1. What Foxime is and what it is used for

Foxime is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotic are similar to penicillin.

Foxime kills bacteria and it can be used to treat infections of the:

- Kidneys and bladder (Urinary tract).

- Blood (septicemia) Skin and flesh immediately under the skin.

- Bones.

- Heart valves.

- Brain (meningitis).

- Abdomen (peritonitis).

- Some sexually transmitted infections (gonorrhoea).

It can also be used to prevent and treat infections following surgical operations.

2. Before you are given Foxime

Do not use Foxime

- You are allergic (hypersensitive) to cefotaxime.

- You are allergic to any similar antibiotics (known as “cephalosporins”).

- You have ever had a serious allergic reaction when given penicillin or similar antibiotics.

- You are allergic to lidocaine.

Tell your doctor or nurse if any of the above apply to you.

Take Special care with foxime

You must tell the doctor or nurse if any of the following apply to you:

- You have a history of allergies or asthma.

- You are on a low sodium diet.

- You have a heart or kidney disorder.

- You are having any blood or urine tests.

- You have a history of gastro-intestinal problems e.g. colitis, which causes diarrhea containing blood.

Taking other medicines

Tell the doctor or nurse if you are taking any of the following medicines:

- The contraceptive pill (in which case you will need to take extra contraceptive precautions such as using a condom).

- Any diuretic medicine (“water tablets”) e.g. furosemide.

- Another antibiotic e.g. chloramphenicol or Aminoglycoside antibiotics.

- Probenecid (for gout).

Please tell your doctor if you are taking, or have recently taken, any other medicines including any that you may have bought without a prescription.

Pregnancy and breast-feeding

If you are pregnant, think you might be pregnant or are breastfeeding, you must tell your doctor before you are given this medicine.

Driving and using machines

If you are given high doses of cefotaxime, you may feel dizzy/drowsy or fall asleep or experience convulsions (fits) or unusual body movements. If this happens, you should not drive or operate machinery.

3. How Foxime is given

Foxime is given by IM or IV injection.

Adults:

On average the daily dose is 3 g in divided doses which can be increased  to 12 g/day in specific cases.

In urinary tract infections a dose of 2 g/day may be sufficient.

In meningitis 6 g/day can be given.

Pre-operative prophylaxis in endoscopic prostate resection, 1 g IV can be given on induction of anesthesia.

Children and infants:

On average the daily dose is 50 mg/kg of body weight, divided in three IV injections. The dose can be increased to 200 mg/kg/day in specific cases.

Prematures:

On average the daily dose is 50 mg/kg of body weight, divided in two IV injections. The dose can be increased to 100 mg/kg/day in severe infections.

Patients with kidney problems:

Lower doses may be given if you have severe kidney problems. Patients on dialysis machines will be monitored for the correct dose.

Reconstitution:

- For the 0.5 g IM or IV injection, dissolve  the contents  of one vial using 2 ml of sterile water for injection.

- For the 1 g IM injection, dissolve the contents of one vial using 4 ml from the lidocaine hydrochloride ampoule.

- For the 1 g IV injection, dissolve the contents of one vial  using 4 ml of sterile water for injection.

If you think you have missed an injection

This is unlikely as you will probably receive this medicine in hospital. If you think you have missed a dose, speak to your doctor or nurse.

If you have been given more of this medicine than you should

This is unlikely to happen but if it does, the doctor will treat any symptoms that follow.

4. Possible side effects

Like all medicines, Foxime injection can cause side effects, although not everybody gets them.

As with other antibiotics, some people find they have an allergy to it.

Tell your doctor immediately if any of the following rare symptoms occur:

- Sudden wheeziness and tightness of chest.

- Swelling of eyelids, face, lips or throat.

- Skin lumps or “hives” (nettle rash).

- Severe skin rashes with itching.

- Serious illness with blistering of the skin, mouth, eyes and genitals.

- Loss of consciousness, abnormal movements or convulsions (fits).

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

The following side effects may occur in some patients treated with Foxime injection. Tell your doctor if any become troublesome:

Very common side effects (probably affecting more than 1 in 10 patients)

- Pain at the injection site.

Uncommon side effects (probably affecting less than 1 in 100 patients)

- Reduction in blood platelets which increases risk of bruising or bleeding.

- Reduction in number of white blood cells which makes infections more likely.

- Increase in number of white blood cells.

- Fever.

- Increase in liver enzymes and/or bilirubin.

- Kidney problems.

- Skin rash, itching, ‘hives’ (nettle rash).

- Difficulty breathing.

- Convulsions (fits).

- Diarrhea.

- Redness and swelling at injection site.

Side effects occurring with unknown frequency

- Secondary infections.

- Serious allergic reactions which may cause difficulty in breathing or dizziness.

- Serious allergic reaction which causes swelling of the face or throat.

- Difficulty in breathing or wheezing.

- Headache. Dizziness.

- Loss of consciousness, abnormal movements.

- Feeling sick (nausea).

- Being sick (vomiting).

- Stomach pains.

- Diarrhea containing blood.

- Inflammation of the liver (hepatitis).

- Skin and whites of the eyes turn yellow (jaundice).

- Painful joints.

- Irregular heart rhythm.

- Inflammation of the kidneys which may cause dark discolouration of urine, cloudy/bloody urine, or any change in your urine output.

Treatment with high doses of Foxime, particularly in patients with kidney problems, has been known to cause loss of consciousness, abnormal movements and convulsions (“fits”).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Foxime
Keep out of reach of children.
Store below 30°C.
Keep contents in the carton until consumed.
After Reconstitution:
The reconstituted solutions are stable for 24 hours in a refrigerator (2-8°C). 
From a microbiological point of view, the product should be used immediately. If not 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. 
Do not use beyond the expiry date or if the product shows any signs of deterioration.