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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).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

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