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Baclofen: Pediatric drug information

Baclofen: Pediatric drug information
(For additional information see "Baclofen: Drug information" and see "Baclofen: Patient 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;
  • Lyvispah;
  • Ozobax DS;
  • Ozobax [DSC]
Brand Names: Canada
  • APO-Baclofen;
  • Baclofen-10;
  • Baclofen-20;
  • Lioresal DS [DSC];
  • Lioresal Intrathecal;
  • Lioresal [DSC];
  • MYLAN-Baclofen;
  • PMS-Baclofen;
  • RIVA-Baclofen
Therapeutic Category
  • Skeletal Muscle Relaxant, Nonparalytic
Dosing: Pediatric

Dosage guidance:

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

Dosage form information: Baclofen is available as both an oral solution and oral suspension; concentration varies by product; use extra caution during product selection and preparation and verify correct product/concentration is chosen.

Spasticity

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 administered daily) may be used with subsequent titration to 8 hourly doses (Ref).

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 (Ref); titration intervals of every 7 days have been used in pediatric patients ≥2 years (Ref). Maximum daily dose: 40 mg/day (Ref). 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 (Ref). Note: To minimize dose-related side effects (eg, sedation), lower initial doses (ie, 2.5 mg once to 3 times daily) may be considered and have been reported in pediatric patients >2 years (Ref).

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 (Ref). 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 (Ref).

Children ≥8 years and Adolescents: Limited data available in children <12 years: Oral: Initial: 5 mg 3 times daily; titrate dose to patient response every 3 to 7 days to usual dose of 30 to 40 mg/day; some patients ≥12 years may require every-6-hour dosing; maximum daily dose: 80 mg/day (Ref). Note: Lower initial doses (5 to 10 mg/day) have also been described (Ref). 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 (Ref).

Intrathecal: Note: Dosage adjustments may be required often during the first few months of therapy to adjust for lifestyle 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 deep vein thrombosis (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; dosing for this age group based on expert consensus recommendations (Ref).

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 (Ref).

Children ≥4 years and Adolescents: Intrathecal: Initial: 50 mcg (1 mL) for 1 dose; for patients considered very small for age, a 25 mcg initial screening dose may be considered; following administration of screening dose, 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 increase screening dose in 25 mcg increments every 24 hours until a 4- to 8-hour positive clinical response is demonstrated or 100 mcg/dose is given. Patients not responding to screening dose of 100 mcg should not be considered for chronic infusion/implanted pump (Ref).

Initial 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 or if negative reactions to the screening test dose (change in mental status, loss of function, or change in vital signs) occurred, then infuse a dose equivalent to the screening dose over 24 hours (Ref).

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 (Ref).

Maintenance dose titration (Ref):

Children and Adolescents: Intrathecal:

Inpatient titration: Daily dose may be increased periodically (eg, during pump refills) by 10% to 20% of dose; usual dose change is 50 mcg; maximum increment change: 100 mcg. Note: At lower doses, a 20% increase may be reasonable, but at higher doses a 20% increase may be excessive. Daily dose may be decreased by 10% to 20% for adverse effects.

Outpatient titration: Daily dose may be increased periodically (eg, during pump refills) by 5% to 10% of daily dose (usual dose change is 25 mcg). Daily dose may be decreased by 10% to 20% for adverse effects.

Usual maintenance dose: Children and Adolescents: Intrathecal: 100 to 2,000 mcg daily (Ref); 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: Adult

(For additional information see "Baclofen: Drug information")

Dosage guidance:

Safety: A gradual dose taper (eg, over ≥1 to 2 weeks) is advised unless discontinuation is due to significant adverse effects or overdose-related emergencies; if withdrawal symptoms occur during discontinuation of chronic oral baclofen therapy, decrease dose at a more gradual rate (Ref). Abrupt discontinuation of oral or intrathecal baclofen may result in severe adverse effects, including multiple organ-system failure and death.

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 (Ref).

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 (Ref). In general, muscle relaxants should be used temporarily (eg, for a few days or intermittently for a few days when needed) (Ref).

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

Spasticity

Spasticity:

Oral:

Granules: Initial: 5 mg 3 times daily; may increase by 5 mg per dose every 3 days based on response and tolerability; maximum dose: 80 mg per day (20 mg 4 times per day).

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 (Ref).

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 (Ref): 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 (Ref). 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) (Ref):

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 (Ref). 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 (Ref).

Peritoneal dialysis:

Oral, intrathecal: Avoid use. Baclofen clearance by peritoneal dialysis has not been characterized. Multiple case reports have reported hospitalization for encephalopathy (Ref). 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 (Ref).

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 (Ref). 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) (Ref).

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

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

Dosing: Hepatic Impairment: Adult

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

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). Neonatal withdrawal has also been reported in neonates whose mothers were treated with oral baclofen throughout pregnancy (Ratnayaka 2001).

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). Neonatal withdrawal has been reported within hours to days after delivery.

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: Asthenia (≤15%), confusion (≤11%), dizziness (2% to 15%), drowsiness (≤63%), headache (2% to 11%), hypotonia (2% to 35%)

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%), tremor (≤1%)

Neuromuscular & skeletal: Back pain (≤2%)

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, inhibited ejaculation (Saval 2008), 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, malaise, opisthotonus, personality disorder, slurred speech

Neuromuscular & skeletal: Muscle rigidity, 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)

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), neonatal withdrawal (Ratnayaka 2001), suicidal ideation (Pelissier 2017; WeiBhaar 2012), transient ischemic attacks (Chauvin 2020)

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:

• Older adult: 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 products: 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.

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

Packet, Oral:

Lyvispah: 5 mg (90 ea [DSC]) [contains saccharin sodium]

Lyvispah: 5 mg (90 ea) [contains saccharin sodium; strawberry flavor]

Lyvispah: 10 mg (90 ea [DSC]) [contains saccharin sodium]

Lyvispah: 10 mg (90 ea) [contains saccharin sodium; strawberry flavor]

Lyvispah: 20 mg (90 ea [DSC]) [contains saccharin sodium]

Lyvispah: 20 mg (90 ea) [contains saccharin sodium; strawberry flavor]

Solution, Intrathecal:

Lioresal: 0.05 mg/mL (1 mL)

Lioresal: 10 mg/20 mL (20 mL); 10 mg/5 mL (5 mL); 40 mg/20 mL (20 mL) [latex free]

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 [DSC]) [contains methylparaben, propylparaben; grape flavor]

Ozobax DS: 10 mg/5 mL (237 mL, 473 mL) [contains methylparaben, propylparaben]

Generic: 5 mg/5 mL (473 mL); 10 mg/5 mL (237 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 (allura red ac dye), propylene glycol, quinoline yellow (d&c yellow #10), sodium benzoate]

Generic: 25 mg/5 mL (120 mL, 250 mL, 300 mL)

Tablet, Oral:

Generic: 5 mg, 10 mg, 20 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Pack (Lyvispah Oral)

5 mg (per each): $3.93

10 mg (per each): $3.93

20 mg (per each): $3.93

Solution (Baclofen Intrathecal)

10 mg/20 mL (per mL): $7.08 - $11.60

40 mg/20 mL (per mL): $28.38 - $46.39

Solution (Baclofen Oral)

5 mg/5 mL (per mL): $1.31

10 mg/5 mL (per mL): $3.72

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 DS Oral)

10 mg/5 mL (per mL): $4.14

Solution Prefilled Syringe (Baclofen Intrathecal)

50 mcg/mL (per mL): $52.80

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

Suspension (Baclofen Oral)

25 mg/5 mL (per mL): $6.53

Suspension (Fleqsuvy Oral)

25 mg/5 mL (per mL): $7.26

Tablets (Baclofen Oral)

5 mg (per each): $0.34 - $1.54

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

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

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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 ([DSC]); 2000 mcg/mL ([DSC]); 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

Extemporaneous Preparations

Note: Baclofen is commercially available as 1 mg/mL or 5 mg/mL oral suspension (First-Baclofen compounding kit [1 mg/mL or 5 mg/mL]; Fleqsurvy 5 mg/mL) or as a 1 mg/mL oral solution (Ozobax). 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):2353-2355.8266961

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):2179-2184.8879325
Administration: Pediatric

Oral: Administer without regard to meals. If nausea occurs, may administer with food or milk (Ref).

Oral liquid: Baclofen is available as both an oral solution and oral suspension; concentration varies by product; use extra caution during product selection and preparation and verify correct product/concentration is chosen. When using oral liquid product, administer with a calibrated measuring device; do not use a household teaspoon (overdosage may occur).

Oral suspension: Shake well prior to administration.

Oral granules: Contents of packet may be emptied into the mouth and swallowed or may be mixed with up to 15 mL of liquid or soft food (eg, applesauce, yogurt, pudding). If mixing with food, entire mixture should be consumed within 2 hours of mixing. If multiple packets are needed to complete dose, each packet must be mixed with separate volume of liquid or food.

Administration via feeding tube: Oral granules may be administered by NG tube ≥8 French, gastrostomy tubes (G tube) ≥12 French, percutaneous endoscopic gastrostomy (PEG) tube ≥14 French, or gastrojejunostomy (GJ) tube ≥16 French. Prior to administration, flush feeding tube with up to 15 mL of water using a catheter tip syringe. Empty contents of 1 packet into 15 mL of liquid (eg apple juice or milk) and mix until granules wetted. Draw up suspension of granules/liquid into dosing syringe and administer via feeding tube. Using same syringe, flush the feeding tube with 15 mL of water after administration. Repeat process if multiple packets are needed to complete a dose. If dosing syringe is allowed to stand for ≥15 minutes prior to administration, invert syringe 3 times to ensure baclofen is mixed; administration must be completed within 2 hours of initial mixing.

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.

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:

Granules: Contents of packet may be emptied into the mouth and swallowed or may be mixed with up to 15 mL of liquid or soft food (eg, applesauce, yogurt, pudding). If mixing with food, entire mixture should be consumed within 2 hours of mixing. If multiple packets are needed to complete dose, each packet must be mixed with separate volume of liquid or food.

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

Feeding tube: Oral granules may be administered by NG tube ≥8 French, gastrostomy tubes (G tube) ≥12 French, percutaneous endoscopic gastrostomy (PEG) tube ≥14 French, or gastrojejunostomy (GJ) tube ≥16 French. Prior to administration, flush feeding tube with up to 15 mL of water using a catheter tip syringe. Empty contents of 1 packet into 15 mL of liquid (eg, apple juice, milk) and mix until granules are wetted. Draw up suspension of granules/liquid into dosing syringe and administer via feeding tube. Using same syringe, flush the feeding tube with 15 mL of water after administration. Repeat process if multiple packets are needed to complete a dose. If dosing syringe is allowed to stand for ≥15 minutes prior to administration, invert syringe 3 times to ensure baclofen is mixed; administration must be completed within 2 hours of initial mixing.

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.

Oral granules: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Oral solution:

Ozobax: Store refrigerated at 2°C to 8°C (36°F to 46°F). Dispense in a light-resistant container.

Ozobax DS: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Dispense in a light-resistant container.

Oral suspension: Store at 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F). Discard any unused portion 2 months after first opening.

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

Use

Oral: Tablets, granules (eg, Lyvispah), solution (eg, Ozobax), suspension (eg, Fleqsuvy): Management of reversible spasticity associated with multiple sclerosis or spinal cord lesions (FDA approved in ages ≥12 years and adults).

Intrathecal: Management of severe spasticity of spinal cord origin (eg, spinal cord injury, multiple sclerosis) or cerebral origin (eg, cerebral palsy, traumatic brain injury); may also be considered as an alternative to destructive neurosurgical procedures (Gablofen, Lioresal: FDA approved in ages ≥4 years and adults). Note: 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.

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.

Administration issues:

Different concentrations of the oral liquid are available; ensure appropriate strength and dose of oral liquid prior to administering, dispensing, and prescribing.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

DexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. 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: CNS Depressants may enhance the CNS depressant effect of Doxylamine. 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

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

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. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider therapy modification

Ixabepilone: 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

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

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

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

Zuranolone: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. 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).

Monitoring Parameters

Monitor for signs and symptoms of baclofen withdrawal (eg, altered mental status, exaggerated rebound spasticity, hallucinations, high fever, hypertension, hyperthermia, muscle rigidity, tachycardia, seizure, agitation, confusion, delusions, insomnia, paranoid ideation). Consider EEG in patients with epilepsy if clinically indicated (decreased seizure threshold has been reported). Monitor closely for signs and symptoms of overdose (eg, drowsiness, dizziness, somnolence, hypothermia, respiratory depression, seizures, rostral progression of hypotonia, 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 (Adult Data Unless Noted)

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: Granules: 5.5 hours; 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); Solution: 0.75 hours; Suspension: 1 hour.

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Lioresal;
  • (AR) Argentina: Baclodox | Baclofeno Cevallos | Baclox | Bafen | Flimab | Lioresal | Lioresal intratecal | Roclofeno;
  • (AT) Austria: Baclofen meduna | Baclofen sintetica | Lioresal;
  • (AU) Australia: Apo-baclofen | Baclo | Baclohexal | Bacthecal | Clofen | Cm baclofen | Dbl baclofen | Lioresal | Sintetica baclofen intrathecal | Stelax | Tw baclofen;
  • (BD) Bangladesh: Bacaid | Bacben | Bacifen | Backtone | Baclobac | Bacloflex | Baclon | Bacmax | Bacofen | Bactab | Beclo | Beclovan | Beklo | C Bac | Easybak | Fenobac | Flexibac | Flexifen | Flexilax | Liofen | Liorel | Lioresal | Liosal | Lirosal | Lospan | Maxolax | Muslofen | Mylofen | Myobac | Myorel | Reflexen | Relofen | Rembac | Restobac | Skelofen | Smr | Spafen | Spaflex | Spakem | Spinafen | Spinofen | Starbac | Xanbac;
  • (BE) Belgium: Baclofen Aguettant | Baclofen merck-generics | Lioresal | Lioresal intrathec | Spacyr;
  • (BG) Bulgaria: Baclofen pharmadvice;
  • (BR) Brazil: Baclofeno | Baclon | Lioresal;
  • (CH) Switzerland: Baclocalm | Baclofen intrathecal sintetica | Baclofen sintetica | Lioresal;
  • (CI) Côte d'Ivoire: Lioresal;
  • (CL) Chile: Baclofeno | Cetril | Lioresyl;
  • (CN) China: Lioresal | Shu fen | Spinax | Zufen;
  • (CO) Colombia: Baclosan | Balanfen | Balyria | Distentia | Lioresal | Spastifen;
  • (CZ) Czech Republic: Baclofen meduna;
  • (DE) Germany: Baclaxiro | Baclofen AL | Baclofen dura | Baclofen meduna | Baclofen neuraxpharm | Baclofen sintetica | Baclofen Sun | Gablofen | Lebic | Lioresal;
  • (EC) Ecuador: Diafen | Lioresal;
  • (EE) Estonia: Baclofen meduna | Baclofen sintetica | Baclophen | Baclosal | Lioresal | Lioresal intrathecal;
  • (EG) Egypt: Lioresal | Mylobac;
  • (ES) Spain: Lioresal;
  • (FI) Finland: Baclofen Merck NM | Baclofen sintetica | Baclon | Baclopar | Baklofen mylan | Lioresal;
  • (FR) France: Baclocur | Baclofene aguettant | Baclofene eg | Baclofene irex | Baclofene sun | Lioresal;
  • (GB) United Kingdom: Baclofen almus | Baclofen arrow | Baclofen berk | Baclofen cox | Baclofen Focus | Baclofen kent | Baclofen sandoz | Baclofen Teva | Baclospas | Balgifen | Gablofen | Lioresal | Lyflex | Relamex | Trav baclofen;
  • (GR) Greece: Miorel | Vioridon;
  • (HK) Hong Kong: Apo-baclofen | Apt Baclofen | Lioresal | Pms baclofen | Qualisal;
  • (HR) Croatia: Lioresal;
  • (HU) Hungary: Lioresal;
  • (ID) Indonesia: Lioresal;
  • (IE) Ireland: Baclopar | Lioresal;
  • (IL) Israel: Baclosal | Lioresal;
  • (IN) India: Bacfen | Bacfen xl | Baclesta | Baclocare | Baclof | Bacloren | Baclorest | Baclosol | Baclosure | Baclosure xl | Baclotab | Baclotop | Bolofen | Chinofen | Fenbac xr | Gleefen | Liofen | Lioresal | Spinospas | Tefsole;
  • (IT) Italy: Baclofene bioindustria | Baclofene doc | Baclofene Mylan | Lioresal;
  • (JO) Jordan: Baclocalm | Lioresal;
  • (JP) Japan: Gabalon | Lioresal | Siobarofen | Torobamin | Torobamin choseido;
  • (KE) Kenya: Balcon;
  • (KR) Korea, Republic of: Baclafon | Baclan | Baclen | Baclfen | Baclon | Bacron | Baken | Bancloven | Barapa | Baront | Baropan | Baropen | Bigafen | Chinofen | Curofen | Daewoo baclofen | Dapro | Dongkoo baclofen | Gl baclofen | Handok baclofen | Hawon baclofen | Lioresal | Newgenpharm baclofen | Prex | Prinda | Rexfen | Samsung baclofen;
  • (KW) Kuwait: Lioresal;
  • (LB) Lebanon: Lioresal;
  • (LT) Lithuania: Lioresal | Lioresal intrathec;
  • (LU) Luxembourg: Lioresal;
  • (LV) Latvia: Baclofen ratiopharm | Baclosal | Lioresal;
  • (MA) Morocco: Lioresal;
  • (MX) Mexico: Mylinax;
  • (MY) Malaysia: Baclofen sintetica | Clofen | Liobac | Lioresal | Musafen | Pms baclofen;
  • (NG) Nigeria: Baclofen bp;
  • (NL) Netherlands: Baclofen Actavis | Baclofen sintetica | Baclofen Teva | Gablofen | Lioresal;
  • (NO) Norway: Baclofen intrathecal | Baclofen nmd grossist | Baclofen sintetica | Baklofen | Lionova | Lioresal;
  • (NZ) New Zealand: Alpha-baclofen | Lioresal | Pacifen;
  • (PE) Peru: Baclodrint | Baclofeno | Espast;
  • (PH) Philippines: Baclo | Lioresal | Liosal | Onelaxant R | Trilaxant;
  • (PK) Pakistan: Aerofin | Bacfen | Bacgen | Baclast | Baclin | Bacmax | Baflex | Bakin | Beclotab | Biobec | Fexibil | Lioresal | Liorex;
  • (PL) Poland: Baclofen sintetica | Lioresal;
  • (PR) Puerto Rico: First baclofen | Gablofen | Lioresal | Lioresal DS | Ozobax;
  • (PT) Portugal: Baclofeno | Baclofeno generis | Lioresal;
  • (PY) Paraguay: Diafen | Lioresal;
  • (QA) Qatar: Baclocalm | Lioresal;
  • (RO) Romania: Lioresal;
  • (RU) Russian Federation: Baclasan | Baclosan;
  • (SA) Saudi Arabia: Apo-baclofen | Colmifen | Lioresal | Pms baclofen;
  • (SE) Sweden: Baclofen medical valley | Baklofen 2care4 | Baklofen Alternova | Baklofen Bluefish | Baklofen Merck NM | Baklofen mylan | Gablofen | Lionova | Lioresal;
  • (SG) Singapore: Apo-baclofen | Colmifen | Lioresal;
  • (SI) Slovenia: Baclofen polpharma | Fezea | Lioresal;
  • (TH) Thailand: Baclosal | Bafen | Centrafen | Fenisal | Liobac | Lioresal | Musclofen | Myofen;
  • (TN) Tunisia: Liorefen | Lioresal | Pms baclofen;
  • (TR) Turkey: Lioresal;
  • (TW) Taiwan: Baclon | Bacone | Bacton | Bafen | Balax | Befon | Colmifen | Gabalon | Gablofen | Legafen | Lioresal | Maclofen | Mulax | Muscofen | Pacifen | Pickton | Solofen | Spinax | Sugei;
  • (UY) Uruguay: Baclof | Baclopert | Diafen | Lioresal;
  • (VN) Viet Nam: Bamifen;
  • (ZA) South Africa: Aspen baclofen | Bacentra intrathecal | Baclofen unichem | Lioresal | Norton-baclofen | Teva baclofen
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