Edaravone Injection is an antioxidant drug often used for managing conditions associated with oxidative stress, such as amyotrophic lateral sclerosis (ALS) and acute ischemic stroke. Below is a specification for the Edaravone Injection 20 mL: 30 mg.
1. Composition:
- Active Ingredient: Edaravone, a free radical scavenger.
- Concentration: 30 mg per 20 mL solution (1.5 mg/mL).
- Formulation: Aqueous solution intended for intravenous (IV) administration.
2. Pharmacological Action:
- Antioxidant Properties: Edaravone acts as a free radical scavenger, reducing oxidative damage in cells.
- Reduction of Neuronal Damage: Helps prevent brain cell injury due to ischemia (lack of blood flow), often seen in stroke.
- Cytoprotective Effect: Reduces the severity of symptoms in neurodegenerative diseases by protecting nerve cells.
3. Indications:
- Acute Ischemic Stroke: Reduces damage during ischemic stroke to improve recovery and outcomes.
- Amyotrophic Lateral Sclerosis (ALS): Used to slow disease progression in ALS patients, reducing the decline in physical function.
4. Dosage and Administration:
- Route: Administered by intravenous infusion, generally under medical supervision.
- Typical Dosage:
- For Stroke: Often administered as 30 mg (1 vial) twice daily, typically for 14 days, with variations based on patient response.
- For ALS: A cycle regimen is usually followed, involving daily administration for 14 days followed by a 14-day drug-free period, with subsequent cycles adjusted per treatment guidelines.
- Infusion Duration: Typically infused over 30-60 minutes.
5. Storage Conditions:
- Temperature: Store at a controlled room temperature, generally between 15°C and 30°C.
- Protect from Light: Keep in a protective container to avoid degradation from light.
- Shelf Life: Commonly 2-3 years from the date of manufacture if stored properly.
6. Contraindications:
- Allergy: Contraindicated in patients with known hypersensitivity to edaravone or its excipients.
- Renal Impairment: Should be used cautiously in patients with severe renal dysfunction.
7. Precautions and Warnings:
- Allergic Reactions: Watch for signs of hypersensitivity reactions, which may be serious and include anaphylaxis.
- Liver Function: Monitor liver function as edaravone may elevate liver enzymes.
- Pregnancy and Lactation: Use only if the benefit outweighs the potential risk to the fetus or infant, as safety in pregnancy and lactation has not been established.
8. Side Effects:
- Common: Headache, dizziness, fatigue, nausea, and rash.
- Severe: Allergic reactions, including anaphylaxis, and potential liver function abnormalities.
9. Packaging:
- Typically packaged in 20 mL glass vials, each containing 30 mg of edaravone, ready for dilution and infusion.
Edaravone Injection should be administered under the guidance of a healthcare professional who can monitor for efficacy and potential side effects.
){kind=link}