Lioresal

Lioresal (Baclofen) is used for treating muscle spasms caused by multiple sclerosis or other diseases.

Product dosage: 10mg
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Product dosage: 25mg
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Synonyms Alpha-baclofen Apo-baclofen Baclodrint Baclofene Baclofeno Baclofenum Baclon Baclopar Baclosal Baclosan Bamifen Barambo Befon Bio-baclofen Clofen Colmifen Diafen Espast Flexibac Gabalon Kemstro Lebic Liofen Lioresal intratecal Lioresyl Lyflex Miorel Onelaxant Pacifen Pharmaclofen Pms-baclofen Ratio-baclofen Solofen Stelax Vioridon

Lioresal (baclofen) is a centrally-acting skeletal muscle relaxant specifically indicated for the management of spasticity. It is a first-line therapeutic agent for patients experiencing muscle spasticity resulting from multiple sclerosis, spinal cord injuries, and other diseases of spinal origin. By acting on GABA receptors at the spinal level, it effectively reduces the frequency and amplitude of muscle spasms, leading to significant improvements in daily function, comfort, and range of motion. This comprehensive guide provides expert medical information for healthcare professionals and informed patients.

Features

• Active Pharmaceutical Ingredient: Baclofen
• Mechanism of Action: Agonist at GABA-B receptors, inhibiting monosynaptic and polysynaptic reflexes at the spinal level
• Available Formulations: Oral tablets (10mg, 20mg) and Intrathecal solution for pump delivery
• Prescription Status: Rx-only, requiring careful medical supervision
• Onset of Action: Oral administration typically shows effects within a few hours to a few days for spasticity relief

Benefits

• Significant reduction in the frequency and severity of painful muscle spasms and clonus.
• Improved passive and active range of motion in affected limbs, facilitating physiotherapy.
• Enhanced ability to perform activities of daily living (ADLs) and improved overall functional capacity.
• Reduction in muscle hypertonicity, leading to greater patient comfort and decreased pain.
• For intrathecal administration: Targeted delivery allows for effective spasticity management with lower systemic doses and reduced side effects.
• Can aid in easing nursing care and the use of orthotic devices for patients with severe spasticity.

Common use

Lioresal is primarily prescribed for the management of spasticity. Its most common applications include treating the signs and symptoms of spasticity resulting from multiple sclerosis (particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity). It is also extensively used for managing spasticity due to spinal cord injuries and other spinal cord diseases (e.g., transverse myelitis, amyotrophic lateral sclerosis). Its use is generally not indicated for spasticity resulting from stroke or cerebral palsy, as its efficacy for these conditions is less well-established and the risk of adverse effects may be higher.

Dosage and direction

Dosage must be individualized for each patient. The following is a general guideline for oral administration. Therapy should be started at a low dosage and increased gradually.

• Initial Dose: 5 mg orally three times a day.
• Titration: The dose may be increased by 5 mg per dose every three days to a maximum of 20 mg four times a day (80 mg daily), based on patient response and tolerability.
• Usual Maintenance Dose: 40-80 mg daily divided into three or four doses.
• Dosage in Renal Impairment: Requires significant dose reduction and extended dosing intervals. Consult prescribing information.
• Discontinuation: Abrupt withdrawal must be avoided. Dosage should be reduced slowly over a period of 1-2 weeks to prevent hallucinations, seizures, and rebound spasticity.
• Intrathecal Use: Dosing is highly specialized and is determined via screening dose prior to pump implantation. Maintenance doses are typically a fraction of the oral dose and are administered continuously via an implanted pump. This must be managed exclusively by clinicians experienced in intrathecal therapy.

Precautions

• Renal Impairment: Baclofen is primarily excreted unchanged by the kidneys. Use with extreme caution and at reduced doses in patients with impaired renal function.
• Seizure Disorders: Lioresal may lower the seizure threshold. Use with caution in patients with a history of seizures or EEG abnormalities.
• Stroke/Cerebral Palsy Patients: Efficacy is less proven, and patients may experience increased weakness, sedation, and confusion.
• Psychiatric Disorders: Use with caution in patients with schizophrenia, confusional states, or other psychotic disorders, as symptoms may be exacerbated.
• Autonomic Dysreflexia: Patients with spinal cord injury at T6 or above should be monitored closely, as abrupt withdrawal may precipitate autonomic dysreflexia.
• Pregnancy and Lactation: Use only if the potential benefit justifies the potential risk to the fetus. Baclofen is excreted in human milk.

Contraindications

Lioresal is contraindicated in patients with a known hypersensitivity to baclofen or any component of the formulation.

Possible side effect

The most common side effects are transient drowsiness, dizziness, weakness, and fatigue. These often diminish with continued therapy.

• Very Common (>10%): Drowsiness/sedation, dizziness, weakness, fatigue.
• Common (1-10%): Headache, insomnia, nausea, constipation, hypotension, urinary frequency.
• Uncommon (<1%): Confusion, depression, hallucinations, euphoria, muscle pain, rash, blurred vision, tinnitus, dry mouth, increased perspiration, impotence.
• Rare but Serious: Seizures, severe hypotension, respiratory depression, hepatic dysfunction, severe confusion or psychosis. Intrathecal administration carries specific risks including pump failure, catheter complications, and meningitis.

Drug interaction

• CNS Depressants (Alcohol, Opioids, Benzodiazepines, Sedatives): Concomitant use may result in additive CNS depression, sedation, dizziness, and respiratory depression. Extreme caution is advised.
• Antihypertensives: May potentiate the effects of antihypertensive agents, increasing the risk of hypotension.
• MAO Inhibitors and Tricyclic Antidepressants: May increase CNS depressive effects.
• Levodopa/Carbidopa: Cases of mental confusion, agitation, and hallucinations have been reported.
• Drugs Affecting Renal Function: May alter the clearance of baclofen.

Missed dose

If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Do not double the dose to make up for a missed one.

Overdose

Signs and Symptoms: The most prominent manifestations are CNS depression (somnolence progressing to coma), respiratory depression, hypotonia, seizures, hyporeflexia, vomiting, and blurred vision. Cardiovascular manifestations include bradycardia, hypotension, and ECG changes. Management: There is no specific antidote. Management involves securing the airway and ensuring adequate ventilation. Gastric lavage may be considered if performed soon after ingestion. Cardiovascular support with IV fluids and vasopressors may be necessary. Seizures may be treated with benzodiazepines. In cases of significant renal impairment, hemodialysis may accelerate elimination.

Storage

• Store at room temperature (20°C to 25°C or 68°F to 77°F), protected from light and moisture.
• Keep in the original container, tightly closed.
• Keep out of reach of children and pets.
• Do not flush medications down the toilet or pour them into a drain. Dispose of unused medication via a official medicine take-back program.

Disclaimer

This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

“Lioresal has been a cornerstone in my MS spasticity management. The titration process required patience, but the resultant reduction in painful leg spasms has dramatically improved my sleep and ability to transfer from my wheelchair.” - M.S., Patient “As a physiatrist, I find Lioresal to be an invaluable tool. For the right patient, the functional gains achieved through reduced spasticity are profound, allowing for more effective participation in physical therapy and improved quality of life.” - Dr. A.K., Specialist Physician “The transition to intrathecal baclofen was life-changing for my son after his spinal cord injury. The targeted delivery provided the muscle relaxation he needed without the overwhelming drowsiness he experienced with high oral doses.” - J.L., Caregiver