Version November 2024
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.
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.
Alcohol use disorder (alternative agent) (off-label use):
Oral: Initial: 5 mg 3 times daily; may increase dose after 3 to 5 days based on response and tolerability to 10 mg 3 times daily; may increase further as needed to a maximum dose of 60 mg/day in divided doses (Ref).
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 (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:
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.
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).
Oral and intrathecal: There are no dosage adjustments provided in the manufacturer’s labeling.
Oral: Refer to adult dosing; use with caution. If benefits are not observed, withdraw the drug slowly.
(For additional information see "Baclofen: Pediatric drug information")
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 oral solutions and oral suspensions; concentration varies by product; use extra caution during product selection and preparation and verify correct product/concentration is chosen.
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.
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.
Oral, Intrathecal: There are no dosage adjustments provided in the manufacturer's labeling.
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)
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
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%), erectile dysfunction (≤2%), urinary frequency (≤6%), urinary incontinence (≤2%), urinary retention (≤8%)
Nervous system: Agitation (≤1%), changes in thinking (≤1%), chills (≤1%), coma (≤2%), depression (2%), fatigue (2% to 4%), insomnia (≤7%), pain (≤4%), paresthesia (≤7%), seizure (≤10%; including exacerbation of epilepsy), 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, bradycardia, chest pain, hypertension, palpitations, syncope, vasodilation
Dermatologic: Alopecia, contact dermatitis, dermal ulcer, hyperhidrosis, skin rash
Endocrine & metabolic: Weight gain
Gastrointestinal: Abdominal pain, anorexia, dysgeusia, dysphagia, fecal incontinence, gastrointestinal hemorrhage, occult blood in stools, tongue irritation
Genitourinary: Dysuria, hematuria, inhibited ejaculation, nocturia, oliguria, vaginitis
Hematologic & oncologic: Carcinoma, leukocytosis, petechial rash
Nervous system: Akathisia, amnesia, anxiety, ataxia, dysarthria, dysautonomia, euphoria, excitement, hallucination, hyporeflexia, hypothermia, hysteria, malaise, opisthotonus, personality disorder, slurred speech
Neuromuscular & skeletal: Dystonia, muscle rigidity, myalgia
Ophthalmic: Accommodation disturbance, blurred vision, diplopia, miosis, mydriasis, nystagmus disorder, strabismus
Otic: Tinnitus
Renal: Nephrolithiasis
Respiratory: Apnea, 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: Abnormal orgasm (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)
Hypersensitivity to baclofen or any component of the formulation
Intrathecal formulation: IV, IM, SubQ, or epidural administration
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.
First-Baclofen suspension is a compounding kit. Refer to manufacturer’s labeling for compounding instructions.
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: 40,000 mcg/20 mL (20 mL); 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, 473 mL)
Solution Prefilled Syringe, Intrathecal [preservative free]:
Gablofen: 50 mcg/mL (1 mL) [antioxidant free, latex free]
Gablofen: 20,000 mcg/20 mL (20 mL) [antioxidant free]
Gablofen: 10,000 mcg/20 mL (20 mL); 40,000 mcg/20 mL (20 mL) [antioxidant free, pyrogen free]
Generic: 50 mcg/mL (1 mL)
Suspension, Oral:
Fleqsuvy: 25 mg/5 mL (120 mL, 300 mL) [contains fd&c red #40 (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, 15 mg, 20 mg
May be product dependent
Pack (Lyvispah Oral)
5 mg (per each): $4.32
10 mg (per each): $4.32
20 mg (per each): $4.32
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): $7.26
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
15 mg (per each): $2.60
20 mg (per each): $0.16 - $5.13
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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]
Generic: 10 mg, 20 mg
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.
En teral feeding tube:
The following recommendations are based upon the best available evidence and clinical expertise. Senior editorial team: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN.
Oral granules:
Gastric (eg, NG, percutaneous endoscopic gastrostomy [PEG]) or post-pyloric (eg, jejunostomy) tubes (≥8 French): Mix packet contents with 15 mL of purified water until granules wetted. Draw up suspension of granules/liquid into enteral dosing syringe and administer via feeding tube; repeat process if multiple packets are needed to complete a dose. Administer within 2 hours of initial mixing. If mixture in enteral dosing syringe is allowed to stand for ≥15 minutes prior to administration, invert syringe 3 times to ensure baclofen is mixed (Ref).
General guidance: Hold enteral nutrition during baclofen administration (Ref). Flush feeding tube with an appropriate volume of purified water before administration (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Oral solution (commercially available):
Gastric tubes (eg, NG, PEG): Dilute with equal volume of purified water prior to administering to reduce osmolality and viscosity; draw up diluted solution into enteral dosing syringe and administer via feeding tube (Ref).
General guidance: Hold enteral nutrition during baclofen administration (Ref). Flush feeding tube with an appropriate volume of purified water before administration (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Oral suspension (commercially available): Enteral administration of oral suspension has not been evaluated.
Oral tablets:
Gastric (eg, NG, PEG) or post-pyloric (eg, jejunal) tubes (≥8 French): Crush tablets into a fine powder and disperse in purified water (≥10 mL) prior to administration, then draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).
General guidance: Hold enteral nutrition during baclofen administration (Ref). Flush feeding tube with an appropriate volume of purified water before administration (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Note: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties among manufacturers.
The following feeding tube recommendations are based upon the best available evidence and clinical expertise. Senior editor panel: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter, PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang, MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN.
Note: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties among manufacturers.
Oral:Administer without regard to meals. If nausea occurs, may administer with food or milk (Ref).
Oral liquid: Baclofen is available as both oral solutions and oral suspensions; concentration varies by product; use extra caution during product selection and preparation and verify correct product/concentration is chosen.
Oral solution (commercially available): Administer with a calibrated measuring device; do not use a household teaspoon (overdosage may occur).
Administration via feeding tube:
Gastric tubes (eg, NG, percutaneous endoscopic gastrostomy [PEG]): Dilute oral solution with equal volume of purified water prior to administering to reduce osmolality and viscosity; draw up diluted solution into enteral dosing syringe and administer via feeding tube (Ref).
General guidance: Hold enteral nutrition during baclofen administration (Ref). Flush feeding tube with an appropriate volume of purified water before administration (Ref); consult ASPEN recommendations (Ref) or institution-specific protocols for appropriate flush volume. Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Oral suspension (commercially available) : Shake well prior to administration. Administer with a calibrated measuring device; do not use a household teaspoon (overdosage may occur).
Administration via feeding tube: Enteral feeding tube administration of oral suspension has not been evaluated.
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:
Gastric (eg, NG, PEG) or post-pyloric (eg, jejunostomy) tubes (≥8 French): Mix content of each oral granules packet with 15 mL of purified water until granules wetted. Draw up suspension of granules/liquid into enteral dosing syringe and administer via feeding tube; repeat process if multiple packets are needed to complete a dose. Administer within 2 hours of initial mixing. If mixture in enteral dosing syringe is allowed to stand for ≥15 minutes prior to administration, invert syringe 3 times to ensure baclofen is mixed (Ref).
General guidance: Hold enteral nutrition during baclofen administration (Ref). Flush feeding tube with an appropriate volume of purified water before administration (Ref); consult ASPEN recommendations (Ref) or institution-specific protocols for appropriate flush volume. Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Oral tablets:
Administration via feeding tube:
Gastric (eg, NG, PEG) or post-pyloric (eg, jejunal) tubes (≥8 French): Crush tablet(s) to a fine powder and disperse in purified water (≥10 mL) prior to administration; then draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).
General guidance: Hold enteral nutrition during baclofen administration (Ref). Flush feeding tube with an appropriate volume of purified water before administration (Ref); consult ASPEN recommendations (Ref) or institution-specific protocols for appropriate flush volume. Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
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.
Spasticity:
Oral:
Solution (Ozobax), tablet: Management of reversible spasticity associated with multiple sclerosis or spinal cord lesions.
Granules (Lyvispah), solution (Ozabax DS), suspension (Fleqsuvy): Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity; may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Intrathecal: Management of severe spasticity of spinal cord origin (eg, spinal cord injury, multiple sclerosis) or cerebral origin (eg, cerebral palsy, traumatic brain injury) in patients ≥4 years of age; may be considered as an alternative to destructive neurosurgical procedures.
Limitations of use: Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long-term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS adverse effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least 1 year after the injury before consideration of long-term intrathecal baclofen therapy.
Alcohol use disorder; Hiccups; Muscle spasm and/or musculoskeletal pain
Baclofen may be confused with Bactroban
Lioresal may be confused with lisinopril, Lotensin
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (epidural and intrathecal medications) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care Settings).
Different concentrations of the oral liquid are available; ensure appropriate strength and dose of oral liquid prior to administering, dispensing, and prescribing.
None known.
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 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
Loxapine: CNS Depressants may enhance the CNS depressant effect of Loxapine. Risk D: Consider therapy modification
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
Tricyclic Antidepressants: May enhance the adverse neuromuscular effect of Baclofen. Baclofen may enhance the CNS depressant effect of Tricyclic Antidepressants. Risk C: Monitor therapy
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
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).
Baclofen is present in breast milk.
The relative infant dose (RID) of oral baclofen is 5% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 80 mg/day.
In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).
The RID of baclofen was calculated using a milk concentration of 0.38 mcg/mL, providing an estimated daily infant dose via breast milk of 0.057 mg/kg/day. This milk concentration was obtained following maternal administration of oral baclofen 20 mg four times a day, shortly after birth (Lin 2014). A case report notes breast milk concentrations following maternal use of intrathecal baclofen 330 mcg/day throughout pregnancy were 0.617 ng/mL (Hara 2018). Adverse events were not observed in a breastfed infant following maternal use of intrathecal baclofen 200 mcg/day throughout pregnancy and postpartum (breast milk concentrations not sampled) (Morton 2009).
Information related to milk concentrations is limited (Eriksson 1981; Lin 2014). Withdrawal symptoms may occur in a breastfed infant when maternal baclofen is discontinued or breastfeeding is stopped. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Regular EEG in patients with epilepsy (loss of seizure control has been reported); monitor for signs and symptoms of baclofen withdrawal (oral or intrathecal; eg, altered mental status, exaggerated rebound spasticity, hallucination, high fever, hypertension, hyperthermia, muscle rigidity, tachycardia, seizure, agitation, confusion, delusions, insomnia, and paranoid ideation); prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms; monitor closely during the initial phase of pump use and when adjusting the dosing rate and/or the concentration in the reservoir. monitor closely for signs and symptoms of overdose (eg, drowsiness, dizziness, somnolence, hypothermia, respiratory depression, seizures, rostral progression of hypotonia, and loss of consciousness progressing to coma), which may appear suddenly or insidiously, especially during the initial screening and dose-titration phase of treatment, and during reintroduction of therapy after a period of interruption.
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
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).
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