Flumazenil Injection

What is this medication?

FLUMAZENIL (flu MAY za nil) reverses the effects of benzodiazepines, which are used to treat anxiety and cause drowsiness during a procedure. It is often used after the procedure to help you wake up. It may also be used to treat overdose.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Romazicon

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Head injury
• Heart disease
• History of substance use disorder
• Liver disease
• Long term use of benzodiazepines, such as alprazolam, diazepam, lorazepam
• Lung or breathing disease, such as asthma
• Mental health conditions
• Seizures
• An unusual or allergic reaction to flumazenil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

• Certain medications for depression, anxiety, or mental health conditions
• Medications that help you fall asleep
• Nalmefene

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

After your procedure, be sure to follow all of the instructions given to you by your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Mood and behavior changes—anxiety, nervousness, irritability and restlessness, confusion, hallucinations, feeling distrust or suspicion of others
• Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site
• Seizures
• Shortness of breath or trouble breathing

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Blurry vision
• Dizziness
• Headache
• Pain, redness, or irritation at injection site
• Sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.