Baclofen

Adults Baclofen is indicated in patients with severe chronic spasticity of spinal or cerebral origin (associated with injury, multiple sclerosis, cerebral palsy) who are unresponsive to oral baclofen or other orally administered antispastic agents and/or those patients who experience unacceptable side-effects at effective oral doses.

In patients with spasticity due to head injury a delay of at least one year before treatment with Baclofen is recommended, to allow the symptoms of spasticity to stabilise. Baclofen may be considered as an alternative to ablative neurosurgical procedures.

Paediatric population Baclofen is indicated in patients aged 4 to <18 years with severe chronic spasticity of cerebral origin or of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable undesirable effects at effective oral doses.

Baclofen Injection (baclofen injection) is indicated for: • The management of patients with severe spasticity due to spinal cord injury or multiple sclerosis who are unresponsive to oral baclofen or who experience unacceptable side effects at effective oral doses.

Baclofen Injection therapy may be considered as an alternative to destructive neurosurgical procedures. 2 Recommended Dose and Dosage Adjustment). g. spasticity following hypoxic encephalopathy, head injury, or stroke; however, clinical experience is limited.

1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of baclofen injection has not been studied in patients under 18 years of age. Its use in pediatric patients is not recommended unless the benefits outweigh the risk.

2 Geriatrics Geriatrics (> 65 years of age): Elderly patients may be more susceptible to the side effects of oral baclofen in the titration stage and this may also apply to intrathecal baclofen.

INDICATIONS AND USAGE

Baclofen tablets, USP 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 treatment will aid in restoring residual function.

Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

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