Edaravone Injection 20ml: 30mg

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.