Consumer medicine information

What is in this leaflet?

This leaflet answers some common questions about sevoflurane.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking sevoflurane against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What sevoflurane is used for.

Sevoflurane belongs to a group of medicines called halogenated anaesthetic agents, which are breathed in to induce (commence) and/or maintain anaesthesia.

This medicine is added by an anaesthetist to the air you breathe when you go for surgery. It is a colourless liquid supplied in a bottle. It is given by your anaesthetist using a vaporiser, which turns the liquid into a gas so that you can breathe it in.

Sevoflurane is used for inducing and maintaining heavy sleep needed during surgery. The drug produces loss of consciousness and loss of pain sensations during surgery.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you receive sevoflurane.

Before you are due to receive sevoflurane.

You must tell your doctor if:

1. You have previously had any problems with a general anaesthetic.
2. You, or anyone in your family has malignant hyperthermia (a rare type of severe fever).
3. You have recently had any other general anaesthetic, or had more than one general anaesthetic over a short period of time.
4. You have had sevoflurane before and experienced an allergic reaction.
5. You have or have had any of the following medical conditions:

- Any problems with your liver including hepatitis.
- Brain disorders eg seizures (fits or epilepsy) or cancer
- Heart disease; for example coronary artery disease, high or low blood pressure
- Lung problems, for example asthma
- Any problems with your kidneys
- Any problems with your nerves and muscles (neuromuscular disease)

6. You are on the following medications:

- Muscle relaxants
These medicines may affect the way your doctor gives you sevoflurane.

7. You are pregnant or suspect you may be pregnant.

The safety of sevoflurane during pregnancy is not yet known.

8. You are breast-feeding.

When you must not receive it.

Sevoflurane should not be given to patients who are not suitable for receiving a general anaesthetic.

Sevoflurane should not be given to patients who are allergic or sensitive to sevoflurane or to other halogenated anaesthetic agents.

Sevoflurane should not be given to patients who are known or suspected to be susceptible to malignant hyperthermia.

Before sevoflurane is started

Sevoflurane may affect your ability to drive or operate machinery and you MUST NOT drive or operate a machine for at least 24 hours after anaesthesia.

Ask your doctor when you can return to work involving machinery or heavy equipment.

If your doctor chooses to use sevoflurane, and you are to go home immediately after your operation, do not consume any alcohol for the next 24 hours.

How sevoflurane is given

Only persons trained in the administration of general anaesthesia give sevoflurane. It is given using a vaporiser. A special mask will be placed over your mouth and nose and the medication will be breathed in through the mask.

The dose of sevoflurane will be adjusted to keep you at the right depth of sleep.

If you are given too much sevoflurane.

As sevoflurane is given under strict supervision it is unlikely that you will receive too much. However the anaesthetist can reduce the dose of sevoflurane and provide oxygen should your blood pressure be too low or you have difficulty in breathing.

Side Effects

As with all medicines, unwanted effects sometimes happen. Rarely sevoflurane may produce unwanted effects, which you may wish to know about.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Sevoflurane may cause some lowering of blood pressure and breathing rate and changes in heart rate. You will not know about these things since you will be asleep but your anaesthetist will adjust the dose of sevoflurane as necessary and will give you other medicines if needed.

Sevoflurane may cause seizures in some people.

Sevoflurane may cause disturbances of liver function in some people. After your operation, tell your doctor if you develop the following symptoms of liver problems: nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions and/or dark coloured urine.

Some people may experience shivering, nausea and vomiting upon waking from general anaesthesia.

It is possible that sevoflurane may cause a rare group of symptoms known as malignant hyperthermia. The features of this are muscle rigidity, fast pulse, breathing heavily and quickly, bluish lips and skin, changes in blood pressure and fever. Your doctor will treat this by stopping the sevoflurane and using other medications as needed.

After anaesthesia there may be a brief rise in your white blood cell count. Your doctor will monitor this if it happens.

Product description

What it looks like

Sevoflurane is a colourless liquid supplied in an aluminium bottle.

Ingredients

Each bottle contains 250mL of the active substance sevoflurane.

Sponsor

Sevoflurane is distributed in Australia by:

Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie NSW 2146

This leaflet was prepared in December 2006

AUST R 106647

Published by MIMS March 2007

1 Name of Medicine

Sevoflurane.

2 Qualitative and Quantitative Composition

Sevoflurane 100% w/v.
List of excipients. None.

3 Pharmaceutical Form

Sevoflurane is a volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anaesthetic drug. Sevoflurane is a clear, colourless, stable liquid containing no additives or chemical stabilizers.

4 Clinical Particulars

4.9 Overdose

Symptoms of overdose include respiratory depression and circulatory insufficiency. In the event of overdosage, or what may appear to be overdosage, the following action should be taken: discontinue administration of sevoflurane, maintain a patent airway, initiate assisted or controlled ventilation with 100% oxygen and maintain adequate cardiovascular function.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Compound A has been shown to be nephrotoxic in rats after exposures that have varied in duration from one to three hours. No histopathologic change was seen at a concentration of up to 270 ppm for one hour. Sporadic single cell necrosis of proximal tubule cells has been reported at a concentration of 114 ppm after a 3-hour exposure to Compound A in rats. The LC50 reported at 1 hour is 1050-1090 ppm (male-female) and, at 3 hours, 350-490 ppm (male-female).
Genotoxicity. No mutagenic effect was noted in the Ames test and no chromosomal aberrations were induced in cultured mammalian cells.
Carcinogenicity. Studies on carcinogenesis have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Active ingredient: sevoflurane. Molecular formula: C₄H₃F₇O. Molecular Weight: 200.05.
Physical constants. Boiling point at 760 mmHg: 58.6°C. Specific gravity at 20°C: 1.520 to 1.525. Vapour pressure in mmHg: 157 mmHg at 20°C, 197 mmHg at 25°C, 317 mmHg at 36°C.
Distribution partition coefficients at 37°C. Blood/ gas: 0.63 - 0.69; water/ gas: 0.36; olive oil/ gas: 47-54; brain/ gas: 1.15.
Mean component/ gas partition coefficients at 25°C for polymers used commonly in medical applications. Conductive rubber: 14.0; butyl rubber: 7.7; polyvinylchloride 17.4; polyethylene 1.3.
Sevoflurane is nonpungent. It is miscible with ethanol, ether, chloroform and petroleum benzene and it is slightly soluble in water. Sevoflurane is stable when stored under normal room lighting conditions according to instructions.
Sevoflurane is chemically stable. No discernible degradation occurs in the presence of strong acids or heat. The only known degradation reaction in the clinical setting is through direct contact with CO₂ absorbents (soda lime and Baralyme) producing pentafluoroisopropenyl fluoromethyl ether (PIFE, C₄H₂F₆O), also known as compound A, and trace amounts of pentafluoromethoxy isopropyl fluoromethyl ether (PMFE, C₅H₆F₆O), also known as compound B. Sevoflurane is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass or copper beryllium.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSEVOFL.gif CAS number. 28523-86-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes

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