Consumer medicine information

Cefuroxime SXP 750 mg Powder for injection

Cefuroxime

BRAND INFORMATION

Brand name

Cefuroxime SXP

Active ingredient

Cefuroxime

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cefuroxime SXP 750 mg Powder for injection.

1. Why am I being given CEFUROXIME SXP?


CEFUROXIME SXP contains the active ingredient cefuroxime sodium. CEFUROXIME SXP is used to prevent infections during surgery.
For more information, see Section 1. Why am I being given CEFUROXIME SXP? in the full CMI.

2. What should I know before I am given CEFUROXIME SXP?


You should not be given CEFUROXIME SXP if you have ever had an allergic reaction to cefuroxime sodium, penicillins, other beta-lactams or any other cephalosporin antibiotics.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given CEFUROXIME SXP? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with CEFUROXIME SXP and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How am I given CEFUROXIME SXP?

  • CEFUROXIME SXP can be given in two ways: as an injection into a vein or as a drip (intravenous infusion).
  • CEFUROXIME SXP must only be given by a doctor or a nurse.
  • Your doctor will decide on the dose and length of time that you will receive CEFUROXIME SXP.

More instructions can be found in Section 4. How am I given CEFUROXIME SXP? in the full CMI.

5. What should I know while being given CEFUROXIME SXP?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are being given CEFUROXIME SXP.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you are being given CEFUROXIME SXP.
  • If you become pregnant while being given this medicine, tell your doctor immediately.
  • If you are about to have any blood tests, tell your doctor that you are being given this medicine.
  • Tell your doctor if you have or have had any kidney conditions.
Driving or using machines
  • CEFUROXIME SXP may cause drowsiness, dizziness or light-headedness in some people. Make sure you know how you react to CEFUROXIME SXP before you drive a car, operate machinery, or do anything else that could be dangerous.
Looking after your medicine
  • CEFUROXIME SXP is stored in a hospital ward or pharmacy in a dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while being given CEFUROXIME SXP? in the full CMI.

6. Are there any side effects?


Common side effects include white furry, sore tongue and mouth, sore, itchy vagina with or without discharge, swelling and redness along the vein, swelling, pain or tenderness at the injection site, headache, dizziness, nausea, vomiting, diarrhoea, abdominal pain, tendency to bruise or bleed easily, rash or itchy skin.
Serious side effects include chills or fever, which may be accompanied by shivering, ringing in the ears or hearing loss, low blood pressure, prolonged or severe diarrhoea or stomach cramps, chest pain, seizures, severe skin reactions or allergic reactions. Signs of an allergic reaction such as 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, limb weakness or numbness, loss of memory, vision, and/or intellect severe headache or migraine, cognitive and behavioral problems, sexual dysfunction, anxiety, depression, or other psychiatric disorders, or altered sensation, tingling, or numbness.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Cefuroxime SXP

Active ingredient

Cefuroxime

Schedule

S4

 

Notes

Distributed by Southern XP Pty Ltd

1 Name of Medicine

Cefuroxime sodium.

2 Qualitative and Quantitative Composition

Each vial contains 750 mg or 1.5 g cefuroxime as cefuroxime sodium. See Table 1.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CEFSXP01.gif For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
White or almost white to yellowish powder.

4 Clinical Particulars

4.9 Overdose

Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see Section 4.2 Dose and Method of Administration; Section 4.4 Special Warnings and Precautions for Use).
Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Non-clinical data reveal no specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and toxicity to reproduction and development.
Gamma glutamyl transpeptidase activity in rat urine is inhibited by various cephalosporins, however the level of inhibition is less with cefuroxime. This may have significance in the interference in clinical laboratory tests in humans.
Genotoxicity. Non-clinical data reveal no specific hazard for humans based on conventional studies of genotoxicity.
Carcinogenicity. No carcinogenicity studies have been performed; however, there is no evidence to suggest carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFURO.gif Chemical name: sodium;(6R,7R)-3-(carbamoyloxymethyl)-7-[[(2Z)-2-(furan-2-yl)-2-methoxyiminoacetyl] amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.
Chemical formula: C16H15N4NaO8S.
Molecular weight: 446.366.
CAS number. 56238-63-2.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription only medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CEFSXPST.gif