Teglutik Riluzole Oral Suspension

1. Indications and Usage
Amyotrophic Lateral Sclerosis (ALS):
Indicated for the treatment of amyotrophic lateral sclerosis (ALS). It is used to prolong survival or the time to mechanical ventilation support.
2. Dosage and Administration
Route of Administration:
Oral Use ONLY.
Adult Dosage:
Dose: 100 mg daily, administered as 50 mg every 12 hours.
Timing: Administer at least 1 hour before or 2 hours after a meal to minimize food effects on bioavailability.
Preparation:
Shake the bottle gently for at least 30 seconds before each dose. Administer using the provided oral syringe.
Missed Dose:
If a dose is missed, skip it and resume the scheduled dosing. Do not double the dose.
3. Mechanism of Action
Glutamate Antagonist:
Riluzole is a benzothiazole derivative that acts as a glutamate antagonist.
Neuroprotective Effect:
It inhibits the release of glutamate and stabilizes voltage-gated sodium channels, thereby reducing excitotoxicity and preventing further damage to motor neurons.
4. Safety and Warnings
Hepatotoxicity:
Riluzole is associated with hepatotoxicity. ALT elevations (up to 5x ULN) occur in approximately 3-5% of patients.
Monitoring: Monitor serum ALT levels before starting, every month for the first 3 months, and periodically thereafter.
Neutropenia:
Rare cases of neutropenia have been reported. Monitor blood counts if signs of infection occur.
Interstitial Lung Disease (ILD):
ILD has been reported rarely. Evaluate for pulmonary symptoms.
Adverse Reactions
Most Common:
Nausea, fatigue/asthenia, dizziness, abdominal pain, and vomiting.
Laboratory Abnormalities:
Increased serum transaminases (ALT/AST) is the most significant laboratory abnormality.
6. Drug Interactions
CYP1A2 Inhibitors:
Co-administration with strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) may significantly increase Riluzole plasma concentrations, increasing the risk of toxicity.
Inducers:
CYP1A2 inducers (e.g., smoking, omeprazole) may decrease the efficacy of Riluzole.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Riluzole.
Storage:
Store in the original package to protect from moisture and light.