Flumazenil - 100 Micrograms/ml Solution for Injection/Infusion

Flumazenil - 100 Micrograms/ml Solution for Injection/Infusion - 500 Micrograms in 5ml (10)

What is Flumazenil 100 Micrograms/ml Solution for Injection/Infusion and what is it used for?

Flumazenil is a counteragent (antidote) for the complete or partial reversal of the central sedative effects of benzodiazepines (specific group with sedative, sleep inducing, muscle relaxing and anxiolytic properties).

It may therefore be used in anaesthesia to wake you up after certain diagnostic tests or in intensive care if you have been held under sedative conditions.

Flumazenil may also be used for the diagnosis and treatment of intoxications or overdose with benzodiazepines.

Flumazenil may also be used in children (older than 1 year) to wake them up after they have been held under sedative conditions with benzodiazepines.

What do you need to know before you are given Flumazenil?

Flumazenil will be given to you by a specially trained doctor under strict supervision.

You must NOT be given Flumazenil if you are:

• Allergic (hypersensitive) to Flumazenil or any of the other ingredients of this medicine.
• Taking benzodiazepines to control a life-threatening condition such as an increase in brain pressure (raised intracranial pressure) or a serious epileptic seizure (status epilepticus).

Warnings and precautions

Before you receive Flumazenil, tell your doctor if you:

• Have epilepsy and have taken benzodiazepines for a long period. Flumazenil can cause seizures.
• Have liver problems.
• Have or in the past have had a serious head injury. Flumazenil can cause increased pressure in your brain.
• Were anxious before an operation or had an anxious seizure or have long term anxiety.
• Have had panic attacks in the past. Flumazenil can cause new attacks.
• Have had long-term or high dosage treatment of benzodiazepines. A rapid injection of Flumazenil at a dose higher than 1000 micrograms can cause withdrawal symptoms.
• Have a history of alcoholism or other substance abuse. You have a higher risk of benzodiazepine tolerance and dependence and therefore a higher risk of withdrawal symptoms. Your anaesthetist will adjust your dose carefully.

How Flumazenil is given to you

Flumazenil is administered in the vein (intravenously) either diluted or undiluted.

Flumazenil will be given to you under strict supervision of a doctor with experience in anaesthesia. The doctor will determine how much Flumazenil to give. This depends on your age, weight, how well your liver and kidneys are working and what you need the medicine for.

Flumazenil can be used in combination with other agents, which are used to return somebody to consciousness.

Adults

The dosage depends on the situation; usually, an initial dose of 200 micrograms is administered into your vein over 15 seconds.

If your state of consciousness does not improve sufficiently after 60 seconds, another dose of 100 micrograms can be administered. This can be repeated after 60 seconds until you reach a sufficient state of consciousness.

The maximum dose that can be administered is 1000 micrograms after anaesthesia and 2000 micrograms in intensive care.

The treatment is discontinued every 6 hours in order to determine if sedation re-occurs.

Children older than 1 year

Usually, an initial dose of 10 micrograms per kilogram body weight (up to 200 micrograms) is administered into a vein over 15 seconds.

If the state of consciousness does not improve sufficiently after 45 seconds, another dose of 10 micrograms per kilogram body weight (up to 200 micrograms) can be administered. This can be repeated after 60 seconds up to four times to a maximum total dose of 50 micrograms per kilogram body weight or 1000 micrograms, whichever is lower.

How to store Flumazenil

• Keep this medicine out of the sight and reach of children. 
• Do not store above 25°C. Do not freeze. Keep the ampoules in the outer carton in order to protect from light.
• After opening, the solution has to be used immediately. Any unused solution from opened ampoules should be discarded.
• Do not use this medicine if you notice that the solution is not clear and colourless.
• Do not use Flumazenil after the expiry date which is stated on the packaging after “EXP:” The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Shelf-life after dilution:

Chemical and physical in-use stability of the dilutions has been demonstrated for 24 hours at 25°C. From the microbiological point of view, the dilutions should be used immediately.

If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

What does Flumazenil contain?

The active substance is flumazenil.

1 ml solution for injection/infusion contains 100 micrograms of flumazenil.

1 ampoule with 5ml solution contains 500 micrograms of flumazenil.

The other ingredients are disodium edetate, glacial acetic acid, sodium chloride, sodium hydroxide and water for injections

Contents

• Pack of 10 x 5ml ampoules of Flumazenil 100 Micrograms/ml Solution for Injection/Infusion

References and useful links for more information on Flumazenil 100 Micrograms/ml Solution for Injection/Infusion:

• National Institute for Health and Care Excellence (NICE): https://bnf.nice.org.uk/drugs/flumazenil/
• Electronic Medicines Compendium: https://www.medicines.org.uk/emc/product/6300/smpc#gref
• Report an issue with a medicine to the MHRA Yellow Card scheme: https://yellowcard.mhra.gov.uk/