Edaravone is a potent, synthetic, lipophilic free radical scavenger and antioxidant. It is a pyrazolone derivative specifically indicated for the treatment of Amyotrophic Lateral Sclerosis (ALS) and acute ischemic stroke. In the Indian context, its primary approved use is for ALS, where it is believed to slow the decline in physical function by mitigating oxidative stress, a key contributor to motor neuron degeneration. It is administered as a slow intravenous infusion.
Adult: For ALS: 60 mg (i.e., 40 mL of the 1.5 mg/mL solution) administered as a 60-minute intravenous infusion once daily. Treatment is cyclical: Initial cycle: daily for 14 days, followed by a 14-day drug-free period. Subsequent cycles: daily for 10 days out of 14-day periods, followed by 14-day drug-free periods.
Note: Must be diluted before infusion. Withdraw 40 mL (60 mg) of edaravone injection (1.5 mg/mL) and add to 100 mL of 0.9% Sodium Chloride Injection, USP. Administer via controlled intravenous infusion pump over 60 minutes. Do not mix with other medications. Inspect for particulate matter and discoloration before use. Use immediately after preparation.
Edaravone exerts its neuroprotective effects by scavenging a variety of free radicals, including hydroxyl radicals, peroxyl radicals, and peroxynitrite. In ALS, oxidative stress is implicated in the pathogenesis of motor neuron injury. By inhibiting lipid peroxidation and reducing oxidative damage to vascular endothelial cells and neuronal cells, edaravone is believed to slow the progression of functional decline.
Pregnancy: Category C (US FDA). Animal studies have shown fetal toxicity. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.
Driving: Edaravone may cause dizziness, gait disturbance, and fatigue. Patients should be cautioned about operating machinery or driving until they know how the medication affects them.
| Sulfonamides (e.g., Cotrimoxazole) | Increased risk of hypersensitivity reactions due to shared sulfite/sulfa moiety. Potential for cross-reactivity. | Major |
| Other drugs containing sulfites (e.g., some epinephrine, dopamine injections) | Increased risk of sulfite-induced allergic reactions. | Moderate |
| Strong UGT inducers (e.g., Rifampicin, Carbamazepine, Phenytoin) | May increase the metabolism of edaravone, potentially reducing its efficacy. | Moderate |
| Nephrotoxic drugs (e.g., Aminoglycosides, NSAIDs, Vancomycin) | Additive risk of renal impairment. | Moderate |
| Hepatotoxic drugs (e.g., Paracetamol high dose, Statins, Azole antifungals) | Additive risk of hepatic injury. | Moderate |