Lioresal Intrathecal Ampul 10 Mg/5Ml

Description

Lioresal Intrathecal contains baclofen as its active ingredient. Baclofen is a muscle relaxant specifically targeting the spinal cord to relieve muscle spasms, stiffness, and pain associated with severe spasticity. Unlike oral forms of baclofen, Lioresal Intrathecal is administered directly into the cerebrospinal fluid, which allows for more effective targeting of the central nervous system with lower doses, minimizing systemic side effects.

Uses of Lioresal Intrathecal

Lioresal Intrathecal is primarily prescribed to manage severe spasticity associated with the following conditions:

• Multiple sclerosis
• Spinal cord injuries or diseases
• Cerebral palsy
• Brain injuries

This intrathecal form of baclofen is specifically recommended for patients who have not responded well to oral antispastic medications or who have experienced intolerable side effects at higher oral doses.

Dosage and Administration

Dosage: The dosage of Lioresal Intrathecal is highly individualized and is adjusted based on the patient’s response to the initial screening dose and subsequent titrations. It is critical that the medication is administered under the supervision of a healthcare professional.

Administration: Lioresal Intrathecal is administered via a surgically implanted pump, such as the Medtronic SynchroMed II pump. This pump continuously delivers the drug through a catheter placed in the intrathecal space, directly into the cerebrospinal fluid surrounding the spinal cord.

Recommended Dosage for Lioresal Intrathecal

• Initial Screening Dose: Before initiating long-term therapy, a single screening dose ranging from 25 to 50 mcg of Lioresal Intrathecal is administered via bolus injection to determine the patient’s responsiveness.
• Continuous Infusion Dose: If the patient responds positively, continuous infusion therapy is started with a dose typically double the effective screening dose, administered over a 24-hour period.
• Maintenance Dose: The maintenance dose for long-term treatment is tailored to the individual. Patients with spasticity of cerebral origin typically require doses between 90 to 703 mcg/day, while those with spasticity of spinal origin may need between 300 to 800 mcg/day. Pediatric patients often require lower doses based on body weight.

Side Effects of Lioresal Intrathecal

Like all medications, Lioresal Intrathecal can cause side effects. These can range from mild to severe, and it is important to monitor any symptoms closely and inform healthcare providers immediately if they occur.

Precautions and Warnings

• Regular Monitoring: It is essential that patients receiving Lioresal Intrathecal attend all scheduled follow-up appointments to monitor drug levels and ensure the proper functioning of the intrathecal pump.
• Sudden Discontinuation: Abrupt discontinuation of Lioresal Intrathecal can lead to severe withdrawal symptoms such as high fever, muscle rigidity, altered mental state, and even life-threatening complications. Regular refills and close supervision are vital to prevent these occurrences.
• Drug Interactions: Patients should inform their healthcare provider of any other medications they are taking. Lioresal Intrathecal may interact with central nervous system depressants, including morphine and benzodiazepines, increasing the risk of drowsiness or respiratory depression.

Contraindications for Lioresal Intrathecal

Lioresal Intrathecal is contraindicated in certain situations, which must be carefully considered by healthcare providers before administration:

• Hypersensitivity: Patients with known hypersensitivity to baclofen or any of the components in the formulation should not use this medication.
• Infections: Lioresal Intrathecal should not be used in patients with an active infection, especially at the site of catheter implantation.
• Spinal Anomalies: The use of this medication is contraindicated in individuals with significant spinal deformities or conditions that could complicate the administration of the drug.
• Body Size: The pump system should not be implanted in patients with insufficient body mass to safely support the device.

Storage and Handling

Lioresal Intrathecal should be stored at room temperature, away from heat and direct sunlight. The medication comes in single-use ampules to maintain sterility and should not be refrigerated. Proper disposal of unused or expired medication should follow local guidelines, and the product should be kept out of reach of children and pets.

Administration Frequency

Lioresal Intrathecal is typically administered through continuous infusion using a programmable intrathecal pump. The frequency and dosage are determined by the patient’s individual response and the severity of spasticity. The pump can be adjusted to deliver more medication during periods of increased muscle spasticity, providing flexibility in treatment.

Can Patients Self-Administer Lioresal Intrathecal?

No, Lioresal Intrathecal cannot be self-administered. This medication requires a surgically implanted pump, and its dosage is carefully calibrated by healthcare professionals. Patients and caregivers are educated about maintaining the pump, attending scheduled refill visits, and monitoring for any potential issues, such as changes in spasticity levels or pump malfunctions.

Lifestyle Modifications While on Lioresal Intrathecal

Patients using Lioresal Intrathecal must make certain lifestyle adjustments to ensure the medication’s effectiveness and minimize complications.

• Regular Medical Follow-ups: Patients must attend scheduled refill appointments to avoid running out of medication. Missing these appointments could lead to withdrawal symptoms, which can be life-threatening.
• Physical Activity: Patients should engage in appropriate physical therapy or exercise to maintain muscle strength and flexibility. However, overexertion should be avoided to prevent muscle fatigue.
• Diet and Hydration: A well-balanced diet and adequate hydration are important for maintaining overall health and supporting muscle function.
• Medication Management: Patients should avoid alcohol and other central nervous system depressants while on Lioresal Intrathecal. These substances can interact with baclofen, increasing the risk of adverse side effects such as dizziness and drowsiness.
• Home Safety: Depending on the severity of spasticity, patients may need to make modifications to their home environment to ensure safety and accessibility.
• Emergency Plan: It’s important to have an emergency plan in place for managing serious side effects or pump malfunctions.

Conclusion

Lioresal Intrathecal is a highly effective treatment option for patients suffering from severe spasticity due to conditions such as multiple sclerosis, cerebral palsy, and spinal cord injuries. Its unique mode of delivery allows for targeted relief with fewer systemic side effects compared to oral baclofen. However, the complexity of its administration and the potential for serious side effects require close monitoring and strict adherence to prescribed regimens. By working closely with healthcare providers and making necessary lifestyle adjustments, patients can achieve significant relief from spasticity and improve their quality of life.