Baclofen (Baclofen) - Indications and Dosage

INDICATIONS AND USAGE

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.

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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).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