Lioresal dosed orally caused delayed fetal growth ossification of bones at doses that also caused maternal toxicity in rats and rabbits, and when given intraperitoneally, baclofen at high doses caused widening of the vertebral arch in rat fetuses.

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HOW TO USETake this medication by mouth with or without food as directed by your doctorusually 3 times a dayTo reduce your risk of side effectsyour doctor may direct . you to start this medication at a low dose and gradually increase your doseFollow your doctor’s instructions carefully.The dosage is based on your medical condition and response to treatmentDo not increase your dose or take it more often than prescribed.Use this medication regularly to get the most benefit from itTo help you remembertake it at the same times each dayDo not stop taking this medication without consulting your doctorSome conditions may become worse when this drug is suddenly stoppedAlsoyou may experience withdrawal symptoms such as hallucinations and seizuresTo prevent withdrawal reactionsyour doctor may reduce your dose graduallyConsult your doctor or pharmacist for more detailsand report any withdrawal reactions immediately.It may take 1 to 2 months or longer to get the full benefit from this medicationTell your doctor if your condition does not improve or if it worsens.

Because of the possibility of sedationpatients should be cautioned regarding the operation of automobiles or other dangerous machineryand activities made hazardous by decreased alertnessPatients should also be cautioned that the central nervous system effects of Lioresal may be additive to those of alcohol and other CNS depressants.

INCIDENCE OF MOST FREQUENT1ADVERSE EVENTS IN PATIENTS WITH SPASTICITY OF CEREBRAL ORIGIN IN PROSPECTIVELY MONITORED CLINICAL TRIALS.

Inactive IngredientsCellulose compoundsmagnesium stearatepovidoneand starch.

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