Classes
DEA Class; Rx
Common Brand Names; Lysteda
- Antifibrinolytic Agents
Description
Oral and injectable antifibrinolytic
Used for bleeding prophylaxis during tooth extraction in patients with hemophilia and for treatment of cyclic heavy menstrual bleeding
May increase the risk of thromboembolic events
Indications
Indicated for the treatment of cyclic heavy menstrual bleeding
For the treatment of cyclic menorrhagia (heavy menstrual bleeding).
Contraindications
Hypersensitivity
Women using combination hormonal contraceptives
Active thromboembolic disease (eg, DVT, pulmonary embolism, or cerebral thrombosis)
History of thrombosis or thromboembolism, including retinal vein or artery occlusion
Intrinsic risk of thrombosis or thromboembolism (eg, thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy)
Adverse Effects
Headache (50.4%)
Nasal and sinus symptoms (25.4%)
Back pain (20.7%)
Abdominal pain (19.8%)
Musculoskeletal pain (11.2%)
1-10%
Arthralgia (6.9%)
Muscle cramps and spasms (5.8%)
Migraine (6%)
Anemia (5.6%)
Fatigue (5.2%)
Nausea, vomiting, and diarrhea
Allergic skin reactions
Anaphylactic shock and anaphylactoid reactions
Thromboembolic events (eg, DVT, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction); cases have been associated with concomitant use of combination hormonal contraceptives Impaired color vision and other visual disturbances
Dizziness
Warnings
Increased risk for thrombosis when coadministered with combination oral contraceptive (see Contraindications), Factor IX complex concentrates, anti-inhibitor coagulant concentrates, or oral tretinoin
Venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein occlusions, have been reported
Severe allergic reaction reported; anaphylactic shock reported with IV product
May cause cerebral edema and cerebral infarction in women with subarachnoid hemorrhage
Ligneous conjunctivitis reported
Pregnancy and Lactation
Not indicated for use in pregnant women; there are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; tranexamic acid crosses the placenta; animal reproduction studies have not identified adverse developmental outcomes with oral administration of tranexamic acid to pregnant rats at doses up to 4 times the recommended human dose
Tranexamic acid is present in the mother’s milk at a concentration of about one hundredth of the corresponding serum concentration
Maximum Dosage
3,900 mg/day PO; 40 mg/kg/day IV.
3,900 mg/day PO; 40 mg/kg/day IV.
3,900 mg/day PO; 40 mg/kg/day IV has been used after tooth extraction in hemophilia patients.
12 years: 3,900 mg/day PO; 40 mg/kg/day IV has been used after tooth extraction in hemophilia patients.
1 to 11 years: Safety and efficacy have not been established for oral dosing; 40 mg/kg/day IV has been used after tooth extraction in hemophilia patients.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tranexamic acid
tablet
- 650mg
