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 mg to 80 mg daily).

The following dosage titration schedule is suggested:

5 mg t.i.d. (three times in a day) 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. (four times in a day)).

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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS , Abrupt Drug Withdrawal).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, 5 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with “16” on one side and “09” on the other side, containing 5 mg baclofen, USP are supplied as follows:

NDC 70771-1586-1 in bottle of 100 tablets

Baclofen Tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with “1285” on one side and break line on the other side, containing 10 mg baclofen, USP are supplied as follows:

NDC 70771-1448-1 in bottle of 100 tablets

NDC 70771-1448-5 in bottle of 500 tablets

NDC 70771-1448-0 in bottle of 1000 tablets

Baclofen Tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with “1286” on one side and break line on the other side, containing 20 mg baclofen, USP are supplied as follows:

NDC 70771-1449-1 in bottle of 100 tablets

NDC 70771-1449-5 in bottle of 500 tablets

NDC 70771-1449-0 in bottle of 1000 tablets

PHARMACIST: Dispense in a tight container (USP).

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

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured by:

Cadila Healthcare Ltd.,

India

Rev.: 04/20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1448-1 in bottles of 100 tablets

Baclofen Tablets, USP

10 mg

Rx only

10mg
(click image for full-size original)

NDC 70771-1449-1 in bottles of 100 tablets

Baclofen Tablets, USP

20 mg

Rx only

20 mg
(click image for full-size original)

NDC 70771-1586-1 in bottles of 100 tablets

Baclofen Tablets, USP

5 mg

Rx only

label
(click image for full-size original)
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1448
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 1285
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1448-1 100 TABLET in 1 BOTTLE None
2 NDC:70771-1448-5 500 TABLET in 1 BOTTLE None
3 NDC:70771-1448-0 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211659 12/06/2018
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1449
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 1286
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1449-1 100 TABLET in 1 BOTTLE None
2 NDC:70771-1449-5 500 TABLET in 1 BOTTLE None
3 NDC:70771-1449-0 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211659 12/06/2018
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1586
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 16;09
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1586-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211659 05/07/2020
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Zydus Worldwide DMCC (557951127)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 677605858 ANALYSIS (70771-1448), ANALYSIS (70771-1449), ANALYSIS (70771-1586), MANUFACTURE (70771-1448), MANUFACTURE (70771-1449), MANUFACTURE (70771-1586)

Revised: 04/2020 Cadila Healthcare Limited

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