndrome or a history of endometrial cancer in a first-degree relative, women receiving unopposed oestrogen or tamoxifen.
• Intrathecal and epidural administration of tranexamic acid is contraindicated. • Patients with a history or risk of thrombosis should not be given M-TRANEXAMIC ACID (tranexamic acid), unless at the same time it is possible to give treatment with anticoagulants.
The preparation should not be given to patients with acquired disturbances of colour vision. If disturbances of vision arise during the course of treatment the administration of the preparation should be discontinued. • Patients with active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism, and cerebral thrombosis.
• Patients with subarachnoid haemorrhage: the limited clinical experience shows that a M-TRANEXAMIC ACID (Tranexamic Acid Tablets, BP) Page 5 of 25 reduced risk for re-bleeding is offset by an increase in the rate of cerebral ischaemia.
• Haematuria (see 7 WARNINGS and PRECAUTIONS) • M-TRANEXAMIC ACID is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
Hematologic Avoid concomitant use of M-TRANEXAMIC ACID with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. Patients with irregular menstrual bleeding should not use M-TRANEXAMIC ACID until the cause M-TRANEXAMIC ACID (Tranexamic Acid Tablets, BP) Page 8 of 25 of the irregularity has been established.
Patients should consult their doctor if menstrual bleeding is not reduced after three menstrual cycles. If menstrual bleeding is not adequately reduced by M-TRANEXAMIC ACID, an alternative treatment should be considered. 2 Recommended Dose and Dosage Adjustment).
Neurologic Convulsions have been reported in association with tranexamic acid treatment. Ophthalmologic Visual disturbances including visual impairment, vision blurred, impaired color vision have been reported with tranexamic acid. ) if possible, before treatment is initiated and regularly during treatments.
Renal Tranexamic acid therapy is not indicated in haematuria caused by diseases of the renal parenchyma. Intravascular precipitation of fibrin frequently occurs in these conditions and may aggravate the disease. In addition, in cases of massive renal hemorrhage of any cause, antifibrinolytic therapy carries the risk of clot retention in the renal pelvis.
2 Recommended Dose and Dosage Adjustment).
Reproductive Health:
Female and Male Potential • Fertility There are limited clinical data regarding the impact of tranexamic acid on fertility. After both oral and intravenous administration, tranexamic acid passes into the semen and inhibits its fibrinolytic activity, but without affecting the motility of the spermatozoa.
Sensitivity/Resistance 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. Patients should be closely monitored for the possibility of a severe allergic reaction occurring following its administration.
1 Pregnant Women M-TRANEXAMIC ACID (Tranexamic Acid Tablets, BP) Page 9 of 25 Tranexamic acid passes through the placenta. The concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/L, as high as in the maternal blood.
Fibrinolytic activity is very high in neonates. It is not known for certain whether a reduction of this activity during the first hours of life is harmful. Kullander and Nilsson who have wide experience with tranexamic acid in connection with childbirth have observed no negative effect on the infants.
For decisions regarding the use of tranexamic acid during pregnancy, the potential risk of tranexamic acid administration on the fetus should always be considered along with the mother’s clinical need for tranexamic acid; an accurate risk-benefit evaluation should drive the treating physician’s decision.
Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes.
There are cases of fetal structural abnormalities that resulted in death of the newborn following administration of tranexamic acid to the mother during conception or the first trimester of pregnancy; however, due to other confounding factors the actual risk of major birth defects with use of tranexamic acid during pregnancy is not clear.
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