Gablofen (BACLOFEN INJECTION)
Gablofen (BACLOFEN INJECTION) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Gablofen; Generic name: BACLOFEN INJECTION; Drug class: gamma-Aminobutyric Acid-ergic Agonist [EPC].
| Brand name | Gablofen |
|---|---|
| Generic name | BACLOFEN INJECTION |
| Drug class | gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| Manufacturer | Piramal Critical Care Inc |
| Used for | 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. GABLOF |
| Dosage | 2 DOSAGE AND ADMINISTRATION 2.1 Use Only in Medtronic SynchroMed ® Programmable Pump (or other pumps labeled for intrathecal administration of GABLOFEN) GABLOFEN is approved only for use with the Medtronic SynchroMed ® Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN. Refer to the manufacturer’s manual for specific instructions and precautions for programming the pump and/or refilling the reservoir. It is important to select the appropriate refill kit for the p |
| Warnings | BOXED WARNING WARNING: DO NOT DISCONTINUE ABRUPTLY Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill schedulin |
| Active ingredient(s) | BACLOFEN |
| Route | INTRATHECAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00d3e846-dd92-448d-9ab8-6a07be823cc1 |