GABLOFEN

Generic Name for GABLOFEN

Baclofen 50mcg/mL, 500mcg/mL, 2000mcg/mL; for intrathecal inj; preservative-free.


Legal Classification

Rx


Pharmacological Classification

Muscle relaxant (central), antispastic agent.


Manufacturer

CNS Therapeutics


INDICATIONS FOR GABLOFEN

Severe spasticity of cerebral or spinal origin, when oral baclofen not appropriate.

DOSAGE FOR GABLOFEN

<4yrs: not recommended. ≥4yrs: Give test dose 1st by intrathecal inj via spinal catheter or lumbar puncture (see literature for dose and timing; use 50mcg/mL syringe). Dose titration: see literature. Maintenance: titrate individually; use lowest effective dose; maintain some degree of muscle tone. Spinal cord origin: usually 300–800mcg/day. Cerebral origin: usually 90–700mcg/day. Avoid abrupt cessation (may be severe/fatal); closely monitor pump, alarms, and refill schedule; wean orally-administered antispasticity drugs carefully.

CONTRAINDICATIONS FOR GABLOFEN

Not for IV, IM, SC or epidural administration.

WARNINGS/PRECAUTIONS FOR GABLOFEN

Do not discontinue abruptly; may result in high fever, altered mental status, rebound spasticity, muscle rigidity. 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. 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). Allow at least one year after traumatic brain injury before starting. Psychosis. Schizoaffective disorders. Confusion. Autonomic dysreflexia. Infections. Hospitalize immediately if pump malfunction suspected. Pregnancy (Cat.C). Nursing mothers: not recommended.

INTERACTIONS FOR GABLOFEN

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 literature).

ADVERSE REACTIONS GABLOFEN

Hypotonia, somnolence, dizziness, paresthesia, GI upset, headache, constipation, convulsion, hypotension, coma, drowsiness, psychosis, confusion, agitation, leukocytosis, chills, urinary retention; CNS depression, cardiovascular collapse, respiratory failure; others.

HOW IS GABLOFEN SUPPLIED

Screening dose prefilled syringe (50mcg/1mL)—1
Single-use vial (10,000mcg/20mL)—1
Single-use vial (40,000mcg/20mL)—1

RELATED DISEASE:

Spasticity


Original Source:http://www.empr.com/gablofen/muscle-spasms/drug/8381/
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