Avelox Iv 400 Consumer Medicine Information
moxifloxacin 400 mg/250 mL (as hydrochloride)
Intravenous infusion solution
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about AVELOX IV. It does not contain all of the available information on AVELOX IV.
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 AVELOX IV against the benefits they expect it will have for you.
Please read this leaflet carefully. If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT AVELOX IS USED FOR
AVELOX IV is a sterile intravenous antibiotic used in adults for the treatment of serious infections of the lung, airway and sinuses. However, your doctor may prescribe this medicine for another use. If you want more information, ask your doctor.
AVELOX IV contains the active ingredient called moxifloxacin, which is an antibiotic belonging to a group of medicines called quinolones. These antibiotics work by killing the bacteria that are causing your infection.
AVELOX IV is available by prescription only, and is used in a hospital environment only.
AVELOX IV is not addictive.
BEFORE YOU ARE GIVEN AVELOX IV
When you must not have AVELOX IV
You must not have AVELOX IV if:
- you have an allergy to moxifloxacin, other medicines belonging to the quinolone chemical family (e.g. ciprofloxacin, norfloxacin, nalidixic acid) or any of the ingredients in AVELOX IV listed at the end of this leaflet
- you have a medical condition of abnormal heart rhythm (specifically, the condition medically known as "prolongation of the Q-T interval" or "prolonged Q-T syndrome")
- you are taking another medicine use to treat abnormal heart rhythm (e.g. medicines containing the active ingredient quinidine, procainamide, amiodarone, sotalol)
- you have low potassium levels in your body
- you are pregnant or think you may be pregnant. It is not known if it is safe for you to receive AVELOX IV while you are pregnant. Drugs similar to AVELOX IV have caused joint disease in immature animals. Tell your doctor if you are or may be pregnant.
- if you are breast-feeding. AVELOX IV is excreted in breast milk and there is a possibility that the breast-fed baby may be affected. Your doctor will tell you whether you should be given AVELOX IV and temporarily stop breast-feeding while you are given this medicine.
Do not have AVELOX IV after the expiry date printed on the pack. The EXPIRY date is marked on the bottle or bag as well as on the label of the carton. For example, 11 05 refers to the eleventh month of 2005.
Do not use the contents of the bottle or bag if it is cloudy or has little specs in it.
Before you are given AVELOX IV
Tell your doctor if:
- you or your family have a history of heart rhythm problems.
- you have low potassium levels.
- you have a previous known allergy to moxifloxacin or any other ingredients in AVELOX IV, or to any other medicines that you have used in the past.
- You suffer or have suffered from fits (seizures, convulsions), have had a stroke, liver problems, or other medical problems.
Taking other medicines
Tell your doctor if you are taking any other medicines, including those that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when receiving AVELOX IV with other medicines.
AVELOX IV may have an effect on the electro-cardiogram (ECG - an electrical record of the activity of the heart) and may add to the effect of other medicines on the ECG. You should advise your doctor of any other medicines you are currently taking, particularly those affecting the heart rhythm.
Tell your doctor if you are taking warfarin, an anticoagulant medicine. You may still take Avelox. Your doctor may wish to perform INR testing and adjust your warfarin dose as appropriate.
HOW AVELOX IV IS GIVEN
AVELOX IV is given as a slow injection into a vein, usually as a drip, by a doctor or a nurse.
Dose and duration of treatment
This depends on your condition, and will be decided by your doctor.
The usual adult dose is 400mg once a day for 7-14 days. In some cases, your doctor will put you on AVELOX tablets as soon as possible, after being given AVELOX IV.
WHILE YOU ARE RECEIVING AVELOX IV
Things you must do
- Tell your doctor or nurse:
- If you develop an allergic reaction e.g a skin rash while receiving AVELOX IV, even following a single dose.
- If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped receiving AVELOX IV. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medications for diarrhoea without checking with your doctor.
- If you feel unwell or you develop symptoms mentioned in the Side Effects section (see below)
Things you must not do
Do not interfere with the equipment that is used to infuse AVELOX IV into your body. Changes to the settings of the equipment must only be carried out by your doctor or the nurse who is looking after you.
SIDE EFFECTS
Tell your doctor or nurse as soon as possible if you do not feel well while you are receiving AVELOX IV.
AVELOX IV helps most people with bacterial infections, but it may have unwanted side effects. Sometimes they are serious, most of the time they are not. You may need to stop receiving the injection or have medical treatment if you get some of the serious side effects.
Tell your doctor if you notice any of the following side effects which have been reported after treatment with AVELOX IV.
- Headache
- dizziness or lightheadedness
- stomach upsets such as feeling sick (nausea), diarrhoea, heartburn or stomach pains
- vomiting
- redness or pain at the site of injection
These are the more common side effects of AVELOX IV. They are usually mild and short-lived.
Tell your doctor immediately, if you notice any of the following:
- palpitations or fainting spells
- severe skin rashes
- swelling of the face, lips, mouth or throat
- fainting
- yellowing of the skin and eyes, also called jaundice
- severe watery or bloody diarrhoea, even if it occurs several weeks after receiving AVELOX treatment.
- fits (seizures, convulsions)
These are serious side effects. If you have them, you may need urgent medical attention, and AVELOX IV will need to be discontinued.
The Achilles tendon (extending from the calf to the heel of the foot) or other tendons have been torn after therapy with quinolone antibiotics. Tell your doctor immediately if you feel any discomfort, pain or inflammation of this or any other tendon.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
AFTER YOU HAVE RECEIVED AVELOX IV
When treatment is to be stopped, your prescribing doctor may need to alter the dose of other medicine(s) accordingly and monitor your condition.
Each bottle or bag of AVELOX IV is to be used once only. Any unused portion remaining in the bottle or bag must be discarded.
Storage
AVELOX IV will be stored in the pharmacy or on the ward. The bottles or bags are kept in a cool, dry place away from sunlight, where the temperature stays below 30°C. Do not refrigerate.
If you have any further questions on AVELOX IV, or are unsure of the information given above, please see your doctor or nurse, who will be able to assist you.
PRODUCT DESCRIPTION
What it looks like
AVELOX IV 400mg is a ready to use, clear yellow solution for infusion.
AVELOX IV is available in glass bottles in packs of 1 and 5's. It is also available in flexibags in packs of 5's and 12's.
Ingredients
Active Ingredients:
- Moxifloxacin (as hydrochloride) 400mg per 250 ml
Inactive Ingredients:
- sodium chloride
- water for injection
DATE OF PREPARATION
November 2002
