Consumer medicine information

Hospira™Ceftriaxone Sodium Powder for Injection

ceftriaxone sodium (kef-try-AXE-own)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Hospira™ Ceftriaxone Sodium Powder 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 ceftriaxone against the benefits they expect it will have for you.

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

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

What Hospira™Ceftriaxone Sodium Powder for Injection is used for

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

It is also used to prevent infections following surgery.

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

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

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

This medicine is not addictive.

This medicine is available only with a doctor’s prescription.

Before you are given Hospira™Ceftriaxone Sodium Powder for Injection

When you must not be given it

Hospira™ Ceftriaxone Sodium Powder for Injection should not be given to you if you have an allergy to:

  • any medicine containing ceftriaxone
  • other cephalosporin antibiotics
  • any of the 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.

Hospira™ Ceftriaxone Sodium Powder for Injection should not be given to you if you have had a serious allergic reaction to penicillins.

Hospira™ Ceftriaxone Sodium Powder for Injection should not be mixed with lignocaine and given to you if you have had an allergic reaction to lignocaine. Sometimes this medicine is mixed with lignocaine hydrochloride so that the injection into the muscle is less painful.

Hospira™ Ceftriaxone Sodium Powder for Injection should not be given to neonates (especially premature neonates) who may be at risk of developing, or have abnormally high amounts of bile pigment (bilirubin) in the blood.

Safety and effectiveness in children and infants have not been established.

If you are not sure whether you should be given Hospira™ Ceftriaxone Sodium Powder for Injection, talk to your doctor.

Before you are given it

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

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

Tell your doctor if you have or have had any of the following medical conditions:

  • kidney or liver disease
  • stomach or intestine diseases, such as inflammation of the large intestine (bowel).

Tell your doctor if you are pregnant or intend to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you are given Hospira™ Ceftriaxone Sodium Powder for Injection.

Taking other medicines

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

Some medicines and ceftriaxone may interfere with each other. These include:

  • chloramphenicol, another medicine used to treat infections.

This medicine may be affected by ceftriaxone or may affect how well it works. You may need different amounts of your medicine, or you may need to use a different medicine.

Talk to your doctor or pharmacist about the need for an additional method of contraception while you are being treated with ceftriaxone. Some antibiotics may decrease the effectiveness of some birth control pills, although this has not been shown with ceftriaxone.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while being given this medicine.

How Hospira™ Ceftriaxone Sodium Powder for Injection is given

How much is given

Your doctor will decide what dose you will receive. This depends on your infection and other factors, such as your weight. For most infections, Hospira™ Ceftriaxone Sodium Powder for Injection is usually given once or twice a day.

How it is given

Hospira™ Ceftriaxone Sodium Powder for Injection can be given in the following ways:

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

This medicine must only be given by a doctor or nurse.

How long it is given for

Your doctor will decide how long you will receive this medicine for.

The length of treatment is usually 4 to 14 days, although some infections may require longer treatment. Sometimes only a single dose is required for the treatment or prevention of certain infections.

If you are given too much (overdose)

As Hospira™ Ceftriaxone Sodium Powder for Injection is given under medical supervision, it is very unlikely that you will receive too much.

However, if you experience severe side effects after being given this medicine, tell your doctor immediately.

Immediately telephone your doctor or the Poisons Information Centre (call 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Hospira™ Ceftriaxone Sodium Powder for Injection. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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

Ask your doctor if you have any concerns.

While you are being given Hospira™ Ceftriaxone Sodium Powder 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, pharmacist or nurse immediately. Do this even if it occurs several weeks after ceftriaxone 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 ceftriaxone, tell your doctor or pharmacist. Also tell your doctor or pharmacist if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of ceftriaxone allows fungi to grow and the above symptoms to occur. Ceftriaxone does not work against fungi.

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

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

If you have to test your urine for sugar while you are being given this medicine, make sure your doctor knows which type of test you use. Ceftriaxone may affect the results of some of these tests.

If you have to have any blood tests, tell your doctor you are being given this medicine. Ceftriaxone may affect the results of some blood tests.

Tell any other doctors, dentists or pharmacists who treat you that you are being given this medicine.

Things to be careful of

Be careful driving or operating machinery until you know how ceftriaxone affects you. Ceftriaxone generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, ceftriaxone may cause dizziness in some people. If this occurs, do not drive. If you drink alcohol, dizziness may be worse.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given ceftriaxone. Ceftriaxone 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.

If you are over 65 years of age you may have an increased chance of getting side effects.

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

Ask your doctor, nurse 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:

  • nausea, vomiting or mild diarrhoea
  • swelling, pain or tenderness at or near the injection site
  • headache or dizziness
  • oral thrush – white, furry, sore tongue and mouth
  • vaginal thrush – sore and itchy vagina and/or discharge.

These side effects are usually mild.

Tell your doctor as soon as possible if you notice the following:

  • sharp pain or a severe steady ache in the upper abdomen.

This side effect may require medical attention. This side effect is rare.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital (if you are not already in hospital) if you notice any of the following:

  • severe persistent diarrhoea
  • allergic reaction (for example, 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)
  • excessive peeling of the skin.

These are very serious side effects. You may need urgent medical attention or hospitalisation. 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 Hospira™ Ceftriaxone Sodium Powder 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 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.

Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After being given Hospira™ Ceftriaxone Sodium Powder for Injection

Storage

Hospira™ Ceftriaxone Sodium Powder for Injection will generally be stored in the pharmacy or on the ward.

The medicine is kept in a cool dry place, protected from light, where the temperature stays below 25°C. Once the powder for injection has been diluted to form a solution, it will be used as soon as possible. If storage is necessary, the solution will be kept in the fridge (at 2 to 8°C) for not more than 24 hours, and used as soon as practicable after removal from refrigeration. This medicine should not be frozen.

Product description

What it looks like

A white or yellowish crystalline powder in a glass vial. When Hospira™ Ceftriaxone Sodium Powder for Injection is made into a solution before injection, the solution ranges in colour from light yellow to amber.

Ingredients

Hospira™ Ceftriaxone Sodium Powder for Injection contains the active ingredient ceftriaxone sodium, equivalent to 1 g or 2 g of ceftriaxone.

Hospira™ Ceftriaxone Sodium Powder for Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

Hospira™ Ceftriaxone Sodium Powder for Injection is supplied by:
Hospira Pty Ltd
ABN 13 107 058 328
Level 3
500 Collins Street
Melbourne VIC 3000
Australia

Hospira™ Ceftriaxone Sodium Powder for Injection is available in the following presentations:
1 g /vial – AUST R 167648
2 g /vial – AUST R 167651

This leaflet was prepared in June 2011

Published by MIMS December 2013