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Lioresal

Pronunciation

Generic Name: Baclofen
Class: GABA-derivative Skeletal Muscle Relaxants
VA Class: MS200
Chemical Name: 4-Amino-3-(4-chlorophenyl)-butanoic acid
Molecular Formula: C10H12ClNO2
CAS Number: 1134-47-0

Warning(s)

  • Intrathecal Baclofen Withdrawal
  • Abrupt discontinuance of intrathecal baclofen has resulted in high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity; in rare cases, progression to rhabdomyolysis, multisystem organ failure, and death has occurred.113

  • Give careful attention to programming and monitoring of infusion system, refill scheduling and procedures, and pump alarms to prevent abrupt discontinuance.113 (See Warnings under Cautions.)

  • Advise patients and caregivers of the importance of keeping scheduled refill visits and of the early signs and symptoms of baclofen withdrawal.113

  • Give special attention to patients at apparent risk for withdrawal (e.g., spinal cord injury at T6 level or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).113

  • Consult technical manual of implantable infusion system for additional postimplant clinician and patient information.113

Introduction

Skeletal muscle relaxant and antispastic agent; a GABA derivative.113 128

Uses for Lioresal

Spasticity

Oral management of spasticity and its sequelae secondary to severe chronic disorders such as multiple sclerosis and other types of spinal cord lesions.112 128 Not indicated for use in patients with rheumatic disorders.128 Efficacy not established in patients with stroke, cerebral palsy, or Parkinson’s disease; use not recommended in these patients.128

Intrathecal management of severe spasticity of spinal cord origin in patients who do not tolerate or respond adequately to oral baclofen;109 110 113 114 115 116 117 118 119 120 considered an alternative to destructive neurosurgical procedures.113 Also, intrathecal management of intractable spasticity secondary to severe chronic disorders such as multiple sclerosis and other types of spinal diseases such as spinal ischemia, spinal tumor, transverse myelitis, cervical spondylosis, and degenerative myelopathy; designated an orphan drug by FDA for use in these conditions.112

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Intrathecal management of severe spasticity of cerebral origin, including cerebral palsy and acquired brain injury;113 121 122 123 124 125 126 127 considered an alternative to destructive neurosurgical procedures.113 Designated an orphan drug by FDA for management of spasticity in patients with cerebral palsy.112 Patients with spasticity secondary to traumatic brain injury should wait ≥1 year after the injury before considering long-term intrathecal baclofen therapy.113

Lioresal Dosage and Administration

General

  • Clinical goal is to maintain muscle tone as close to normal as possible and to minimize frequency and severity of spasms without inducing intolerable adverse effects.113 115 May be important to maintain some degree of muscle tone and allow occasional spasms to help support circulatory function, minimize risk of DVT occurrence, and optimize activities of daily living and ease of care.113

  • Individualize dosage according to patient’s requirements and response; use lowest dosage that produces optimum response.113 128

  • Some patients require 1–2 months of oral treatment for full benefit.b If benefits are not evident after a reasonable trial period, discontinue therapy by slowly reducing daily dosage.128

  • Prior to implantation of pump for chronic intrathecal baclofen therapy, patient must exhibit positive response (clinically important decrease in muscle tone and/or frequency and/or severity of spasms over 4- to 8-hour observation period) to initial intrathecal test dose(s) (screening phase).110 113 115

  • In patients receiving intrathecal baclofen therapy, closely monitor patients in a fully equipped and staffed environment during initial test for responsiveness and dosage-titration period immediately following implantation of pump.113 Resuscitative equipment should be immediately available for use in case of life-threatening or intolerable adverse effects.113

  • Tolerance may develop during chronic intrathecal baclofen therapy.113 115 No firm recommendations regarding amelioration of tolerance; patients occasionally have been hospitalized and intrathecal baclofen dosage decreased gradually over 2- to 4-week period, during which baclofen was alternated with other methods of spasticity management.113 115 Sensitivity to baclofen may return after a few days, and continuous intrathecal baclofen therapy may be resumed at the previously effective initial dosage.113 115

Administration

Administer orally or intrathecally.113 127 128

Baclofen injection for intrathecal administration is not recommended or intended for IV, IM, sub-Q, or epidural administration.113 115

Avoid abrupt discontinuance (because of risk of precipitating withdrawal).113 127 128 Reduce dosage slowly when discontinuing drug, except for serious adverse reactions.113 128 (See Warnings under Cautions.)

Oral Administration

Administer orally 3 times daily.128

Intrathecal Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer test dose(s) during screening phase by direct intrathecal injection (via lumbar puncture or catheter) over ≥1 minute employing barbotage.110 113 114 115

Administer maintenance regimen by continuous intrathecal infusion into a lumbar intrathecal space via an implantable controlled-infusion device (e.g., Medtronic SynchroMed pump).110 113 114 115

Consult manufacturer’s labeling for specialized administration techniques.113

Consult manual provided by manufacturer of implantable infusion device for specific instructions and precautions for programming pump and/or refilling reservoir.113 Various pumps (with different reservoir volumes) and refill kits are available; clinicians must be familiar with these products in order to select the appropriate refill kit for the particular pump in use.113

Dilution

To prepare test doses for screening phase, use 1-mL ampuls containing 50 mcg of baclofen without further dilution.113 Ampuls are for single use only; discard any unused portion.113

For maintenance therapy in patients receiving concentrations other than the commercially available strengths (i.e., 0.5 or 2 mg/mL), injection concentrate must be diluted with sterile, preservative-free 0.9% sodium chloride for injection.113

Rate of Administration

Test dose(s): Direct intrathecal injection by barbotage over ≥1 minute.113

Maintenance regimen: Continuous intrathecal infusion.113

Dosage

Pediatric Patients

Spasticity
Oral

Children ≥12 Years of Age: Initially, 5 mg 3 times daily.128 Increase daily dosage by 15 mg (in 3 divided doses) at 3-day intervals (i.e., 5 mg 3 times daily for 3 days, then 10 mg 3 times daily for 3 days, then 15 mg 3 times daily for 3 days, then 20 mg 3 times daily for 3 days) until optimum effect is achieved.128

Usual dosage in children ≥12 years of age is 40–80 mg daily.128

Screening for Response to Intrathecal Baclofen in Severe Spasticity
Intrathecal

Administer test dose of 50 mcg (1 mL of 50-mcg/mL solution) into intrathecal space by barbotage over ≥1 minute; may consider an initial dose of 25 mcg in very small children.113

If response observed at 4–8 hours after initial test dose is less than desired, administer a second test dose of 75 mcg (1.5 mL of a 50-mcg/mL solution) 24 hours after first test dose.113

If response observed at 4–8 hours after the second test dose remains inadequate, administer a final test dose of 100 mcg (2 mL of a 50-mcg/mL solution) 24 hours after second test dose.113

Patients not responding to 100-mcg test dose are not candidates for chronic intrathecal therapy.110 113 115

Maintenance Therapy for Severe Spasticity
Intrathecal

Following establishment of responsiveness to intrathecal baclofen, administer initial daily dose over 24 hours.113 115

Initial daily dose is twice the test dose that produced a positive response with a duration not >8 hours.113 115 If positive response to test dose persisted >8 hours, initial dose is the same as the test dose that produced a positive response.113 115

Following the initial infusion dose in children with spasticity of spinal cord or cerebral origin, increase daily dosage slowly (by 5–15% increments at 24-hour intervals) until desired clinical response is achieved.113 115

May need to adjust maintenance dosage often during initial months of therapy.113 115 During periodic pump refills, increase the 24-hour dose by up to 10–40% in patients with spasticity of spinal cord origin or up to 5–20% in those with spasticity of cerebral origin as necessary to maintain adequate control of symptoms.113 115 In patients who develop intolerable adverse effects, reduce the 24-hour dose by 10–20%.113 115

Patients achieving relatively satisfactory relief may derive further benefit from more complex dosing schedules.110 113 115 For example, patients who commonly experience an exacerbation of spasticity that disrupts sleep may require a 20% increase in the hourly infusion rate (programmed to begin approximately 2 hours before the time of desired clinical benefit).110 113 115

Maintenance dosage in most children >12 years of age: 300–800 mcg daily (range: 12–2003 mcg daily) in those with spasticity of spinal cord origin;110 113 115 90–703 mcg daily (range: 22–1400 mcg daily) in those with spasticity of cerebral origin.113

Average maintenance dosage in children <12 years of age: 274 mcg daily (range: 24–1199 mcg daily).113

Adults

Spasticity
Oral

Initially, 5 mg 3 times daily.128 Increase daily dosage by 15 mg (in 3 divided doses) at 3-day intervals (i.e., 5 mg 3 times daily for 3 days, then 10 mg 3 times daily for 3 days, then 15 mg 3 times daily for 3 days, then 20 mg 3 times daily for 3 days) until optimum effect is achieved.128

Usual dosage is 40–80 mg daily.128

Screening for Response to Intrathecal Baclofen in Severe Spasticity
Intrathecal

Administer test dose of 50 mcg (1 mL of 50-mcg/mL solution) into intrathecal space by barbotage over ≥1 minute.113

If response observed at 4–8 hours after initial test dose is less than desired, administer a second test dose of 75 mcg (1.5 mL of a 50-mcg/mL solution) 24 hours after first test dose.113

If response observed at 4–8 hours after the second test dose remains inadequate, administer a final test dose of 100 mcg (2 mL of a 50-mcg/mL solution) 24 hours after second test dose.113

Patients not responding to 100-mcg test dose are not candidates for chronic intrathecal therapy.110 113 115

Maintenance Therapy for Severe Spasticity
Intrathecal

Following establishment of responsiveness to intrathecal baclofen, administer initial daily dose over 24 hours.113 115

Initial daily dose is twice the test dose that produced a positive response with a duration not >8 hours.113 115 If positive response to test dose persisted >8 hours, initial dose is the same as the test dose that produced a positive response.113 115

Following the initial infusion dose, increase daily dosage slowly until the desired clinical response is achieved: increase dosage by 10–30% increments at 24-hour intervals in adults with spasticity of spinal cord origin and by 5–15% increments at 24-hour intervals in adults with spasticity of cerebral origin.113 115

May need to adjust maintenance dosage often during initial months of therapy.113 115 During periodic pump refills, increase the 24-hour dose by up to 10–40% in patients with spasticity of spinal cord origin or up to 5–20% in those with spasticity of cerebral origin as necessary to maintain adequate control of symptoms.113 115 In patients who develop intolerable adverse effects, reduce the 24-hour dose by 10–20%.113 115

Patients achieving relatively satisfactory relief may derive further benefit from more complex dosing schedules.110 113 115 For example, patients who commonly experience an exacerbation of spasticity that disrupts sleep may require a 20% increase in the hourly infusion rate (programmed to begin approximately 2 hours before the time of desired clinical benefit).110 113 115

Maintenance dosage in most patients: 300–800 mcg daily (range: 12–2003 mcg daily) in those with spasticity of spinal cord origin;110 113 115 90–703 mcg daily (range: 22–1400 mcg daily) in those with spasticity of cerebral origin.113

Prescribing Limits

Pediatric Patients

Spasticity
Oral

Some clinicians suggest that daily dosages up to 150 mg are well tolerated and provide additional therapeutic benefit in some patients; however, one manufacturer states that dosage should not exceed 80 mg daily (20 mg 4 times daily).128

Intrathecal

Limited experience with maintenance dosages >1000 mcg daily.113

Adults

Spasticity
Oral

Some clinicians suggest that daily dosages up to 150 mg are well tolerated and provide additional therapeutic benefit in some patients; however, one manufacturer states that dosage should not exceed 80 mg daily (20 mg 4 times daily).128

Intrathecal

Limited experience with maintenance dosages >1000 mcg daily.113

Special Populations

Renal Impairment

Reduction of oral or intrathecal dosage may be necessary.113 128

Geriatric Patients

Increase oral dosage more gradually.b

Patients with Psychiatric or Brain Disorders

Increase oral dosage more gradually.b

Cautions for Lioresal

Contraindications

  • Known hypersensitivity to baclofen or any ingredient in the formulation.113 128

Warnings/Precautions

Warnings

Abrupt Withdrawal of Oral Therapy

Abrupt discontinuance of oral baclofen may result in hallucinations and seizures.127 128

Abrupt Withdrawal of Intrathecal Therapy

Abrupt discontinuance of intrathecal baclofen has resulted in high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity; in rare cases, progression to rhabdomyolysis, multisystem organ failure, and death have occurred.113

Symptoms usually appear within hours to days following interruption of therapy.113 Early symptoms may include return of baseline spasticity, pruritus, hypotension, and paresthesias.113 Advanced withdrawal syndrome may resemble autonomic dysreflexia, sepsis, malignant hyperthermia, neuroleptic malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.113

Rapid, accurate diagnosis and treatment in emergency room or intensive care setting are needed to prevent potentially life-threatening CNS and systemic effects.113

Restore intrathecal baclofen therapy at or near the dosage used prior to interruption.113

If reinstitution of intrathecal delivery is delayed, drugs that enhance GABA effects (e.g., oral or enteral baclofen; oral, enteral, or IV benzodiazepines) may prevent potentially fatal sequelae.113 However, do not rely on oral or enteral baclofen alone to halt progression of intrathecal baclofen withdrawal.113

Experience in Intrathecal Administration

Should be administered intrathecally only by qualified individuals familiar with the administration techniques and patient management problems.113 115

Initial test for responsiveness to intrathecal baclofen, implantation of pump, and subsequent periods of dosage titration must be performed in a medically supervised setting that is adequately equipped for the management of potential complications; resuscitative equipment should be readily available.113 115

Risks of Intrathecal Administration

Potentially life-threatening CNS depression, cardiovascular collapse, and respiratory failure reported following intrathecal administration.113 Fatalities (including one case of unexpected death after administration of 3 test doses and 2 cases of sudden and unexpected death occurring within 2 weeks of pump implantation) reported rarely during intrathecal therapy; however, manufacturer states that causal relationship not established.113

Patients, caregivers, and health-care providers should receive adequate information regarding the risks of intrathecal baclofen therapy, including information on recognition and management of potential overdosage and proper care of the pump and catheter insertion site.113

Management of Controlled Infusion Device

Delay implantation of controlled-infusion device until response to test dose(s) is adequately evaluated.113

Familiarization with the implantable infusion device (e.g., instructions and precautions for pump programming and refilling) is essential.113

Fill drug reservoir under aseptic conditions (to avoid bacterial contamination and serious infection), following the directions provided by the device’s manufacturer; only fully trained and qualified personnel should fill reservoir.113 Follow proper refill frequency to avoid depletion of drug reservoir during use.113 114 115

Monitor patient carefully, particularly during the initial phase of pump use, dosage titration, and reservoir refilling to ensure an acceptable, reasonably stable response.113

Any sudden increase in dosage requirement should suggest the possibility of pump and/or catheter malfunction (i.e., catheter kink or dislodgement).113 If no increase in response is observed with upward titration of dosage, check pump function and catheter patency.113 115

Intrathecal Baclofen Overdose

Signs of intrathecal baclofen overdose may appear suddenly or over a period of time.113

Acute, massive overdose may present as coma.113

Less sudden and/or less severe forms of overdose may present with drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia, and loss of consciousness progressing to coma.113

Overdose generally related to pump malfunction or dosing error.113

If overdose appears likely, immediately take patient to hospital for assessment and emptying of pump reservoir.113

Fill pump with extreme caution; refill only through the pump reservoir refill septum.113 If reservoir refill septum is not properly accessed, inadvertent injection into sub-Q tissue can occur, possibly resulting in life-threatening overdosage or early depletion of reservoir.113 Some pumps are equipped with a catheter access port that allows direct access to the intrathecal catheter; direct injection into this catheter may cause life-threatening overdosage.113

General Precautions

Autonomic Dysreflexia

Use intrathecal baclofen with caution in patients with a history of autonomic dysreflexia; the presence of nociceptive stimuli or abrupt withdrawal of therapy may precipitate episode of dysreflexia.113

CNS Depression

Risk of sedation and/or drowsiness.113 128 Performance of activities requiring mental alertness may be impaired.113 128

Concurrent use of other CNS depressants may potentiate CNS depression.113 128 (See Specific Drugs under Interactions.)

Maintenance of Muscle Tone

Use with caution and titrate dosage carefully when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain increased or optimal body function.113 128

Neurological Disorders

Possible exacerbation of psychotic disorders, schizophrenia, or confusional states; use with caution and monitor such patients carefully.113

Possible deterioration in seizure control and EEG in epileptic patients; monitor patient’s clinical state and EEG at regular intervals.128

Concomitant Antispasmodic Therapies

If intrathecal therapy is to be employed, attempt to discontinue concomitant oral antispasmodic drugs to avoid possible overdose and drug interactions, either prior to screening phase or following implantation of infusion device.113 Monitor patient carefully; avoid abrupt dosage reduction or discontinuance of concomitant antispasmodics.113

Presence of Infection

Presence of infection may interfere with assessment of the patient’s response to baclofen test dose(s),113 increase surgical complications after pump implantation, and complicate attempts to adjust dosage.113 115

Patients being considered for intrathecal baclofen therapy should be without concurrent infection.113

Intrathecal Mass

Development of intrathecal mass at the tip of implanted catheter reported following long-term intrathecal baclofen therapy.113 Most common sequelae or manifestations include decreased therapeutic response (i.e., worsening spasticity, return of spasticity despite previous response, withdrawal symptoms, poor response to escalating doses, frequent or large dosage increases), pain, and neurologic deficit or dysfunction.113

Monitor patients carefully for any new neurologic manifestations.113 If new neurologic manifestations suggestive of an intrathecal mass occur, consider neurosurgical consultation, since many symptoms of inflammatory mass are similar to those associated with severe spasticity.113 In some cases, an imaging procedure may be appropriate to confirm or rule out diagnosis of an intrathecal mass.113

Ovarian Cysts

Ovarian cysts found in about 4% of multiple sclerosis patients receiving oral baclofen for up to 1 year; cysts disappeared spontaneously despite continued baclofen use in most patients.113 128 Estimated rate of occurrence in healthy females is approximately 1–5%.113 128

Specific Populations

Pregnancy

Category C.113

Lactation

Distributed into milk following oral administration; not known whether baclofen distributes into milk following intrathecal administration.113

Nursing not recommended in women receiving oral baclofen.128 Women receiving intrathecal baclofen should nurse infant only if potential benefit justifies potential risks to infant.113

Pediatric Use

Safety and efficacy of oral baclofen not established in children <12 years of age.128

Safety and efficacy of intrathecal baclofen not established in children <4 years of age.113

Children being considered for intrathecal therapy should have sufficient body mass to accommodate the pump.113 Consult directions provided by the device’s manufacturer.113

Renal Impairment

Excreted principally in urine as unchanged drug; use with caution in patients with impaired renal function.113 128 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

For oral baclofen, drowsiness, dizziness, weakness, fatigue.128

For intrathecal baclofen in patients with spasticity of spinal cord origin, somnolence, dizziness, nausea, hypotension, headache, seizures, hypotonia.113

For intrathecal baclofen in patients with spasticity of cerebral origin, agitation, constipation, somnolence, leukocytosis, chills, urinary retention, hypotonia.113

Interactions for Lioresal

Specific Drugs

Insufficient experience with concomitant use of intrathecal baclofen and other drugs to predict specific drug-drug interactions.113

Drug

Interaction

CNS depressants (e.g., alcohol)

Additive CNS depression.113 128

Morphine (epidural)

Hypotension and dyspnea may occur when administered with intrathecal baclofen.113

Lioresal Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration,128 with peak blood concentrations attained within 2–3 hours.b GI absorption is reduced as dosage is increased.128

Following intrathecal administration, plasma concentrations are 100 times less than those achieved following oral administration.113

Onset

Oral administration: Onset in hours to weeks.b

Intrathecal injection: Onset in 0.5–1 hour in adults; peak effect in about 4 hours.113

Continuous intrathecal infusion: Onset at 6–8 hours in adults; peak effect at 24–48 hours.113

Onset and peak response may vary depending on dose and severity of symptoms.113

Duration

Following intrathecal injection, effects may last 4–8 hours.113 Duration may vary depending on dose and severity of symptoms.113

Distribution

Extent

Widely distributed following oral administration, but only small amounts cross the blood-brain barrier.8 16 109 b

Crosses the placentab and distributes into milk following oral administration.113

Plasma Protein Binding

30%.b

Elimination

Metabolism

About 15% of a dose is metabolized in the liver, mostly by deamination.b

Elimination Route

Excreted mainly (70–80%) in urine as unchanged drug or metabolites; remainder is excreted in feces.b

Half-life

Serum half-life: 2.5–4 hours.b

CSF elimination half-life: 1.51 hours for the first 4 hours following intrathecal injection.113 Following intrathecal administration, CSF clearance of baclofen approximates CSF turnover.113

Stability

Storage

Oral

Tablets

Well-closed containers at 20–25°C.128

Parenteral

Injection

≤30°C.113 Refrigeration not required.113 Do not freeze or autoclave.113

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility113

Compatible

Sodium chloride 0.9%

Drug Compatibility
Admixture CompatibilityHID

Compatible

Clonidine HCl

Morphine sulfate

Actions

  • Decreases frequency and amplitude of muscle spasms (tonic reflexes) that arise in response to muscle stretching in patients with various spinal cord lesions.b

  • Simultaneously and equally suppresses cutaneous reflexes and muscle tone but only slightly depresses amplitude of tendon jerks (phasic reflexes).b

  • Inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary afferent terminals; actions at supraspinal sites also may occur and contribute to drug’s clinical effect.113 128

  • Intrathecal administration in animals increases antinociception and decreases muscle rigidity and spasticity.106 107 108

Advice to Patients

  • Importance of not abruptly discontinuing therapy.113 128 For patients receiving intrathecal baclofen, importance of keeping scheduled refill visits and of recognizing early signs and symptoms of withdrawal.113

  • If baclofen is to be administered intrathecally, risks associated with intrathecal baclofen therapy, recognition and management of overdosage, and proper care of pump and catheter insertion site.113

  • Risk of drowsiness; exercise caution when driving or operating machinery.113 128

  • Potential for additive CNS depression if other CNS depressants (e.g., alcohol) are used concomitantly.113 128

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.113 128

  • Importance of women informing their clinician if they are or plan to become pregnant or to breast-feed.113 128

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Baclofen

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg*

Baclofen Tablets (scored)

20 mg*

Baclofen Tablets (scored)

Parenteral

For injection concentrate, for intrathecal administration via compatible infusion device or for intrathecal injection

50 mcg/mL

Gablofen

CNS Therapeutics

Lioresal Intrathecal

Medtronic

0.5 mg/mL

Gablofen

CNS Therapeutics

Lioresal Intrathecal

Medtronic

2 mg/mL

Gablofen

CNS Therapeutics

Lioresal Intrathecal

Medtronic

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Baclofen 10MG Tablets (NORTHSTAR RX): 30/$13.99 or 90/$34.98

Baclofen 20MG Tablets (UPSHER-SMITH): 30/$17.99 or 90/$45.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 23, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

7. Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971; 4:15-7. [IDIS 21127] [PubMed 4938243]

8. Anon. Control of spasticity. Br Med J. 1973; 4:751-2. [PubMed 4758569]

13. Jones RF, Lance JW. Baclofen (Lioresal) in the long-term management of spasticity. Med J Aust. 1976; 1:654-7. [IDIS 70798] [PubMed 820953]

14. Duncan GW, Shahani BT, Young RR. An evaluation of baclofen treatment for certain symptoms in patients with spinal cord lesions. Neurology. 1976; 28:441-6.

16. Brogden RN, Speight TM, Avery GS. Baclofen: a preliminary report of its pharmacological properties and therapeutic efficacy in spasticity. Drugs. 1974; 8:1-14. [IDIS 47602] [PubMed 4154834]

106. Yaksh TL, Reddy SVR. Studies in the primate on the analgetic effects associated with intrathecal actions of opiates, α-adrenergic agonists and baclofen. Anesthesiology. 1981; 54:451-67. [PubMed 6112935]

107. Wilson PR, Yaksh TL. Baclofen is antinociceptive in the spinal intrathecal space of animals. Eur J Pharm. 1978; 51:323-30.

108. Sawynok J, Dickson C. D-Baclofen is an antagonist at baclofen receptors mediating antinociception in the spinal cord. Pharmacology. 1985; 31:248-59. [PubMed 2999839]

109. Knutsson E, Lindblom U, Martensson A. Plasma and cerebrospinal fluid levels of baclofen (Lioresal) at optimal therapeutic responses in spastic paresis. J Neurol Sci. 1974; 23:473-84. [PubMed 4154365]

110. Penn RD, Savoy SM, Corcos D et al. Intrathecal baclofen for severe spinal spasticity. New Engl J Med. 1989; 320:1517-21. [IDIS 254995] [PubMed 2657424]

111. Medtronic, Inc, Boston, MA: Personal communication.

112. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food Drug and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul.

113. Medtronic Inc. Lioresal intrathecal (baclofen injection) prescribing information. Minneapolis, MN; 2011 Oct. From DailyMed website.

114. Penn RD, Kroin JS. Long-term intrathecal baclofen infusion for treatment of spasticity. J Neurosurg. 1987; 66:181-5. [PubMed 3806200]

115. Medtronic Inc. Lioresal (baclofen) intrathecal injection SynchroMed infusion pump product monograph. Minneapolis, MN; 1992 (UC9202606EN NP-1564)

116. Parke B, Penn RD, Savoy SM et al. Functional outcome after delivery of intrathecal baclofen. Acta Phys Med Rehabil. 1989; 70:30-2.

117. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992; 77:236-40. [PubMed 1625011]

118. Kravitz HM, Corcos DM, Hansen G et al. Intrathecal baclofen. Effects on nocturnal leg muscle spasticity. Am J Phys Med Rehabil. 1992; 71:48-52. [PubMed 1739446]

119. Latash ML, Penn RD, Corcos DM et al. Effects of intrathecal baclofen on voluntary motor control in spastic paresis. J Neurosurg. 1990; 72:388-92. [PubMed 2303873]

120. Latash ML, Penn RD, Corcos DM et al. Short-term effects of intrathecal baclofen in spasticity. Exp Neurol. 1989; 103:165-72. [PubMed 2912760]

121. Albright AL, Barron WB, Fasick MP et al. Continuous intrathecal baclofen infusion for spasticity of cerebral origin.

122. Albright AL, Cervi A, Singletary J. Intrathecal baclofen for spasticity in cerebral palsy. JAMA. 1991; 265:1418-22. [IDIS 279342] [PubMed 1999883]

123. Lazorthes Y, Sallerin-Caute B, Verdie JC et al. Chronic intrathecal baclofen administration for control of severe spasticity. J Neurosurg. 1990; 72:393-402. [PubMed 2303874]

124. Rifici C, Kofler M, Kronenberg M et al. Intrathecal baclofen application in patients with supraspinal spasticity secondary to severe traumatic brain injury. Funct Neurol. 1994; 9:29-34. [PubMed 8082851]

125. Medtronic Inc., Minneapolis, MN: Personal communication.

126. Medtronic Inc. Investigation of the administration of Lioresal intrathecal (baclofen injection) for the management of spasticity of cerebral origin: treatment IND protocol. Protocol No. NVD94-043/version 1.1a. Minneapolis, MN: Medtronic Inc; 1994 Dec.

127. Geigy. Lioresal (baclofen) tablets prescribing information. Summit, NJ; 1996 Mar.

128. Teva Pharmaceuticals USA. Baclofen tablets, USP prescribing information. Sellersville, PA; 2010 May. From DailyMed website.

b. AHFS drug information 2012. McEvoy GK, ed. Baclofen. Bethesda, MD: American Society of Health-System Pharmacists; 2012:1402-5.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:204-5.

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