Lioresal (baclofen) is a centrally-acting skeletal muscle relaxant specifically indicated for the management of severe spasticity resulting from conditions such as multiple sclerosis, spinal cord injuries, and other spinal cord diseases. It functions as a gamma-aminobutyric acid (GABA) agonist, primarily exerting its effects at the spinal cord level to inhibit monosynaptic and polysynaptic reflex transmission. This targeted mechanism of action allows for a significant reduction in muscle tone and frequency of spasms without directly interfering with neuromuscular function. By alleviating the painful and disabling symptoms of spasticity, Lioresal facilitates enhanced patient comfort, improved range of motion, and greater capacity for participation in physiotherapy and activities of daily living. Treatment should be initiated and monitored by a healthcare professional experienced in the management of spasticity.

Features

• Active pharmaceutical ingredient: Baclofen USP.
• Available in oral tablet formulations (10 mg and 20 mg strengths).
• Also available as an intrathecal solution for implantable pump delivery in treatment-resistant cases.
• Selective agonist for GABA-B receptors.
• Works primarily at the spinal cord level.
• Requires a prescription and professional medical supervision.

Benefits

• Significantly reduces muscle spasticity and hypertonia, leading to decreased muscle stiffness.
• Alleviates associated symptoms such as pain, clonus, and muscle spasms, improving overall comfort.
• Enhances functional abilities, including range of motion and voluntary movement, aiding in rehabilitation.
• Facilitates ease of nursing care and activities of daily living for patients with severe disability.
• May improve sleep quality by reducing painful nocturnal spasms.
• The intrathecal formulation allows for direct delivery to the cerebrospinal fluid, maximizing efficacy and minimizing systemic side effects in complex cases.

Common use

Lioresal is primarily prescribed for the management of signs and symptoms of spasticity in patients with multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. It is also indicated for patients with spinal cord injuries and other spinal cord diseases (e.g., transverse myelitis, amyotrophic lateral sclerosis). The therapeutic goal is to improve function and alleviate discomfort, making it a cornerstone of spasticity management protocols in neurology and physical medicine and rehabilitation. It is not indicated for the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Dosage and direction

Dosage must be individualized for each patient. Therapy should be started at a low dosage and increased gradually until the desired therapeutic effect is achieved.

• Initial Dose: 5 mg orally three times a day.
• Titration: The dosage may be increased by 5 mg per dose every three days to a maximum of 80 mg daily (20 mg q.i.d.), based on patient response and tolerability.
• Usual Maintenance Dose: 40-80 mg daily administered in divided doses.
• Administration: Tablets should be taken with food or milk to minimize potential gastrointestinal upset.
• Discontinuation: Abrupt withdrawal must be avoided. Dosage should be reduced slowly over a period of one to two weeks under close medical supervision to prevent hallucination, psychosis, and rebound spasticity.

Intrathecal administration is a highly specialized procedure involving surgical implantation of a pump and is managed exclusively by trained clinicians.

Precautions

Lioresal should be used with caution in certain patient populations and conditions.

• Renal Impairment: Baclofen is primarily excreted by the kidney. Dosage reduction is necessary in patients with impaired renal function.
• Elderly Patients: Increased sensitivity to the drug may occur; a lower starting dose is recommended.
• Stroke Patients: Efficacy for spasticity due to cerebral origin is less well established; use with caution due to potential for sedation and dizziness.
• Psychiatric Disorders: Use with caution in patients with pre-existing psychiatric or depressive disorders, confusional states, or schizophrenia.
• Autonomic Dysreflexia: Patients with spinal cord injury at T6 or above should be monitored for autonomic dysreflexia.
• Pregnancy and Lactation: Use only if the potential benefit justifies the potential risk to the fetus or infant. Baclofen is excreted in human milk.
• Operating Machinery: Patients should be warned about the potential for drowsiness, sedation, and dizziness and advised against driving or operating hazardous machinery until their response is known.

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. Patients should be advised that these effects are often dose-related and may diminish over time.

• Very Common (>10%): Drowsiness, dizziness.
• Common (1-10%): Fatigue, confusion, headache, insomnia, nausea, hypotension, constipation.
• Uncommon (0.1-1%): Depression, hallucinations, euphoria, muscle pain, urinary frequency, rash, dry mouth, blurred vision, tinnitus.
• Rare (<0.1%): Seizures, syncope, respiratory depression, severe hypotension, elevated liver enzymes.

Drug interaction

Concomitant use of Lioresal with other CNS depressants can lead to additive effects, increasing the risk of sedation, dizziness, and respiratory depression.

• CNS Depressants: Alcohol, benzodiazepines (e.g., diazepam, lorazepam), opioids (e.g., morphine, oxycodone), sedating antihistamines, tricyclic antidepressants.
• Antihypertensives: May potentiate the effects of antihypertensive drugs, increasing the risk of hypotension.
• MAO Inhibitors: Concurrent use may intensify the CNS depressant and hypotensive effects of baclofen.
• Lithium: May increase lithium toxicity.

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. The patient should not double the dose to make up for a missed one. Maintaining a consistent dosing schedule is important for stable therapeutic effect.

Overdose

Overdose manifests as a profound exaggeration of Lioresal’s known pharmacological effects.

• Signs and Symptoms: Coma, respiratory depression, absence of reflexes, flaccidity, hypothermia, bradycardia, hypotension, hypothermia, seizures, and vomiting.
• Management: There is no specific antidote. Management involves securing the airway, ensuring adequate ventilation, and providing comprehensive supportive care. Gastric lavage may be considered if performed soon after ingestion. Hemodialysis may be beneficial in cases of significant renal impairment. In cases of intrathecal overdose, aspiration of cerebrospinal fluid via the pump reservoir may be attempted by a trained clinician.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep in the original container, tightly closed.
• Keep all medications out of the reach of children and pets.

Disclaimer

This information is for educational purposes only and 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 before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• “As a neurologist with over 20 years of experience treating MS patients, Lioresal remains a first-line option for managing debilitating spasticity. The titration protocol is key to maximizing benefit while minimizing sedation. It has significantly improved the quality of life for countless of my patients.” – Dr. A. Reynolds, MD, Neurology
• “After my spinal cord injury, the constant muscle spasms were unbearable. Starting on Lioresal was a turning point in my rehabilitation. It gave me the relief needed to engage effectively with physical therapy. The side effects were manageable after we found the right dose.” – M. Chen, Patient
• “From a nursing perspective, Lioresal facilitates patient care immensely. Reducing severe spasticity makes positioning, hygiene, and transfers safer and more comfortable for both the patient and the caregiver. It’s a critical tool in our spasticity management arsenal.” – J. Abara, RN
• “The intrathecal delivery system for baclofen is a game-changer for patients with severe, oral-medication-resistant spasticity. The precision of delivery allows for remarkable efficacy with a fraction of the systemic side effects. It requires a dedicated team but the outcomes can be profound.” – Dr. S. Petrova, Physical Medicine & Rehabilitation