The precise mechanism of action of Lioresal is not fully known. Lioresal is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although Lioresal is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, Lioresal has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Lioresal is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Lioresal is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.
Lioresal 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 lioresal treatment will aid in restoring residual function.
Lioresal may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Lioresal is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of lioresal 10mg (Baclofen) in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.
Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of Lioresal may be additive to those of alcohol and other CNS depressants.
Lioresal should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.
In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking Lioresal.
It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with lioresal 25mg.
Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with Lioresal for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.
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