Auro Cefotaxime 250 mg/500 mg/1000 mg/2000 mg Injection

AURO CEFOTAXIME is indicated for the treatment of infections caused by susceptible strains of organisms in the following infections:

• Upper Respiratory Tract Infections:
• Pneumococcal infections – Pneumonia, bronchitis, cellulitis, otitis media
• Haemophilus influenzae infections – Otitis media, laryngotracheobronchitis, meningitis (in children)
• Urinary tract infections:
• E.coli infections – Pneumonia, urinary tract infections, meningitis (in children)
• Gastrointestinal Infections:
• Shigella infections – Bacillary dysentery
• Salmonella infections – Enteritis
• Other:
• Neisseria meningitides – Meningitis (in children)
• Acute uncomplicated cystitis caused by E. coli and Klebsiella pneumoniae.

Note: Bacteriological tests to determine causative organisms and sensitivities are recommended. AURO CEFOTAXIME is indicated perioperatively to reduce the incidence of post-operative infections in patients undergoing surgical procedures classified as potentially contaminated.

Do not take AURO CEFOTAXIME:

• If you are hypersensitive (allergic) to cefotaxime, cephalosporin or any of the other ingredients of AURO CEFOTAXIME.
• If you are hypersensitivity (allergic) to penicillin and other beta-lactam antibiotics.

Take special care with AURO CEFOTAXIME (Powder for injection):

• If you have a history of gastrointestinal disease, especially ulcerative colitis, regional enteritis or antibiotic-associated colitis.
• If you have been diagnosed with renal function impairment – A reduced dose may be required.
• Porphyria: Safety has not been established.

Pregnancy and Breast-feeding: Safety of AURO CEFOTAXIME in pregnant and lactating women has not been established.

If you are pregnant or breast feeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Taking other medicines with AURO CEFOTAXIME:

• Concurrent administration of potentially nephrotoxic medicines or diuretics may increase the risk of possible nephrotoxicity.
• A positive Coombs reaction appears in patients who receive large doses of AURO CEFOTAXIME.
• Haemolysis is not usually associated with the phenomenon but it may interfere with cross-matching of blood.
• If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of AURO CEFOTAXIME with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional, for advice.

Always take AURO CEFOTAXIME exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

If you have the impression that the effect of AURO CEFOTAXIME is too strong or too weak, talk to your doctor or pharmacist.

AURO CEFOTAXIME is administered intravenously (i.e. in the blood) or IM (i.e. into the muscle) as directed by your doctor.

If you take more AURO CEFOTAXIME than you should:

Symptoms of overdose: Encephalopathy (impairment of consciousness, abnormal movements and seizures) has been reported.

Treatment of overdose: Treatment is symptomatic and supportive. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.

AURO CEFOTAXIME can have side effects.

Blood and lymphatic system disorders

• Frequent: eosinophilia
• Less frequent: haemolytic anaemia, neutropenia, thrombocytopenia (reversible)

The following side effects have been reported and frequencies are unknown:

• Agranulocytosis

Cardiovascular disorders

The following side effects have been reported and frequencies are unknown:

• Arrhythmias following rapid bolus infusion through a central venous catheter

Nervous system disorders

• Frequent: headache

The following side effects have been reported and frequencies are unknown:

• *confusion, *encephalopathy

Gastrointestinal disorders

• Frequent: diarrhoea, nausea, vomiting, abdominal pain

Renal and urinary disorders

• Less frequent: decrease in renal function (especially when co-prescribed with aminoglycosides)

The following side effects have been reported and frequencies are unknown:

• *interstitial nephritis

Hepato-biliary disorders

The following side effects have been reported and frequencies are unknown:

• Transient increases in hepatic enzyme levels and/or bilirubin (Values may exceed twice the upper limit of normal and lead to asymptomatic cholestatic liver injury.)

Skin and subcutaneous tissue disorders

• Less frequent: rash, pruritus, urticaria, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis

General disorders and administration site conditions

• Less frequent: *local inflammatory reactions at the injection site

Immune system disorders

• Less frequent: Hypersensitivity reactions including skin rashes, urticaria, pruritus, bronchospasm, drug fever, serum sickness, shock, anaphylaxis

Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Keep all medicines out of the reach and sight of children. Store below 25 °C. Protect from light. Keep the vials in the carton until required for use. Discard any unused portion of the re-constituted solution in the vial. KEEP OUT OF REACH OF CHILDREN.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).