Austedo Dosage

Generic name: DEUTETRABENAZINE 6mg
Dosage form: tablet, coated
Drug class: VMAT2 inhibitors

Medically reviewed by Drugs.com. Last updated on Sep 30, 2023.

Dosing Information

The dose of AUSTEDO XR and AUSTEDO is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. Table 1 displays the recommended dosage and important administration instructions of AUSTEDO XR and AUSTEDO when first prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor).

Table 1: Recommended Dosage and Important Administration Instructions for AUSTEDO XR and AUSTEDO

	AUSTEDO XR extended-release tablet	AUSTEDO tablet
Recommended Starting Dosage	12 mg once daily (12 mg per day)	6 mg twice daily (12 mg per day)
Recommended Dose Titration	The dosage of AUSTEDO XR or AUSTEDO may be increased at weekly intervals in increments of 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg [see Clinical Trials (14.1, 14.2)].
Important Administration Instructions	Administer AUSTEDO XR with or without food [see Clinical Pharmacology (12.3)]. Swallow AUSTEDO XR whole. Do not chew, crush, or break tablets. Administer AUSTEDO XR once daily.	Administer AUSTEDO with food [see Clinical Pharmacology (12.3)]. Swallow AUSTEDO whole. Do not chew, crush, or break tablets. Administer AUSTEDO total daily dosages of 12 mg or above in two divided doses.
Switching Between AUSTEDO and AUSTEDO XR	When switching between AUSTEDO tablets (twice daily) and AUSTEDO XR extended-release tablets (once daily), switch to the same total daily dosage.

Switching Patients from Tetrabenazine to AUSTEDO XR or AUSTEDO

Discontinue tetrabenazine and initiate AUSTEDO XR or AUSTEDO the following day. The recommended initial dosing regimen of AUSTEDO XR or AUSTEDO in patients switching from tetrabenazine to AUSTEDO XR or AUSTEDO is shown in Table 2.

Table 2: Recommended Initial Dosing Regimen when Switching from Tetrabenazine to AUSTEDO XR or AUSTEDO


Current tetrabenazine daily dosage	Initial regimen of AUSTEDO XR extended-release tablet	Initial regimen of AUSTEDO tablet
12.5 mg	6 mg once daily	6 mg once daily
25 mg	12 mg once daily	6 mg twice daily
37.5 mg	18 mg once daily	9 mg twice daily
50 mg	24 mg once daily	12 mg twice daily
62.5 mg	30 mg once daily	15 mg twice daily
75 mg	36 mg once daily	18 mg twice daily
87.5 mg	42 mg once daily	21 mg twice daily
100 mg	48 mg once daily	24 mg twice daily

After patients are switched to AUSTEDO XR or AUSTEDO, the dose may be adjusted at weekly intervals [see Dosage and Administration (2.1)].

Dosage Adjustment with Strong CYP2D6 Inhibitors

In patients receiving strong CYP2D6 inhibitors, the total daily dosage of AUSTEDO XR or AUSTEDO should not exceed 36 mg [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Dosage Adjustment in Poor CYP2D6 Metabolizers

In patients who are poor CYP2D6 metabolizers, the total daily dosage of AUSTEDO XR or AUSTEDO should not exceed 36 mg [see Use in Specific Populations (8.7)].

Discontinuation and Interruption of Treatment

Treatment with AUSTEDO XR or AUSTEDO can be discontinued without tapering. Following treatment interruption of greater than one week, AUSTEDO XR or AUSTEDO therapy should be re-titrated when resumed. For treatment interruption of less than one week, treatment can be resumed at the previous maintenance dose without titration.