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Edaravone (oral/injection)

Name of the generic: edaravone (oral/injection) [E-DAR-a-vone]

Brand Names: Radicava, Radicava ORS
Formulas of dosage: intravenous solution (30 mg/100 milliliters) Oral suspension (105 mg/5 mL)
Drug class: Miscellaneous central nervous system agents

What is Edaravone?

Edaravone can be used to treat adults suffering from amyotrophic lateral degeneration (ALS).Edaravone could also be used to treat conditions that are not covered in this guide.

Side effects of Edaravone

Edaravone may cause a severe reaction to an allergic condition. Certain side effects can occur either immediately or following the injection. Inform your physician that you are feeling dizzy, nauseated, lightheaded, and sweaty, or that you are experiencing headaches, chest tightness, back discomfort, breathing problems, or swelling in your face.See a doctor immediately. If you notice symptoms or warning signs of an allergic reaction that include hives, trouble breathing, and swelling of your lips, face, and throat, as well as your tongue,

Edaravone may cause serious side effects.If symptoms arise such as:

  • The bronchospasm (wheezing, chest tightness, difficulty breathing)
  • A feeling of lightheadedness, as if you've passed out.

Common adverse effects of edaravone could include:

  • Bruising;
  • Headaches migraine
  • Difficulties with balance, and problems with balance or walking.

This isn't a complete listing of all the side adverse effects. Other scenarios could occur. Consult your physician for medical advice on any adverse consequences. It is possible to report any side negative effects in writing to FDA at 1-800-FDA-1088. FDA via 1-800-FDA-1088.

Warnings

Only use it according to the directions. Inform your doctor if you take other medications or suffer from any other medical condition or allergies.

Prior to use this drug

It is not recommended to treat with edaravone in case you are sensitive to it.

Contact your doctor if have ever had the following symptoms:

  • Asthma or a sulfite allergy.

It is unknown whether edaravone could harm an unborn baby. Consult your physician if you are expecting or planning to be pregnant.Check with your doctor to see whether it is safe to breastfeed when using edaravone.

How to take Edaravone?

Follow the instructions on the label of your prescription, and read all medication guides and instruction sheets. Follow the medication precisely as directed.Edaravone is generally prescribed during the treatment cycle. It is possible that you will need to take the medication only for the initial 2 weeks of every cycle. Your physician will decide the duration of treatment with the drug edaravone.Edaravone injections are given in the form of an injection into a vein by a medical doctor. The injection of Edaravone must be administered slowly, and the IV infusion could take at least 60 minutes to finish.Follow the instructions for when to stop eating in order to take the medication. Stop eating before bedtime the night before.Intake the oral suspension in the morning on an empty stomach. Don't eat for at least 1 hour following each dose.The oral suspension may be administered via the feeding tube. Consult your physician or pharmacist for clarification if you are unsure of the directions.Be sure to read and follow the instructions on setting up and using the medication prior to making the first dosage. Consult your physician or pharmacist for assistance if you don't understand these directions.

The bottle should be turned upside-down and the oral suspension (liquid) stirred for at least 30 minutes. You can measure a dose using the measuring device supplied (not an ordinary spoon). Dispose of any medicine that is not used for 15 days following opening.Keep the oral suspension in a straight place at room temperature, away from direct light. Discard any medicine that is not opened within 30 days of receiving the medication.

Details on dosage

Usual Adult Dose for Amyotrophic Lateral Sclerosis:

Initial treatment cycle: 60 mg twice every day as an IV infusion for 14 days. Then 14 days of drug-free treatment
Subsequent treatment cycles: 60 mg every day as an infusion IV for 10 days of 14-day time frames, followed by 14-day periods of drug-free
Comments:
Infuse each 60 mg dose in two 30 mg bags of infusion over a period of 30 minutes (infusion rate about 1 mg/min [3.33 milliliters per minute]).
Upon first noticing any sign or symptom of hypersensitivity, immediately stop the infusion.
Treatment for amyotrophic lateral sclerosis (ALS)

What happens if I miss the dose?

Contact your doctor for advice in case you missed a dose or have missed your medication. You need to make an appointment for your medication.

What happens if I overdose?

Get medical attention in an emergency or contact the Poison Help Line toll-free at 1-800-222-1222.

What should be avoided?

Follow the instructions of your physician regarding any limitations on foods, drinks, or activities.

Interaction with other drugs

Other medications can impact edaravone. This includes prescription and non-prescription medications, vitamins, and herbal products. Discuss with your doctor all the other medicines you take.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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