Generic Name and Formulations:
Baclofen 50mcg/mL, 500mcg/mL, 2000mcg/mL; for intrathecal inj; preservative-free.
Severe spasticity of cerebral or spinal origin, when oral baclofen is not appropriate.
<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 muscle tone possibly close to normal. Spinal cord origin: usually 300–800mcg/day. Cerebral origin: usually 90–703mcg/day. 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; may result in high fever, altered mental status, rebound spasticity, muscle rigidity. Have resuscitative equipment and trained personnel available. 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. Do not use chronically if test dose ineffective. For chronic dosing use approved pump (eg, Medtronic SynchroMed Infusion System). Allow at least one year after traumatic brain injury before starting. Infections. Psychosis. Schizoaffective disorders. Confusion. Autonomic dysreflexia. Renal impairment. Hospitalize immediately if pump malfunction suspected. Pregnancy (Cat.C). Nursing mothers: not recommended.
Hypotension, dyspnea with morphine. Additive CNS depression with alcohol, other CNS depressants. Do not mix with other drugs in pump or catheter.
Muscle relaxant (central), antispastic agent.
Hypotonia, somnolence, dizziness, nausea, vomiting, paresthesia, headache, convulsion, hypotension, agitation, constipation, leukocytosis, chills, urinary retention, coma, drowsiness, psychosis, confusion; CNS depression, cardiovascular collapse, respiratory failure; others.
Single use ampules—1; Refill Kits—1, 2 (w. ampules and supplies)
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