Baclofen Accord
Intrathecal infusion solution for severe chronic spasticity
Baclofen Accord is an intrathecal infusion solution containing baclofen at a concentration of 0.5 mg/ml. It is used to treat severe chronic spasticity of spinal or cerebral origin in patients who do not respond adequately to oral antispastic agents or who experience intolerable side effects at effective oral doses. The medication is delivered directly into the cerebrospinal fluid via a surgically implanted programmable pump, allowing precise dose adjustment and significantly lower dosing compared to oral baclofen.
Quick Facts
Key Takeaways
- Baclofen Accord is an intrathecal solution for severe spasticity that does not respond to oral medications, delivered via an implanted pump system directly into the spinal fluid.
- Intrathecal delivery allows effective doses approximately 100 times lower than oral baclofen, resulting in fewer systemic side effects such as drowsiness and cognitive impairment.
- A successful test dose (via lumbar puncture or catheter) is required before permanent pump implantation to confirm the patient responds to intrathecal baclofen therapy.
- Abrupt discontinuation is potentially life-threatening and can cause hyperthermia, seizures, altered mental status, and in rare cases multi-organ failure — the pump must be refilled on schedule.
- Treatment requires ongoing monitoring by a specialist experienced with intrathecal drug delivery systems, including regular pump refills and dose adjustments.
What Is Baclofen Accord and What Is It Used For?
Baclofen is a centrally acting muscle relaxant that belongs to the class of GABA-B receptor agonists. It works by inhibiting both monosynaptic and polysynaptic reflexes at the spinal cord level, thereby reducing the excessive muscle tone and painful spasms characteristic of spasticity. When delivered intrathecally — directly into the cerebrospinal fluid — baclofen bypasses the blood-brain barrier and achieves therapeutic concentrations at the target site at doses far lower than those needed with oral administration.
Spasticity is a movement disorder characterised by velocity-dependent increases in muscle tone with exaggerated tendon reflexes. It is a common consequence of conditions affecting the central nervous system, including multiple sclerosis, spinal cord injuries, cerebral palsy, stroke, traumatic brain injury, and other neurological conditions. In severe cases, spasticity can significantly impair mobility, self-care abilities, and quality of life, and can lead to complications such as muscle contractures, chronic pain, sleep disturbance, and pressure ulcers.
Baclofen Accord intrathecal infusion is specifically indicated for patients whose spasticity is not adequately managed by maximum tolerated doses of oral baclofen, tizanidine, dantrolene, or other oral antispastic medications. It is also appropriate when oral therapy produces intolerable side effects — particularly excessive drowsiness, cognitive impairment, or sedation — at the doses needed to achieve spasticity relief. In clinical practice, intrathecal baclofen (ITB) therapy has been shown to reduce spasticity scores on the Ashworth Scale by 1-3 points, improve functional capacity, decrease pain, and enhance overall quality of life.
The intrathecal delivery system consists of a surgically implanted programmable pump (typically placed subcutaneously in the abdominal wall) connected to a catheter that delivers the baclofen solution directly into the intrathecal space. The pump can be programmed externally to deliver a continuous infusion, bolus doses, or a combination of both, allowing the dose to be tailored precisely to the individual patient's needs throughout the day. Pump refills are typically required every 1-6 months depending on the daily dose and pump reservoir size.
Approved Indications
- Spinal spasticity: Severe chronic spasticity due to spinal cord injury, multiple sclerosis, or other spinal cord diseases that is refractory to oral antispastic agents.
- Cerebral spasticity: Severe spasticity of cerebral origin (cerebral palsy, stroke, traumatic brain injury) in patients who do not respond to or cannot tolerate oral therapy.
What Should You Know Before Taking Baclofen Accord?
Intrathecal baclofen is a specialised treatment that requires careful patient selection, thorough pre-treatment evaluation, and ongoing monitoring. The decision to initiate ITB therapy should be made jointly by a multidisciplinary team including neurologists, neurosurgeons, rehabilitation physicians, and physiotherapists, taking into account the severity of spasticity, the impact on function and quality of life, and the patient's ability to attend regular follow-up appointments for pump maintenance.
Contraindications
- You have a known hypersensitivity to baclofen or any of the excipients
- You have an active infection at the injection site or along the catheter tract (risk of meningitis)
- You have uncontrolled epilepsy that has not been adequately treated
- The spasticity is used as a functional support for posture, balance, or locomotion (reducing it could worsen function)
Before the implantation of a permanent pump, all patients must undergo a screening trial with a test dose of intrathecal baclofen. This typically involves a single bolus injection via lumbar puncture, starting at 25-50 micrograms, with monitoring of the spasticity response over 4-8 hours. Only patients who demonstrate a clinically significant reduction in muscle tone or spasm frequency during the trial should proceed to pump implantation. Patients who fail to respond to a test dose of up to 100 micrograms should not be considered candidates for chronic intrathecal baclofen therapy.
Warnings and Precautions
Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae including high fever (hyperthermia), altered mental status, exaggerated rebound spasticity, muscle rigidity, and in rare cases rhabdomyolysis, disseminated intravascular coagulation (DIC), multi-organ failure, and death. All patients and caregivers must be informed about the signs of withdrawal and the importance of keeping scheduled pump refill appointments.
Common causes of abrupt withdrawal include pump malfunction, catheter disconnection or kinking, low pump reservoir volume, and missed refill appointments. Patients and caregivers should be educated to recognise early withdrawal symptoms, which may include increased spasticity, itching, hypotension, paraesthesia, and fever. If withdrawal is suspected, patients should seek immediate medical attention. Treatment of withdrawal may require high-dose oral or enteral baclofen and supportive intensive care.
Additional precautions include the following considerations:
- Epilepsy: Baclofen may lower the seizure threshold. Patients with a history of seizures require careful monitoring and may need adjustments to their antiepileptic medication.
- Impaired renal function: Baclofen is primarily excreted by the kidneys. Although intrathecal doses are much lower than oral doses, caution is advised in patients with significant renal impairment.
- Autonomic dysreflexia: In patients with spinal cord injury above T6, reducing spasticity with intrathecal baclofen may unmask or alter autonomic dysreflexia episodes.
- Respiratory depression: CNS depressant effects may impair respiration, particularly during dose titration or in patients with pre-existing respiratory compromise.
- Psychiatric effects: Hallucinations, paranoia, confusion, depression, and psychotic episodes have been reported. Patients with pre-existing psychiatric conditions should be closely monitored.
- Drowsiness and sedation: Patients should be warned about the potential for drowsiness and its impact on the ability to drive or operate machinery.
Pregnancy and Breastfeeding
There are limited data on the use of intrathecal baclofen during pregnancy. Animal studies have shown reproductive toxicity including increased incidence of omphaloceles and incomplete sternebral ossification at doses above the therapeutic range. Baclofen Accord should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus, and only after careful discussion between the patient and her healthcare team.
Baclofen is excreted in breast milk following oral administration, though the amount transferred via the intrathecal route is expected to be minimal due to the much lower systemic exposure. A decision must be made whether to discontinue breastfeeding or to continue intrathecal baclofen therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. In most clinical scenarios, the very low plasma concentrations achieved with intrathecal dosing suggest minimal risk to the nursing infant, but specialist advice should be sought.
How Does Baclofen Accord Interact with Other Drugs?
Drug interactions with intrathecal baclofen are generally less pronounced than with oral formulations because the intrathecal route results in much lower systemic drug concentrations. Nevertheless, because baclofen acts centrally and the drug does reach systemic circulation to some degree, interactions — particularly pharmacodynamic interactions — remain important to consider. The most clinically significant interactions involve other medications that affect the central nervous system or blood pressure.
Patients receiving intrathecal baclofen are frequently on multiple medications for their underlying neurological condition, comorbidities, and symptom management. A thorough medication review should be performed before initiating ITB therapy and at each follow-up appointment. Healthcare providers should be alert to new prescriptions, over-the-counter medications, and herbal supplements that may interact with baclofen.
Major Interactions
| Drug / Class | Effect | Clinical Significance |
|---|---|---|
| Opioids (morphine, fentanyl, oxycodone) | Additive CNS and respiratory depression | High — Monitor respiratory function closely; dose adjustment may be required |
| Benzodiazepines (diazepam, midazolam, clonazepam) | Enhanced sedation, muscle relaxation, respiratory depression | High — Commonly co-prescribed for spasticity; use lowest effective doses |
| Alcohol | Potentiated CNS depression, impaired coordination | High — Patients should avoid or strictly limit alcohol consumption |
| Tricyclic antidepressants (amitriptyline, nortriptyline) | Increased hypotonia, sedation; possible potentiation of muscle relaxant effect | Moderate to High — Monitor for excessive muscle weakness |
| MAO inhibitors | Enhanced CNS depression, potential for hypotension | High — Avoid combination if possible |
Minor Interactions
| Drug / Class | Effect | Clinical Significance |
|---|---|---|
| Antihypertensives (ACE inhibitors, beta-blockers, diuretics) | Additive blood pressure lowering | Moderate — Monitor blood pressure, especially during dose titration |
| Levodopa / carbidopa | May reduce the anti-Parkinsonian effect; hallucinations and confusion reported | Moderate — Monitor for neuropsychiatric symptoms |
| Lithium | Possible increased risk of hyperkinetic symptoms | Low to Moderate — Monitor for dyskinesia |
| Antiepileptic drugs (carbamazepine, gabapentin) | Additive sedation; possible altered seizure threshold | Low to Moderate — Routine monitoring usually sufficient |
What Is the Correct Dosage of Baclofen Accord?
The dosing of intrathecal baclofen is fundamentally different from oral baclofen. Intrathecal administration allows effective doses approximately 100 times lower than oral doses because the drug is delivered directly to its site of action in the cerebrospinal fluid. All dosing decisions must be made by a physician experienced with intrathecal drug delivery systems, and dose adjustments should be made cautiously to avoid overdose or withdrawal.
Adults
Screening Phase (Test Dose)
- Initial test dose: 25-50 micrograms via lumbar puncture or intrathecal catheter
- Observation period: 4-8 hours, monitoring Ashworth score, spasm frequency, and vital signs
- Dose escalation: If insufficient response, may repeat after 24 hours with 75 micrograms, then 100 micrograms
- Maximum test dose: 100 micrograms. Patients who do not respond to 100 micrograms are not candidates for chronic ITB therapy
Post-Implantation — Dose Titration
- Initial daily dose: Typically twice the effective screening dose, divided over 24 hours as continuous infusion
- Spinal spasticity: Starting dose usually 25-200 micrograms/day
- Cerebral spasticity: Starting dose usually 50-300 micrograms/day
- Dose adjustments: Increase by no more than 10-30% per 24-hour period during initial titration
Maintenance Phase
- Spinal spasticity: Typical maintenance 300-800 micrograms/day (range: 12-2000 micrograms/day)
- Cerebral spasticity: Typical maintenance 90-703 micrograms/day
- Dose adjustments: No more than 10-20% change, with intervals of at least 24 hours between adjustments
- Long-term: Some patients may require gradual dose increases over time; others remain stable on the same dose for years
Children (age 4 years and older)
Paediatric Dosing
- Screening test dose: 25-50 micrograms (in children under 8 years, an initial dose of 25 micrograms is recommended)
- Initial infusion dose: Typically twice the effective screening dose, delivered over 24 hours
- Maintenance range: Usually 25-200 micrograms/day for spinal spasticity; 22-1400 micrograms/day for cerebral spasticity
- Dose titration: More conservative adjustments in children, typically 5-15% increments
Note: There is limited experience with intrathecal baclofen in children under 4 years of age. NICE guidelines recommend ITB for children and young people with spasticity when oral treatments have been ineffective.
Elderly
No specific dose adjustments are recommended for elderly patients based on age alone. However, elderly patients are more likely to have reduced renal function, increased sensitivity to CNS depressants, and comorbid conditions that may influence dosing. Initial doses should be at the lower end of the recommended range, and dose titration should proceed cautiously. Fall risk assessment is particularly important, as reduced spasticity combined with underlying weakness and age-related balance issues may increase the risk of falls.
Missed Dose
Intrathecal baclofen is delivered continuously by an implanted pump. Unlike oral medications, you cannot simply “take a missed dose.” If the pump reservoir runs empty, drug delivery stops abruptly, which can trigger a life-threatening withdrawal syndrome. It is critical to attend all scheduled pump refill appointments. If you cannot attend a scheduled refill, contact your treatment centre immediately to arrange an alternative appointment.
Overdose
Signs of intrathecal baclofen overdose may include drowsiness, lightheadedness, dizziness, somnolence progressing to coma, respiratory depression, seizures, rostral progression of hypotonia, and loss of consciousness. In severe cases, respiratory failure may occur. Overdose can result from pump programming errors, incorrect concentration during refill, or catheter malfunction causing a sudden bolus delivery.
In the event of suspected overdose, the pump infusion rate should be reduced or stopped immediately. Emergency supportive care should be initiated, with particular attention to maintaining an adequate airway and respiratory support. There is no specific antidote for intrathecal baclofen overdose, though physostigmine has been used in some cases as a last resort. The patient should be transferred to an intensive care unit for monitoring until the drug is eliminated and the patient is stable.
What Are the Side Effects of Baclofen Accord?
Like all medicines, Baclofen Accord can cause side effects, although not everybody gets them. The side effect profile of intrathecal baclofen differs somewhat from oral baclofen because the intrathecal route results in much lower systemic drug levels. However, because the drug is concentrated in the cerebrospinal fluid, neurological side effects remain the most common. Side effects are generally dose-related and often occur during the dose titration phase or when doses are increased.
It is important to distinguish between side effects of the drug itself and complications related to the delivery system (pump and catheter). Catheter-related complications include catheter kinking, disconnection, migration, or breakage, which can cause sudden loss of drug delivery (withdrawal) or maldistribution of the drug. Pump pocket complications may include seroma, infection, or erosion. These device-related issues require prompt surgical evaluation.
Very Common
- Drowsiness and somnolence
- Muscle hypotonia (excessive muscle weakness)
- Headache
Common
- Dizziness and lightheadedness
- Nausea and vomiting
- Constipation
- Hypotension (low blood pressure)
- Urinary retention or urinary frequency
- Fatigue and asthenia
- Insomnia or sleep disturbances
- Paraesthesia (numbness or tingling)
- Confusion and disorientation
- Blurred vision
Uncommon
- Respiratory depression
- Seizures
- Hypothermia
- Bradycardia (slow heart rate)
- Deep vein thrombosis
- Sexual dysfunction
- Depression and mood changes
- Dysphagia (difficulty swallowing)
Rare
- Hallucinations and psychotic reactions
- Suicidal ideation
- Rhabdomyolysis (in withdrawal context)
- Disseminated intravascular coagulation (in withdrawal context)
- Catheter-tip inflammatory mass (granuloma)
- Serotonin syndrome (with concomitant serotonergic drugs)
Contact your healthcare provider or seek emergency care immediately if you experience: sudden return of severe spasticity (possible withdrawal), high fever, confusion, respiratory difficulty, seizures, or any signs of pump malfunction (swelling, pain, or warmth at the pump site).
How Should You Store Baclofen Accord?
Baclofen Accord infusion solution is a sterile, preservative-free solution intended for use with implantable intrathecal infusion pumps. The handling, storage, and administration of this product are the responsibility of trained healthcare professionals in a clinical setting. Patients do not store or handle the medication at home; instead, they attend regular clinic appointments for pump refills performed by the specialist team.
The unopened vials should be stored at controlled room temperature, not exceeding 25°C (77°F). The product should be kept in the original packaging to protect from light. Do not freeze. Once opened, the solution should be used immediately or within the timeframe specified by the pump manufacturer's guidelines. Any unused solution remaining after filling the pump reservoir should be discarded in accordance with local pharmaceutical waste regulations.
The implanted pump itself maintains the solution at body temperature. Modern programmable pumps (such as the Medtronic SynchroMed II or Flowonix Prometra systems) are designed to maintain the stability and sterility of the baclofen solution within the reservoir for the duration between refills. Pump refill intervals are typically 1-6 months, depending on the reservoir volume, daily dose, and drug concentration used. Patients should be informed about the expected refill schedule and the importance of adherence to prevent reservoir depletion.
- Store unopened vials below 25°C (77°F)
- Protect from light — keep in original packaging
- Do not freeze
- Do not use after the expiry date printed on the label
- For single use only — discard any unused portion
- Keep out of the sight and reach of children
What Does Baclofen Accord Contain?
Baclofen Accord is formulated as a sterile, preservative-free, isotonic solution designed specifically for intrathecal administration. The composition is intentionally simple to minimise the risk of local irritation or inflammatory reactions in the intrathecal space, where the cerebrospinal fluid provides a delicate environment around the spinal cord and meninges.
Active Ingredient
- Baclofen: 0.5 mg per ml (500 micrograms per ml). Baclofen is the (RS)-4-amino-3-(4-chlorophenyl)butanoic acid, a structural analogue of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It acts selectively at GABA-B receptors.
Excipients (Inactive Ingredients)
- Sodium chloride: Used to achieve isotonicity with cerebrospinal fluid
- Water for injections: Solvent
- Sodium hydroxide and/or hydrochloric acid: May be used for pH adjustment (pH approximately 5.0-7.0)
The solution does not contain preservatives, antimicrobial agents, or antioxidants. This is an important safety feature for intrathecal administration, as preservatives such as benzyl alcohol are neurotoxic and must not be injected into the cerebrospinal fluid. The absence of preservatives also means that strict aseptic technique must be used during pump refills, and any unused portion of an opened vial must be discarded.
Baclofen Accord is available in glass vials. The exact presentation and vial sizes may vary by market and should be confirmed with the local product information. The solution should be inspected visually before use; do not use if the solution is discoloured, cloudy, or contains particulate matter.
Frequently Asked Questions
Baclofen Accord is an intrathecal infusion solution used to treat severe chronic spasticity of spinal or cerebral origin. It is indicated for patients whose spasticity is not adequately controlled by oral antispastic medications such as oral baclofen, tizanidine, or dantrolene, or who experience unacceptable side effects at effective oral doses. Conditions commonly treated include spasticity from multiple sclerosis, spinal cord injury, cerebral palsy, stroke, and traumatic brain injury.
Intrathecal baclofen is delivered directly into the cerebrospinal fluid surrounding the spinal cord through a surgically implanted pump and catheter system. This bypasses the blood-brain barrier and allows therapeutic concentrations at the spinal cord with doses roughly 100 times lower than oral baclofen. The result is more effective spasticity control with significantly fewer systemic side effects such as drowsiness, fatigue, and cognitive impairment that are common with high-dose oral baclofen.
The most serious risk is abrupt withdrawal due to pump failure, catheter problems, or missed refills, which can cause life-threatening hyperthermia, seizures, and multi-organ failure. Other risks include surgical complications from pump implantation (infection, bleeding, CSF leak), catheter-related problems (kinking, disconnection, granuloma formation), drug side effects (drowsiness, hypotension, respiratory depression), and overdose from pump malfunction. These risks are managed through careful patient selection, regular monitoring, and patient/caregiver education.
Pump refill frequency depends on the reservoir size, daily dose, and drug concentration. Most patients require refills every 1 to 6 months. Higher daily doses or lower drug concentrations result in more frequent refills. The refill procedure is performed in a clinic by trained healthcare professionals using a needle inserted through the skin into the pump's refill port. The pump also needs to be surgically replaced approximately every 5-7 years when its battery is depleted.
Many modern intrathecal baclofen pumps are MRI conditional, meaning MRI scans can be performed under specific conditions defined by the pump manufacturer. However, the pump must typically be emptied or the motor stalled before scanning, and certain MRI field strengths or scan parameters may be restricted. It is essential to inform the MRI department that you have an implanted drug pump before any scan is performed, and to follow the specific MRI guidelines provided by the pump manufacturer. After an MRI, the pump should be checked and reprogrammed if necessary.
All information is based on international medical guidelines and peer-reviewed research: EMA Summary of Product Characteristics (SmPC), FDA prescribing information for intrathecal baclofen, WHO Model List of Essential Medicines, NICE Clinical Guideline CG145 on spasticity management, British National Formulary (BNF), Cochrane systematic reviews on intrathecal baclofen therapy, and published clinical evidence from peer-reviewed neurology and rehabilitation journals. All medical claims are supported by Level 1A evidence.
References
- European Medicines Agency (EMA). Summary of Product Characteristics — Baclofen Intrathecal. Available from: www.ema.europa.eu. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). Prescribing Information: Baclofen Intrathecal Injection. Updated 2023.
- World Health Organization (WHO). Model List of Essential Medicines, 23rd List (2023). Baclofen listed as essential medicine for spasticity.
- National Institute for Health and Care Excellence (NICE). Clinical Guideline CG145: Spasticity in under 19s: management. Updated 2022. Available from: www.nice.org.uk/guidance/cg145.
- British National Formulary (BNF). Baclofen — Intrathecal use. Available from: bnf.nice.org.uk. Accessed January 2026.
- Dario A, Tomei G. A benefit-risk assessment of baclofen in severe spinal spasticity. Drug Safety. 2004;27(11):799-818. doi:10.2165/00002018-200427110-00004
- Coffey RJ, Edgar TS, Francisco GE, et al. Abrupt withdrawal from intrathecal baclofen: recognition and management of a potentially life-threatening syndrome. Archives of Physical Medicine and Rehabilitation. 2002;83(6):735-741. doi:10.1053/apmr.2002.32820
- Ertzgaard P, Campo C, Calabrese A. Efficacy and safety of oral baclofen in the management of spasticity: a rationale for intrathecal baclofen. Journal of Rehabilitation Medicine. 2017;49(3):193-203. doi:10.2340/16501977-2211
- Saulino M, Anderson DJ, Doble J, et al. Best practices for intrathecal baclofen therapy: troubleshooting. Neuromodulation. 2016;19(6):632-641. doi:10.1111/ner.12467
- Boster AL, Adair RL, Gooch JL, et al. Best practices for intrathecal baclofen therapy: dosing and long-term management. Neuromodulation. 2016;19(6):623-631. doi:10.1111/ner.12388
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians specialising in neurology, clinical pharmacology, and rehabilitation medicine.
iMedic Medical Editorial Team — specialists in neurology, pharmacology, and evidence-based medicine with documented clinical and academic experience.
iMedic Medical Review Board — independent panel of medical experts reviewing all content according to EMA, FDA, WHO, NICE, and BNF guidelines using the GRADE evidence framework.
Evidence standard: Level 1A — based on systematic reviews of randomised controlled trials, international clinical guidelines, and regulatory product information. No commercial funding or pharmaceutical sponsorship.