Baclofen (Page 2 of 2)

Dosage and Administration Section

DOSAGE AND ADMINISTRATION

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily).

The following dosage titration schedule is suggested:

5 mg t.i.d. for 3 days

10 mg t.i.d. for 3 days

15 mg t.i.d. for 3 days

20 mg t.i.d. for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).

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BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0156(NDC:31722-998) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (BACLOFEN) BACLOFEN 10 mg

Product Characteristics Color white Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code I114 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:80425-0156-3 90 TABLET in 1 BOTTLE None 2 NDC:80425-0156-1 30 TABLET in 1 BOTTLE None 3 NDC:80425-0156-2 60 TABLET in 1 BOTTLE None 4 NDC:80425-0156-4 120 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212378 10/09/2020

Labeler — Advanced Rx Pharmacy of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Operations
Advanced Rx Pharmacy of Tennessee, LLC		117023142	repack (80425-0156)

Revised: 05/2023 Advanced Rx Pharmacy of Tennessee, LLC