Baclofen: Targeted Muscle Spasticity Relief for Neurological Disorders
Baclofen
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Baclofen is a centrally acting skeletal muscle relaxant primarily indicated for the management of muscle spasticity associated with multiple sclerosis, spinal cord injuries, and other neurological conditions. As a gamma-aminobutyric acid (GABA) derivative, it acts specifically on GABA-B receptors at the spinal cord level, producing inhibition of monosynaptic and polysynaptic reflex transmission. This pharmacological profile makes it particularly valuable in reducing muscle tone, decreasing the frequency and intensity of spasms, and improving functional capacity in appropriate patient populations. Clinical evidence supports its role in both oral and intrathecal administration formats, with the latter reserved for severe spasticity unresponsive to oral therapy or producing intolerable side effects.
Features
- Chemical name: 4-amino-3-(4-chlorophenyl)butanoic acid
- Molecular formula: C₁₀H₁₂ClNO₂
- Mechanism: GABA-B receptor agonist with central action
- Bioavailability: Approximately 70-85% following oral administration
- Protein binding: 30%
- Half-life: 2.5-4 hours
- Metabolism: Hepatic (15% of dose)
- Excretion: Primarily renal (70-80% unchanged)
- Available formulations: Oral tablets (10mg, 20mg) and intrathecal solution
Benefits
- Reduces painful muscle spasms and clonus through selective spinal cord inhibition
- Improves range of motion and functional mobility in spasticity patients
- Decreases muscle rigidity, facilitating nursing care and rehabilitation efforts
- May reduce autonomic hyperreflexia symptoms in spinal cord injury patients
- Enables dose titration flexibility with oral and intrathecal administration options
- Demonstrates relatively rapid onset of action within hours to days of initiation
Common use
Baclofen is primarily prescribed for the management of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. It is also indicated for spinal cord injuries and other spinal cord diseases including transverse myelitis, syringomyelia, and motor neuron disease. Off-label uses include treatment of intractable hiccups, alcohol withdrawal syndrome, and certain types of chronic pain syndromes. The medication is particularly valuable in patients where spasticity interferes with daily activities, sleep, or nursing care. Clinical response typically manifests as reduced muscle tone and frequency of spasms within days to weeks of initiation.
Dosage and direction
Initial oral dosing for adults typically begins with 5mg three times daily, which may be increased gradually every three days by 15mg per day until optimal therapeutic effect is achieved. The maximum recommended daily dose is 80mg (20mg four times daily). For children over 12 years, dosing follows similar titration principles with maximum daily doses not exceeding 60-80mg depending on weight and response. Intrathecal administration requires specialized equipment and programming by qualified healthcare professionals, with initial screening doses typically ranging from 25-100 mcg and maintenance doses titrated based on response. Dosage adjustments are necessary in renal impairment, with recommendations for reduced dosing or extended intervals when creatinine clearance falls below 50 mL/min. Administration with food may minimize gastrointestinal discomfort.
Precautions
Abrupt discontinuation of baclofen may precipitate withdrawal symptoms including hallucinations, seizures, and rebound spasticity, particularly with long-term high-dose therapy. Gradual tapering over 1-2 weeks is recommended. Caution is advised in patients with seizure disorders, as baclofen may lower seizure threshold. Renal impairment requires dosage adjustment due to primarily renal excretion. Patients should be warned about potential sedation and impaired alertness, particularly during dose escalation. Special caution is necessary in elderly patients due to increased sensitivity to CNS effects and higher risk of renal impairment. Regular monitoring of renal function and spasticity assessment using standardized scales (Ashworth, Modified Ashworth) is recommended during therapy.
Contraindications
Baclofen is contraindicated in patients with known hypersensitivity to baclofen or any component of the formulation. It should not be used for the treatment of skeletal muscle spasm resulting from rheumatic disorders. Intrathecal administration is contraindicated in patients with infection at the injection site, uncontrolled bleeding diathesis, or spinal abnormalities that would prevent proper catheter placement. The oral formulation is generally avoided during pregnancy unless potential benefits outweigh risks, as human data is limited. Breastfeeding is not recommended due to secretion in human milk and potential infant sedation.
Possible side effect
Common adverse reactions (≥10%) include drowsiness, dizziness, weakness, and fatigue. Less frequent side effects (1-10%) comprise nausea, constipation, hypotension, headache, and insomnia. Serious but rare adverse events (<1%) include respiratory depression, seizures, hallucinations, and severe hypotension. Intrathecal administration carries additional risks including catheter-related complications, meningitis, and pump malfunction. Paradoxical increase in spasticity may occur with intrathecal therapy. Laboratory abnormalities may include elevated AST, alkaline phosphatase, and blood glucose. Most side effects are dose-dependent and often diminish with continued therapy or dose reduction.
Drug interaction
Baclofen may potentiate CNS depression when combined with alcohol, benzodiazepines, opioids, or other sedating medications. Concurrent use with antihypertensive agents may enhance hypotensive effects. Monoamine oxidase inhibitors may increase CNS toxicity risk. Caution is advised with tricyclic antidepressants due to potential additive sedation and anticholinergic effects. Interactions with levodopa may exacerbate psychiatric symptoms in Parkinson’s disease patients. Baclofen may increase blood glucose levels, potentially requiring adjustment of antidiabetic medications. Close monitoring is recommended when initiating or discontinuing concomitant medications that affect CNS function.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Doubling doses to make up for missed administration is not recommended due to increased risk of adverse effects. Patients should be educated about maintaining consistent dosing intervals to minimize fluctuations in spasticity control. For intrathecal therapy, missed doses or pump alarms require immediate contact with the healthcare provider due to risk of withdrawal symptoms.
Overdose
Baclofen overdose manifests as profound CNS depression including coma, respiratory depression, hypotonia, hyporeflexia, seizures, and cardiac conduction abnormalities. Management includes supportive care with airway protection, ventilatory support, and hemodynamic stabilization. Gastric lavage may be considered if presentation is early after ingestion. There is no specific antidote; however, physostigmine has been used with variable success in reversing CNS effects. Hemodialysis may be effective due to baclofen’s relatively low molecular weight and limited protein binding. Patients should be monitored for at least 24 hours due to potential for delayed onset and prolonged duration of symptoms, particularly with large ingestions.
Storage
Store tablets at controlled room temperature (20-25°C/68-77°F) in tightly closed containers protected from moisture. Intrathecal solution should be stored refrigerated at 2-8°C (36-46°F) and protected from freezing. Once transferred to the pump reservoir, stability varies by pump model and concentration—consult manufacturer guidelines. Keep all formulations out of reach of children and pets. Do not use solutions that appear discolored or contain particulate matter. Proper disposal of unused medication through take-back programs is recommended to prevent environmental contamination and accidental exposure.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Individual therapeutic decisions should be made in consultation with a qualified healthcare professional familiar with the patient’s specific medical history and current condition. Dosage recommendations may vary based on individual patient factors including age, renal function, concomitant medications, and disease severity. The prescriber should reference complete prescribing information before initiating therapy. Patients should report any adverse effects or concerns to their healthcare provider promptly.
Reviews
Clinical studies demonstrate baclofen’s efficacy in reducing spasticity scores by 1-2 points on the Modified Ashworth Scale in approximately 60-70% of patients with multiple sclerosis or spinal cord injury. Patient-reported outcomes typically show improvement in sleep quality, pain scores, and ease of care. Systematic reviews note superior efficacy compared to placebo with number needed to treat of 3-4 for clinically significant improvement. Long-term studies support maintained efficacy for up to 12 months with appropriate dose titration. Intrathecal therapy shows particular benefit in severe spasticity cases, with 70-80% of patients achieving adequate control when oral therapy fails. Most reviews emphasize the importance of individualized dosing and careful monitoring for optimal outcomes.