KEMSTRO™ 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 treatment with KEMSTRO™ will aid in restoring residual function.

KEMSTRO™ may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

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

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

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 three times a day for 3 days 10 mg three times a day for 3 days 15 mg three times a day for 3 days 20 mg three times a day 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 four times 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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).

Administration

Using dry hands, the patient should be instructed to place the tablet on the tongue, where it will disintegrate and can then be swallowed with or without water.

Patients with Renal Impairment

Because baclofen is primarily excreted unchanged by the kidneys, it should be given with caution and it may be necessary to reduce the dosage in patients with impaired renal function.

KEMSTRO™  (baclofen orally disintegrating tablets) 10 mg are white, round, orange-flavored, scored and engraved “10” on the unscored side and “SP” above and “351” below the score on the other side. They are supplied as follows:

Bottles of 100                       NDC 0091-3351-01

KEMSTRO™  (baclofen orally disintegrating tablets) 20 mg are white, round, orange-flavored, scored and engraved “20” on the unscored side and “SP” above and “352” below the score on the other side. They are supplied as follows:

Bottles of 100                               NDC 0091-3352-01

Dispense in a tight container as defined in the USP/NF with a child-resistant closure.

Store at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F). Protect from moisture.

Manufactured for: SCHWARZ PHARMA., Milwaukee, WI 53201, USA. By: CIMA., Eden Prairie, MN 55344, USA. FDA rev date:

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