Edaravone 30 mg/100mL
Edaravone · INJECTION, SOLUTION · Piramal Critical Care Inc.
Edaravone is a injection, solution containing edaravone at 30 mg/100mL, taken intravenous. Manufactured by Piramal Critical Care Inc..
Key Facts
- Brand Name
- Edaravone
- Generic Name
- Edaravone
- NDC Code (Product)
66794-259- Manufacturer
- Piramal Critical Care Inc.
- Strength
- 30 mg/100mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA216199
- Marketing Start
- 07/08/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Edaravone Injection: The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes as follows ( 2.1 ) Initial treatment cycle: daily dosing for 14 days followed by a 14 day drug-free period ( 2.1 ) Subsequent treatment cycles: daily dosing for 10 days out of 14 day periods, followed by 14-day drug-free periods ( 2.1 ) 2.1 Dosage Information The recommended dosage of edaravone injection: an intravenous infusion of 60 mg administered over a 60-minute period. Administer Edaravone injection according to the following schedule: An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. 2.2 Preparation and Administration Information for Edaravone Injection Edaravone injection is for intravenous infusion only. Preparation Do not use if the oxygen indicator has turned blue or purple before opening the package . Once the overwrap package is opened, use within 24 hours [see How Supplied/Storage and Handling (16.1 , 16.2 )]. Parenteral drug products should be inspected visually for pa…
Contraindications
4 CONTRAINDICATIONS Edaravone injection is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred [see Warnings and Precautions (5.1 , 5.2 )]. Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in edaravone injection ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Sulfite Allergic Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (at least 10% of patients treated with edaravone injection and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Piramal Crtical Care, Inc. at 1-800-414-1901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, placebo-controlled trials, 184 patients with ALS were administered edaravone injection 60 mg in treatment cycles for 6 months. The population consisted of Japanese patients who had a median age of 60 years (range 29 to 75) and were 59% male. Most (93%) of these patients were living independently at the time of screening. Most Common Adverse…
Frequently Asked Questions
What is Edaravone used for?
Edaravone contains Edaravone. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Edaravone a controlled substance?
Edaravone is not classified as a controlled substance by the DEA.
What is the generic name for Edaravone?
The generic name for Edaravone is Edaravone. There are 6 other brand versions of Edaravone.
What is the NDC code for Edaravone 30 mg/100mL?
The NDC (National Drug Code) for Edaravone 30 mg/100mL is 66794-259, listed by Piramal Critical Care Inc..