Baclosign (baclofen) is a centrally acting skeletal muscle relaxant specifically formulated for the management of spasticity resulting from multiple sclerosis, spinal cord injuries, and other neurological diseases. It functions as a gamma-aminobutyric acid (GABA) agonist, primarily acting at the spinal cord level to inhibit monosynaptic and polysynaptic reflex transmission. This targeted mechanism significantly reduces the frequency and/or severity of spasms and clonus while alleviating associated pain and improving range of motion. By facilitating easier performance of daily activities and therapeutic exercises, Baclosign represents a cornerstone in the neurorehabilitation pharmacopeia for appropriate patient populations.

Features

• Active pharmaceutical ingredient: Baclofen USP
• Available in 10 mg and 20 mg oral tablet strengths
• Formulated for consistent bioavailability and predictable pharmacokinetics
• White, round, scored tablets for accurate dose splitting
• Manufactured under cGMP (current Good Manufacturing Practices) standards
• Prescription-only medication requiring careful medical supervision

Benefits

• Reduced Muscle Hypertonicity: Effectively diminishes excessive muscle tone, allowing for improved voluntary movement.
• Symptom Relief: Alleviates painful spasms, clonus, and muscular rigidity, contributing to enhanced comfort.
• Functional Improvement: Facilitates physiotherapy, nursing care, and activities of daily living by reducing spasticity-related limitations.
• Central Action with Targeted Effect: Works primarily at the spinal level, offering a focused mechanism to manage neurological spasticity.
• Established Efficacy Profile: Backed by decades of clinical use and research in neurological disorders.

Common use

Baclosign is indicated for the management of spasticity. It is most commonly prescribed for patients experiencing spasticity due to multiple sclerosis (particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity) and for spasticity resulting from spinal cord injuries and other spinal cord diseases. Its use is targeted at symptomatic relief that aids in functional restoration and rehabilitation efforts. 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 optimum effect is achieved.

• Initial Dose: 5 mg administered orally three times daily.
• Titration: The dosage may be increased by 15 mg (e.g., one additional 5 mg tablet per dose) daily at approximately 3-day intervals until the desired effect is achieved.
• Therapeutic Dosage: The optimum therapeutic dosage typically ranges from 40 mg to 80 mg daily administered in divided doses. The total daily dose should not exceed 80 mg (20 mg q.i.d.).
• Administration: Tablets should be taken with a full glass of water, with or without food. The scored tablets can be split for dose adjustment.
• Discontinuation: Abrupt cessation should be avoided. Dosage should be reduced slowly over a period of 1 to 2 weeks to minimize the risk of withdrawal symptoms, including hallucinations and seizures.

Precautions

• Use with caution in patients with a history of autonomic dysreflexia.
• May cause drowsiness, dizziness, or blurred vision; patients should be cautioned about operating machinery or driving.
• Carefully monitor patients with a history of peptic ulcer disease.
• Use with caution in patients with impaired renal function; dosage reduction may be necessary.
• Psychiatric and cardiovascular parameters should be monitored during therapy, especially during the titration phase.
• Not recommended for use in patients with stroke or cerebral palsy, as efficacy has not been established and risk may outweigh benefit.

Contraindications

• Hypersensitivity to baclofen or any component of the formulation.
• Avoid use for the treatment of muscle spasm associated with rheumatic disorders.

Possible side effects

The most common side effects are transient and often dose-related. They include:

• Drowsiness
• Dizziness
• Weakness and fatigue
• Nausea
• Constipation
• Insomnia
• Headache
• Hypotension (low blood pressure) Less common but more serious side effects require immediate medical attention:
• Hallucinations
• Confusion or agitation
• Mood changes (e.g., depression)
• Seizures (particularly upon abrupt withdrawal)
• Visual disturbances
• Urinary frequency

Drug interaction

Baclosign has CNS depressant effects. Concomitant use with other agents that cause CNS depression can potentiate these effects.

• Alcohol, Opioids, Benzodiazepines, Sedatives/Hypnotics: Increased risk of profound sedation, respiratory depression, and dizziness.
• Antihypertensives: May potentiate hypotensive effects.
• MAO Inhibitors and Tricyclic Antidepressants: May increase CNS depressant and cardiovascular effects.
• Lithium: May increase lithium toxicity. A comprehensive review of the patient’s complete medication list, including over-the-counter products and supplements, is essential before initiating therapy.

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 regular dosing schedule should be resumed. Do not double the dose to make up for a missed one.

Overdose

Manifestations of overdose include vomiting, muscular hypotonia, drowsiness, dilated pupils, respiratory depression, seizures, and coma. Signs of overdose may appear suddenly. Management is primarily supportive and symptomatic. There is no specific antidote. Airway protection and ventilatory support are paramount. ECG monitoring is advised. Hemodialysis may be beneficial in removing baclofen from the bloodstream, especially in patients with renal impairment.

Storage

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). Keep the container tightly closed. Protect from light and moisture. Keep out of reach of children and pets. Dispose of unused medication properly via a drug take-back program.

Disclaimer

This information is for educational purposes 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

“Baclosign has been instrumental in my MS management plan. The titration process was smooth under my neurologist’s guidance, and the reduction in painful leg spasms has significantly improved my quality of sleep and ability to participate in physical therapy.” - Patient M., 54 “As a physiatrist, I find Baclosign to be a reliable first-line agent for managing upper motor neuron spasticity. Its predictable pharmacokinetics allow for fine-tuned dosing to achieve functional goals for my patients in rehabilitation.” - Dr. A. Chen, MD “The scored tablets make dose adjustments straightforward. While initial drowsiness was noted, it subsided after the first week, and the therapeutic benefit for my spinal cord injury-related spasticity has been substantial.” - Patient R., 41