PDFLARGE FONT PDF

DBL™ Cefotaxime Sodium for Injection

cefotaxime sodium (kef-oh-TACK-sim SO-dee-uhm)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about DBL™ Cefotaxime Sodium for Injection. It does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given DBL™ Cefotaxime Sodium for Injection against the benefits this medicine is expected to have for you.

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

Keep this leaflet in a safe place. You may need to read it again.

What DBL™ Cefotaxime Sodium for Injection is used for

Cefotaxime is an antibiotic used to treat infections in different parts of the body caused by bacteria.

It is also used to prevent infections before, during and after surgery.

Cefotaxime will not work against infections caused by viruses such as colds or the flu.

Cefotaxime belongs to a group of antibiotics called cephalosporins (kef-a-loe-SPOR-ins). These antibiotics work by killing the bacteria that are causing your infection.

Your doctor may have prescribed cefotaxime for another reason. Ask your doctor if you have any questions about why cefotaxime has been prescribed for you.

This medicine is available only with a doctors prescription.

DBL™ Cefotaxime Sodium for Injection is not addictive.

Before you are given DBL™ Cefotaxime Sodium for Injection

When you must not be given it

DBL™ Cefotaxime Sodium for Injection should not be given to you if you have an allergy to:

  • cefotaxime
  • other cephalosporins
  • any of the ingredients listed at the end of this leaflet

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.

Cefotaxime should not be given to you if you have had a major allergic reaction to penicillins.

Cefotaxime should not be mixed with lignocaine and given to you if you have had an allergic reaction to lignocaine, or if you have heart failure or heart block. Sometimes DBL™ Cefotaxime Sodium for Injection is mixed with lignocaine hydrochloride so that the injection into the muscle is less painful.

If you are not sure whether you should be given this medicine, talk to your doctor.

Do not use DBL™ Cefotaxime Sodium for Injection if the packaging is torn or shows signs of tampering.

Before you are given it

Tell your doctor if you have had any type of allergic reaction to penicillin medicines. You may have an increased chance of being allergic to cefotaxime if you are allergic to penicillins.

Tell you doctor if you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have, or have ever had, any of the following health problems or medical conditions:

  • kidney disease
  • liver disease
  • severe bowel conditions.
  • a low white blood cell count (neutropenia)
  • you are on a low salt diet

Tell your doctor if you are pregnant or intend to become pregnant. DBL™ Cefotaxime Sodium for Injection is not recommended for use during pregnancy. If there is a need to consider cefotaxime during your pregnancy, your doctor will discuss with you the benefits and risks of using it.

Tell your doctor if you are breast-feeding or plan to breast-feed. DBL™ Cefotaxime Sodium for Injection is not recommended while you are breast-feeding. If there is a need to consider cefotaxime while you are breast feeding, your doctor will discuss the possible risks and benefits of using it.

If you have not told your doctor about any of the above, tell them before you are given cefotaxime.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with cefotaxime. These include:

  • aminoglycoside antibiotics (such as gentamicin)
  • probenecid
  • diuretics (such as frusemide).
  • opiates and diphenoxylate (medicines used to stop diarrhoea)

These medicines may be affected by cefotaxime, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Talk to your doctor about the need for an additional method of contraception while being given DBL™ Cefotaxime Sodium for Injection. Some antibiotics may decrease the effectiveness of some birth control pills, although this has not been shown with cefotaxime.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while being given DBL™ Cefotaxime Sodium for Injection.

How DBL™ Cefotaxime Sodium for Injection is given

DBL™ Cefotaxime Sodium for Injection may be given in two ways:

  • as a slow injection or infusion (intravenous drip) into a vein
  • as a deep injection into a large muscle.

DBL™ Cefotaxime Sodium for Injection should only be given by a doctor or nurse.

Your doctor will decide what dose you will receive and how long you will receive DBL™ Cefotaxime Sodium for Injection for. This depends on your infection and other factors, such as your weight. For most infections, it is usually given in divided doses throughout the day.

Sometimes only a single dose of DBL™ Cefotaxime Sodium for Injection is required for the treatment of certain infections.

If you are given too much (overdose)

As DBL™ Cefotaxime Sodium for Injection is given under medical supervision; it is very unlikely that you will receive too much.

Immediately telephone your doctor the Poisons Information Centre 13 11 26 for advice if you think that you or anyone else has taken/used too much DBL™ Cefotaxime Sodium for Injection. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep these telephone numbers handy.

Symptoms of a cefotaxime overdose may include the side effects listed below in the ‘Side Effects’ section, but are usually of a more severe nature.

Ask your doctor or pharmacist if you have any concerns.

While you are being given DBL™ Cefotaxime Sodium for Injection

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea, tell your doctor or nurse immediately. Do this even if it occurs several weeks after cefotaxime has been stopped. Do not take any diarrhoea medicine without first checking with your doctor. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

If you get a sore white mouth or tongue while being given or soon after stopping cefotaxime, 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 DBL™ Cefotaxime Sodium for Injection allows fungi to grow and the above symptoms to occur. Cefotaxime does not work against fungi.

If you become pregnant while you are being treated with cefotaxime, tell your doctor immediately.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are being given cefotaxime.

If you have to test your urine for sugar while you are being given DBL™ Cefotaxime Sodium for Injection, make sure your doctor knows which type of test you use. This medicine may affect the results of some of these tests.

If you have to have any blood tests, tell your doctor you are being given DBL™ Cefotaxime Sodium for Injection. This medicine may affect the results of some blood tests.

Tell all the doctors, dentists and pharmacist who are treating you that you are being given DBL™ Cefotaxime Sodium for Injection.

Things you must not do

Do not give DBL™ Cefotaxime Sodium for Injection to anyone else, even if they have the same condition as you.

Do not use DBL™ Cefotaxime Sodium for Injection to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how DBL™ Cefotaxime Sodium for Injection affects you.

Cefotaxime generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, it may cause dizziness, drowsiness, tiredness in some people.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being treated with DBL™ Cefotaxime Sodium for Injection. Cefotaxime helps most people with infections, but it may have unwanted side-effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side-effects.

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

While using it

Tell your doctor or nurse if you notice any of the following and they worry you:

  • a white, furry, sore tongue and mouth (oral thrush)
  • a sore and itchy vagina and/or discharge (vaginal thrush)
  • nausea or diarrhoea
  • pain or tenderness near the injection site.

These side effects are usually mild.

Tell your doctor or nurse immediately if you notice any of the following:

  • fever
  • severe persistent diarrhoea (which may develop during treatment or up to several weeks after you stop cefotaxime)
  • signs of an allergic reaction, such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing
  • changes in the rhythm or rate of the heartbeat.
  • ulceration or lesions on the skin or in the mouth
  • conjunctivitis (inflammation or swelling of the eyes with possibly itchiness and discharge)
  • decreased urine output or fluid retention with swelling of the legs, ankles or feet.

These are very serious side effects. You may need urgent medical attention. These side effects are rare.

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with DBL™ Cefotaxime Sodium for Injection:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea which may also be bloody
  • fever, in combination with one or both of the above.

These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention. However, these side effects are rare.

Do not take any diarrhoea medicine without first checking with your doctor. This medicine can change bacteria, which is normally present in the bowel and normally harmless, to multiply and therefore cause the above symptoms. You may need urgent medical attention. However, this side effect is rare.

Tell your doctor if you notice any other effects. Other side effects not listed above may also occur in some patients.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After being given DBL™ Cefotaxime Sodium for Injection

Storage

DBL™ Cefotaxime Sodium for Injection may be stored in the pharmacy or in the ward.

Store DBL™ Cefotaxime Sodium for Injection in a cool dry place where the temperature stays below 25°C. Keep the vial away from light.

Do not store DBL™ Cefotaxime Sodium for Injection or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep DBL™ Cefotaxime Sodium for Injection where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine, or it has passed their expiry date, ask your pharmacist what to do with any vials that are left over.

Product description

What it looks like

A white to pale yellow crystalline powder in a glass vial.

Ingredients

DBL™ Cefotaxime Sodium for Injection contains the active ingredient

Cefotaxime Sodium, equivalent to 1 g or 2 g of Cefotaxime.

DBL™ Cefotaxime Sodium for Injection contains 48.2mg of sodium per gram.

DBL™ Cefotaxime Sodium for Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

DBL™ Cefotaxime Sodium for Injection is supplied by:

Australian Sponsor:

Pfizer Australia Pty Ltd
38-42 Wharf Road
WEST RYDE NSW 2114
Toll Free Number: 1800 675 229
www.pfizer.com.au

DBL™ Cefotaxime Sodium for Injection is available in the following strengths

1 g AUST R 78702

2 g AUST R 78703

This leaflet was updated in September 2018

Published by MIMS November 2018

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Dr Me Pty Limited, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.