Indications for GABLOFEN:
Severe spasticity of cerebral or spinal origin, when oral baclofen is not appropriate.
Adults and Children:
<4yrs: not established. ≥4yrs: Give test dose 1st by intrathecal inj via spinal catheter or lumbar puncture (see full labeling for dose and timing; use 50mcg/mL syringe). Dose titration: see full labeling. Maintenance: titrate individually; use lowest effective dose; maintain some degree of muscle tone. Spinal cord origin: usually 300–800mcg/day. Cerebral origin: usually 90–703mcg/day (24–1199mcg/day in <12yrs). Avoid abrupt cessation (may be severe/fatal); closely monitor pump, alarms, and refill schedule; wean orally-administered antispasticity drugs carefully.
Not for IV, IM, SC or epidural administration.
Do not discontinue abruptly.
Abrupt discontinuation may result in high fever, altered mental status, rebound spasticity, muscle rigidity; avoid. Apparent risk patients (eg, spinal cord injury at T-6 or higher, communicative impairment, history of withdrawal symptoms): closely monitor infusion system, dosing schedule, refills, pump alarms, clinical signs of withdrawal or overdose. Avoid use of prefilled syringe in an aseptic setting to fill pumps prior to implantation. Supervise 1st dose, during titration and refills; have resuscitative equipment and trained personnel available. Do not use chronically if test dose ineffective. For chronic dosing use approved pump (eg, Medtronic SynchroMed II Programmable). Intrathecal mass formation; monitor patients on intraspinal therapy for any new neurological signs or symptoms. Allow at least one year after traumatic brain injury before starting. Intrathecal mass formation; monitor patients on intraspinal therapy for new neurological signs or symptoms; consider consult if symptoms develop. Psychosis. Schizoaffective disorders. Confusion. Autonomic dysreflexia. Infections. Ovarian cysts. Hospitalize immediately if pump malfunction suspected. Pregnancy. Nursing mothers.
Muscle relaxant (central), antispastic agent.
Hypotension, dyspnea with morphine. Additive CNS depression with alcohol, other CNS depressants. Do not mix with other drugs in pump or catheter. Physostigmine may be useful in reversing effects (see full labeling).
Hypotonia, somnolence, dizziness, paresthesia, nausea, headache, constipation, convulsion, urinary retention, drowsiness, hypotension, agitation, leukocytosis, chills, coma, confusion; psychosis, CNS depression, respiratory failure, cardiovascular collapse.
Prefilled syringes (50mcg/mL, 10000mcg/20mL, 20000mcg/20mL, 40000mcg/20mL)—1; Vials (10000mcg/20mL, 20000mcg/20mL, 40000mcg/20mL)—1