Austedo Xr Generic Name & Formulations
Tabs—60; XR Tabs—30
Mechanism of Action
Austedo Xr Indications
Austedo Xr Dosage and Administration
Swallow whole. Take with or without food. Individualize. Initially 12mg once daily; may titrate at weekly intervals by 6mg/day increments (max 48mg/day). Switching between Austedo and Austedo XR: switch to the same total daily dosage. Switching from tetrabenazine: see full labeling. Concomitant strong CYP2D6 inhibitors or poor CYP2D6 metabolizers: max 36mg/day (max 18mg/dose).
Austedo Xr Contraindications
Austedo Xr Boxed Warnings
Austedo Xr Warnings/Precautions
Increased risk of depression and suicidality in Huntington's patients; monitor for emergence or worsening of depression, suicidality, or unusual changes in behavior; consider discontinuing if not resolved. Avoid in congenital long QT syndrome or history of cardiac arrhythmias. Assess QT interval before and after dose increases of Austedo ≥24mg/day or other QT-prolonging drugs. Bradycardia. Hypokalemia. Hypomagnesemia. Monitor for neuroleptic malignant syndrome (NMS); discontinue and treat if develops. Reduce dose or discontinue if akathisia or parkinsonism develops. History of breast cancer. Consider discontinuing if symptomatic hyperprolactinemia develops. Risk of long-term ophthalmologic effects due to binding to melanin-containing tissues; consider monitoring. Reevaluate periodically. Poor CYP2D6 metabolizers. Pregnancy. Nursing mothers.
Austedo Xr Pharmacokinetics
Following oral administration of deutetrabenazine, the extent of absorption is at least 80%.
Peak plasma concentrations of deutetrabenazine are reached within ~3–4 hours after dosing.
Effect of Food:
Austedo XR: Food had no effect.
Austedo: Peak plasma concentration was increased by approximately 50% in the presence of food.
Median volume of distribution: 500 to 730 L.
Plasma protein bound: 60% to 68% (for α-HTBZ); 59% to 63% (β-HTBZ).
Renal (75–86%), fecal (8–11%).
Half-life: ~9 to 10 hours.
Clearance: 65 to 200 L/hour.
Austedo Xr Interactions
Austedo Xr Adverse Reactions
Austedo Xr Clinical Trials
Austedo Xr Note
Austedo Xr Patient Counseling