Product image of Lioresal (Baclofen) supplied by GNH India

Lioresal

Active Ingredient:
Baclofen
Origin:
EU

Lioresal (Baclofen)

Baclofen, the active ingredient in Lioresal, is a muscle relaxant presented as an intrathecal solution for intrathecal use. It reduces spasticity by acting on the central nervous system and is indicated for patients with multiple sclerosis, spinal cord injury, or cerebral palsy who experience increased muscle tone and involuntary muscle contractions.

GNH India supplies Lioresal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. Our distribution network ensures consistent quality and regulatory compliance across all regions.

Manufacturer / TM Owner

Novartis Farmacéutica S.A.

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Indications & Clinical Uses

  • Baclofen is used to manage spasticity, a condition of increased muscle tone, in several neurological disorders.
  • Multiple sclerosis: reduces muscle stiffness, decreases spasms, and can improve functional mobility in patients with spasticity related to MS.
  • Spinal cord injury: alleviates involuntary muscle contractions, lowers tone, and supports rehabilitation efforts in individuals with post‑injury spasticity.
  • Cerebral palsy: decreases hypertonia, eases limb rigidity, and assists in motor control for children and adults experiencing spasticity.

How It Works

  • Baclofen acts as an agonist at GABA_B receptors in the spinal cord, inhibiting the release of excitatory neurotransmitters such as glutamate and aspartate. This reduces neuronal firing and diminishes the reflex arcs that contribute to increased muscle tone, thereby providing antispastic effects. The drug’s action is primarily localized to the dorsal horn, where it modulates interneuron activity and suppresses polysynaptic pathways involved in spasticity.

Side Effects

Baclofen may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Drowsiness: feeling unusually sleepy or fatigued.
  • Dizziness: light‑headed sensation or loss of balance.
  • Weakness: reduced muscle strength or general fatigue.
  • Nausea: upset stomach or urge to vomit.
  • Dry mouth: reduced salivation leading to throat discomfort.
  • Constipation: difficulty passing stool or infrequent bowel movements.

Serious or Rare Side Effects

  • Seizures: occurrence of convulsive episodes.
  • Respiratory depression: slowed or shallow breathing that may require medical attention.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.

Precautions & Warnings

When using intrathecal baclofen, clinicians should observe several safety considerations to minimize risks.

  • Patient selection: assess severity of spasticity and suitability for intrathecal therapy.
  • Dose titration: initiate at low dose and adjust gradually under medical supervision.
  • Monitoring: observe for signs of hypotension, respiratory changes, or neurological deterioration.
  • Contraindications: avoid in patients with known hypersensitivity to baclofen or active infection at the implantation site.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited.
  • Store at ambient temperature: keep the solution in the original container, protect from light and freeze, and store below 25 °C.

Avoid Interactions

Baclofen can interact with other medications, affecting its efficacy or safety profile.

Major Interactions (Avoid)

  • Opioids: combined central nervous system depression may increase risk of respiratory depression.
  • Benzodiazepines: additive sedative effects can enhance drowsiness and dizziness.
  • Antihypertensives: may potentiate blood pressure lowering, leading to hypotension.

Moderate Interactions (Monitor Closely)

  • Anticonvulsants: may alter seizure threshold, requiring dose adjustments.
  • Alcohol: enhances sedative properties and can worsen dizziness.
  • CYP450 inhibitors: may affect baclofen metabolism, though limited data exist.

Frequently Asked Questions

Lioresal is the brand name for baclofen formulated as an intrathecal solution. It is prescribed to manage spasticity—abnormally increased muscle tone—in conditions such as multiple sclerosis, spinal cord injury and cerebral palsy. By delivering the medication directly into the cerebrospinal fluid, it provides targeted relief of muscle stiffness and involuntary contractions.

Baclofen acts as an agonist at GABA_B receptors located primarily in the dorsal horn of the spinal cord. Activation of these receptors inhibits the release of excitatory neurotransmitters, reduces neuronal firing, and dampens reflex pathways that contribute to heightened muscle tone. This mechanism results in decreased spasticity and improved motor control.

The dose of intrathecal baclofen is individualized by the prescribing physician based on the severity of spasticity, patient weight, and response to therapy. Dosing typically begins with a low initial volume delivered via an implanted pump and is titrated upward in small increments under clinical supervision. Exact dosing regimens should be obtained from the treating neurologist or physiatrist.

Safety data for intrathecal baclofen during pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. Use is generally reserved for situations where the potential benefit to the mother outweighs possible risks to the fetus or infant. Healthcare providers should discuss individual risk factors and consider alternative therapies when appropriate.

To request Lioresal, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, and will ask for trade or institutional credentials. After verification, the sales team provides pricing, availability, shipping details—including any cold‑chain requirements—and assists with import documentation.

Compared with oral baclofen, the intrathecal formulation delivers medication directly to the central nervous system, allowing lower total doses and often fewer systemic side effects such as drowsiness. Other agents like tizanidine or diazepam act through different mechanisms and may cause more sedation or hypotension. Choice of therapy depends on the severity of spasticity, patient tolerance, and the feasibility of pump implantation.

Lioresal intrathecal solution should be stored at ambient temperature, preferably below 25 °C, in its original sealed container. Protect the product from direct sunlight, moisture and freezing temperatures. Before use, inspect the vial for any particulate matter or discoloration, and handle it with aseptic technique to maintain sterility for intrathecal administration.

Lioresal is administered via an implanted intrathecal pump that delivers a controlled volume of baclofen directly into the cerebrospinal fluid. The pump is surgically placed in the abdominal wall, with a catheter extending to the intrathecal space. Dosing is programmed by a qualified clinician, and the pump may be refilled percutaneously in an outpatient setting according to the prescribed schedule.

Serious adverse events include respiratory depression, seizures, and severe allergic reactions such as anaphylaxis. Abrupt discontinuation of intrathecal baclofen can lead to withdrawal syndrome, characterized by high fever, altered mental status, and rebound spasticity, which may be life‑threatening. Patients should be monitored closely for these signs, and any sudden changes in therapy should be managed by a healthcare professional.

Lioresal is contraindicated in individuals with known hypersensitivity to baclofen or any component of the formulation. It should also be avoided in patients with active infection at the pump implantation site, uncontrolled epilepsy, or severe respiratory insufficiency. Patients with certain cardiac conditions or those taking interacting central nervous system depressants should be evaluated carefully before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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