Approved November 13, 2009

TRANEXAMIC ACID
(FDA Category 3S)

LYSTEDA(TM) (Xanodyne Pharms) a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin

DOSING INFORMATION: The recommended oral dose is 1300 milligrams three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Dosage adjustments are necessary in patients with renal impairment.

PHARMACOKINETICS: The absolute bioavailability is 45%. Food has minimal effect on absorption. Tranexamic acid is 3% bound to plasma proteins with no apparent binding to albumin. Tranexamic acid undergoes minimal metabolism with more than 95% of the dose excreted in the urine as unchanged drug. The terminal half-life is 11 hours.

CAUTIONS: Tranexamic is contraindicated in women with active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism. Serious visual or ocular adverse events may occur. The risk of thrombosis may increase with the concomitant use of certain drugs including hormonal contraception. Women with a subarachnoid hemorrhage are at risk for cerebral edema or cerebral infarction. The most common adverse events are headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue.

FDA APPROVED INDICATIONS: Tranexamic acid is indicated for the treatment of cyclic heavy menstrual bleeding.