Description
Composition and Formulation
Each milliliter of Lioresal Intrathecal contains the following components:
- Baclofen U.S.P.: 50 mcg (0.05 mg)
- Sodium chloride: 9 mg
- Water for injection: q.s.
The solution is formulated to maintain a pH range between 5.0 and 7.0, and the medication is supplied in single-use ampules. It is important to note that the ampules should not be autoclaved, as this could degrade the medication.
Mechanism of Action
Baclofen is a structural analog of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter. Baclofen primarily works by inhibiting monosynaptic and polysynaptic reflexes at the spinal level. It is believed to achieve this by reducing the release of excitatory neurotransmitters from primary afferent terminals. Baclofen exerts its effects through stimulation of the GABA B receptor subtype, which plays a critical role in reducing muscle rigidity and spasms.
Indications and Usage
Lioresal Intrathecal is specifically indicated for the treatment of severe spasticity, especially in cases where oral medications or other treatments have proven ineffective. It is particularly beneficial for individuals suffering from spasticity due to conditions such as:
- Multiple sclerosis
- Cerebral palsy
- Spinal cord injuries
- Brain injuries
Dosage and Administration
Lioresal Intrathecal is available in different concentrations, with one of the primary screening doses being 0.05 mg/mL (50 mcg/mL). The administration of this medication requires precise monitoring by trained healthcare professionals and is delivered intrathecally through an implanted pump system, such as the Medtronic SynchroMed II. The infusion pump is surgically implanted, and the medication is delivered via a catheter placed in the spinal fluid.
Key Dosage Considerations:
- Initial Screening Dose: A single dose of 25-50 mcg may be administered to assess the patient’s response.
- Continuous Infusion: Once the patient responds positively to the screening dose, continuous infusion is started. The dose may vary between 90-800 mcg per day depending on individual needs.
- Pediatric Patients: Pediatric dosing is highly variable, with doses ranging from 24 to 1199 mcg/day depending on age and body size.
Side Effects and Precautions
Lioresal Intrathecal is generally well-tolerated, but it does carry the potential for side effects. These may range from mild to severe, depending on individual patient response.
| Side Effect Type | Common Side Effects | Less Common Side Effects | Rare Side Effects |
|---|---|---|---|
| Neurological | Drowsiness, Dizziness, Weakness | Confusion, Lightheadedness | Numbness or tingling in extremities |
| Gastrointestinal | Nausea, Constipation, Increased urination | Sweating, Unusual tiredness | Loss of appetite, Diarrhea, Stomach pain |
| Musculoskeletal | Muscle weakness | Joint pain, Muscle discomfort | |
| Respiratory & Other | Headache, Trouble sleeping | Faintness when rising | Stuffy nose, Weight gain |
If these side effects persist or worsen, medical attention is required. More serious complications, such as sudden weakness or difficulty breathing, may be a sign of an overdose or an adverse reaction.
Drug Interactions
Lioresal has several significant drug interactions, which can impact its efficacy or increase the risk of side effects. Patients should inform their healthcare provider of all medications they are taking before starting Lioresal Intrathecal therapy.
| Interaction Type | Examples |
|---|---|
| Major Drug Interactions | Adderall, Ambien, Ativan, Xanax, Valium |
| Moderate Drug Interactions | Aspirin, Gabapentin, Metformin, Seroquel |
| Minor Drug Interactions | Minimal, but caution is still advised |
In addition to drug interactions, alcohol should be strictly avoided as it can exacerbate side effects such as drowsiness and dizziness.
Storage and Handling
Lioresal Intrathecal ampules do not require refrigeration and should be stored at room temperature. Each ampule is intended for single-use only, and any unused portion should be discarded. The medication is stable at body temperature (37°C) and compatible with cerebrospinal fluid (CSF). Proper disposal of unused ampules is necessary to avoid accidental misuse.
Contraindications and Warnings
There are several contraindications for the use of Lioresal Intrathecal. The following conditions preclude the use of this medication:
- Hypersensitivity: Patients with known hypersensitivity to baclofen or its excipients should avoid this medication.
- Infections: Any infection at the pump implantation site increases the risk of complications.
- Spinal Anomalies: Patients with significant spinal abnormalities may not be suitable candidates for intrathecal delivery.
- Body Size: Individuals with insufficient body size may not be able to safely accommodate the implanted pump system.
Special Precautions:
- Abrupt Discontinuation: Abruptly stopping Lioresal Intrathecal can result in severe withdrawal symptoms, such as high fever, altered mental status, muscle rigidity, and in rare cases, rhabdomyolysis or multiple organ failure.
- CNS Depression: There is a risk of life-threatening central nervous system (CNS) depression, respiratory failure, or cardiovascular collapse.
- Overdose Management: Caregivers should be well-informed of the signs of overdose, including extreme drowsiness, confusion, or loss of muscle control, and the necessary steps to manage it.
Benefits of Lioresal Intrathecal
Lioresal Intrathecal offers several benefits for patients suffering from severe spasticity, particularly those who have not responded well to oral medications.
| Benefit | Description |
|---|---|
| Targeted Muscle Relaxation | Direct administration into the spinal fluid allows for more effective muscle control. |
| Improved Mobility | Reduces muscle spasms and stiffness, improving overall mobility and quality of life. |
| Pain Reduction | Eases the pain associated with severe spasticity, leading to better daily function. |
| Enhanced Physical Therapy | By reducing spasticity, patients may experience improved outcomes in physical therapy. |
Conclusion
Lioresal Intrathecal provides a highly specialized treatment option for individuals suffering from severe spasticity due to neurological conditions. Its intrathecal delivery method allows for a more focused treatment approach, minimizing side effects commonly seen with oral administration. Proper administration, regular monitoring, and adherence to prescribed dosing schedules are essential to achieve the best outcomes while minimizing risks. Patients considering Lioresal Intrathecal should work closely with healthcare professionals to ensure the treatment is appropriate for their specific medical condition.
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