KEMSTRO SUMMARY
KEMSTRO™ (baclofen orally disintegrating tablets)
KEMSTRO™ (baclofen orally disintegrating tablets) is a muscle relaxant and antispastic. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.
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.
|