Baclofen (Page 2 of 2)

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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).

HOW SUPPLIED

Product: 50090-2493

NDC: 50090-2493-0 60 TABLET in a BOTTLE

NDC: 50090-2493-1 30 TABLET in a BOTTLE

NDC: 50090-2493-3 90 TABLET in a BOTTLE

baclofen

Label Image

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2493(NDC:0527-1330) Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE STARCH, CORN SILICON DIOXIDE MAGNESIUM STEARATE

Product Characteristics Color WHITE (white) Score 2 pieces Shape ROUND (round) Size 9mm Flavor Imprint Code LCI;1330 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-2493-3 90 TABLET in 1 BOTTLE None 2 NDC:50090-2493-0 60 TABLET in 1 BOTTLE None 3 NDC:50090-2493-1 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078220 07/01/2007

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-2493), REPACK (50090-2493)

Revised: 02/2021 A-S Medication Solutions