Baclofen

g. tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord. g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury. Patient selection is important when initiating Baclofen therapy; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/or physiotherapy.

Treatment should not be commenced until the spastic state has become stabilised. Paediatric population Baclofen is indicated in patients 0 to <18 years for the symptomatic treatment of spasticity of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.

Baclofen is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord.

Baclofen Injection USP (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 USP therapy may be considered as an alternative to destructive neurosurgical procedures. 2 Recommended Dose and Dosage Adjustment Screening Phase). 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 have 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.

1 INDICATIONS AND USAGE GABLOFEN is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump.

For spasticity of spinal cord origin, chronic infusion of GABLOFEN via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses.

Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. GABLOFEN is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed ® Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN [see Clinical Studies (14)] .