June 30, 2016
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Baclofen

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Baclofen




Indications
Dosage
How Supplied

INDICATIONS

Baclofen tablets are 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 tablet treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.The efficacy of baclofen tablets 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 40-80 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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).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 are supplied as:

10 mg: White colored, circular, flat, uncoated tablets with 'N029' debossed on one side and scoreline on the other side.

Boxes of 10 x 10 UD 100 NDC 63739-479-10

20 mg: White colored, circular, flat, uncoated tablets with 'N030' debossed on one side and scoreline on the other side.

Boxes of 10 x 10 UD 100 NDC 63739-480-10

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

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

Split tablet to be stored at controlled room temperature (20° to 25°C) for not more than 2 weeks.

Manufactured by: Piramal Enterprises Limited, 247 Business Park A-Wing, 6th floor, LBS Marg, Vikrolu (W) Mumbai 400083. Distributed by: McKess on Packaging Services a business unit of McKesson Corporation, 7107 Weddington Rd. Concord, NC 28027. Revised: Jun 2013

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/22/2016

Indications
Dosage
How Supplied

Baclofen - User Reviews

Baclofen User Reviews

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