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Austedo XR
deutetrabenazine
Black Box Warnings .
Depression and Suicidality
incr. risk of depression and suicidality in patients w/ Huntington dz, esp. if depression history or prior suicide attempts or ideation; weigh risk vs. benefit; observe all patients for new or worsening depression, suicidality, or unusual behavior changes; inform patients and caregivers of depression and suicidality risk and instruct to report any concerning behaviors; contraindicated if actively suicidal or if untreated/inadequately treated depression
Adult Dosing .
Dosage forms: ER TAB: 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, 48 mg; convenience pack
Dosage Form Details
- [convenience pack components]
- Info: 4-wk titration pack contains 12 mg ER tab x7 and 18 mg ER tab x7 and 24 mg ER tab x7 and 30 mg ER tab x7
chorea, Huntington dz-associated
- [12-48 mg PO qd]
- Start: 12 mg PO qd, then may incr. by 6 mg/day qwk; Max: 48 mg/day; Info: max 36 mg/day in CYP2D6 poor metabolizers; switch from IR to ER form at same total daily dose; do not cut/crush/chew tab; retitrate if tx interrupted >1wk; see pkg insert for conversion from tetrabenazine
tardive dyskinesia
- [12-48 mg PO qd]
- Start: 12 mg PO qd, then may incr. by 6 mg/day qwk; Max: 48 mg/day; Info: max 36 mg/day in CYP2D6 poor metabolizers; switch from IR to ER form at same total daily dose; do not cut/crush/chew tab; retitrate if tx interrupted >1wk; see pkg insert for conversion from tetrabenazine
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.