BACLOFEN 0.5MG/ML INJECTION 20 ML 5 PCS

Product Overview

Baclofen 0.5mg/ml Injection is a specialized medication designed for the effective management of severe chronic spasticity. Each package contains 5 vials, with each vial holding 20ml of sterile solution. This potent muscle relaxant is administered via the intrathecal route, typically through an implanted pump system, providing targeted relief for debilitating muscle stiffness and spasms.
This formulation is crucial for patients whose spasticity is severe enough to warrant direct spinal delivery, often resulting from conditions such as multiple sclerosis, spinal cord injuries, or cerebral palsy. Its precise delivery mechanism helps to minimize systemic side effects while maximizing therapeutic efficacy at the site of action, improving patient mobility and comfort.

Benefits

Significantly reduces muscle spasms and stiffness.
Alleviates associated pain and discomfort, enhancing patient comfort.
Improves range of motion and facilitates physical therapy and rehabilitation.
Enhances overall quality of life for individuals suffering from severe chronic spasticity.
Delivers medication directly to the spinal cord for more effective and localized action.
Offers a targeted approach to spasticity management, potentially reducing systemic side effects compared to oral baclofen at high doses.

How To Use

1. Baclofen 0.5mg/ml Injection is strictly for intrathecal use and must be administered by a qualified healthcare professional experienced in intrathecal drug delivery.
2. The initial dose is carefully titrated by a physician in a hospital setting to determine the optimal therapeutic response and minimize adverse effects.
3. The medication is typically delivered via an implanted, programmable pump system that provides continuous or bolus infusions directly into the intrathecal space around the spinal cord.
4. Regular monitoring and periodic pump refills are necessary to maintain effective treatment and ensure patient safety.
5. Patients and caregivers should receive thorough education on the pump system operation, potential signs of complications, and the importance of adherence to follow-up appointments.

Caution & Warnings

* Abrupt discontinuation of intrathecal Baclofen can lead to life-threatening adverse events including high fever, altered mental status, exaggerated rebound spasticity, muscle rigidity, rhabdomyolysis, multiple organ-system failure, and death. Always ensure continuous supply and professional management.
* Careful patient selection and ongoing monitoring by trained healthcare professionals are essential to manage potential risks and ensure optimal outcomes.
* Patients should be monitored closely for signs of overdose, which may include profound somnolence, dizziness, lightheadedness, hypotension, respiratory depression, and even coma.
* Potential side effects include drowsiness, dizziness, nausea, headache, hypotension, confusion, and urinary retention. Report any persistent or severe side effects to your physician.
* Use with caution in patients with renal impairment, epilepsy, or existing psychiatric disorders, as these conditions may require dose adjustments or increased monitoring.
* Avoid concurrent use of alcohol or other central nervous system (CNS) depressants, as this may exacerbate the sedative effects of Baclofen.
* Pregnancy and lactation: Use only if the potential benefit to the mother outweighs the potential risk to the fetus or infant. Consult a physician before use if pregnant or breastfeeding.
* Risk of infection at the implant site or catheter-related complications must be considered and managed promptly by a healthcare professional.

Ingredients

Active Ingredient: Baclofen 0.5mg/ml
Inactive Ingredients: Sodium Chloride, Water for Injection.

Product Details

Drug Type: Prescription Only Medicine (POM)
Dosage Form: Solution for Intrathecal Injection
Strength: 0.5 mg/ml
Package Size: 5 vials x 20 ml
Manufacturer: Sun Pharmaceutical Industries
Storage: Store at controlled room temperature (20-25°C). Protect from freezing and excessive heat. Protect from light.
Administration Route: Intrathecal