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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).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

Baclofen Tablets USP, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1330” on one side and plain on the other side, containing 10 mg Baclofen USP. Available in bottles of 30 (NDC 43063-864-30), 60 (NDC 43063-864-60) and 90 (NDC 43063-864-90).

Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1337” on one side and plain on the other side, containing 20 mg Baclofen USP. Available in bottles of 30 (NDC 43063-865-30), 60 (NDC 43063-865-60) and 90 (NDC 43063-865-90).

PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

PRINCIPAL DISPLAY PANEL — 10 mg

Baclofen Tablets, USP

10 mg

Rx Only

43063864 Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg

Baclofen Tablets, USP

20 mg

Rx Only

image
(click image for full-size original)
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-864(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
CELLULOSE, MICROCRYSTALLINE
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:43063-864-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-864-60 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:43063-864-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078220 07/01/2007
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-865(NDC:0527-1337)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (round) Size 10mm
Flavor Imprint Code LCI;1337
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-865-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-865-60 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:43063-865-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 12/20/2005
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-864), repack (43063-865)

Revised: 06/2022 PD-Rx Pharmaceuticals, Inc.

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