GNH USA

Europe — EMA

Lioresal Intrathecal

GNH USA supplies Lioresal Intrathecal (Baclofen), a GABA_B agonist antispastic agent for multiple sclerosis and spinal cord injury spasticity.

Baclofen

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What is Baclofen?

Baclofen, the active ingredient in Lioresal Intrathecal, is a GABA_B receptor agonist presented as an intrathecal solution for direct spinal administration. It is used to reduce muscle spasticity in patients with multiple sclerosis or spinal cord injury, providing targeted relief where oral therapy may be insufficient.

GNH USA supplies Lioresal Intrathecal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and specialty clinics worldwide. The product complies with EU pharmaceutical standards and is manufactured under GMP conditions.

What is Baclofen used for?

Lioresal Intrathecal, an intrathecal antispastic agent, is indicated for conditions involving central nervous system‑mediated muscle hypertonia. - Multiple sclerosis spasticity: reduces muscle tone and improves mobility in patients with MS‑related spasticity. - Spinal cord injury spasticity: alleviates involuntary muscle contractions and facilitates rehabilitation in individuals with SCI‑induced spasticity. - Severe refractory spasticity: provides targeted relief when oral antispasmodics are ineffective.

What are the side effects of Baclofen?

Baclofen administered intrathecally may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects: - Headache: mild to moderate pain in the head. - Drowsiness: increased sleepiness or fatigue. - Nausea: feeling of queasiness. - Injection site discomfort: pain or irritation at the catheter insertion point.

Serious or Rare Side Effects: - Respiratory depression: reduced breathing effort that may require monitoring. - Seizures: occurrence of convulsive episodes. - Severe hypotonia: marked loss of muscle tone. - Infection: meningitis or catheter‑related infections.

What precautions apply to Baclofen?

When using intrathecal baclofen, clinicians should observe specific precautions to minimize risks and ensure safe administration. - Patient selection: assess for contraindications such as allergy to baclofen or active infection at the catheter site. - Dose titration: adjust dosage gradually under specialist supervision to avoid abrupt withdrawal or overdose. - Monitoring: observe for signs of respiratory depression, hypotension, or neurological changes during initiation. - Catheter care: maintain sterile technique and regularly inspect the intrathecal catheter for blockage or infection. - Withdrawal risk: abrupt discontinuation can cause severe rebound spasticity; ensure continuous delivery. - Store at ambient temperature: keep the solution below 25°C in the original container, protect from light and moisture.

What does Baclofen interact with?

Baclofen may interact with other medicines, altering its efficacy or increasing adverse effects.

Major Interactions (Avoid): - Opioids: combined use can enhance central nervous system depression, increasing risk of respiratory depression. - Benzodiazepines: additive sedative effects may lead to excessive drowsiness or hypotension. - Antihypertensives: concurrent use may cause pronounced blood pressure lowering.

Moderate Interactions (Monitor Closely): - Anticonvulsants: may require dose adjustments as baclofen can affect seizure threshold. - Muscle relaxants: additive antispastic effects could increase weakness. - Alcohol: can potentiate sedation and dizziness.

Frequently asked questions

What is Lioresal Intrathecal used for?+
Lioresal Intrathecal is a baclofen‑containing intrathecal solution prescribed to manage severe muscle spasticity in patients with multiple sclerosis or spinal cord injury when oral antispasmodic therapy is inadequate. By delivering the drug directly into the cerebrospinal fluid, it provides targeted relief of involuntary muscle contractions and improves functional mobility.
How does baclofen work in Lioresal Intrathecal?+
Baclofen is a selective agonist of GABA_B receptors in the spinal cord. Activation of these metabotropic receptors inhibits calcium channels, reducing the release of excitatory neurotransmitters such as glutamate. This dampens spinal reflex activity, leading to decreased muscle tone and relief of spasticity.
What is the usual dose of Lioresal Intrathecal?+
The dosage of Lioresal Intrathecal is individualized and determined by the prescribing physician based on the patient’s severity of spasticity, prior response to oral baclofen, and tolerance. Dose titration is performed under specialist supervision to achieve optimal symptom control while minimizing adverse effects.
Is Lioresal Intrathecal safe during pregnancy or breastfeeding?+
Safety data for intrathecal baclofen in pregnancy and lactation are limited, and the product is classified as pregnancy category unknown. Clinicians should weigh potential benefits against risks and consider alternative therapies. Breastfeeding decisions should be made in consultation with a healthcare professional.
How do I order Lioresal Intrathecal from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.
How does Lioresal Intrathecal compare with oral baclofen?+
Intrathecal delivery bypasses the blood‑brain barrier, allowing lower total doses and higher concentrations at the spinal cord compared with oral baclofen. This can result in greater spasticity control with fewer systemic side effects. However, it requires surgical implantation of a delivery pump and ongoing catheter maintenance, whereas oral therapy is non‑invasive.
What are the storage requirements for Lioresal Intrathecal?+
Store the intrathecal solution at ambient temperature, preferably below 25 °C, in its original sealed container. Protect the product from direct light, moisture and extreme temperature fluctuations. Do not freeze or shake the vial, and keep it out of reach of children.
How is Lioresal Intrathecal administered?+
Lioresal Intrathecal is administered via an implanted infusion pump that delivers the baclofen solution directly into the cerebrospinal fluid through a catheter placed in the intrathecal space. The pump is programmed by a qualified clinician to deliver a continuous or programmable dose according to the patient’s therapeutic needs.
What are the most serious risks associated with Lioresal Intrathecal?+
The most serious risks include respiratory depression, severe hypotonia, seizures, and infection such as meningitis or catheter‑related sepsis. Abrupt discontinuation can cause rebound spasticity, which may be life‑threatening. Patients should be monitored closely, especially during dose changes or pump malfunction, and any signs of infection or neurological decline require immediate medical attention.
Who should not use Lioresal Intrathecal?+
Lioresal Intrathecal is contraindicated in patients with known hypersensitivity to baclofen or any component of the formulation, active infection at the catheter insertion site, or uncontrolled severe cardiac or respiratory disease. It should also be avoided in individuals for whom surgical implantation of an intrathecal pump is not feasible or who cannot adhere to the required follow‑up and monitoring schedule.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Baclofen
Route
Intrathecal Use
Manufacturer
Novartis Poland Sp. Z O. O.
Origin
EU

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