Cefepime Alphapharm

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

contains the active ingredient cefepime hydrochloride
CONSUMER MEDICINE INFORMATION

What is in this leaflet

The medicine which your doctor has prescribed for you is called Cefepime Alphapharm. The information in this leaflet answers some questions you may have about Cefepime Alphapharm.
This leaflet does not contain all the information about Cefepime Alphapharm. Your doctor or pharmacist has been provided with full information, and can answer any questions you may have. Follow your doctor's advice, even if it differs from what is in this leaflet.
You should read this leaflet carefully before Cefepime Alphapharm is given to you.
Keep this leaflet with your medicine. You may need to read it again

What CEFEPIME ALPHAPHARM is used for

Cefepime Alphapharm contains cefepime which belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing the infection.
Cefepime Alphapharm is an injectable antibiotic used for serious infections in adults caused by bacteria in the lungs (pneumonia and bronchitis), in the kidney and bladder (urinary tract infections), in the skin, inside the abdomen (peritonitis and biliary tract infections), in the womb or vagina, or in the blood (septicaemia). It may be given before surgery or if you have a lack of white blood cells with fever.
Cefepime Alphapharm is also used for serious infections in children over 2 months of age caused by bacteria in the lungs (pneumonia), in the kidney and bladder (urinary tract infections), or in the skin; or in the blood; or if the child has a lack of white blood cells with fever.
There may be other reasons why your doctor has prescribed Cefepime Alphapharm. Ask your doctor why Cefepime Alphapharm has been prescribed for you.

Before you take CEFEPIME ALPHAPHARM

When you must not take it

You should not be given Cefepime Alphapharm if:
you have an allergy to Cefepime Alphapharm, or to other cephalosporins or to any ingredient listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, difficulty breathing or fever.
you have had a serious reaction to penicillin.

Before you start to take it

Before you are given Cefepime Alphapharm your doctor must know:
if you have ever had any type of allergic reaction to penicillin medicines
if you have any allergies to other medicines or to any other substances such as foods, preservatives or dyes
if you have ever had any other health problems or medical conditions such as:
kidney disease
severe bowel conditions or bowel disease
frequent infections such as fever, severe chills, sore throat or mouth ulcer or lack of white blood cells.
a recent bone marrow transplant
cancer of the blood
low blood pressure
if you have ever suffered diarrhoea as a result of taking medicine

Pregnancy and breast-feeding

Tell your doctor if:
you are pregnant or intend to become pregnant
breast-feeding or plan to breast-feed
Like most medicines Cefepime Alphapharm is not recommended for women who are pregnant or breast feeding.
However your doctor will discuss with you the possible risks and benefits of using Cefepime Alphapharm during pregnancy.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy or health food shop. Some medicines may interfere
with Cefepime Alphapharm, these include:
any other antibiotic
fluid tablets (diuretics) such as Lasix, Midamor, or Moduretic.
These medicines may be affected by Cefepime Alphapharm, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Children

Cefepime Alphapharm may be given to infants (over 2 months old) and children; Cefepime Alphapharm is not recommended if the infant is less than 2 months old.

How to take Cefepime Alphapharm

Your doctor will decide what dose you will receive. The usual adult dose is 1 gram given by injection every 12 hours (2 each day) for 7 to 10 days.
The dose of Cefepime Alphapharm for children aged 2 months to 12 years old will depend on the weight of the child, the severity of the infection and the medical condition of the child.

How it is given

Cefepime Alphapharm is given as a slow injection (or drip) directly into a vein or as a deep injection into a large muscle.
The injection will be given to you by a nurse or doctor, you will not be giving the injection to yourself.

Overdose

Usually you will be in hospital when receiving Cefepime Alphapharm. Your doctor has information on how to recognize and treat an overdose. Ask your doctor or nurse if you have any concerns when you are receiving Cefepime Alphapharm.

While you are taking Cefepime Alphapharm

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, you must tell your doctor.
If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately even if it occurs several weeks after Cefepime Alphapharm has been stopped.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without checking with your doctor first.
If you get a sore white mouth or tongue while receiving or soon after stopping Cefepime Alphapharm, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
This may mean you have a fungal infection called thrush. Sometimes the use of Cefepime Alphapharm allows fungi to grow and the symptoms described above to occur. Cefepime Alphapharm does not work against fungi.
If you become pregnant while you are being given Cefepime Alphapharm tell your doctor.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are receiving Cefepime Alphapharm.
If you have your urine tested for sugar while you are receiving Cefepime Alphapharm, make sure your doctor knows which test is used. Cefepime Alphapharm may affect the results of some of these tests.
Tell all the doctors, dentists and pharmacists who are treating you that you are receiving Cefepime Alphapharm.

Things to be careful of

Be careful driving or operating machinery until you know how Cefepime Alphapharm affects you. Cefepime Alphapharm generally does not cause any problems with your ability to drive a car or operate machinery. However as with other medicines, Cefepime Alphapharm may cause dizziness, drowsiness or tiredness in some people.

SIDE EFFECTS

It is important that you tell a nurse, doctor or pharmacist if you experience any problems when you are being treated with Cefepime Alphapharm.
Cefepime Alphapharm helps most people with infections, but it may cause some unwanted side effects in a few people. All medicines have side effects, some times they are serious, most of the time they are not. You may need special medical treatment if you get some of the side effects.
Infections:
If there are any germs present which are not sensitive to Cefepime Alphapharm, they may flourish during Cefepime Alphapharm therapy and cause other infections such as thrush.
Laboratory Tests:
Cefepime Alphapharm may cause adverse effects to the blood, liver or kidneys which are detected by laboratory testing. It may be necessary to monitor these effects by having your blood samples analysed regularly. Your doctor will advise if it is necessary for you to have these tests done.
Call for a nurse or doctor if you experience any of the following:
Chest pain, increased heart beat, feeling faint, breathing difficulty, chills, dizziness, asthma
feel confused, suffer hallucinations, twitching muscles or experience a seizure
Tell your doctor or pharmacist if you notice any of the following and they worry you:
oral thrush - white, furry, sore tongue and mouth
vaginal thrush - sore and itchy vagina and/or discharge
itching or burning while passing urine
cough, sore throat, mouth ulcers
swelling, pain and inflammation at the site of the injection
any change to your bowel habits - diarrhoea or constipation
pain in the gut, indigestion or upset stomach
skin rash or itchiness, skin redness
sweating, feeling unwell, fluid retention, headache, weakness, numbness
insomnia, anxiety, nervousness, confusion

After treatment with Cefepime Alphapharm is finished

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after the treatment with Cefepime Alphapharm has stopped:
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may also be bloody
fever with one or both of the above symptoms
These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore you may need urgent medical attention. Although this side effect is rare, do not take diarrhoea medicine without first checking with your doctor.
The list above is not a complete list of ALL possible side effects. Your doctor can tell you more about the safety of Cefepime Alphapharm. Also, as with any medicine, there are some side effects which are not yet known. Ask your doctor if you have any questions.

After taking CEFEPIME ALPHAPHARM

Storage

Cefepime Alphapharm will be stored in the pharmacy or the Ward. The powder for injection is usually kept in a cool dry place where the temperature stays below 25 degrees Celsius. Protect from light.

Product description

What it looks like

CEFEPIME ALPHAPHARM is a white to pale yellow colour.

Ingredients

Active ingredient per vial:
CEFEPIME ALPHAPHARM 1g - contains cefepime (as hydrochloride) 1g
CEFEPIME ALPHAPHARM 2g - contains cefepime (as hydrochloride) 2g
Inactive ingredients:
L-arginine
The contents of each vial are dissolved in sterile water, 5% glucose or saline for injections before the injection is given.

Supplier

CEFEPIME ALPHAPHARM is supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.mylan.com.au
 
Australian Registration Numbers
CEFEPIME ALPHAPHARM 1g -
AUST R 161029
CEFEPIME ALPHAPHARM 2g -
AUST R 161030
 
This document was prepared in
November 2017