What is the prescribing information for tranexamic acid (TXA) orally for dysmenorrhea and what other medication is often prescribed with it for dysmenorrhea/menorrhagia?

Tranexamic Acid Prescribing Information for Dysmenorrhea/Menorrhagia

Direct Answer

Tranexamic acid is NOT indicated for dysmenorrhea (painful periods), but IS highly effective for menorrhagia (heavy menstrual bleeding), with a recommended oral dose of 1.3 grams (two 650 mg tablets) three times daily for up to 5 days during menstruation, not to exceed 3.9 grams per day. 1, 2 NSAIDs (particularly mefenamic acid) are the medication most commonly prescribed alongside tranexamic acid, as they address both dysmenorrhea and reduce menstrual blood loss. 3, 4, 5

Critical Distinction: Dysmenorrhea vs. Menorrhagia

• Dysmenorrhea refers to painful menstrual cramps, for which tranexamic acid has no therapeutic benefit since it only addresses bleeding, not pain. 6, 4
• Menorrhagia (heavy menstrual bleeding) is the actual indication for tranexamic acid, where it reduces menstrual blood loss by 34-59% through its antifibrinolytic mechanism. 6, 5

Prescribing Information for Tranexamic Acid (Oral)

Standard Dosing Regimen

• Dose: 1.3 grams (two 650 mg tablets) three times daily during menstruation 2
• Maximum daily dose: 3.9 grams per day (this is the only dose that met all three primary efficacy endpoints in clinical trials) 2
• Duration: Up to 5 days during active menstrual bleeding only 1, 2
• Alternative regimen: 1 gram four times daily for 4-5 days starting from the first day of menstruation 6, 7

Weight-Based Alternative

• 30-50 mg/kg/day in divided doses, not exceeding 3.9 grams daily 1

Dose Titration for Older Women

• Start at 500 mg twice daily, gradually increasing up to 1000 mg 3-4 times daily as needed, staying within the 4-gram maximum 1

Renal Impairment

• Dose reduction required since tranexamic acid is primarily eliminated through renal clearance 1

Absolute Contraindications

• Active thromboembolic disease 1
• Known hypersensitivity to tranexamic acid 1
• Recent thrombosis (within 3 hours for postpartum use, though this timing is specific to postpartum hemorrhage context) 8

Relative Contraindications

• Atrial fibrillation 8, 1
• Known thrombophilia 8, 1
• History of seizures 1
• Cardiovascular disease (increased risk of thrombosis and MI) 3

Medication Commonly Prescribed WITH Tranexamic Acid

NSAIDs (First-Line Companion Therapy)

NSAIDs are the most appropriate medication to prescribe alongside tranexamic acid because they address both dysmenorrhea (pain relief) and reduce menstrual blood loss through a different mechanism (prostaglandin inhibition). 3, 4, 5

Specific NSAID Options:

• Mefenamic acid: 500 mg every 8 hours for 5 days during menstruation (reduces blood loss by 20% and provides dysmenorrhea relief) 5
• Flurbiprofen: 100 mg twice daily for 5 days (effective for both pain and bleeding) 4
• Diclofenac sodium: 150 mg in three divided doses on day 1, followed by 25 mg three times daily on days 2-5 6
• Indomethacin: Demonstrated significant reductions in menstrual blood loss 3

Why NSAIDs Work Well With Tranexamic Acid:

• NSAIDs reduce menstrual blood loss through prostaglandin inhibition (different mechanism than tranexamic acid's antifibrinolytic action) 3, 5
• NSAIDs provide dysmenorrhea relief, which tranexamic acid does not address 4
• Recommended duration is 5-7 days during days of bleeding 3
• Avoid aspirin, as it has not shown effectiveness and may increase blood loss 3

Comparative Efficacy

• Tranexamic acid is significantly more effective than NSAIDs alone for reducing menstrual blood loss (54% reduction vs. 20% with mefenamic acid) 5
• Tranexamic acid reduced blood loss more than mefenamic acid, flurbiprofen, etamsylate, and oral luteal phase norethisterone 6, 5
• The levonorgestrel-releasing intrauterine device (LNG-IUD) is more effective than tranexamic acid (71-95% reduction in menstrual blood loss), but 44% of patients develop amenorrhea, which may be unacceptable to some 6

Common Pitfall to Avoid

• Do NOT exceed 3.9-4 grams daily maximum, as this can lead to neurotoxicity and seizures, particularly in patients with renal impairment 1
• Do NOT prescribe tranexamic acid for dysmenorrhea alone without heavy bleeding, as it provides no pain relief 4
• Do NOT use tranexamic acid in patients with cardiovascular disease due to increased thrombotic risk 3

Adverse Effects

• Most commonly reported adverse events are gastrointestinal: nausea, vomiting, diarrhea, and dyspepsia (12% incidence, not significantly different from placebo) 6
• No evidence of increased incidence of thrombotic events in women using tranexamic acid for menorrhagia 7
• Both the 3.9 g/day and 1.95 g/day doses were well tolerated with no serious study-related adverse events 2