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Zyvox

TABLETS AND ORAL SUSPENSION

linezolid
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Zyvox. It does not contain all the information that is known about Zyvox. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Zyvox is used for

Zyvox contains the active ingredient, linezolid.
Zyvox is an antibiotic (an agent used to destroy certain types of bacteria). It is used in the treatment of bacterial infections such as pneumonia, skin infections or blood infections.
Depending on the type of bacteria, you may be given additional medicines.
Your doctor, however, may prescribe Zyvox for another purpose.
Ask your doctor if you have any questions about why Zyvox has been prescribed for you or your child.
This medicine is not addictive.

Before taking Zyvox

When you must not take it

Do not take Zyvox or give Zyvox to your child before you talk to your doctor or pharmacist if you or your child:
are allergic to linezolid or any of the other ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
have uncontrolled high blood pressure
have pheochromocytoma (a type of tumour of the adrenal gland)
have thyrotoxicosis (an overactive thyroid gland)
have flushing or other symptoms caused by a carcinoid tumour
are taking or have taken in the last two weeks any medicine that is a monoamine oxidase inhibitor (e.g., moclobemide, phenelzine or tranylcypromine to treat depression or selegiline to treat Parkinson's disease)
any cold or flu medicine containing pseudoephedrine
adrenaline, a medicine used to treat severe allergic reactions
any other medicine that increases blood pressure (e.g., noradrenaline, dopamine, dobutamine)
are taking any medicine that is an SSRI or serotonin re-uptake inhibitor, which are types of medicine to treat depression, anxiety, panic attacks, obsessive-compulsive disorders or obesity (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, sibutramine, venlafaxine)
tricyclic antidepressants, which are medicines to treat depression (e.g., amitriptyline, clomipramine, dothiepin, doxepin, imipramine, nortriptyline, trimipramine)
some medicines to treat migraine (e.g.naratriptan, sumatriptan, zolmitriptan)
pethidine, a medicine to treat pain.
buspirone, a medicine to treat anxiety
Do not take Zyvox if the packaging is torn or shows signs of tampering.
Do not take Zyvox tablets after the expiry date printed on the pack has passed.
Do not take or give your child Zyvox oral suspension if it is more than 3 weeks since you received it from the pharmacist.
If you have any concerns about you or your child taking Zyvox speak to your doctor or pharmacist.

Before you take Zyvox

Tell the doctor if you or your child:
have diarrhoea
have allergies to any other medicines or substances, such as foods, preservatives or dyes
have phenylketonuria
The oral suspension contains aspartame and this is partly converted into phenylalanine
are anaemic or have had any abnormal blood test results (e.g., low haemoglobin or platelets).
Tell the doctor if you:
are pregnant or planning to become pregnant.
are breastfeeding or intend to breastfeed
If you are pregnant or breastfeeding, the doctor may decide not to prescribe Zyvox.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell the doctor if you or your child have been treated with or are taking:
any medicine that inhibits monoamine oxidase, (e.g., moclobemide, phenelzine or tranylcypromine to treat depression or selegiline to treat Parkinson's disease)
any cold or flu medicine containing pseudoephedrine
adrenaline, a medicine used to treat severe allergic reactions
any other medicine that increases blood pressure (e.g., noradrenaline, dopamine, dobutamine)
are taking any medicine that is an SSRI or serotonin re-uptake inhibitor, which are types of medicine to treat depression, anxiety, panic attacks, obsessive-compulsive disorders or obesity (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, sibutramine, venlafaxine)
tricyclic antidepressants, which are medicines to treat depression (e.g., amitriptyline, clomipramine, dothiepin, doxepin, imipramine, nortriptyline, trimipramine)
some medicines to treat migraine (e.g., naratriptan, sumatriptan, zolmitriptan)
pethidine, a medicine to treat pain.
buspirone, a medicine to treat anxiety
rifampicin, a medicine to treat tuberculosis and some other infections
any medicine that could reduce the levels of haemoglobin (the pigment in red blood cells which carries oxygen) or platelets (blood cells which help blood to clot)
Ask the doctor or pharmacist if you are not sure about this list of medicines.
Also tell the doctor if your or your child's diet contains a lot of mature cheese, yeast extracts, meat extracts, soya bean extracts (e.g., soy sauce), draught beers or wine.
Zyvox may react with a substance which is naturally present in these foods.

How to take Zyvox

It is recommended that treatment with Zyvox begin in a hospital.
Follow all directions given by your or your child's doctor carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask the doctor or pharmacist for help.
Gently mix the oral suspension by slowly turning the bottle over a few times before you use it. DO NOT SHAKE THE BOTTLE.
Do not take or give Zyvox oral suspension to your child if it is more than 3 weeks since you received it from your pharmacist.

When to take it

Take the dose as prescribed by your doctor.
Give the dose to your child as prescribed by your child's doctor.
Zyvox can be taken before, during or after meals.
If you or your child are on dialysis, take Zyvox after dialysis.

How much to take

Tablets
The recommended dose for adults and adolescents 12 years and older is one 600mg tablet twice daily (every 12 hours).
Oral suspension
The recommended dose for babies and children up to 12 years of age is 10mg/kg three times daily (every 8 hours).
The recommended dose for adults and adolescents 12 years and older is 30mL (600mg) twice daily.
Ask your or your child's doctor if you want more information about the dose of Zyvox and how it is given.

How long to take it

Continue taking Zyvox until you or your child finish the tablets or oral suspension unless your doctor recommends otherwise.
Do not stop taking Zyvox unless your doctor tells you to, even if you feel better.
Do not stop giving Zyvox to your child unless your child's doctor tells you to, even if your child feels better.
If you or your child do not complete the full course prescribed by the doctor, the bacteria causing the infection may continue to grow and multiply. The infection may not clear completely or it may return.
A course of treatment usually lasts 10 to 14 days, but may be up to 28 days.

If you forget to take it

If it is almost time for your or your child's next dose, skip the missed dose and take the next dose when you or your child are meant to. Otherwise, take it or give it to your child as soon as you remember, and then go back to taking Zyvox as you would normally.
Do not take a double dose or give a double dose to your child to make up for the dose that you missed.
If you have trouble remembering to take the medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or pharmacist or Poisons Information Centre (in Australia phone 13 11 26 and in New Zealand phone 0800 POISON or 0800 764 766) or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Zyvox.
Do this even if there are no signs of discomfort or poisoning.
You or your child may need urgent medical attention.
Keep the telephone numbers for these places handy.
The possible effects of overdose are vomiting, tremors (shaking), unsteadiness or lack of coordination.

While taking Zyvox

Things you must do

Follow all instructions given by your or your child's doctor. In some cases, additional blood tests may be required.
If the symptoms of the infection do not improve within a few days, or if they become worse, tell your or your child's doctor.
As part of the treatment, you or your child may be given other medicines including other antibiotics. It is important to keep taking these medicines as well as Zyvox unless you are told otherwise by your or your child's doctor or pharmacist.
It is important to tell your or your child's doctor if you or your child develop diarrhoea during or after treatment with Zyvox. Do this even if it occurs several weeks after Zyvox has been stopped.
Do not take or give your child any medicine to treat diarrhoea without first checking with the doctor.
Diarrhoea may be caused by a serious condition affecting the bowel. You or your child may need urgent medical care.
If you or your child get a sore white mouth or tongue while taking or soon after stopping Zyvox tell the doctor.
Tell the doctor if you or your child get vaginal itching or discharge.
This may mean you or your child have a fungal infection called thrush. Sometimes the use of Zyvox allows fungi to grow which causes the symptoms described above. Zyvox does not work against fungi.
Tell your doctor immediately if you become pregnant while you are taking Zyvox.
Tell all doctors, dentists and pharmacists who are treating you or your child that you are taking Zyvox.

Things you must not do

Do not start taking any other medicines, prescription or not, without first telling your doctor or pharmacist.
Do not give your child any other medicines, prescription or not, without first telling your child's doctor or pharmacist.
Do not take or give your child any medicine to treat diarrhoea without first checking with the doctor.
Diarrhoea may be caused by a serious condition affecting the bowel. You or your child may need urgent medical care.
Avoid eating too much mature cheese, yeast extracts, meat extracts or soya bean extracts (e.g., soy sauce). Avoid drinking alcohol, especially draught beers and wine.
This is because Zyvox may react with a substance which is naturally present in these foods.
If you or your child develop a throbbing headache after eating, tell your doctor or health care professional.
Do not give Zyvox to anyone else, even if they seem to have the same condition as you.
Do not take Zyvox to treat any other complaint unless your doctor tells you to do so.

Things to be careful of

Be careful driving or operating machinery, until you know how Zyvox affects you.
No effects on the ability to drive or use machines have been seen with Zyvox. However, as with many other medicines, Zyvox may cause dizziness or tiredness in some people.

Side effects

Tell your or your child's doctor or pharmacist as soon as possible if you or your child do not feel well while taking Zyvox.
This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Do not be alarmed by the following lists of side effects.
You or your child may not experience any of them.

While taking it

Tell your or your child's doctor or pharmacist if you notice any of the following and they worry you:
headache
sore, white mouth or tongue (oral thrush)
vaginal itching or discharge (vaginal thrush)
pain, cramping or "bloating" of the abdomen
nausea or vomiting
metallic taste
change in the colour of the tongue
change in the colour of teeth. This may be reversible.
See your doctor immediately and before you or your child take the next dose of Zyvox if you notice any of the following:
skin reactions (hives, rash or itching)
visual disturbances or numbness or weakness of the arms and legs (rare side effects that have been primarily reported in patients treated for longer than 28 days)
tiredness, headaches, being short of breath when exercising, dizziness, looking pale, fever and chills, sore throat or bruising (these symptoms may indicate a decrease in the level of your blood cells)
sweating, feeling drunk and dizzy, muscle twitching, fever and shivering, confusion.
These may be symptoms of the serotonin syndrome, which is a rare but serious side effect.
If any of the following happen to you or your child, tell your or your child's doctor immediately or go to Accident and Emergency at your nearest hospital:
seizure
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, severe itching or hives or blisters on the skin.
These may be signs of a serious allergic reaction or side effect. You or your child may need urgent medical attention or hospitalisation. These side effects are rare.

After finishing it

Tell your or your child's doctor or pharmacist if you or your child get any of the following side effects, particularly if they occur several weeks after stopping treatment with Zyvox:
severe stomach cramps
watery and severe diarrhoea (which may be bloody), fever, in combination with one or both of the above.
Zyvox can cause some bacteria, which are normally present in the bowel and normally harmless, to multiply and cause these symptoms. You or your child may need urgent medical attention.
Tell your doctor if you notice any other side effects.
Other side effects not listed above may also occur in some people.

After using Zyvox

Storage

Keep your tablets or oral suspension in the original packaging, including outer carton, until it is time to take them. Keep oral suspension bottles tightly closed.
If you take the medicine out of the pack it may not keep well.
Keep Zyvox in a cool dry place where the temperature stays below 25°C.
Do not store Zyvox or any other medicines in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep Zyvox where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Zyvox or to stop giving Zyvox to your child, or the medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.
The oral suspension should be used within 3 weeks. Return any unused suspension to your pharmacist for disposal.

Product description

What it looks like

Zyvox tablets are white, oval tablets with a film coating. The tablets are marked on one side with "ZYVOX 600mg" in red ink. The tablets are available in blister packs of 10 tablets.
Zyvox oral suspension is a white, fluid which is orange flavoured. It is supplied in an amber glass bottle with a screw cap. A measuring spoon with 2.5mL and 5mL markings is also provided.

Ingredients

The active ingredient in Zyvox is linezolid.
Tablets
Zyvox tablets contain 600mg of linezolid.
The tablets also contain:
microcrystalline cellulose (E460i)
maize starch
sodium starch glycollate type A
hydroxypropylcellulose (E463)
magnesium stearate (E572).
The film coating contains:
hypromellose (E464)
titanium dioxide (E171)
macrogol 400
carnauba wax (E903).
Oral suspension
Zyvox oral suspension contains 20mg of linezolid per 1mL (total 150mL).
Other ingredients are:
sucrose
mannitol (E421)
microcrystalline cellulose (E460i)
carmellose sodium (E466)
aspartame (E951)
anhydrous colloidal silica (E551)
sodium citrate (E331)
xanthan gum (E415)
sodium benzoate (E211)
citric acid anhydrous (E330)
sodium chloride.
The granules are flavoured with Mafco magnasweet, orange flavour, orange cream flavour, Sweet-am powder, vanilla flavour and peppermint flavour.
Important information about some of the ingredients in Zyvox Oral Suspension
This medicine contains aspartame, sodium benzoate, sucrose and sodium as well as other ingredients.
Aspartame is partly converted into phenylalanine.
Sodium benzoate is known to be a mild irritant to the skin, eyes and mucous membranes. In the quantities present in Zyvox suspension (0.2%) no harmful effects are expected.
Sodium may be harmful in a low-sodium diet.
Each 5mL of suspension contains about 1 gram of sucrose. Zyvox is not suitable for treating people with hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.
Sucrose may cause gastrointestinal complaints and diarrhoea.

Supplier

Zyvox is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free Number: 1800-675 229
 
It is supplied in New Zealand by:
Pfizer New Zealand Ltd
PO Box 3998
Auckland
Toll Free Number: 0800-736 363

Australian Registration Numbers

Zyvox can be identified by an Australian Register Number which is found on the carton.
Tablets
AUST R 79694 (blister pack)
Oral Suspension
AUST R 79695 (bottle)

Date of preparation

This leaflet was revised in March 2010.
 
© Pfizer Australia Pty Ltd
® = Registered trademark