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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).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

10 mg tablets are supplied as scored, flat bevelled edge, round, white tablets debossed “BN scoreline 10″ on one side and “G” on the other

Bottles of 100 NDC 57315-001-01

Bottles of 500 NDC 57315-001-04

Bottles of 1000 NDC 57315-001-02

20 mg tablets are supplied as scored, flat bevelled edge, round, white tablets debossed “BN scoreline 20″ on one side and “G” on the other

Bottles of 100 NDC 57315-002-01

Bottles of 500 NDC 57315-002-04

Bottles of 1000 NDC 57315-002-02

Dispense in a well-closed container, as described in the USP, using a child-resistant closure.

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

Manufactured in Australia by:

ALPHAPHARM PTY LTD

15 Garnet Street

Carole Park Qld 4300

AUSTRALIA

1646/3 Revised September 2008

BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57315-001
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
Colloidal Silicon Dioxide
Crospovidone
Magnesium Stearate
Maize (corn) starch
microcrystalline cellulose
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code BN;10;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57315-001-04 500 TABLET (500 TABLET) in 1 BOTTLE None
2 NDC:57315-001-01 100 TABLET (100 TABLET) in 1 BOTTLE None
3 NDC:57315-001-02 1000 TABLET (1000 TABLET) in 1 BOTTLE None
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57315-002
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
Colloidal Silicon Dioxide
Crospovidone
Magnesium Stearate
Maize (corn) starch
microcrystalline cellulose
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code BN;20;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57315-002-04 500 TABLET (500 TABLET) in 1 BOTTLE None
2 NDC:57315-002-02 1000 TABLET (1000 TABLET) in 1 BOTTLE None
3 NDC:57315-002-01 100 TABLET (100 TABLET) in 1 BOTTLE None
Labeler — ALPHAPHARM PTY LTD

Revised: 09/2008 ALPHAPHARM PTY LTD

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