Flumazenil Injection, USP (Fresenius Kabi Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Reversing drowsiness, sedation and other effects caused by a medicine within a group of medicines called benzodiazepines. It may be used to wake you up after anesthesia or if you have been in intensive care.

What it does:

Flumazenil Injection, USP contains the active ingredient flumazenil. Flumazenil is a benzodiazepine antagonist. It works by blocking receptors in the brain and central nervous system that benzodiazepines need to reach to be active, which helps reduce drowsiness and sedation caused by benzodiazepines.

When it should not be used:

• If you have had an allergic reaction to flumazenil or to benzodiazepines in the past
• If you are allergic to any of the ingredients it contains (see ‘What the nonmedicinal ingredients are’)
• If you are taking a benzodiazepine for control of a life- threatening condition (eg. increased pressure in the head, seizures).
• If you are experiencing side effects due to an overdose of a medicine used to treat depression

What the medicinal ingredient is:

Flumazenil

What the nonmedicinal ingredients are:

1.8 mg methylparaben, 0.2 mg propylparaben, 0.1 mg disodium edetate, 9.0 mg sodium chloride and 0.1 mg acetic acid; sodium hydroxide and hydrochloric acid to adjust pH and water for injection.

What dosage forms it comes in:

Flumazenil Injection, USP is a sterile solution for intravenous injection and contains 0.1 mg flumazenil per mL of solution. Flumazenil Injection, USP is available in multiple-dose glass vials:

5 mL fill in a 6.5 mL vial; packaged in trays of 10 vials

WARNINGS AND PRECAUTIONS

• Flumazenil Injection, USP may affect your ability to be alert. Driving, operating machinery and other hazardous activities should therefore be avoided altogether for at least 24 hours.

• You must not consume alcohol or other drugs that affect your central nervous system.

• Although Flumazenil Injection, USP is given to reverse drowsiness, you may experience a return of drowsiness for up to 24 hours after Flumazenil Injection, USP is given. If you notice a return of drowsiness or experience shortness of breath, contact your doctor as soon as possible.

BEFORE you use Flumazenil Injection, USP talk to your doctor or pharmacist if you:

• have liver problems
• have anxiety or panic disorders
• have heart problems or irregular heart beat

• are pregnant or planning to become pregnant, discuss with your doctor the benefits and risks of using Flumazenil Injection, USP during pregnancy.

• are breast-feeding as flumazenil may pass into breast milk. Therefore, breast-feeding should be interrupted for 24 hours when Flumazenil Injection, USP is used.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood store without a prescription.

Some medicines may interfere with Flumazenil Injection, USP. These medicines include:

• medicines within the benzodiazepine group (examples: clonazepam, chlordiazepoxide, diazepam, flurazepam or bromazepam)

These medicines are affected by Flumazenil Injection, USP. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of the above, tell him/her before you start taking Flumazenil Injection, USP.

PROPER USE OF THIS MEDICATION

Usual dose:

Flumazenil Injection, USP should be administered intravenously by a physician with experience in anesthesiology at your doctor’s office, hospital or clinic. Your doctor will decide what dose you will receive which will depend on your particular condition.

Overdose:

If you think you, or a person you are caring for, have taken too much Flumazenil Injection, USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications Flumazenil Injection, USP can cause some side effects. For most patients these side effects are likely to be minor and temporary as your body adjusts to the medicine. However, some may be serious. Consult your doctor or pharmacist as soon as you can if you do not feel well while taking Flumazenil Injection, USP.

Seek urgent medical attention if you experience:

• Allergic reactions (very rare)

If you have an allergic reaction, see a doctor straight away. The signs may include: sudden swelling of the throat, face, lips or mouth. This can make it difficult to breathe or swallow; sudden swelling of the hands, feet or ankles; skin rash or itching.

• Convulsions (seizures)

These are more likely to happen in people who already have

epilepsy or severe liver problems or people who have taken medicines called benzodiazepines for a long time.

The most common side effects are:

• Nausea
• Vomiting

Less common possible side effects are:

• Feeling of anxiousness, fear or panic

• Dizziness and sweating

  • Increase of blood pressure (flushing) and heart rate
  • Headaches, mood swings and chills
  • Rash, blurred vision, tremors, low blood pressure, urinary incontinence, and constipation
  • Panic attacks in patients that have a history of panic disorders.

Withdrawal symptoms

• If you have recently been taking a benzodiazepine (for example to help you sleep or to treat anxiety), you may get withdrawal symptoms after having Flumazenil Injection, USP. This may happen even if you stopped taking these medicines a few days or weeks before having Flumazenil Injection, USP. Withdrawal symptoms include disturbed sleep, depression, feeling nervous, feeling irritable, feeling dizzy, a rapid heartbeat, diarrhea and sweating.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking Flumazenil Injection, USP, contact your doctor, nurse or pharmacist.

Flumazenil Injection, USP should be stored between 15 ºC and 30 ºC.

Multidose vial. Discard unused portion 28 days after initial puncture.

Infusion solutions containing flumazenil should be used within 24 hours, and unused portions discarded.

Keep this medicine out of the reach and sight of children.

If you want more information about Flumazenil Injection, USP:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Consumer Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-877-821-7724.

Fresenius Kabi Canada Ltd. 165 Galaxy Blvd, Suite 100

Toronto, ON M9W 0C8

Last revised: MAY 08, 2025

HOW TO STORE IT

Reporting Side Effects

MORE INFORMATION