Baclofen (Lexi-Drugs)

ALERT: US Boxed Warning
  Abrupt withdrawal (injection):
Pronunciation

(BAK loe fen)

Brand Names: US

Gablofen; Lioresal; Lioresal Intrathecal

Brand Names: Canada

APO-Baclofen; Baclofen-10; Baclofen-20; DOM-Baclofen; Lioresal; Lioresal DS; Lioresal Intrathecal; MYLAN-Baclofen; NOVO-Baclofen [DSC]; PHL-Baclofen [DSC]; PMS-Baclofen; RATIO-Baclofen; RIVA-Baclofen

Pharmacologic Category

Skeletal Muscle Relaxant

Dosing: Adult

Spasticity:

Oral: Initial: 5 mg 3 times daily; may increase by 5 mg per dose every 3 days (ie, 5 mg 3 times daily for 3 days, then 10 mg 3 times daily for 3 days, etc.) until optimal response is reached. Usual dosage range: 40 to 80 mg daily. Do not exceed 80 mg daily (20 mg 4 times daily).

Intrathecal:

Screening dose: Initial: 50 mcg 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.

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

Initial total daily dose via pump: 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, dosage adjustments may be made by increasing daily dose slowly by 10% to 30% (spasticity of spinal cord origin) or 5% to 15% (spasticity of cerebral origin) once every 24 hours until satisfactory response.

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

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. 5% to 10% of patients receiving chronic therapy 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.

Alcoholic liver disease, alcohol abstinence (off-label use): Oral:

Initial: 5 mg 3 times daily for 3 days

Maintenance: May increase dose at a 3 to 5 day interval based on patient tolerance (ACG [Singal 2018]) to 10 mg 3 times daily (maximum: 15 mg 3 times daily) (AASLD [Runyon 2012]; ACG [Singal 2018]; Addolorato 2007).

Gastroesophageal reflux disease (off-label use): Oral: 10 mg 4 times daily (Ciccaglione 2003)

Hiccups (off-label use): Oral: 5 to 10 mg 3 times daily (maximum: 75 mg daily in divided doses) (Guelaud 1995; Zhang 2014)

Nystagmus (off-label use): Oral: 5 mg 3 times daily; may increase at weekly intervals until optimal response is reached or intolerable adverse effects occur. Dosage range studied: 15 to 120 mg daily in divided doses (Cormer 2006; Dieterich 1991). Additional data may be necessary to further define the role of baclofen in the treatment of this condition.

Trigeminal neuralgia (off-label use): Oral: Initial: 5 to 10 mg 3 times daily (dose may be as low as 10 mg daily); may increase dose by 10 mg every other day over 1 to 2 weeks. Dosage range studied: 30 to 80 mg daily in 3 to 4 divided doses (Fromm 1984). Additional data may be necessary to further define the role of baclofen in the treatment of this condition.

Dosing: Geriatric

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

Dosing: Renal Impairment: Adult

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

The following dosage adjustments have been recommended (Vlavonou 2014; renal function estimated using the Cockcroft-Gault formula):

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

CrCl 50 to 80 mL/minute: Initial: 5 mg every 12 hours

CrCl 30 to <50 mL/minute: Initial: 2.5 mg every 8 hours

CrCl <30 mL/minute (not on dialysis): Initial: 2.5 mg every 12 hours.

ESRD on hemodialysis: Avoid use (based on case reports; Chen 1997; El-Husseini 2011; Lee 2013; Su 2009); if baclofen must be used, initiate at a low dose with careful monitoring for toxicity (Lee 2013). Baclofen is readily removed by hemodialysis, with a report of 79% removal in a 4 hour session (Roberts 2015).

Intrathecal: 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: Adult

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

Dosing: Pediatric

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. There is limited published data in infants and children; the following is a compilation of small prospective studies (Milla 1977; Scheinberg 2006) and one large retrospective analysis of baclofen use in children (Lubsch 2006). Efficacy results variable (AAN [Delgado 2010]):

Infants ≥4 months and Children <2 years: Limited data available: 10 to 20 mg daily divided every 8 hours; begin at low end of range and titrate dose to patient response, titration intervals of every 3 days to weekly have been used in pediatric patients ≥2 years (Millia 1997; Scheinberg 2006). Maximum daily dose: 40 mg/day (Lubsch 2006). Note: To minimize dose-related side effects (eg, sedation), lower initial doses (eg, 2.5 mg once daily) and slower titration may be considered (eg, weekly) and has been reported in pediatric patients >2 years (Scheinberg 2006).

Children 2 to 7 years: Limited data available: 20 to 40 mg daily divided every 8 hours; begin at low end of range (or even lower [2.5 to 10 mg daily] and titrate dose to patient response; titration intervals of every 3 days to weekly have been used in pediatric patients. Maximum daily dose: 60 mg/day (Lubsch 2006; Millia 1997; Scheinberg 2006)

Children ≥8 years and Adolescents: Limited data available in children <12 years: 30 to 40 mg daily divided every 8 hours; begin at low end of range (or even lower [10 mg to 15 mg daily in 3 divided doses]) and titrate dose to patient response, titration intervals of every 3 days to weekly have been used (Millia 1997; Scheinberg 2006); some patients ≥12 years may require every 6 hour dosing; usual maximum daily dose range: 60 to 80 mg/day (Lubsch 2006; Millia 1977). Note: 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: 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: 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: 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: 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):

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: 100 to 2,000 mcg daily (Berweck 2014); the manufacturer provides the following:

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

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

Dosing: Renal 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.

Use: Labeled Indications

Spasticity:

Oral: Management of reversible spasticity associated with multiple sclerosis or spinal cord lesions

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; 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 side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.

Use: Off-Label: Adult

  Alcoholic liver disease (alcohol abstinence)Level of Evidence [B, G]

In a randomized, placebo-controlled study in patients with alcoholic liver disease, treatment with baclofen significantly improved the proportion of patients who achieved and maintained alcohol abstinence Ref.

Based on the American College of Gastroenterology (ACG) for Alcoholic Liver Disease and American Association for the Study of Liver Diseases (AASLD) guidelines for the management of adult patients with ascites due to cirrhosis, baclofen may be used to reduce alcohol craving and consumption in patients with ascites due to alcoholic liver disease.

  Gastroesophageal reflux diseaseLevel of Evidence [B]

Data from a meta-analysis and a controlled trial support the use of baclofen for gastroesophageal reflux disease (GERD); baclofen was associated with reductions in the number of reflux episodes and rate of transient lower esophageal sphincter relaxations in patients with GERD RefAccess Full Off-Label Monograph

  Hiccups (singultus)Level of Evidence [B]

Baclofen may be a useful alternative in patients with intractable hiccups from various causes that have been unresponsive to other therapies. Access Full Off-Label Monograph

  NystagmusLevel of Evidence [C]

Inconsistent results have been reported with baclofen use for the treatment of nystagmus Ref. It is unclear why some patients with nystagmus benefit from baclofen therapy and others do not. However, given the lack of a definitive symptomatic treatment for this disease, a therapeutic trial of baclofen may be warranted before more invasive or risky approaches such as botulinum toxin injections or surgery are attempted.

  Trigeminal neuralgiaLevel of Evidence [C]

Limited evidence from a small double-blind crossover trial suggests baclofen is beneficial for trigeminal neuralgia Ref. A larger controlled study is needed to firmly establish efficacy, optimal dose, dose titration, and possible combinations with other drugs for trigeminal neuralgia.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Alcoholic Liver Disease:

ACG, “American College of Gastroenterology Clinical Guideline: Alcoholic Liver Disease,” January 2018

Ascites:

AASLD Practice Guidelines: “Management of Adult Patients with Ascites Due to Cirrhosis: Update 2012,” 2012

Cerebral Palsy:

“Pharmacologic Treatment of Spasticity in Children and Adolescents with Cerebral Palsy (An Evidence-Based Review),” Practice Parameters 2010

Administration: Injectable Detail

pH: 5 to 7

Administration: Oral

Administer without regards to meals.

Administration: 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.

Administration: Pediatric

Oral: Administer with food or milk

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.

Storage/Stability

Injection: Do not store above 30°C (86°F). Does not require refrigeration. Do not freeze or heat sterilize. Discard any unused solution.

Tablets: Store at 20°C to 25°C (68°F to 77°F).

Preparation for Administration: Adult

Intrathecal: Screening doses are a 50 mcg/mL concentration and only the 1 mL screening ampul or screening syringe (50 mcg/mL) is used; do not further dilute. Maintenance infusions for patients who require concentrations other than 500 mcg/mL, 1,000 mcg/mL, or 2,000 mcg/mL must be diluted with preservative-free sodium chloride.

Preparation for Administration: Pediatric

Parenteral: Intrathecal: For screening dosages, dilute with preservative-free sodium chloride to a final concentration of 50 mcg/mL. For maintenance infusions, concentrations of 500 to 2,000 mcg/mL may be used; if preparing a concentration that is not commercially available, preservative-free sodium chloride must be used.

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

Note: A baclofen suspension (1 mg/mL or 5 mg/mL) is commercially available as a compounding kit (First-Baclofen). Compounded oral suspension may be available in multiple concentrations (eg, up to 10 times more concentrated); use caution to avoid confusion; verify concentration.

5 mg/mL Oral Suspension (ASHP Standard Concentration) (ASHP 2017)

A 5 mg/mL oral suspension may be made with tablets. Crush thirty 20 mg tablets in a mortar and reduce to a fine powder. Add a small amount of glycerin and mix to a uniform paste. Mix while adding Simple Syrup, NF in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add a sufficient quantity of vehicle to make 120 mL. Label “shake well” and “refrigerate.” Stable for 35 days (Johnson 1993).

Johnson CE, Hart SM. Stability of an extemporaneously compounded baclofen oral liquid. Am J Hosp Pharm. 1993;50(11):2353-2355.[PubMed 8266961]

10 mg/mL Oral Suspension: Note: Commercially available suspension is more dilute (eg, up to 10 times more dilute); use caution to avoid confusion; verify concentrations.

A 10 mg/mL oral suspension may be made with tablets. Crush one-hundred-twenty 10 mg tablets in a mortar and reduce to a fine powder. Add small portions (60 mL) of a 1:1 mixture of Ora-Sweet and Ora-Plus and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 120 mL. Label “shake well” and “refrigerate.” Stable for 60 days (Allen 1996).

Allen LV Jr, Erickson MA 3rd. Stability of baclofen, captopril, diltiazem hydrochloride, dipyridamole, and flecainide acetate in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1996;53(18):2179-2184.[PubMed 8879325]

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience insomnia, nausea, headache, or constipation. Have patient report immediately to prescriber signs of withdrawal (high fever, mental changes, increased spasm, or muscle rigidity), severe loss of strength and energy, severe dizziness, passing out, confusion, severe fatigue, behavioral changes, seizures, vision changes, angina, muscle pain, muscle weakness, muscle rigidity, burning or numbness feeling, difficulty breathing, slow breathing, shallow breathing, urinary retention, change in amount of urine passed, hematuria, mood changes, hallucinations, abnormal movements, twitching, change in balance, difficulty swallowing, difficulty speaking, involuntary eye movements, or abnormal heartbeat (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  High alert medication:
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:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• 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 intrathecal baclofen 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 gastrointestinal 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. 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 patients with renal impairment, initiation of oral baclofen at lower doses and/or extended intervals has been suggested (Aisen 1994; Chen 1997; Chou 2006; El-Husseini 2011; Peces 1998; Su 2009; Vlavonu 2014).

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

• Seizure disorder: Use with caution in patients with a history of seizure disorder; monitor regularly for loss of seizure control. Seizures have been reported with withdrawal from intrathecal baclofen as well as in patients maintained on therapeutic doses of intrathecal baclofen.

Special populations:

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

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

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Abrupt withdrawal: [US Boxed Warning]: Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae (hyperpyrexia, 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 requires careful attention to programming and monitoring of 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. In most cases, symptoms of withdrawal (eg, return of baseline spasticity, hypotension, paresthesia, pruritus) appear within hours to a few days following interruption of therapy. Priapism may develop or recur if treatment with intrathecal baclofen is interrupted. Clinically, the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis. Suggested treatment for intrathecal baclofen withdrawal is restoration of intrathecal baclofen at or near the same dosage as before therapy was interrupted. Abrupt withdrawal of oral therapy has been associated with hallucinations and seizures; gradual dose reductions (over ~1 to 2 weeks) are recommended in the absence of severe adverse reactions.

• 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 stroke, Parkinson disease, or cerebral palsy; therefore, use is not recommended. 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.

Geriatric Considerations

The elderly are more sensitive to the effects of baclofen and are more likely to experience adverse CNS effects at higher doses.

Pregnancy Considerations

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).

Breast-Feeding 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 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). Recommendations for use in breastfeeding women vary by manufacturer.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Central nervous system: Hypotonia (2% to 35%), drowsiness (6% to 21%), confusion (1% to 11%), headache (2% to 11%)

Gastrointestinal: Nausea (1% to 12%), vomiting (2% to 11%)

1% to 10%:

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

Central nervous system: Seizure (≤10%), dizziness (2% to 8%), insomnia (≤7%), paresthesia (≤7%), hypertonia (≤6%), pain (≤4%), speech disturbance (≤4%), depression (2%), coma (≤2%), abnormality in thinking (≤1%), agitation (≤1%), chills (≤1%)

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

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

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

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

Ophthalmic: Amblyopia (≤2%)

Respiratory: Hypoventilation (≤4%), pneumonia (≤2%), dyspnea (≤1%)

Miscellaneous: Accidental injury (≤4%)

<1%, postmarketing, and/or case reports: Abdominal pain, accommodation disturbance, akathisia, albuminuria, alopecia, amnesia, ankle edema, anorexia, anxiety, apnea, ataxia, blurred vision, bradycardia, carcinoma, chest pain, contact dermatitis, decreased libido, deep vein thrombophlebitis, dehydration, dermal ulcer, diaphoresis, diplopia, dysarthria, dysautonomia, dysgeusia, dysphagia, dystonia, dysuria, epilepsy, erectile dysfunction, euphoria, excitement, facial edema, fecal incontinence, fever, gastrointestinal hemorrhage, hallucination, hematuria, hyperglycemia, hyperhidrosis, hypertension, hyperventilation, hypothermia, hysteria, inhibited ejaculation, intestinal obstruction, leukocytosis, loss of postural reflex, malaise, miosis, muscle rigidity, myalgia, mydriasis, nasal congestion, nephrolithiasis, nocturia, nystagmus disorder, occult blood in stools, oliguria, opisthotonus, orgasm disturbance, pallor, palpitations, paranoid ideation, personality disorder, petechial rash, priapism, pulmonary embolism, scoliosis, scoliosis progression, sedated state, sexual disorder, skin rash, slurred speech, strabismus, suicidal ideation, syncope, taste disorder, tinnitus, tongue irritation, vaginitis, vasodilatation, weight gain, weight loss

Allergy and Idiosyncratic Reactions
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): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Risk X: Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of 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 patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants.Risk D: Consider therapy modification

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

Cannabis: May enhance the CNS depressant effect of CNS Depressants. 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

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

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. 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. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. 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. Risk D: Consider therapy modification

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone 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

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

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

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

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. 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 adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification

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

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

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

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

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

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. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Risk D: Consider therapy modification

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

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

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Risk D: Consider therapy modification

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

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol 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

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

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

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

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

Monitoring Parameters

Regular electroencephalogram (EEG) in patients with epilepsy (loss of seizure control has been reported).

Advanced Practitioners Physical Assessment/Monitoring

Obtain regular EEG in patients with epilepsy. Obtain renal function tests; dosage adjustment may be needed. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. Avoid abrupt withdrawal of drug therapy especially with infusion. Monitor for therapeutic response and changes in response or symptoms.

Nursing Physical Assessment/Monitoring

Check ordered labs and test and report abnormalities. Monitor and educate patient to report seizures. Monitor for improved patient response to therapy.

Dosage Forms Considerations

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

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); 10 mg/20 mL (20 mL [DSC]); 10 mg/5 mL (5 mL [DSC]); 40 mg/20 mL (20 mL [DSC]) [antioxidant free]

Lioresal Intrathecal: 40 mg/20 mL (20 mL) [antioxidant free]

Lioresal Intrathecal: 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL) [antioxidant free, pyrogen free]

Solution Prefilled Syringe, Intrathecal [preservative free]:

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

Gablofen: 50 mcg/mL (1 mL [DSC]); 10,000 mcg/20 mL (20 mL [DSC]); 40,000 mcg/20 mL (20 mL [DSC]); 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]

Tablet, Oral:

Generic: 5 mg, 10 mg, 20 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intrathecal:

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

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

Tablet, Oral:

Lioresal: 10 mg

Lioresal DS: 20 mg

Generic: 10 mg, 20 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • M03BX01
Generic Available (US)

May be product dependent

Pricing: US

Solution (Baclofen Intrathecal)

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

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

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

Solution (Lioresal Intrathecal Intrathecal)

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

500 mcg/mL (per mL): $14.18

2000 mcg/mL (per mL): $56.71

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): $1.24

10 mg (per each): $0.50 – $2.47

20 mg (per each): $0.86 – $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.

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

Pharmacodynamics/Kinetics

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%

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: 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)

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

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date
January 20, 1982
References

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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.[PubMed 25028414]10.1177/0883073814535504

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Dieterich M, Straube A, Brandt T, Paulus W, Büttner U. The effects of baclofen and cholinergic drugs on upbeat and downbeat nystagmus. J Neurol Neurosurg Psychiatry. 1991;54(7):627-632.[PubMed 1654396]

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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.[PubMed 26810267]

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Gablofen (baclofen) [prescribing information]. Bethlehem, PA: Primal Critical Care Inc; April 2017.

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.[PubMed 7758557]

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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.

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Khorasani A and Peruzzi WT, “Dantrolene Treatment for Abrupt Intrathecal Baclofen Withdrawal,” Anesth Analg, 1995, 80(5):1054-6.[PubMed 7726408]

Lee J, Shin HS, Jung YS, et al. Two cases of baclofen-induced encephalopathy in hemodialysis and peritoneal dialysis patients. Ren Fail. 2013;35(6):860-862.[PubMed 23682655]

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Lin HH, Barton N, Wiegand TJ. Baclofen distribution into breast milk – a potential for toxicity? J Med Toxicol. 2014;10:86.

Lioresal Intrathecal (baclofen) [prescribing information]. Roswell, GA: Saol Therapeutics Inc; January 2019.

Lioresal Intrathecal (baclofen) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; November 2017.

Lubsch L, Habersang R, Haase M, et al, “Oral Baclofen and Clonidine for Treatment of Spasticity in Children,” J Child Neurol, 2006, 21(12):1090-2.[PubMed 17156708]

May CR, “Baclofen Overdose,” Ann Emerg Med, 1983, 12:171-3.[PubMed 6829997]

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.[PubMed 24851698]

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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]

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Roberge RJ, Martin TG, Hodgman M, et al, “Supraventricular Tachyarrhythmia Associated With Baclofen Overdose,” J Toxicol Clin Toxicol, 1994, 32(3):291-7.[PubMed 8007036]

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Brand Names: International

Alpha-Baclofen (NZ); Baclan (KR); Baclofen-ratiopharm (LU); Baclofene (FR); Baclon (FI, LK, TW); Baclopar (IE); Baclosal (IL, LV); Baclosan (RU); Baclosol (VN); Bacofen (KR); Bacron (KR); Bamifen (VN); Barapa (KR); Clofen (AU); Colmifen (MT, SG); Curofen (KR); Diafen (PY, UY); Espast (PE); Flexibac (LK); Gabalon (JP); Gablofen (NL); Liobac (TH); 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); Pacifen (NZ, TW); Prex (KR); Skelofen (BD); Slaken (BD); Solofen (TW); Spinax (TW); Stelax (AU, HK); Trilaxant (PH); Yylofen (VN)

Baclofen (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(BAK loe fen)

Brand Names: US

Gablofen; Lioresal; Lioresal Intrathecal

Brand Names: Canada

Lioresal; Lioresal D.S.; Lioresal Intrathecal

Warning
  • Infusion:
  • Unsafe side effects have happened when this drug was stopped all of a sudden. Some of these side effects have been high fever, mental changes, more spasms, and muscle stiffness. Rarely, these side effects have led to very bad muscle problems, organ problems, and death. Avoid stopping this drug all of a sudden without talking with your doctor. Be sure you get your pump refilled on time and you know about the pump alarms and what to do if the pump alarm goes off. Tell your doctor if you have ever had signs of withdrawal while getting baclofen tablets or shot. Call your doctor right away if you have signs of withdrawal.
  • Read the package insert for more details.
What is this drug used for?
  • It is used to calm muscles.
  • It is used to treat spasms in patients with MS (multiple sclerosis) or spinal cord disease.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • All products:
  • If you have an allergy to baclofen or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are breast-feeding or plan to breast-feed.
  • Infusion:
  • If you have an infection.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Use with care in children. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Feeling very sleepy.
  • Change in how often urine is passed.
  • Infusion:
  • Feeling very tired or weak.
  • Change in how you act.
  • Seizures.
  • Change in eyesight.
  • Chest pain.
  • Muscle pain or weakness.
  • Muscle stiffness.
  • A burning, numbness, or tingling feeling that is not normal.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Not able to pass urine or change in how much urine is passed.
  • Blood in the urine.
  • Mood changes.
  • Hallucinations (seeing or hearing things that are not there).
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Not able to control eye movements.
  • A heartbeat that does not feel normal.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Feeling sleepy.
  • Dizziness.
  • Feeling tired or weak.
  • Trouble sleeping.
  • Upset stomach.
  • Headache.
  • Constipation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Tablets:
  • Take with or without food.
  • Infusion:
  • It is given into the spine.
What do I do if I miss a dose?
  • Tablets:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Infusion:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • Tablets:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Infusion:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Baclofen (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(BAK loe fen)

Brand Names: US

Gablofen; Lioresal; Lioresal Intrathecal

Brand Names: Canada

Lioresal; Lioresal D.S.; Lioresal Intrathecal

Warning
  • Infusion:
  • Unsafe side effects have happened when this drug was stopped all of a sudden. Some of these side effects have been high fever, mental changes, more spasms, and muscle stiffness. Rarely, these side effects have led to very bad muscle problems, organ problems, and death. Avoid stopping this drug all of a sudden without talking with the doctor. Be sure you get your child’s pump refilled on time and you know about the pump alarms and what to do if the pump alarm goes off. Tell the doctor if your child has ever had signs of withdrawal while getting baclofen tablets or shot. Call the doctor right away if your child has signs of withdrawal.
  • Read the package insert for more details.
What is this drug used for?
  • It is used to calm muscles.
  • It is used to treat spasms in patients with MS (multiple sclerosis) or spinal cord disease.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • Infusion:
  • If your child has an infection.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • Use with care in children. Talk with the doctor.
  • If your child is pregnant:
  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Feeling very sleepy.
  • Change in how often urine is passed.
  • Infusion:
  • Feeling very tired or weak.
  • Change in the way your child acts.
  • Seizures.
  • Change in eyesight.
  • Chest pain.
  • Muscle pain or weakness.
  • Muscle stiffness.
  • A burning, numbness, or tingling feeling that is not normal.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Not able to pass urine or change in how much urine is passed.
  • Blood in the urine.
  • Mood changes.
  • Hallucinations (seeing or hearing things that are not there).
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Not able to control eye movements.
  • A heartbeat that does not feel normal.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Feeling sleepy.
  • Dizziness.
  • Feeling tired or weak.
  • Trouble sleeping.
  • Upset stomach.
  • Headache.
  • Constipation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Tablets:
  • Give this drug with or without food.
  • Infusion:
  • It is given into the spine.
What do I do if my child misses a dose?
  • Tablets:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Infusion:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • Tablets:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Infusion:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.