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Baclofen: Drug information

Baclofen: Drug information
(For additional information see "Baclofen: Patient drug information" and see "Baclofen: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Abrupt withdrawal (injection):

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, which in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Advise patients and caregivers of the importance of keeping scheduled refill visits and educate them on the early symptoms of baclofen withdrawal. 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). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information.

Brand Names: US
  • Fleqsuvy;
  • Gablofen;
  • Lioresal;
  • Ozobax
Brand Names: Canada
  • APO-Baclofen;
  • Baclofen-10;
  • Baclofen-20;
  • DOM-Baclofen;
  • Lioresal DS [DSC];
  • Lioresal Intrathecal;
  • Lioresal [DSC];
  • MYLAN-Baclofen;
  • PMS-Baclofen;
  • RATIO-Baclofen [DSC];
  • RIVA-Baclofen
Pharmacologic Category
  • Skeletal Muscle Relaxant
Dosing: Adult

Note: Gradual dose reduction is advised unless discontinuation is due to significant adverse effects or overdose-related emergencies; chronic oral baclofen therapy should be discontinued over at least 1 to 2 weeks or longer if withdrawal symptoms occur (CSM 1997; O’Rourke 2001). Abrupt discontinuation of oral or intrathecal baclofen may result in severe adverse effects, including multiple organ-system failure and death.

Alcohol use disorder

Alcohol use disorder (alternative agent) (off-label use):

Note: Baclofen for alcohol abstinence has been supported primarily by data from and guidelines for patients with alcoholic liver disease.

Oral: Initial: 5 mg 3 times daily; may increase dose after 3 to 5 days based on response and tolerability to 10 mg 3 times daily; may increase further as needed to a maximum dose of 60 mg/day in divided doses (AASLD [Crabb 2020]; ACG [Singal 2018]; Addolorato 2007; Addolorato 2011).

Hiccups

Hiccups (off-label use):

Oral: Initial: 5 to 10 mg 3 times daily; may increase dose based on response and tolerability; usual maximum dose: 45 mg/day in divided doses (Boz 2001; Guelaud 1995; Zhang 2014).

Muscle spasm and/or musculoskeletal pain

Muscle spasm and/or musculoskeletal pain (adjunctive therapy) (off-label use):

Note: For skeletal muscle spasm and/or pain (eg, low back pain, neck pain) with muscle spasm, usually in combination with a nonsteroidal anti-inflammatory drug and/or acetaminophen (ACP [Chou 2017]; van Tulder 2003). In general, muscle relaxants should be used temporarily (eg, for a few days or intermittently for a few days when needed) (APS 2016).

Oral: Initial: 5 to 10 mg 3 times daily as needed (Isaac 2020).

Spasticity

Spasticity:

Oral:

Solution, tablet: Initial: 5 mg 1 to 3 times daily; may increase by 5 mg per dose every 3 days based on response and tolerability; usual maximum dose: 80 mg/day in divided doses. Some patients may require doses up to 120 mg/day (Galvez-Jimenez 2020; Olek 2020).

Suspension: Initial: 5 mg (1 mL) 3 times daily; may increase by 5 mg (1 mL) per dose every 3 days based on response and tolerability; usual maximum dose: 80 mg (16 mL) per day (20 mg [4 mL] 4 times per day).

Intrathecal:

Note: Use extreme caution when filling the pump; follow manufacturer instructions.

Screening dose: Initial bolus: 50 mcg over ≥1 minute then observe patient for 4 to 8 hours. A positive response consists of a significant decrease in muscle tone, frequency, and/or severity of spasms. If response is inadequate, may give 75 mcg as a second screening dose 24 hours after the first dose; observe patient for 4 to 8 hours. If response is still inadequate, may administer 100 mcg as a final screening dose 24 hours after the second dose. Patients not responding to screening dose of 100 mcg should not be considered for chronic infusion via implanted pump.

Initial total daily continuous infusion dose via implanted pump:

If screening dose provided positive response for >4 hours but <8 hours: Double the screening dose that gave a positive response and administer over 24 hours.

If screening dose provided positive response for >8 hours: Infuse a dose equivalent to the screening dose over 24 hours.

Initial titration after pump implantation: Do not increase dose in first 24 hours to allow steady state to be achieved; thereafter, initial dosage adjustments may be made by increasing daily dose by 10% to 30% (spasticity of spinal cord origin) or by 5% to 15% (spasticity of cerebral origin) once every 24 hours until satisfactory response.

Maintenance dose and titration: Daily dose may be increased periodically (eg, during pump refills) by 10% to 40% (maximum increase: 40%) for spasticity of spinal cord origin or by 5% to 20% (maximum increase: 20%) for spasticity of cerebral origin. Dose may also be decreased 10% to 20% for adverse effects. Most patients have been adequately maintained on 300 to 800 mcg daily (spasticity of spinal cord origin) or 90 to 703 mcg daily (spasticity of cerebral origin). Experience with doses >1,000 mcg daily is limited.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

Oral:

The following dosage adjustments have been recommended (Vlavonou 2014; expert opinion): Note: Kidney function may be estimated using the Cockcroft-Gault formula for dosage adjustment purposes.

CrCl >80 mL/minute: No dosage adjustment necessary.

CrCl 50 to 80 mL/minute: Initial: 5 mg every 12 hours; titrate cautiously to effect; do not exceed 50 mg/day or ~66% of the usual maximum daily dose, whichever is less.

CrCl 30 to <50 mL/minute: Initial: 2.5 mg every 8 hours; titrate cautiously to effect; do not exceed 40 mg/day or ~50% of the usual maximum daily dose, whichever is less.

CrCl <30 mL/minute: Avoid use; in some patients, even low initial doses for short duration have led to toxicity (El-Husseini 2011; Salim 2018). If baclofen use cannot be avoided, initiate at a low dose (eg, 2.5 mg every 12 hours or less); titrate with extreme caution to effect; do not exceed 20 mg/day or ~33% of the usual maximum daily dose, whichever is less.

Intrathecal: Mild to severe impairment: There are no specific dosage adjustments recommended. However, baclofen is primarily eliminated by the kidney; use with caution; dosage reduction may be necessary.

Hemodialysis, intermittent (thrice weekly): Dialyzable (1 case report of 79% removal with a 4-hour session) (Wu 2005):

Oral, intrathecal: Avoid use. Numerous case reports and 1 population-based cohort study have demonstrated significant adverse events related to chronic maintenance dosing and unintentional overdoses (Chauvin 2020; Chen 1997; El-Husseini 2011; Hadjiyannacos 2001; Khazneh 2018; Lee 2013; Pathak 2019; Porter 2017; Su 2009; Wolf 2017). If baclofen use cannot be avoided, initiate at a low dose (eg, 2.5 mg orally every 12 hours or less); titrate with extreme caution to effect (Chauvin 2020).

Peritoneal dialysis:

Oral, intrathecal: Avoid use. Baclofen clearance by peritoneal dialysis has not been characterized. Multiple case reports have reported hospitalization for encephalopathy (Chen 2009; Lee 2013; Lois 2006). If baclofen use cannot be avoided, initiate at a low dose (eg, 2.5 mg orally every 12 hours or less); titrate with extreme caution to effect (Chauvin 2020).

CRRT:

Oral, intrathecal: Avoid use. If baclofen use cannot be avoided, initiate at a low dose; titrate cautiously to effect (expert opinion). Note: CRRT data are primarily limited to the treatment of acute baclofen intoxication, which have demonstrated significant increases in baclofen clearance (Meulendijks 2015). However, because CRRT is often used short term and in acutely ill patients, dose increases in response to increased clearance are not recommended unless clinically indicated (eg, increased spasticity) (expert opinion).

PIRRT (eg, sustained, low-efficiency diafiltration):

Oral, intrathecal: Avoid use. Pharmacokinetics of baclofen in patients receiving PIRRT have not been well characterized (expert opinion).

Dosing: Hepatic Impairment: Adult

Oral and intrathecal: There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Baclofen: Pediatric drug information")

Note: Gradual dose reduction is advised unless discontinuation is due to significant adverse effects or overdose-related emergencies; chronic oral baclofen therapy should be discontinued over at least 1 to 2 weeks or longer if withdrawal symptoms occur (CSM 1997). Abrupt discontinuation of oral or intrathecal baclofen may result in severe adverse effects, including multiple organ-system failure and death.

Spasticity:

Oral: Note: Dose-related side effects (eg, sedation) may be minimized by slow titration; lower initial doses than described below (2.5 to 10 mg daily) may be used with subsequent titration to 8 hourly doses (Scheinberg 2006). There is limited published data in infants and children; the following is a compilation of small prospective studies (Goyal 2016; Milla 1977; Scheinberg 2006) and one large retrospective analysis of baclofen use in children (Lubsch 2006). Efficacy results variable (AAN [Delgado 2010]; Navarrete-Opazo 2016):

Infants ≥4 months and Children <2 years: Very limited data available: Oral: Usual dose: 10 to 20 mg/day in divided doses every 8 hours; begin at low end of range and titrate dose to patient response (Lubsch 2006); titration intervals of every 7 days have been used in pediatric patients ≥2 years (Goyal 2016; Scheinberg 2006). Maximum daily dose: 40 mg/day (Lubsch 2006). Dosing based on a retrospective study of 87 patients (age 9 ± 6 years; range: 0.4 to 23.5 years) with spasticity due to cerebral palsy or traumatic brain injury (Lubsch 2006). Note: To minimize dose-related side effects (eg, sedation), lower initial doses (eg, 2.5 mg once to 3 times daily) may be considered and has been reported in pediatric patients >2 years (Goyal 2016; Scheinberg 2006).

Children 2 to 7 years: Limited data available: Oral: Initial: 2.5 mg 3 times daily; titrate dose by 5 mg increments at weekly intervals to patient response; usual dose: 20 to 40 mg/day. Maximum daily dose: 60 mg/day (Goyal 2016; Lubsch 2006; Milla 1977; Scheinberg 2006). Note: Initial doses of 5 to 10 mg/day divided every 8 hours and more frequent titration intervals (ie, every 3 days) have also been described (Milla 1977).

Children ≥8 years and Adolescents: Limited data available in children <12 years: Oral: Initial: 5 mg 3 times daily; titrate dose to patient response at weekly intervals to usual dose of 30 to 40 mg/day; maximum daily dose: 60 mg/day (Goyal 2016; Lubsch 2006; Milla 1977; Scheinberg 2006); some patients ≥12 years may require every-6-hour dosing; usual maximum daily dose range: 60 to 80 mg/day. Note: Lower initial doses (5 to 10 mg/day) and more frequent titration intervals (every 3 days) have also been described (Milla 1977). Higher maximum daily doses (up to 200 mg/day) have been described in some patients in a retrospective review, usually the higher doses were needed over time (Lubsch 2006).

Intrathecal: Note: Dosage adjustments may be required often during the first few months of therapy to adjust for life style changes due to alleviation of spasticity. Maintain lowest dose that produces adequate response. Most patients require gradual increases over time to maintain optimal response. Sudden large requirements for a dose increase may indicate a catheter complication (eg, kink, dislodgement). Titrate dose to allow sufficient muscle tone and occasional spasms to optimize activities of daily living, support circulation, and possibly prevent DVT formation. Use extreme caution when filling the pump; follow manufacturer instructions carefully. With chronic therapy, 5% to 10% of patients will become refractory to dose adjustments; may consider a drug holiday (hospitalized patients only) with a gradual withdrawal over 2 to 4 weeks and use of alternative spasticity management methods. Following the drug holiday intrathecal baclofen may be resumed at the initial continuous infusion dose. Limited data available in children <4 years old, dosing for this age group based on expert consensus recommendations (Berweck 2014).

Screening dose:

Children <4 years: Limited data available: Intrathecal: Initial: 25 mcg; if response is inadequate, double the initial dose and administer 24 hours after the first dose (Berweck 2014).

Children ≥4 years and Adolescents: Intrathecal: Initial: 50 mcg (1 mL) for 1 dose; following initial administration, observe patient for 4 to 8 hours. A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms. If response is inadequate, may give 75 mcg as a second screening dose 24 hours after the first screening dose; observe patient for 4 to 8 hours. If response is still inadequate, may repeat a final screening dose of 100 mcg given 24 hours after the second screening dose. Patients not responding to screening dose of 100 mcg should not be considered for chronic infusion/implanted pump. Note: A 25 mcg initial screening dose may be considered in very small pediatric patients.

Dose titration following pump implant: Children and Adolescents: After positive response to screening dose, a maintenance intrathecal infusion can be administered via an implanted intrathecal pump.

Initial total daily dose via pump: Children and Adolescents: Intrathecal: Double the screening dose that gave a positive response and administer over 24 hours, unless efficacy of the bolus dose was maintained for >8 hours, then infuse a dose equivalent to the screening dose over 24 hours. Do not increase dose in first 24 hours (to allow steady state to be achieved); thereafter, increase daily dose slowly by 5% to 15% once every 24 hours until satisfactory response is achieved; usual range: 50 to 100 mcg daily (Berweck 2014).

Titration to maintenance dose: Children ≥4 years and Adolescents: Intrathecal: Daily dose may be increased 5% to 20% (maximum increase: 20%); may also be decreased 10% to 20% for adverse effects.

Some experts have suggested the following titration parameters: Children and Adolescents (Berweck 2014): Intrathecal:

Inpatient titration: May adjust by 10% to 20% of dose (usual dose change is 50 mcg); maximum increment change: 100 mcg.

Outpatient titration: May adjust by 10% of daily dose (usual dose change is 25 mcg).

Usual maintenance dose: Children and Adolescents: Intrathecal: 100 to 2,000 mcg daily (Berweck 2014); the manufacturer provides the following:

Children 4 to 12 years: Intrathecal: 24 to 1,199 mcg daily (average: 274 mcg/day).

Children ≥12 years and Adolescents: Intrathecal: 90 to 703 mcg daily; daily doses have ranged from 22 to 1,400 mcg; experience with doses >1,000 mcg daily is limited.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Oral: There are no dosage adjustments provided in the manufacturer's labeling; however, baclofen is primarily renally eliminated; use with caution; dosage reduction may be necessary.

Intrathecal: Children and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; however, baclofen is primarily renally eliminated; use with caution; dosage reduction may be necessary.

Dosing: Hepatic Impairment: Pediatric

Oral, Intrathecal: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Oral: Refer to adult dosing; use with caution. If benefits are not observed, withdraw the drug slowly.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intrathecal:

Gablofen: 40,000 mcg/20 mL (20 mL [DSC])

Generic: 10 mg/20 mL (20 mL); 40 mg/20 mL (20 mL); 20,000 mcg/20 mL (20 mL)

Solution, Intrathecal [preservative free]:

Gablofen: 10,000 mcg/20 mL (20 mL); 20,000 mcg/20 mL (20 mL) [antioxidant free]

Gablofen: 40,000 mcg/20 mL (20 mL)

Lioresal: 0.05 mg/mL (1 mL); 40 mg/20 mL (20 mL) [antioxidant free]

Lioresal: 10 mg/20 mL (20 mL); 10 mg/5 mL (5 mL) [antioxidant free, pyrogen free]

Generic: 10 mg/20 mL (20 mL); 40 mg/20 mL (20 mL); 20,000 mcg/20 mL (20 mL)

Solution, Oral:

Ozobax: 5 mg/5 mL (473 mL) [contains methylparaben, propylparaben; grape flavor]

Generic: 5 mg/5 mL (473 mL)

Solution Prefilled Syringe, Intrathecal [preservative free]:

Gablofen: 50 mcg/mL (1 mL) [antioxidant free, latex free]

Gablofen: 20,000 mcg/20 mL (20 mL) [antioxidant free]

Gablofen: 10,000 mcg/20 mL (20 mL); 40,000 mcg/20 mL (20 mL) [antioxidant free, pyrogen free]

Generic: 50 mcg/mL (1 mL)

Suspension, Oral:

Fleqsuvy: 25 mg/5 mL (120 mL, 300 mL) [contains fd&c red #40, fd&c yellow #10 (quinoline yellow), propylene glycol, sodium benzoate]

Tablet, Oral:

Generic: 5 mg, 10 mg, 20 mg

Generic Equivalent Available: US

May be product dependent

Dosage Forms Considerations

First-Baclofen suspension is a compounding kit. Refer to manufacturer’s labeling for compounding instructions.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intrathecal:

Lioresal Intrathecal: 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL); 0.05 mg/mL (1 mL)

Generic: 500 mcg/mL (20 mL); 0.05 mg/mL (1 mL); 2 mg/mL (5 mL, 20 mL)

Tablet, Oral:

Lioresal: 10 mg [DSC]

Lioresal DS: 20 mg [DSC]

Generic: 10 mg, 20 mg

Product Availability

Fleqsuvy oral suspension: FDA approved February 2022; availability anticipated in March 2022.

Lyvispah oral granules: FDA approved November 2021; anticipated availability currently unknown. Information pertaining to this product within the monograph is pending revision. Lyvispah is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Consult the prescribing information for additional information.

Administration: Adult

Intrathecal: For screening dosages, administer as a bolus injection (50 mcg/mL concentration) by barbotage into the subarachnoid space over at least 1 minute, followed by maintenance continuous infusion. Do not administer intrathecal formulation IV, IM, SUBQ, or epidurally.

Oral: Administer without regards to meals. Shake suspension well; use a calibrated measuring device to administer; do not use a household teaspoon or tablespoon.

Administration: Pediatric

Oral: Administer without regard to meals. If nausea occurs, may administer with food or milk (Lioresal prescribing information [Canada] 2018). When using oral liquid product, administer with an oral syringe; do not use a household teaspoon (overdosage may occur).

Parenteral: Intrathecal: Screening dosage: Administer as a bolus injection by barbotage into the subarachnoid space over at least 1 minute, followed by maintenance infusion via implantable infusion pump; do not abruptly discontinue intrathecal baclofen administration. Do not administer intrathecal formulation IV, IM, SubQ, or epidurally.

Use: Labeled Indications

Spasticity:

Oral:

Solution (Ozobax), tablet: Management of reversible spasticity associated with multiple sclerosis or spinal cord lesions.

Suspension (Fleqsuvy): Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity; may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Intrathecal: Management of severe spasticity of spinal cord origin (eg, spinal cord injury, multiple sclerosis) or cerebral origin (eg, cerebral palsy, traumatic brain injury) in patients ≥4 years of age; may be considered as an alternative to destructive neurosurgical procedures.

Limitations of use: Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long-term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS adverse effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least 1 year after the injury before consideration of long-term intrathecal baclofen therapy.

Use: Off-Label: Adult

Alcohol use disorder; Hiccups; Muscle spasm and/or musculoskeletal pain

Medication Safety Issues
Sound-alike/look-alike issues:

Baclofen may be confused with Bactroban

Lioresal may be confused with lisinopril, Lotensin

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication (intrathecal administration) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions (Significant): Considerations
CNS effects

CNS effects may include confusion, dizziness, drowsiness, sedation, asthenia, nausea, and vomiting (Ref). CNS effects may impair physical or mental abilities and be additive to alcohol and other CNS depressants (eg, opioids, benzodiazepines). Multiple cases describing neurotoxicity due to oral baclofen accumulation in adult patients with varying levels of renal impairment have been reported in the literature. In one study of 6,469 older adults on dialysis (360 receiving baclofen), 7.2% of patients started on baclofen were hospitalized for encephalopathy (median time to hospitalization of 3 days) compared to <0.1% of patients not receiving baclofen (Ref).

Mechanism: Dose-related; related to the pharmacologic action. Reduces the release of excitatory neurotransmitters by binding to the GABA-B presynaptic receptors within the brain stem, dorsal horn of the spinal cord, and other CNS sites (Ref).

Risk factors:

• Oral doses >60 mg/day (Ref)

• Oral (vs intrathecal) administration (Ref)

• Severe kidney dysfunction (eGFR <30 mL/minute/1.73m2) (Ref)

Withdrawal effects

Intrathecal baclofen: Abrupt withdrawal of intrathecal baclofen has been associated with altered mental status, exaggerated rebound spasticity, high fever, and muscle rigidity (which in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death) (Ref).

Oral baclofen: Abrupt withdrawal of oral baclofen has been associated with altered mental status, exaggerated rebound spasticity, hallucination, high fever, hypertension, hyperthermia, muscle rigidity, tachycardia, and seizure. Other symptoms include agitation, confusion, delusions, insomnia, and paranoid ideation (Ref).

Mechanism: Withdrawal; related to the release of excitatory neurotransmitters (Ref).

Onset: Rapid; symptoms appear within hours to a few days following interruption of intrathecal therapy (Ref) and within 12 to 72 hours after discontinuation of oral therapy (Ref).

Risk factors:

• Pump malfunction or removal (eg, battery failure, catheter displacement, infection, intrathecal mass) (Ref)

• Preventable human errors (eg, programming or pump refill errors, oral baclofen administration or refill errors) (Ref)

• Patients with spinal cord injuries at T-6 or above, communication difficulties, or history of withdrawal symptoms from intrathecal or oral baclofen

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Nausea (≤12%), vomiting (≤11%)

Nervous system: Confusion (≤11%), dizziness (2% to 15%), drowsiness (6% to 63%, may be transient), headache (2% to 11%), hypotonia (2% to 35%)

Neuromuscular & skeletal: Asthenia (≤15%)

1% to 10%:

Cardiovascular: Hypotension (≤9%), peripheral edema (2% to 3%)

Dermatologic: Pruritus (4%), urticaria (≤1%)

Gastrointestinal: Constipation (≤6%), diarrhea (≤2%), sialorrhea (3%), xerostomia (≤3%)

Genitourinary: Difficulty in micturition (2%), impotence (≤2%), urinary frequency (≤6%), urinary incontinence (≤2%), urinary retention (≤8%)

Nervous system: Abnormality in thinking (≤1%), agitation (≤1%), chills (≤1%), coma (≤2%), depression (2%), fatigue (2% to 4%), insomnia (≤7%), pain (≤4%), paresthesia (≤7%), seizure (≤10%), speech disturbance (≤4%)

Neuromuscular & skeletal: Back pain (≤2%), tremor (≤1%)

Ophthalmic: Amblyopia (≤2%)

Respiratory: Dyspnea (≤1%), hypoventilation (≤4%), pneumonia (≤2%)

Miscellaneous: Accidental injury (≤4%)

<1%:

Cardiovascular: Ankle edema (Bence 2014), bradycardia (Rifici 2011; Sechrist 2015), chest pain, hypertension, palpitations, syncope, vasodilation

Dermatologic: Alopecia, contact dermatitis, dermal ulcer, hyperhidrosis, skin rash (Pathak 2019; Saddichha 2011)

Endocrine & metabolic: Weight gain (Hemingway 2001; Yang 2013)

Gastrointestinal: Abdominal pain (Chen 1997), anorexia, dysgeusia, dysphagia, fecal incontinence, gastrointestinal hemorrhage, occult blood in stools, tongue irritation

Genitourinary: Dysuria, hematuria, nocturia, oliguria, vaginitis

Hematologic & oncologic: Carcinoma, leukocytosis (Gee 2016), petechial rash

Nervous system: Akathisia (Karol 2011), amnesia (Grande 2008; Zeman 2016), anxiety, ataxia (Porter 2017), dysarthria, dysautonomia, dystonia, euphoria (Das 2016; Ghosh 2017), excitement, hallucination, hyporeflexia, hypothermia (Singh 2009), hysteria, inhibited ejaculation (Saval 2008), malaise, opisthotonus, personality disorder, slurred speech

Neuromuscular & skeletal: Muscle rigidity (withdrawal), myalgia

Ophthalmic: Accommodation disturbance, blurred vision, diplopia, miosis, mydriasis, nystagmus disorder, strabismus

Otic: Tinnitus (Auffret 2014)

Renal: Nephrolithiasis

Respiratory: Apnea (Locatelli 2019; Olivier 2016), hyperventilation nasal congestion

Miscellaneous: Fever (can be high fever with drug withdrawal)

Frequency not defined:

Endocrine & metabolic: Increased serum glucose

Hepatic: Increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Nervous system: Withdrawal syndrome

Postmarketing:

Cardiovascular: Deep vein thrombophlebitis (Carda 2008), pulmonary embolism (Carda 2008), transient ischemic attacks (Chauvin 2020)

Endocrine & metabolic: Decreased libido (Hornyak 2005), weight loss (Arima 2010)

Gastrointestinal: Intestinal obstruction (Karthikeyan 2015), paralytic ileus (Morant 2006)

Genitourinary: Erectile dysfunction (Denys 1998), orgasm disturbance (Hornyak 2005; Saval 2008), priapism, sexual disorder (McGehee 2006; Saval 2008)

Nervous system: Delirium (Chauvin 2020), disorientation (Chauvin 2020), suicidal ideation (Pelissier 2017; WeiBhaar 2012)

Neuromuscular & skeletal: Scoliosis (Panagopoulos 2020), scoliosis progression (Ginsburg 2007; Walker 2017)

Contraindications

Hypersensitivity to baclofen or any component of the formulation

Intrathecal formulation: IV, IM, SubQ, or epidural administration

Warnings/Precautions

Concerns related to adverse effects:

• Intrathecal mass: Cases (most from pharmacy compounded preparations) of intrathecal mass formation at the implanted catheter tip have been reported; patients may experience worsening or return of spasticity, pain, inadequate response to dose adjustments, and/or neurological deficit/dysfunction. Neurosurgical evaluation and/or an appropriate imaging study should be considered if a mass is suspected.

• Urinary retention: May cause acute urinary retention (may be related to underlying disease); use with caution in patients with urinary obstruction.

Disease-related concerns:

• Autonomic dysreflexia: Use with caution in patients with a history of autonomic dysreflexia; presence of nociceptive stimuli or abrupt baclofen withdrawal may cause an autonomic dysreflexic episode.

• Gastrointestinal disorders: Use with caution in patients with peptic ulcer disease, decreased GI motility, and/or GI obstructive disorders.

• Psychiatric disease: Use with caution in patients with psychotic disorders, schizophrenia, or confusional states; may cause exacerbation of condition.

• Renal impairment: Use with caution in patients with renal impairment; baclofen is eliminated primarily unchanged via the kidneys.

• Respiratory disease: Use with caution in patients with respiratory disease.

• Seizure disorder: Loss of seizure control has been reported in patients treated with baclofen; use with caution and monitor patients with a history of seizure disorder.

Special populations:

• Elderly: Use with caution in elderly patients; may be more sensitive to adverse CNS effects, especially at higher doses.

• Neonates: Neonatal withdrawal symptoms (eg, increased muscle tone, jitteriness, tremor, seizure), beginning hours to days after delivery, have been reported in neonates born to mothers treated with baclofen throughout pregnancy.

• Pediatric: Intrathecal: Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion.

Dosage form specific issues:

• Oral solutions: Multiple products available; ensure appropriate strength and dose of the oral formulation prior to administering, dispensing, and prescribing; oral suspension is a concentrated formulation.

Other warnings/precautions:

• Appropriate use: Intrathecal: For use only in an FDA-approved implantable pump for intrathecal baclofen administration; health care providers should be experienced with chronic intrathecal infusion therapy and resuscitative equipment should be readily available. Ensure patient is infection-free and then evaluate patient's response to bolus intrathecal injection (screening phase) prior to implanting pump. Monitor closely during the initial phase of pump use and when adjusting the dosing rate and/or the concentration in the reservoir. Educate patients and caregivers on proper home care of the pump and insertion site. Use extreme caution when filling an implantable pump; pumps should only be refilled through the reservoir refill septum. Inadvertent injection into the subcutaneous tissue can occur if the reservoir refill septum is not properly accessed. Some pumps are equipped with a catheter access port that allows direct access to the intrathecal catheter; direct injection into this catheter access port or inadvertent injection into the subcutaneous tissue may cause a life-threatening overdose. Except in overdose related emergencies, intrathecal baclofen should be reduced slowly if discontinuation is necessary.

• Appropriate use: Oral: Efficacy of oral baclofen has not been established in patients with Parkinson disease or cerebral palsy; therefore, use is not recommended. Use caution in patients with a history of stroke; poor tolerability to baclofen without significant benefit has been observed. Not indicated for spasticity associated with rheumatic disorders. Use with caution when spasticity is utilized to sustain upright posture and balance in locomotion, or when spasticity is necessary to obtain increased function.

• Overdose: Intrathecal use: Monitor closely for signs and symptoms of overdose, which may appear suddenly or insidiously, especially during the initial screening and dose-titration phase of treatment, and during reintroduction of therapy after a period of interruption. Signs/symptoms of overdose may include drowsiness, dizziness, somnolence, hypothermia, respiratory depression, seizures, rostral progression of hypotonia, and loss of consciousness progressing to coma. If overdose is suspected, patient should be evaluated immediately in a hospital setting and the pump reservoir emptied.

Metabolism/Transport Effects

None known.

Drug Interactions

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modification

Botulinum Toxin-Containing Products: Muscle Relaxants (Centrally Acting) may enhance the adverse/toxic effect of Botulinum Toxin-Containing Products. Specifically, the risk for increased muscle weakness may be enhanced. Risk C: Monitor therapy

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modification

Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

Daridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Risk C: Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Lacidipine: Baclofen may enhance the hypotensive effect of Lacidipine. Risk C: Monitor therapy

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modification

Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modification

Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Oxybate Salt Products: CNS Depressants may enhance the CNS depressant effect of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider therapy modification

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Tolperisone: May enhance the adverse/toxic effect of Muscle Relaxants (Centrally Acting). Management: Monitor for increased sedation or CNS effects if tolperisone is combined with other centrally acting muscle relaxants. Consider decreasing the tolperisone dose if these agents are combined. Risk D: Consider therapy modification

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Urapidil: Baclofen may enhance the hypotensive effect of Urapidil. Risk C: Monitor therapy

Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Pregnancy Considerations

Late-onset neonatal withdrawal may occur following in utero exposure. Feeding difficulties, high-pitched cry, hyperthermia, hypertonicity, loose stools, tremors, and seizures have been reported in newborns following maternal use of oral baclofen throughout pregnancy (Duncan 2013; Freeman 2016; Ratnayaka 2001). Use of intrathecal baclofen in pregnant females has been described (Dalton 2008; Hara 2018; Méndez-Lucena 2016; Tandon 2010). Maternal plasma concentrations following administration of intrathecal baclofen are significantly less than those with oral doses; exposure to the fetus is expected to be limited and adverse neonatal events have not been noted in available reports (Morton 2009).

Breastfeeding Considerations

Baclofen is present in breast milk.

The relative infant dose (RID) of oral baclofen is 5% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 80 mg/day.

In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).

The RID of baclofen was calculated using a milk concentration of 0.38 mcg/mL, providing an estimated daily infant dose via breast milk of 0.057 mg/kg/day. This milk concentration was obtained following maternal administration of oral baclofen 20 mg four times a day, shortly after birth (Lin 2014). A case report notes breast milk concentrations following maternal use of intrathecal baclofen 330 mcg/day throughout pregnancy were 0.617 ng/mL (Hara 2018). Adverse events were not observed in a breastfed infant following maternal use of intrathecal baclofen 200 mcg/day throughout pregnancy and postpartum (breast milk concentrations not sampled) (Morton 2009).

Information related to milk concentrations is limited (Eriksson 1981; Lin 2014). Withdrawal symptoms may occur in a breastfed infant when maternal baclofen is discontinued or breastfeeding is stopped. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Regular EEG in patients with epilepsy (loss of seizure control has been reported); monitor for signs and symptoms of baclofen withdrawal (oral or intrathecal; eg, altered mental status, exaggerated rebound spasticity, hallucination, high fever, hypertension, hyperthermia, muscle rigidity, tachycardia, seizure, agitation, confusion, delusions, insomnia, and paranoid ideation); prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms; monitor closely during the initial phase of pump use and when adjusting the dosing rate and/or the concentration in the reservoir. monitor closely for signs and symptoms of overdose (eg, drowsiness, dizziness, somnolence, hypothermia, respiratory depression, seizures, rostral progression of hypotonia, and loss of consciousness progressing to coma), which may appear suddenly or insidiously, especially during the initial screening and dose-titration phase of treatment, and during reintroduction of therapy after a period of interruption.

Mechanism of Action

Inhibits the transmission of both monosynaptic and polysynaptic reflexes at the spinal cord level, possibly by hyperpolarization of primary afferent fiber terminals, with resultant relief of muscle spasticity

Pharmacokinetics

Onset of action: Intrathecal bolus: 30 minutes to 1 hour; Continuous infusion: 6 to 8 hours after infusion initiation.

Peak effect: Intrathecal bolus: 4 hours (effects may last 4 to 8 hours); Continuous infusion: 24 to 48 hours.

Absorption (dose dependent): Oral: Rapid; absorption from the GI tract is thought to be dose dependent; in pediatric patients (age range: 2 to 17 years) with cerebral palsy, absorption from GI tract highly variable and delayed (reported time lag: 0.59 ± 0.28 hours) (He 2014).

Bioavailability: Oral: 74% (Agarwal 2015).

Protein binding: 30%.

Distribution: Volume of distribution: Pediatric patients (age range: 2 to 17 years: Oral: Highly variable: 1.16 L/kg with 43.5% interindividual variability (He 2014).

Metabolism: Hepatic (15% of dose) (He 2014).

Half-life elimination:

Oral:

Pediatric patients with cerebral palsy (age range: 2 to 17 years): 4.5 hours (He 2014).

Adults: Solution: 5.7 hours; Suspension: ~5.6 hours; Tablets: 3.75 ± 0.96 hours (Brunton 2011).

Intrathecal: CSF elimination half-life: 1.51 hours over the first 4 hours.

Time to peak, serum: Oral: 1 hour (0.5 to 4 hours) (Brunton 2011); Suspension: 1 hour.

Excretion: Urine (>70% as unchanged drug) and feces (Brunton 2011).

Pricing: US

Solution (Baclofen Intrathecal)

10 mg/20 mL (per mL): $11.60 - $14.18

40 mg/20 mL (per mL): $46.39 - $56.71

Solution (Gablofen Intrathecal)

10000 mcg/20 mL (per mL): $14.18

20000 mcg/20 mL (per mL): $28.35

40000 mcg/20 mL (per mL): $56.71

Solution (Lioresal Intrathecal)

0.05 mg/mL (per mL): $39.56

10 mg/20 mL (per mL): $14.18

10 mg/5 mL (per mL): $56.71

40 mg/20 mL (per mL): $56.71

Solution (Ozobax Oral)

5 mg/5 mL (per mL): $2.07

Solution Prefilled Syringe (Baclofen Intrathecal)

50 mcg/mL (per mL): $105.51

Solution Prefilled Syringe (Gablofen Intrathecal)

50 mcg/mL (per mL): $105.50

10000 mcg/20 mL (per mL): $15.23

20000 mcg/20 mL (per mL): $30.46

40000 mcg/20 mL (per mL): $61.00

Tablets (Baclofen Oral)

5 mg (per each): $0.89 - $1.24

10 mg (per each): $0.14 - $2.47

20 mg (per each): $0.16 - $5.13

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Baclan (IN, KR);
  • Baclofen-ratiopharm (LU);
  • Baclofene (FR);
  • Baclon (FI, LK, TW);
  • Baclopar (IE);
  • Baclosal (IL, LV);
  • Baclosan (RU);
  • Baclosol (VN);
  • Bacmax (IN);
  • Bacofen (KR);
  • Bacron (KR);
  • Bamifen (VN);
  • Barapa (KR);
  • Bathecal (AU);
  • Clofen (AU);
  • Colmifen (MT, SG);
  • Curofen (KR);
  • Diafen (PY, UY);
  • Espast (PE);
  • Flexibac (LK);
  • Gabalon (JP);
  • Gablofen (NL);
  • Liobac (TH);
  • Liofen (IN);
  • Lionova (DK, NO, SE);
  • Liorel (BD);
  • Lioresal (AE, AR, AT, AU, BB, BD, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CN, CO, CY, CZ, DE, DK, EE, ES, ET, FI, FR, GB, GH, GM, GN, GR, GY, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KW, LB, LK, LR, LU, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, NL, NO, NZ, OM, PH, PK, PL, PT, PY, QA, RO, RU, SA, SC, SD, SE, SG, SI, SL, SN, SR, SY, TH, TN, TR, TT, TZ, UG, VE, YE, ZA, ZM, ZW);
  • Lioresyl (CL);
  • Liosal (BD);
  • Lyflex (GB, IE);
  • Miorel (GR);
  • Mulax (TW);
  • Mylinax (CR, DO, GT, HN, NI, PA, SV);
  • Mylobac (EG);
  • Myorel (LK);
  • Onelaxant-R (PH);
  • Pacifen (NZ, TW);
  • Prex (KR);
  • Skelofen (BD);
  • Slaken (BD);
  • Solofen (TW);
  • Spinax (CN, TW);
  • Stelax (AU, HK);
  • Trilaxant (PH);
  • Yylofen (VN);
  • Zufen (CN)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Addolorato G, Leggio L, Ferrulli A, et al; Baclofen Study Group. Dose-response effect of baclofen in reducing daily alcohol intake in alcohol dependence: secondary analysis of a randomized, double-blind, placebo-controlled trial. Alcohol Alcohol. 2011;46(3):312-317. doi:10.1093/alcalc/agr017 [PubMed 21414953]
  2. Addolorato G, Leggio L, Ferrulli A, et al. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomized, double-blind controlled study. Lancet. 2007;370(9603):1915-1922. doi:10.1016/S0140-6736(07)61814-5 [PubMed 18068515]
  3. Agarwal SK, Kriel RL, Cloyd JC, et al. A pilot study assessing pharmacokinetics and tolerability of oral and intravenous baclofen in healthy adult volunteers. J Child Neurol. 2015;30(1):37-41. doi:10.1177/0883073814535504 [PubMed 25028414]
  4. Aisen ML, Dietz M, McDowell F, Kutt H. Baclofen toxicity in a patient with subclinical renal insufficiency. Arch Phys Med Rehabil. 1994;75(1):109-111. [PubMed 8291951]
  5. Albright AL. Baclofen in the treatment of cerebral palsy. J Child Neurol. 1996;11(2):77-83. doi:10.1177/088307389601100202 [PubMed 8881981]
  6. Alden TD, Lytle RA, Park TS, Noetzel MJ, Ojemann JG. Intrathecal baclofen withdrawal: a case report and review of the literature. Childs Nerv Syst. 2002;18(9-10):522-525. doi:10.1007/s00381-002-0634-8 [PubMed 12382179]
  7. Al-Khodairy AT, Vuagnat H, Uebelhart D. Symptoms of recurrent intrathecal baclofen withdrawal resulting from drug delivery failure: a case report. Am J Phys Med Rehabil. 1999;78(3):272-277. doi:10.1097/00002060-199905000-00018 [PubMed 10340425]
  8. Alstermark C, Amin K, Dinn SR, et al. Synthesis and pharmacological evaluation of novel gamma-aminobutyric acid type B (GABAB) receptor agonists as gastroesophageal reflux inhibitors. J Med Chem. 2008;51(14):4315-4320. doi:10.1021/jm701425k [PubMed 18578471]
  9. Alvis BD, Sobey CM. Oral baclofen withdrawal resulting in progressive weakness and sedation requiring intensive care admission. Neurohospitalist. 2017;7(1):39-40. doi:10.1177/1941874416637404 [PubMed 28042369]
  10. American Pain Society (APS). Principles of Analgesic Use. 7th ed. Chicago, IL: American Pain Society; 2016.
  11. Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52. [PubMed 27060684]
  12. Arima H, Oiso Y. Positive effect of baclofen on body weight reduction in obese subjects: a pilot study. Intern Med. 2010;49(19):2043-2047. doi:10.2169/internalmedicine.49.3918 [PubMed 20930428]
  13. ASHP. Standardize 4 Safety Initiative Compounded Oral Liquid Version 1.01. July 2017. https://www.ashp.org/-/media/assets/pharmacy-practice/s4s/docs/s4s-ashp-oral-compound-liquids.ashx?la=en&hash=4C2E4F370B665C028981B61F6210335AD5D0D1D6.
  14. Auffret M, Rolland B, Deheul S, et al; CAMTEA Team. Severe tinnitus induced by off-label baclofen. Ann Pharmacother. 2014 ;48(5):656-659. doi:10.1177/1060028014525594 [PubMed 24577148]
  15. Baclofen tablet [prescribing information]. Memphis, TN: Northstar Rx LLC; October 2020.
  16. Baclofen tablets [prescribing information]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; April 2021.
  17. Baclofen tablets [prescribing information]. Amityville, NJ: Innogenix, LLC; June 2021.
  18. Bence C, Cottencin O, Deheul S, Gautier S, Bordet R, Rolland B. Baclofen-induced edema in alcohol use disorders. J Clin Pharmacol. 2014 ;54(4):478-481. doi:10.1002/jcph.233 [PubMed 24293402]
  19. Berweck S, Lütjen S, Voss W, et al. Use of intrathecal baclofen in children and adolescents: interdisciplinary consensus table 2013. Neuropediatrics. 2014;45(5):294-308. [PubMed 25188830 ]
  20. Boz C, Velioglu S, Bulbul I, Ozmenoglu M. Baclofen is effective in intractable hiccups induced by brainstem lesions. Neurol Sci. 2001;22(5):409. [PubMed 11917982]
  21. Brunton LL, Chabner BA, Knollmann BC, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, NY: McGraw-Hill Medical; 2011.
  22. Carda S, Cazzaniga M, Taiana C, Pozzi R. Intrathecal baclofen bolus complicated by deep vein thrombosis and pulmonary embolism. A case report. Eur J Phys Rehabil Med. 2008;44(1):87-88. [PubMed 18385632]
  23. Chauvin KJ, Blake PG, Garg AX, et al. Baclofen has a risk of encephalopathy in older adults receiving dialysis. Kidney Int. 2020;S0085-2538(20)30552-4. doi:10.1016/j.kint.2020.04.047 [PubMed 32450156]
  24. Chen KS, Bullard MJ, Chien YY, Lee SY. Baclofen toxicity in patients with severely impaired renal function. Ann Pharmacother. 1997;31(11):1315-1320. doi:10.1177/106002809703101108 [PubMed 9391686]
  25. Chen YC, Chang CT, Fang JT, Huang CC. Baclofen neurotoxicity in uremic patients: is continuous ambulatory peritoneal dialysis less effective than intermittent hemodialysis? Ren Fail. 2009;25(2):297-305. doi:10.1081/jdi-120018730 [PubMed 12739836]
  26. Choo YM, Kim GB, Choi JY, et al. Severe respiratory depression by low-dose baclofen in the treatment of chronic hiccups in a patient undergoing CAPD. Nephron. 2000;86(4):546-547. doi:10.1159/000045866 [PubMed 11124626]
  27. Chou CL, Chen CA, Lin SH, Huang HH. Baclofen-induced neurotoxicity in chronic renal failure patients with intractable hiccups. South Med J. 2006;99(11):1308-1309. doi:10.1097/01.smj.0000247632.84949.27 [PubMed 17195438]
  28. Chou R, Deyo R, Friedly J, et al. Systemic pharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline. Ann Intern Med. 2017;166(7):480-492. doi:10.7326/M16-2458 [PubMed 28192790]
  29. Committee on Safety of Medicines (CSM), Medicines Control Agency. Reminder: severe withdrawal reactions with baclofen. Curr Probl Pharmacovigilance. 1997;23:1-4. https://webarchive.nationalarchives.gov.uk/20090218060434/http://www.mhra.gov.uk/home/groups/pl-p/documents/publication/con2023229.pdf
  30. Cooke DE, Glasstone MA. Baclofen poisoning in children. Vet Hum Toxicol. 1994;36(5):448-450. [PubMed 7839572]
  31. Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and treatment of alcohol-associated liver diseases: 2019 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2020;71(1):306-333. doi:10.1002/hep.30866 [PubMed 31314133]
  32. Dalton CM, Keenan E, Jarrett L, Buckley L, Stevenson VL. The safety of baclofen in pregnancy: intrathecal therapy in multiple sclerosis. Mult Scler. 2008;14(4):571-572. doi: 10.1177/1352458507085552 [PubMed 18562512]
  33. Dapas F, Hartman SF, Martinez L, et al. Baclofen for the treatment of acute low-back syndrome. A double-blind comparison with placebo. Spine (Phila Pa 1976). 1985;10(4):345-349. doi:10.1097/00007632-198505000-00010 [PubMed 2931831]
  34. Dario A, Tomei G. A benefit-risk assessment of baclofen in severe spinal spasticity. Drug Saf. 2004;27(11):799-818. doi:10.2165/00002018-200427110-00004 [PubMed 15350152]
  35. Das S, Palappalllil DS, Purushothaman ST, Rajan V. An unusual case of baclofen abuse. Indian J Psychol Med. 2016;38(5):475-476. doi:10.4103/0253-7176.191383 [PubMed 27833235]
  36. Denys P, Mane M, Azouvi P, Chartier-Kastler E, Thiebaut JB, Bussel B. Side effects of chronic intrathecal baclofen on erection and ejaculation in patients with spinal cord lesions. Arch Phys Med Rehabil. 1998;79(5):494-496. doi:10.1016/s0003-9993(98)90061-2 [PubMed 9596387]
  37. Duncan SD, Devlin LA. Use of baclofen for withdrawal in a preterm infant. J Perinatol. 2013;33(4):327-328. doi:10.1038/jp.2012.107 [PubMed 23536044]
  38. El-Husseini A, Sabucedo A, Lamarche J, Courville C, Peguero A. Baclofen toxicity in patients with advanced nephropathy: proposal for new labeling. Am J Nephrol. 2011;34(6):491-495. doi:10.1159/000333247 [PubMed 22041434]
  39. Eriksson G, Swahn CG. Concentrations of baclofen in serum and breast milk from a lactating woman. Scand J Clin Lab Invest. 1981;41(2):185-187. doi:10.3109/00365518109092032 [PubMed 7313501]
  40. Fleqsuvy (baclofen) [prescribing information]. Wilmington, MA: Azurity Pharmaceuticals Inc; February 2022.
  41. Freeman EH, Delaney RM. Neonatal baclofen withdrawal: A case report of an infant presenting with severe feeding difficulties. J Pediatr Nurs. 2016;31(3):346-349. doi:10.1016/j.pedn.2015.12.004. [PubMed 26810267]
  42. Gablofen (baclofen) [prescribing information]. Bethlehem, PA: Primal Critical Care Inc; October 2020.
  43. Galvez-Jimenez N. Symptom-based management of amyotrophic lateral sclerosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 8, 2020.
  44. Gee SW, Outsen S, Becknell B, Schwaderer AL. Baclofen toxicity responsive to hemodialysis in a pediatric patient with acute kidney injury. J Pediatr Intensive Care. 2016;5(1):37-40. doi:10.1055/s-0035-1568151. [PubMed 31110881]
  45. Ghosh S, Bhuyan D. Baclofen abuse due to its hypomanic effect in patients with alcohol dependence and comorbid major depressive disorder. Clin Psychopharmacol Neurosci. 2017;15(2):187-189. doi:10.9758/cpn.2017.15.2.187 [PubMed 28449569]
  46. Ginsburg GM, Lauder AJ. Progression of scoliosis in patients with spastic quadriplegia after the insertion of an intrathecal baclofen pump. Spine (Phila Pa 1976). 2007;32(24):2745-2750. doi:10.1097/BRS.0b013e31815a5219 [PubMed 18007255]
  47. Goyal V, Laisram N, Wadhwa RK, Kothari SY. Prospective randomized study of oral diazepam and baclofen on spasticity in cerebral palsy. J Clin Diagn Res. 2016;10(6):RC01-RC5. doi:10.7860/JCDR/2016/17067.7975 [PubMed 27504360]
  48. Grande LA, Loeser JD, Samii A. Recurrent transient global amnesia with intrathecal baclofen. Anesth Analg. 2008;106(4):1284-1287, table of contents. doi:10.1213/ane.0b013e318165e1c6 [PubMed 18349207]
  49. Grant JA, Steiner EM, Johnson RH. Treatment of persistent hiccups. J Neurol Neurosurg Psychiatry. 1991;54(5):468. doi:10.1136/jnnp.54.5.468 [PubMed 1865216]
  50. Greenberg MI, Hendrickson RG. Baclofen withdrawal following removal of an intrathecal baclofen pump despite oral baclofen replacement. J Toxicol Clin Toxicol. 2003;41(1):83-85. doi:10.1081/clt-120018277 [PubMed 12645974]
  51. Guelaud C, Similowski T, Bizec JL, Cabane J, Whitelaw WA, Derenne JP. Baclofen therapy for chronic hiccup. Eur Respir J. 1995;8(2):235-237. doi:10.1183/09031936.95.08020235 [PubMed 7758557]
  52. Hadjiyannacos D, Vlassopoulos D, Hadjiconstantinou V. Treatment of intractable hiccup in haemodialysis patients with baclofen. Am J Nephrol. 2001;21(5):427-8. doi:10.1159/000046290 [PubMed 11684810]
  53. Hara T, Nakajima M, Sugano H, et al. Pregnancy and breastfeeding during intrathecal baclofen therapy - a case study and review. NMC Case Rep J. 2018;5(3):65-68. doi:10.2176/nmccrj.cr.2017-0191 [PubMed 30023142]
  54. He Y, Brunstrom-Hernandez JE, Thio LL, et al. Population pharmacokinetics of oral baclofen in pediatric patients with cerebral palsy. J Pediatr. 2014;164(5):1181-1188.
  55. Hemingway C, McGrogan J, Freeman JM. Energy requirements of spasticity. Dev Med Child Neurol. 2001;43(4):277-278. doi:10.1017/s0012162201000524 [PubMed 11305407]
  56. Hornyak JE, McGehee MJ, Kelly B, Lin C. Oral baclofen as a cause of sexual dysfunction: A report of 2 cases. Archives of Physical Medicine and Rehabilitation. 2005;86(9):E39, Poster 197. https://www.archives-pmr.org/action/showPdf?pii=S0003-9993%2805%2900809-9
  57. Isaac Z. Management of non-radicular neck pain in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed April 1, 2020.
  58. Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126. doi:10.1056/NEJM200007133430208 [PubMed 10891521]
  59. Karol DE, Muzyk AJ, Preud'homme XA. A case of delirium, motor disturbances, and autonomic dysfunction due to baclofen and tizanidine withdrawal: a review of the literature. Gen Hosp Psychiatry. 2011;33(1):84.e1-e2. doi:10.1016/j.genhosppsych.2010.10.003 [PubMed 21353141]
  60. Karthikeyan VS, Senthilkumaran K, Easwaran B, Rajbhaskar R. Intestinal pseudo-obstruction following oral baclofen: An unusual complication. J Pharmacol Pharmacother. 2015;6(3):169-171. doi:10.4103/0976-500X.162010 [PubMed 26312004]
  61. Katsinelos P, Pilpilidis J, Xiarchos P, et al. Baclofen therapy for intractable hiccups induced by ultraflex esophageal endoprosthesis. Am J Gastroenterol. 2000;95(10):2986-2987. doi:10.1111/j.1572-0241.2000.03216.x [PubMed 11051387]
  62. Khazneh E, Shamlawi A, Jebrin K, Hamdan Z, Sawalmeh O. Single-dose baclofen-induced neurotoxicity in a patient with end stage renal disease: case report. BMC Nephrol. 2018;19(1):352. doi:10.1186/s12882-018-1167-z [PubMed 30537935]
  63. Lee J, Shin HS, Jung YS, Rim H. Two cases of baclofen-induced encephalopathy in hemodialysis and peritoneal dialysis patients. Ren Fail. 2013;35(6):860-862. doi:10.3109/0886022X.2013.794679 [PubMed 23682655]
  64. Lin HH, Barton N, Wiegand TJ. Baclofen distribution into breast milk - a potential for toxicity? J Med Toxicol. 2014;10:86.
  65. Lioresal Intrathecal (baclofen) [prescribing information]. Roswell, GA: Saol Therapeutics Inc; January 2019.
  66. Lioresal Intrathecal (baclofen) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; May 2020.
  67. Lioresal tablets (baclofen) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; May 2020.
  68. Locatelli F, Formica F, Galbiati S, et al. Polysomnographic analysis of a pediatric case of baclofen-induced central sleep apnea. J Clin Sleep Med. 2019;15(2):351-354. doi:10.5664/jcsm.7644 [PubMed 30736882]
  69. Lois F, Wallemacq P, de Tourtchaninoff M, et al. Prolonged unconsciousness in a patient on automated peritoneal dialysis. Eur J Emerg Med. 2006;13(6):361-363. doi:10.1097/01.mej.0000217992.32235.ff [PubMed 17091060]
  70. Lubsch L, Habersang R, Haase M, Luedtke S. Oral baclofen and clonidine for treatment of spasticity in children. J Child Neurol. 2006;21(12):1090-1092. doi:10.1177/7010.2006.00134 [PubMed 17156708]
  71. Marino RA. Baclofen therapy for intractable hiccups in pancreatic carcinoma. Am J Gastroenterol. 1998;93(10):2000. doi: 10.1111/j.1572-0241.1998.02000.x [PubMed 9772082]
  72. McGehee M, Hornyak JE, Lin C, Kelly BM. Baclofen-induced sexual dysfunction. Neurology. 2006;67(6):1097-1098. doi:10.1212/01.wnl.0000237332.25528.ac [PubMed 17000991]
  73. Medical Advisory Secretariat. Intrathecal baclofen pump for spasticity: an evidence-based analysis. Ont Health Technol Assess Ser. 2005;5(7):1-93. [PubMed 23074476]
  74. Méndez-Lucena C, Chacón Peña J, García-Moreno JM. Intrathecal baclofen for dystonia treatment during pregnancy: a case report. Neurologia. 2016;31(2):131-132. doi:10.1016/j.nrl.2014.04.008 [PubMed 24851698]
  75. Meulendijks D, Khan S, Koks CH, Huitema AD, Schellens JH, Beijnen JH. Baclofen overdose treated with continuous venovenous hemofiltration. Eur J Clin Pharmacol. 2015;71(3):357-361. doi:10.1007/s00228-014-1802-y [PubMed 25567218]
  76. Milla PJ, Jackson AD. A controlled trial of baclofen in children with cerebral palsy. J Int Med Res. 1977;5(6):398-404. doi:10.1177/030006057300100203 [PubMed 338390]
  77. Mirijello A, Addolorato G, D'Angelo C, et al. Baclofen in the treatment of persistent hiccup: a case series. Int J Clin Pract. 2013;67(9):918-921. doi:10.1111/ijcp.12184 [PubMed 23834241]
  78. Mohammed I, Hussain A. Intrathecal baclofen withdrawal syndrome- a life-threatening complication of baclofen pump: a case report. BMC Clin Pharmacol. 2004;4:6. doi:10.1186/1472-6904-4-6 [PubMed 15301690]
  79. Morant A, Noé E, Boyer J, et al. Paralytic ileus: a complication after intrathecal baclofen therapy. Brain Inj. 2006;20(13-14):1451-1454. doi:10.1080/02699050601082016 [PubMed 17378237]
  80. Morton CM, Rosenow J, Wong C, Kirschner KL. Intrathecal baclofen administration during pregnancy: a case series and focused clinical review. PM R. 2009;1(11):1025-1029. doi:10.1016/j.pmrj.2009.07.010 [PubMed 19942189]
  81. Navarrete-Opazo AA, Gonzalez W, Nahuelhual P. Effectiveness of oral baclofen in the treatment of spasticity in children and adolescents with cerebral palsy. Arch Phys Med Rehabil. 2016;97(4):604-618. doi:10.1016/j.apmr.2015.08.417 [PubMed 26321489]
  82. Olek MJ, Narayan RM, Frohman EM, Frohman TC. Symptom management of multiple sclerosis in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed May 7, 2020.
  83. Olivier PY, Joyeux-Faure M, Gentina T, et al. Severe central sleep apnea associated with chronic baclofen therapy: A case series. Chest. 2016;149(5):e127-e131. doi:10.1016/j.chest.2015.10.001 [PubMed 27157226]
  84. O'Rourke F, Steinberg R, Ghosh P, Khan S. Withdrawal of baclofen may cause acute confusion in elderly patients. BMJ. 2001;323(7317):870. [PubMed 11597980]
  85. Ozobax (baclofen) [prescribing information]. Athens, GA: Metacel Pharmaceuticals LLC; May 2020.
  86. Panagopoulos D, Apostolopoulou K, Themistocleous M. Severe neuromuscular scoliosis implicated by dysfunction of intrathecal baclofen pump: Case report and review of the literature. World Neurosurg. 2020;134:390-395. doi:10.1016/j.wneu.2019.11.027 [PubMed 31733394]
  87. Pathak LK, Athavale A, Martinez I. Baclofen-induced toxicity in renal disease with neurotoxicity and skin rash. Proc (Bayl Univ Med Cent). 2019;32(3):425-426. doi:10.1080/08998280.2019.1618659 [PubMed 31384209]
  88. Peces R, Navascués RA, Baltar J, Laurés AS, Alvarez-Grande J. Baclofen neurotoxicity in chronic haemodialysis patients with hiccups. Nephrol Dial Transplant. 1998;13(7):1896-1897. [PubMed 9681766]
  89. Pelissier F, de Haro L, Cardona F, et al. Self-poisoning with baclofen in alcohol-dependent patients: national reports to French Poison Control Centers, 2008-2013. Clin Toxicol (Phila). 2017;55(4):275-284. doi:10.1080/15563650.2017.1284330 [PubMed 28152635]
  90. Porter LM, Merrick SS, Katz KD. Baclofen toxicity in a patient with hemodialysis-dependent end-stage renal disease. J Emerg Med. 2017;52(4):e99-e100. doi:10.1016/j.jemermed.2016.09.025 [PubMed 27789113]
  91. Quality Standards Subcommittee of the American Academy of Neurology (AAN) and the Practice Committee of the Child Neurology Society, Delgado MR, Hirtz D, Aisen M, et al. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010;74(4):336-343. doi: 10.1212/WNL.0b013e3181cbcd2f [PubMed 20101040]
  92. Ratnayaka BD, Dhaliwal H, Watkin S. Drug points: Neonatal convulsions after withdrawal of baclofen. BMJ. 2001;323(7304):85. doi:10.1136/bmj.323.7304.85 [PubMed 11451783]
  93. Reis PV, Vieira CR, Midões AC, Rebelo V, Barbosa P, Gomes A. Intrathecal baclofen infusion pumps in the treatment of spasticity: A retrospective cohort study in a Portuguese Centre. Acta Med Port. 2019;32(12):754-759. doi:10.20344/amp.10482 [PubMed 31851884]
  94. Rifici C, D'Aleo G, D'Aleo P, Bramanti P, Saltuari L, Kofler M. Cardiovascular alterations heralded by intrathecal baclofen bolus. NeuroRehabilitation. 2011;28(4):389-393. doi:10.3233/NRE-2011-0668 [PubMed 21725173]
  95. Roberts JK, Westphal S, Sparks MA. Iatrogenic Baclofen neurotoxicity in ESRD: recognition and management. Semin Dial. 2015;28(5):525-529. doi:10.1111/sdi.12400. [PubMed 26096760]
  96. Saddichha S, Jayaram N, Manjunatha N, Benegal V. Baclofen-induced morbiliform rashes: a case series. J Clin Pharmacol. 2011;51(12):1733-1734. doi:10.1177/0091270010385936 [PubMed 21119092]
  97. Salim SA, Thomas L, Achanti A, et al. Baclofen-induced neurotoxicity in patients with compromised renal function: Review. Int J Clin Pharmacol Ther. 2018;56(10):467-475. doi:10.5414/CP203243 [PubMed 12769509]
  98. Saulino M, Anderson DJ, Doble J, et al. Best practices for intrathecal baclofen therapy: Troubleshooting. Neuromodulation. 2016;19(6):632-641. doi:10.1111/ner.12467 [PubMed 27434299]
  99. Saval A, Chiodo AE. Sexual dysfunction associated with intrathecal baclofen use: a report of two cases. J Spinal Cord Med. 2008;31(1):103-105. doi:10.1080/10790268.2008.11753989 [PubMed 18533420]
  100. Scheinberg A, Hall K, Lam LT, O'Flaherty S. Oral baclofen in children with cerebral palsy: a double-blind cross-over pilot study. J Paediatr Child Health. 2006;42(11):715-20. doi:10.1111/j.1440-1754.2006.00957.x [PubMed 17044900]
  101. Sechrist C, Kinsman S, Cain N. Profound bradycardia after intrathecal baclofen injection in a patient with hydranencephaly. Pediatr Neurol. 2015;53(6):532-534. doi:10.1016/j.pediatrneurol.2015.08.010 [PubMed 26411756]
  102. Seker MM, Aksoy S, Ozdemir NY, et al. Successful treatment of chronic hiccup with baclofen in cancer patients. Med Oncol. 2012;29(2):1369-1370. doi:10.1007/s12032-011-9910-3 [PubMed 21442315]
  103. Siegfried RN, Jacobson L, Chabal C. Development of an acute withdrawal syndrome following the cessation of intrathecal baclofen in a patient with spasticity. Anesthesiology. 1992;77(5):1048-1050. doi:10.1097/00000542-199211000-00034 [PubMed 1443727]
  104. Singal AK, Bataller R, Ahn J, Kamath PS, Shah VH. ACG clinical guideline: alcoholic liver disease. Am J Gastroenterol. 2018;113(2):175-194. doi:10.1038/ajg.2017.469 [PubMed 29336434]
  105. Singh NK, Agarwal A, Salazar L, Henkle JQ. Osborn waves in hypothermia induced by baclofen overdose. BMJ Case Rep. 2009;2009:bcr10.2008.1142. doi:10.1136/bcr.10.2008.1142 [PubMed 21686448]
  106. Su W, Yegappan C, Carlisle EJ, Clase CM. Reduced level of consciousness from baclofen in people with low kidney function. BMJ. 2009;339:b4559. doi:10.1136/bmj.b4559 [PubMed 20044395]
  107. Swigar ME, Bowers MB. Baclofen withdrawal and neuropsychiatric symptoms: a case report and review of other case literature. Compr Psychiatry. 1986;27(4):396-400. doi:10.1016/0010-440x(86)90016-7 [PubMed 3731773]
  108. Tandon SS, Hoskins I, Azhar S. Intrathecal baclofen pump - a viable therapeutic option in pregnancy. Obstet Med. 2010;3(3):119-120. doi:10.1258/om.2010.100016 [PubMed 27576877]
  109. Turkyilmaz A, Eroglu A. Use of baclofen in the treatment of esophageal stent-related hiccups. Ann Thorac Surg. 2008;85(1):328-330. doi:10.1016/j.athoracsur.2007.07.059 [PubMed 18154840]
  110. van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM; Cochrane Back Review Group. Muscle relaxants for nonspecific low back pain: a systematic review within the framework of the Cochrane Collaboration. Spine (Phila Pa 1976). 2003;28(17):1978-1992. doi:10.1097/01.BRS.0000090503.38830.AD [PubMed 12973146]
  111. Vlavonou R, Perreault MM, Barrière O, et al. Pharmacokinetic characterization of baclofen in patients with chronic kidney disease: dose adjustment recommendations. J Clin Pharmacol. 2014;54(5):584-592. doi:10.1002/jcph.247 [PubMed 24414993]
  112. Walker KR, Novotny SA, Krach LE. Does intrathecal baclofen therapy increase prevalence and/or progression of neuromuscular scoliosis? Spine Deform. 2017;5(6):424-429. doi:10.1016/j.jspd.2017.03.006 [PubMed 29050720]
  113. Weißhaar GF, Hoemberg M, Bender K, et al. Baclofen intoxication: a "fun drug" causing deep coma and nonconvulsive status epilepticus--a case report and review of the literature. Eur J Pediatr. 2012;171(10):1541-1547. doi:10.1007/s00431-012-1780-y [PubMed 22729246]
  114. Wolf E, Kothari NR, Roberts JK, Sparks MA. Baclofen toxicity in kidney disease. Am J Kidney Dis. 2018;71(2):275-280. doi:10.1053/j.ajkd.2017.07.005 [PubMed 28899601]
  115. Wu VC, Lin SL, Lin SM, Fang CC. Treatment of baclofen overdose by haemodialysis: a pharmacokinetic study. Nephrol Dial Transplant. 2005;20(2):441-443. doi:10.1093/ndt/gfh297 [PubMed 15615812]
  116. Yang TF, Wang JC, Chiu JW, Lai CJ, Chan RC, Lee SS. Ultrasound-guided refilling of an intrathecal baclofen pump--a case report. Childs Nerv Syst. 2013;29(2):347-349. doi: 10.1007/s00381-012-1953-z [PubMed 23129445]
  117. Zeman A, Hoefeijzers S, Milton F, Dewar M, Carr M, Streatfield C. The GABAB receptor agonist, baclofen, contributes to three distinct varieties of amnesia in the human brain - A detailed case report. Cortex. 2016;74:9-19. doi:10.1016/j.cortex.2015.10.005 [PubMed 26599496]
  118. Zhang C, Zhang R, Zhang S, Xu M, Zhang S. Baclofen for stroke patients with persistent hiccups: a randomized, double-blind, placebo-controlled trial. Trials. 2014;15:295. doi:10.1186/1745-6215-15-295 [PubMed 25052238]
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