Mefoxin®

(cefoxitin sodium, MSD)

PLEASE READ ALL OF THIS LEAFLET CAREFULLY IF YOU HAVE BEEN GIVEN OR WILL BE GIVEN MEFOXIN INJECTION.

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

What is in your injection?

Active ingredient:

The active ingredient in Mefoxin Injection is cefoxitin sodium.

Other ingredients:

There are no other ingredients in Mefoxin Injection.

Mefoxin is supplied as a sterile powder ready for reconstitution in vials containing 1 9 or 2 9 cefoxitin sodium; both strengths are available in packs of 5 vials.

How does your medicine work?

The active ingredient in Mefoxin Injection is cefoxitin sodium, which belongs to a group of medicines known as broad-spectrum antibiotics. This means that Mefoxin is able to kill a wide range of bacteria. Bacteria are germs that may cause infection in various parts of the body.

Who makes your medicine?

Mefoxin Injection is made by Merck Manufacturing Division, Merck Sharp & Dohme Chibret, Clermont-Ferrand, France, for Merck Sharp & Dohme Limited Hoddesdon, Hertfordshire, UK, who hold the Product Licence in the UK and the Product Authorisation in Ireland.

Why do you need this medicine?

Your doctor has probably prescribed Mefoxin for you for either of the following reasons:

  1. because you have an infection caused by bacteria which is making you ill.
  2. you may have just had surgery and been given Mefoxin to prevent infection.

Mefoxin is active against certain bacteria causing infection in the abdomen, urinary tract, genital tract in women, respiratory tract (e.g. lungs, throat, chest) bones and joints, in the blood, and in your skin and tissues. Mefoxin is also active against bacteria causing a type of sexually transmitted disease called gonorrhoea.

Mefoxin is not recommended for the treatment of meningitis, which is inflammation of the membranes surrounding the brain and spinal cord.

Are there patients who should not be given this medicine?

Mefoxin should not be given to patients if they have had an allergic reaction or sensitivity to Mefoxin or other similar antibiotics.

If you think this applies to you, talk to your doctor and follow the advice given.

What else should you know about Mefoxin Injection?

Your doctor should use Mefoxin with care if:

  1. you are or think you may be pregnant.
  2. you are planning to become pregnant.
  3. you are breast-feeding or are planning to breastfeed.
  4. you have had stomach or digestive problems particularly a disease called 'colitis' (antibiotics can cause stomach upsets and diarrhoea in some patients, but it can be more severe in patients who have bowel problems).
  5. you have kidney problems.
  6. you have allergies or bad reactions to this or other antibiotics or other medicines, e.g. penicillin.

If you are unsure or confused, talk to your doctor or pharmacist.

Can Mefoxin Injection be given with other medicines? Mefoxin may be administered along with some other medicines or antibiotics, but it is important that you tell your doctor about all the medicines you are taking, including those obtained without a doctor's prescription .

How should Mefoxin be given?

You will have been given or are about to be given Mefoxin injection by a professional healthcare person. There are two ways that this injection can be administered, either into a muscle (intramuscular injection) or into a vein (intravenous injection). The number of injections you require will depend upon your condition. In the treatment of infections the usual adult dose is 1 9 or 2 9 of Mefoxin every eight hours, which may be given for up to 10 days.

As a preventative measure against bacterial infections prior to surgery, the adult dose is 2 9 usually given; to 1 hour before surgery and then 2 9 every 6 hours for up to 24 hours.

Mefoxin may be used in infants and children. However the intramuscular injection should not be used for infants younger than 3 months of age. For infants under 3 months of age, only the intravenous injection should be used.

In the treatment of infections for babies less than 4 weeks old, the dose is based on body weight and age. For infants and children, dose is based on bodyweight. A guide is given below.

Babies

0-1 week of age - 20-40 mg/kg intravenously every 12 hours.

1-4 weeks of age - 20 40 mg/kg intravenously every 8 hours.

Infants over 4 weeks old and children

20-40 mg/kg every 6 hours or every 8 hours.

As a preventive measure against bacterial infection prior to surgery for infants and children the dose is 30-40 mg/kg ½ to 1 hour before surgery and then every 6 hours for up to 24 hours. For babies, under one month, 30-40 mg/kg may be given intravenously § to 1 hour before surgery and the second and third dose may be given every 8-12 hours.

Mefoxin Injection must not be taken by mouth.

What if you miss a dose or have too much?

It is likely that the times at which you are to have your injections will be set by your healthcare professional. However, if you think you may have missed a dose, or have been given too much medicine, you should notify your healthcare professional as soon as possible.

What unwanted effects could your medicine have?

Like all medicines, Mefoxin may occasionally cause side effects in some patients, the most common of which are pain, inflammation and tenderness in the region where the injection has been administered. Some patients may develop an allergic reaction symptoms being a rash over the body and itching. Severe cases may have fever, or develop swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing. Such patients should receive immediate medical attention.

Other side effects include lowering of the blood pressure, the symptoms of which may be dizziness, fainting and sweating, diarrhoea caused by inflammation of the bowel (called colitis), nausea and vomiting, blood disorders, such as anaemia, which affect the components of the blood, kidney effects liver problems, such as jaundice, symptoms of which are yellowing of the eyes and skin.

If you experience any of these symptoms or have any other unusual symptoms or feelings, consult your doctor as soon as possible.

How should your medicine be kept?

Mefoxin should be stored out of reach of children. It should be stored in a cool place (below 30ºC), out of direct sunlight.

Mefoxin injection should not be used after the expiry date which is clearly marked on the pack.

How can you obtain more information about Mefoxin?

This leaflet gives you some important patient information about Mefoxin Injection. If you have questions after you have read it, ask your doctor or pharmacist, who will give you further information.

® denotes registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.

© Merck Sharp & Dohme Limited, 1995. All rights reserved.

Date of issue: 1995.