Trade Names:Lioresal- Tablets 10 mg- Tablets 20 mg- Intrathecal 0.05 mg/mL (50 mcg/mL)- Intrathecal 10 mg/20 mL (500 mcg/mL)- Intrathecal 10 mg/5 mL (2000 mcg/mL)APO-Baclofen (Canada)Gen-Baclofen (Canada)PMS-Baclofen (Canada)ratio-Baclofen (Canada)
May inhibit transmission of reflexes at spinal level, possibly by action (hyperpolarization) at primary afferent fiber terminals, resulting in relief of muscle spasticity; has CNS depressant properties.
Rapidly and extensively absorbed.
Primarily by the kidney in unchanged form.
Treatment of reversible spasticity resulting from multiple sclerosis. May be of some value in patients with spinal cord injuries and other spinal cord diseases.Intrathecal
Treatment of severe spasticity of spinal cord origin in patients who are unresponsive to or cannot tolerate oral baclofen therapy. Used intrathecally in single bolus test doses; chronic use requires implantable pump.
Therapy for trigeminal neuralgia (tic douloureux); tardive dyskinesia.Intrathecal
Cerebral palsy spasticity in children.
Treatment of spasms from rheumatic disorders, stroke, cerebral palsy and Parkinson disease; use of intrathecal form via IV, IM, subcutaneous, or epidural routes.
PO 5 mg 3 times daily; may be increased by 5 mg/dose every 3 days as needed to max 80 mg/day (20 mg 4 times daily). Intrathecal Refer to manufacturer's manual for implantable pump.ScreeningAdults
1 mL of 50 mcg/mL dilution is administered into the intrathecal space by barbotage over 1 min and patient is observed for 4 to 8 h; may be repeated 24 h later with 75 mcg/1.5 mL and 48 h later with 100 mcg/2 mL. Do not give implantable pump to patients not responding to 100 mcg bolus.Children
The starting screening dose for children is the same as in adult patients (eg, 50 mcg). However, for very small patients, a screening dose of 25 mcg may be tried first.Postimplant Dose Titration Period
To determine the initial total daily dose of baclofen following implant, double the screening dose that gave a positive effect and administer over a 24-h period.Spasticity of Spinal Cord OriginAdults
Intrathecal After the first 24 h, increase the daily dosage slowly in 10% to 30% increments and only once every 24 h, until desired effect is achieved.Spasticity of Cerebral OriginAdults
Intrathecal After the first 24 h, increase the daily dose slowly 5% to 15% once every 24 h, until desired clinical effect is achieved.Children
After the first 24 h, increase the daily dose slowly 5% to 15% only once every 24 h, until the desired effect is achieved.Maintenance Therapy for Spasticity of Spinal Cord Origins
Very often the maintenance dose needs to be adjusted during the first few months of therapy while patients adjust to changes in life-style because of the alleviation of spasticity.Adults
Intrathecal During periodic refills of the pump, the daily dose may be increased 10% to 40%, but no more than 40%, to maintain adequate symptom control. Maintenance dose for long-term continuous infusion has ranged from 12 to 2,003 mcg/day, with most patients adequately maintained on 300 to 800 mcg/day.Maintenance Therapy for Spasticity of Cerebral Origin
Very often the maintenance dose needs to be adjusted during the first few months of therapy while patients adjust to changes in life style because of the alleviation of spasticity.Adults
Intrathecal During the periodic refills of the pump, the daily dose may be increased 5% to 20%, but no more than 20%. Ranges from 22 to 1,400 mcg/day, with most patients adequately maintained on 90 to 703 mcg/day.Children less than 12 yr of age
Average daily dose 274 mcg/day. Requires individual titration. Use the lowest dose with an optimal response.Children at least 12 yr of age
Same as adult. Determination of the optimal dose requires individual titration. Use the lowest dose with an optimal response.
Do not store above 86°F.Intrathecal
Do not store above 86°F. Do not freeze. Do not heat sterilize.
May cause increased sedative effects.Morphine (epidural)
May cause hypotension and dyspnea.
May cause false elevation of AST, alkaline phosphatase, or blood glucose.
Hypotension; palpitations; chest pain.
Drowsiness; weakness in lower extremities; dizziness; seizures; headache; numbness; euphoria; depression; confusion; lethargy; insomnia; hallucinations; paresthesia; asthenia; anxiety; agitation.
Tinnitus; blurred vision; taste disorder; nasal congestion.
Nausea; vomiting; dry mouth; constipation; diarrhea; abdominal pain; anorexia.
Urinary frequency; enuresis; dysuria; impotence.
Dyspnea; pneumonia; hypoventilation.
Hypotonia; slurred speech; muscle pain; ankle edema; excessive perspiration; weight gain; back pain.
Abrupt discontinuation has resulted in high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity that in rare cases advances to rhabdomyolysis, multiple organ system failure and death.
Give special attention to patients at apparent risk (eg, spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).
Category C .
Excreted in breast milk.
Safety of oral baclofen in children younger than 12 yr of age and of intrathecal baclofen in children younger than 4 yr of age has not been established.
Administer with caution. Dosage reduction may be necessary.
Only specially trained personnel should administer baclofen intrathecally because of potentially life-threatening CNS depression, CV collapse, or respiratory failure.
Use with caution because of potential exacerbations.
Fatalities occurred in premarketing trials of intrathecal baclofen; baclofen's role in these deaths is unknown.
Patients should be infection-free before screening trial with baclofen intrathecal.
Baclofen has not significantly benefited patients with stroke; these patients also have poor drug tolerance.
Vomiting, muscular hypotonia, muscle twitching, drowsiness, accommodation disorders, coma, respiratory depression, seizures (oral); drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures (intrathecal).
Copyright © 2009 Wolters Kluwer Health.