Details for: FLUMAZENIL INJECTION
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02249561 | FLUMAZENIL INJECTION | FLUMAZENIL | 0.1 MG / ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 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 lifethreatening 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 non-medicinal ingredients are
methylparaben, propylparaben, sodium chloride, edetate disodium, acetic acid 0.1 mg, hydrochloric acid and/or sodium hydroxide to adjust pH and water for injection.
What dosage form it comes in
Flumazenil Injection 0.1 mg/mL is available in multidose vials
of 5 mL, boxes of 5.
Latex-Free Stopper – Stopper contains no dry natural rubber.
Warnings and precautions
- Flumazenil Injection 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 you central nervous system.
- Although Flumazenil Injection is given to reverse drowsiness, you may experience a return of drowsiness for up to 24 hours after Flumazenil Injection is given. If you notice a return of drowsiness or experience shortness of breath, contact your doctor as soon as possible.
- 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 during pregnancy.
- Are breastfeeding as flumazenil may pass into breast milk. Therefore, breast feeding should be interrupted for 24 hours when Flumazenil Injection 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. These
medicines include:
- medicines within the benzodiazepine group (examples: clonazepam, chlordiazepoxide, diazepam, flurazepam or bromazepam)
If you have not told your doctor about any of the above, tell him/her before you start taking Flumazenil Injection.
Proper use of this medication
Usual Dose
Flumazenil Injection should be administered intravenously by a physician with experienced in anaesthesiology at your doctor’s office, hospital or clinic. Your doctor will decide what dose you will receive which will depend on your particular condition.
Side effects and what to do about them
Like all medications Flumazenil Injection can cause some side
effects. For most patients these side effects are likely to be minor
and temporary as you 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.
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.
- 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.
- 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. This may happen even if you stopped taking these medicines a few days or weeks before having Flumazenil Injection. Withdrawal symptoms include disturbed sleep, depression, feeling nervous, feeling irritable, feeling dizzy, a rapid heartbeat, diarrhea and sweating.
How to store
- Keep Flumazenil Injection in a cool dry place stored at room temperature (15-30°C).
- Keep this medicine out of the reach of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found by contacting the sponsor,
Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger
Boucherville QC
J4B 7K8
Or by e-mail at :
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: May 31, 2011