Generic name:baclofen
Drug class:Skeletal muscle relaxants
Approval date: November 19, 2010
Company: CNS Therapeutics
Treatment for: Severe Spasticity
FDA Approves Gablofen
The United States Food and Drug Administration (FDA) has approved Gablofen (baclofen injection) for use in the management of severe spasticity, a movement disorder often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma and stroke.
Gablofen Medication Guide
Read this leaflet before you start receiving Gablofen and before each injection. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Gablofen?
Gablofen is a muscle relaxer and an antispastic agent.
Gablofen is used to treat severe spasticity, a movement disorder often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma and stroke.
Gablofen may also be used for other purposes not listed in this medication guide.
Warnings
Sudden withdrawal of Gablofen may result in serious complications that include high fever, confusion, muscle stiffness, organ failure and death. Early symptoms of Gablofen withdrawal may include increased spasticity, itching, and tingling of extremities.
If Gablofen withdrawal or a pump malfunction is suspected, you should be taken immediately to a hospital for assessment and treatment.
Sudden withdrawal occurs most frequently due to a delivery problem with the catheter or the pump, or failure to refill the pump on schedule. Pay careful attention to infusion system alarms. If you miss your scheduled pump refill, you should immediately contact your doctor or healthcare provider to reschedule the refill before the pump runs out of drug.
Gablofen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of Gablofen. Do not use Gablofen at a time when muscle tone is needed to assure safe balance and movement for ce...
