Lioresal 10mg Tab

Manufacturer
Novartis

Registraction Number     
MAL07021433AZ


 

Content

• Active Ingredient: Each tablet contains 10 mg of baclofen, a centrally acting muscle relaxant.
• Excipients: The tablet includes inactive ingredients such as wheat starch (containing gluten), lactose, magnesium stearate, and other components to form the tablet.
• Appearance: The tablet is typically a scored, white, round tablet.

Indications

• Multiple Sclerosis: For the relief of spasticity of voluntary muscle resulting from multiple sclerosis.
• Spinal Lesions: For spasticity resulting from spinal lesions, such as tumors of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, and traumatic partial section of the cord.
• Cerebrovascular Accidents: For spasticity arising from cerebrovascular accidents, cerebral palsy, meningitis, and traumatic head injury.
• Other Conditions: Also indicated for spasticity of voluntary muscle arising from neoplastic or degenerative brain diseases.

Instructions

• Dosage: Treatment should be started with a dosage of 15 mg daily, preferably in 2 to 4 divided doses. The dose should be titrated upwards cautiously, by 15 mg/day increments at 3-day intervals until the requisite daily dosage has been attained. In certain patients reacting sensitively, smaller increments may be appropriate.
• Maximum Dose: The maximum recommended daily dose is 100 mg, but this should only be used under careful medical supervision.
• Administration: Lioresal should be taken during meals with a little liquid.
• Discontinuation: Discontinuation of the treatment should always be gradual by successively reducing the dosage over a period of approximately 1 to 2 weeks, except in overdose-related emergencies, or where serious adverse effects have occurred.
• Special Populations:
  • Elderly Patients: May be more susceptible to side effects, particularly in the early stages of introducing Lioresal. Small doses should therefore be used at the start of treatment, with gradual titration under careful supervision.
  • Paediatric Population: Treatment should usually be started with a very low dose (corresponding to approximately 0.3 mg/kg a day), in 2–4 divided doses, preferably in 4 divided doses. The dosage should be cautiously raised at about 1-week intervals until it becomes sufficient for the child's individual requirements.
  • Patients with Impaired Renal Function: A particularly low dosage should be selected, approximately 5 mg daily. These patients should be closely monitored for early signs and/or symptoms of toxicity.
  • Patients with Hepatic Impairment: Lioresal has the potential to elevate liver enzymes. It should be prescribed with caution in patients with hepatic impairment.
  • Patients with Spastic States of Cerebral Origin: Unwanted effects are more likely to occur in these patients. A cautious dosage schedule should be adopted, and patients should be kept under appropriate surveillance.