Consumer Information for: ISOFLURANE USP
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Isoflurane USP is used to put you under general anesthesia.
What it does
Isoflurane USP is used to induce and maintain anesthesia.
When it should not be used
Isoflurane USP should not be used if:
- You have been told that you are allergic to isoflurane or other inhaled general anesthetics, or components of the container.
- You have a history of liver inflammation (hepatitis) due to the use of an inhaled general anesthetic, or have experienced unexplained liver problems (for example jaundice with fever) after a previous use of an inhaled general anesthetic.
- You or any member of your family has experienced a condition called malignant hyperthermia (a genetic disorder that causes rapid raise in body temperature) during an operation.
What the medicinal ingredient is
Isoflurane, USP
What the non-medicinal ingredients are
The finished product is composed solely of the active ingredient, isoflurane, USP.
What dosage form it comes in
Isoflurane USP (Isoflurane, 99.9%) is available in 100 mL and 250 mL amber-colored bottles. The liquid is changed to gas in a vaporizer for inhalation. The vaporizer is designed to be used only with Isoflurane USP.
Warnings and precautions
Serious Warnings and Precautions
- Isoflurane USP should only be administered by qualified individuals trained in general anesthesia in an adequately equipped facility.
- Isoflurane USP may trigger a rise in blood potassium or body temperature. You may experience stiff muscles, changes in blood pressure, rapid breathing, a bluish colour to lips or fingers, rapid or irregular heart rate. Trained healthcare professionals will take care of you if this happens.
You should talk to your anesthesia professional prior to your anesthesia if you are aware of any of the following conditions:
- You have been told that you are allergic to isoflurane or other inhaled general anesthetics, or components of the container.
- You have previously had general anesthesia, particularly if repeated over a short period of time.
- A doctor has difficulty placing a tube down your throat to help you breathe.
- You are pregnant (or may be pregnant).
- You are breast-feeding.
- You or a member of your family suffers from malignant hyperthermia (a genetic disorder that causes rapid raise in body temperature).
- You are suffering from any other illness, such as diabetes, severe headaches, cancer, problems with your nerves or muscles (especially muscular dystrophy), nausea, or vomiting.
- You have or are at risk for developing Increased Intracranial Pressure (ICP). ICP is increased pressure inside the skull with general symptoms such as headache, vomiting without nausea, altered level of consciousness, back pain, and changes to your eyesight.
- You have low blood pressure, heart, kidney, or liver problems.
- You are taking prescription or non-prescription medications or herbal medicines.
Recovery of consciousness following Isoflurane USP administration generally occurs within minutes. Change in mood may persist for several days following administration.
Performance of activities requiring mental alertness or coordination such as operating a motor vehicle or hazardous machinery may be impaired for some time after general anesthesia. Do not drive a motor vehicle or operate hazardous machinery for at least 24 hours after having a general anesthetic.
Interactions with this medication
Serious Drug Interactions
- Tell your healthcare professional if you have muscular diseases (especially muscular dystrophy), and:
- You are taking potassium, and/or
- You have heart problems, especially irregular heart beats
Tell your doctor, nurse or pharmacist about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Drugs that may interact with Isoflurane USP include:
- Other anesthetics, tranquillizers (e.g., benzodiazepines), narcotics (e.g., opioids), muscle relaxants (e.g., pancuronium), and nitrous oxide gas.
- Calcium channel blockers (e.g., used to treat high blood pressure or seizures)
- Beta blockers (e.g., used to treat high blood pressure and heart problems)
- Monoamine Oxidase (MAO) inhibitors (e.g., used to treat depression, anxiety and migraine)
- Isoniazid (a treatment for tuberculosis)
- Indirect-acting sympathomimetics (amphetamines and their derivatives, psychostimulants, appetite suppressants, ephedrine and its derivatives)
- Alcohol (chronic use before anesthesia)
- St. John’s Wort
Proper use of this medication
Usual Dose
Your anesthesia provider will decide what dose of Isoflurane USP you will receive. The dose will vary depending on your age, weight, the type of anesthesia that you are having, and other factors.
Overdose
Overdosage will be handled by the anesthesia provider.
Side effects and what to do about them
Side effects include headache, cough, fatigue, mood changes, and nightmare.
After exposure to Isoflurane USP, you should contact your doctor or anesthesia provider if you have any of the following reactions: | |||
---|---|---|---|
Common | |||
Agitation, Confusion | |||
Chills/Shivering | |||
Difficulty Breathing | |||
Increased Blood Sugar: frequent urination, thirst, and hunger |
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Liver Disorders: yellow color to skin and eyes, dark urine |
|||
Muscle Pain | |||
Nausea, Vomiting | |||
Nervous System Disorders: confusion, nervousness, abnormal gait, dizziness, drowsiness, intellectual function decreased |
|||
Rash | |||
Slow, Rapid, or Irregular Heartbeat | |||
Weakness | |||
Uncommon | |||
High Blood Pressure: headache, altered vision, nausea, vomiting |
|||
Low Blood Pressure: light-headedness, fainting, especially when getting up from a lying or sitting position |
|||
Malignant Hyperthermia: sudden fever with stiffness, pain and weakness in your muscles |
|||
Seizure or Fits | |||
Frequency Unknown | |||
Heart Attack: chest pain, shortness of breath, heart burn, sweating, weakness, fatigue, light-headedness, nausea |
This is not a complete list of side effects. For any unexpected effects while taking Isoflurane USP, contact your doctor, anesthesia provider, or pharmacist.
How to store
Isoflurane USP should only be administered in an adequately equipped facility. Isoflurane USP must be kept out of reach and sight of children. It is stored between 15 °C and 30 °C.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about Isoflurane USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (hc-sc.gc.ca/index-eng.php); the Fresenius Kabi Canada Ltd. website (fresenius-kabi.ca), or by calling 1-877-821-7724.
This leaflet was prepared by:
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Last revised: May 23, 2018
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