INFORMATION FOR PATIENTS

Please read this leaflet carefully before this medicine is given to you. It gives an outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor, nurse or pharmacist. You should keep this leaflet throughout your course of treatment.

THE NAME OF YOUR MEDICINE IS CEFOTAXIME FOR INJECTION 2G

Cefotaxime for Injection 2g contains the active ingredient cefotaxime as cefotaxime sodium. Each vial contains 2g of cefotaxime. The sodium content per vial is 4.18mmol.

Cefotaxime for Injection 2g is an off white to pale yellow powder, which must be made into a solution before injection. It is available in packs of 1, 10, 25 and 50 vials.

HOW DOES YOUR MEDICINE WORK?

Cefotaxime belongs to a group of medicines called cephalosporins, which are antibiotics. These medicines work by killing bacteria that cause infections.

WHAT IS CEFOTAXIME FOR INJECTION 2G USED FOR?

Cefotaxime for Injection is used for the treatment of a range of serious bacterial infections including infections of the blood stream (septicaemia), bones (osteomyelitis), the heart valves (endocarditis), the membranes covering the brain (meningitis) and the lining of the abdomen (peritonitis), and to prevent and treat infections following surgical operations.

BEFORE ADMINISTRATION OF THIS MEDICINE

Cefotaxime for Injection should not be administered if:

• You are allergic to cefotaxime or any other cephalosporin. Before you are given this medicine your doctor should also check whether you have previously had an allergic reaction to penicillin or any other beta-lactam antibiotic,

You should let your doctor know if you are pregnant or could possibly be pregnant, or if you are breast-feeding, before this medicine is administered.

Taking another medicine when Cefotaxime for Injection is being administered can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are being treated with Cefotaxime for Injection unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself.

Examples of medicines that can affect Cefotaxime for Injection are:-

• Aminoglycoside antibiotics such as streptomycin, neomycin or gentamicin
• Frusemide or other strong diuretics, used to get rid of excess water from the body
• Probenecid, used to prevent gout

If you have any doubts about whether you should be given this medicine, then talk to your doctor.

ADMINISTERING THIS MEDICINE

Your doctor or nurse will prepare your injection by dissolving the cefotaxime powder in a suitable fluid for injection. The mixture is usually injected intramuscularly (into a muscle) or given intravenously (into a vein) either by injection or infusion (drip).

Cefotaxime which has been dissolved in a solution which contains lignocaine (a local anaesthetic) should not be given intravenously, or to infants under 30 months, or to patients who are allergic to lignocaine or who have heart block (without a pacemaker) or heart failure.

 

The usual adult (including the elderly) dose by intramuscular or intravenous injection is 1g every twelve hours. Lower doses may be given to patients with severe kidney problems.

The usual dose for children aged one month to twelve years is 100-150 mg per kg body weight daily in two to four divided doses. The usual dose for infants aged one to four weeks is 50mg per kg body weight in two or four divided doses.

Higher doses may be given, particularly in severe infections.

Your doctor will decide the dose that is best for you. If you do not understand, or are in any doubt, ask your doctor or nurse.

ARE THERE ANY SIDE-EFFECTS?

Like many medicines, cefotaxime may cause side-effects in some patients, such as feeling sick, being sick, stomach pain and diarrhoea, particularly when it is first given. The injection site may be sore.

Cefotaxime for Injection may cause allergic reactions such as rash, itching, fever and, very rarely, peeling skin, swelling of the face and difficulty breathing. Tell your doctor immediately if you think you are having an allergic reaction to cefotaxime.

Other side-effects that some patients have had with cefotaxime, particularly if given over long periods, include anaemia or other changes in the blood (which can cause sore throat and mouth ulcers or a tendency to bleed or bruise easily), temporary changes in liver function, kidney problems, painful joints and thrush. Treatment with high doses of cefotaxime, particularly in patients with kidney problems, has been known to cause loss of consciousness, abnormal movements and convulsions. Occasionally, patients have suffered a blood clot in a vein or irregular heart rhythm after intravenous cefotaxime.

Administration of high doses in patients with kidney problems may cause brain disease.

Antibiotic treatment can affect the normal bacteria in the gut, causing new infection (colitis). You should tell your doctor immediately if you develop diarrhoea.

Occasionally, if you have had an intravenous injection there may be swelling around the area of injection or inflammation of the vein.

If you experience any other side-effects or feel that the medicine is affecting you badly, tell your doctor or nurse.

SAFE KEEPING FOR THIS MEDICINE

This medicine should not be used after the date of expiry on the label.

The vials should not be stored above 25°C. Keep the glass container in the outer carton.

From a microbiological view, the product should be used immediately. In use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. Once reconstituted, any unused portion of solution should be discarded.

Cefotaxime for Injection should be kept in a secure place where children cannot get at it.