Cefoxitin 2g Powder for solution for injection or Infusion – patient leaflet, side effects, dosage

1. What Cefoxitin is and what it is used for

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

Your doctor has probably prescribed ‘Cefoxitin’ for you for either of the following reasons:

• because you have an infection caused by bacteria which is making you ill
• you may have just had surgery and been given ‘Cefoxitin’ to prevent infection.

‘Cefoxitin’ 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. ‘Cefoxitin’ is also active against bacteria causing a type of sexually transmitted disease called gonorrhoea.

2. What you need to know before you use Cefoxitin

Do not use Cefoxitin:

• ‘Cefoxitin’ should not be given to patients if they have had an allergic reaction or sensitivity to ‘Cefoxitin’ or other similar antibiotics such as penicillins or cephalosporins.
• 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)
• you have kidney problems

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

Other medicines and Cefoxitin

‘Cefoxitin’ 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.

Pregnancy and breast-feeding

Your doctor should use ‘Cefoxitin’ with care if:

• you are or think you may be pregnant
• you are planning to become pregnant
• you are breast-feeding or are planning to breast-feed

Driving and using machines

Cefoxitin has a major influence on the ability to drive and use machines especially because of the possible occurrence of encephalopathy (see sections 3 and 4)

Cefoxitin contains sodium

This medicinal product contains approximately 51.17 mg and 102.35 mg sodium content for 1g and 2g respectively.

3. How to use Cefoxitin

You will have been given or are about to be given ‘Cefoxitin’ Injection by a professional healthcare person. As ‘Cefoxitin’ injection is supplied as a powder, it must be made into a solution, before administration. Details of appropriate diluents will have been provided for your healthcare professional with each vial of ‘Cefoxitin’. There are three ways that ‘Cefoxitin’ Injection can be administered, by injection into a muscle, (intramuscular injection) or into a vein (intravenous injection), or by a continuous intravenous infusion via a drip. The number of injections you require will depend upon your condition.

Infections: the usual adult dose is 1 g or 2 g of ‘Cefoxitin’ every eight hours, which may be given for up to 10 days. Depending on the severity of the infection the dosage may be increased and/or more frequent dosages given. In patients with kidney problems the dose may be reduced and/or less frequent dosages given depending on renal function.

Uncomplicated urinary tract infections: the usual adult dose is 1 g of ‘Cefoxitin’ given intramuscularly twice a day for 10 days.

Uncomplicated gonorrhoea: the usual adult dose is 2 g of ‘Cefoxitin’ given intramuscularly with 1 g of probenecid (taken by mouth at the same time or up to one hour before).

Caesarian section: a single 2 g dose is administered intravenously as soon as the cord is clamped. If necessary, a second and third dose of 2 g may be administered intravenously 4 hours and 8 hours after the first dose.

Gynaecological surgery: a single dose of 2 g intravenously or intramuscularly has been effective given ½ to 1 hour before surgery for prevention of infections. If surgery is prolonged additional 2 g doses may be given at 6-hour intervals.

Treatment for the prevention of infections does not ordinarily extend beyond 24 hours.

As a preventive measure against bacterial infections prior to surgery: the adult dose is 2 g usually given ½ to 1 hour before surgery and then 2 g every 6 hours for up to 24 hours.

‘Cefoxitin’ 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 only 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 ½ to 1 hour before surgery and the second and third dose may be given every 8-12 hours.

‘Cefoxitin’ Injection must not be taken by mouth.

If you use more Cefoxitin than you should

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 been given too much medicine, you should notify your healthcare professional as soon as possible.

If you forget to use Cefoxitin

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 you should notify your healthcare professional as soon as possible.

4. Possible side effects

Like all medicines, 'Cefoxitin' 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, flushing 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 with blood, caused by inflammation of the bowel (called colitis), nausea and vomiting, blood disorders, Such as anaemia, which affect the components of the blood, (symptoms may be bruising easily, recurrent infection, tiredness. unusually sore throat, bleeding from the gums or into the skin) 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: "http://www.mhra.gov.uk/yellowcard"www.mhra.gov. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cefoxitin

'Cefoxitin' should be stored out of the sight and reach of children. The powder should be stored in a dry place below 25°C.

'Cefoxitin' Injection should not be used after the expiry date which is stated on the label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

After reconstitution:

Although chemical and physical in-use stability has been demonstrated for listed storage time for the reconstitution solutions and diluents, 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.

• for 8 hours at room temperature or under refrigeration for 0.5% Lidocaine Hydrochloride Injection, Water for Injection and 0.9% Sodium Chloride Injection.
• for 8 hours at room temperature for 5% or 10% Dextrose Injection BP, Dextrose and Sodium Chloride Injection BP (5%/0.9%, 5%/0.45%, or 5%/0.2%), Lactated Ringer’s Injection USP, 5% dextrose injection in 0.02% sodium bicarbonate solution, 5% Dextrose in Lactated Ringer’s Injection, M/6 Sodium Lactate Injection BP, 5% Fructose Injection.

Therefore, it’s recommended that the proposed product shall be used immediately after reconstituted.

6. Contents of the pack and other information

What Cefoxitin contains Active ingredient:

Each vial of ‘Cefoxitin’ Injection contains Cefoxitin sodium equivalent to 1 g or 2 g of cefoxitin.

Other ingredients:

There are no other ingredients in 'Cefoxitin' Injection.

'Cefoxitin' is a sterile powder for solution for injection. Both strengths are available in pack of 10 vials.

What Cefoxitin looks like and contents of the pack

‘Cefoxitin 1g Powder for Solution for Injection or Infusion’ is supplied in 15 ml Neutral borosilicate clear glass tubular injection vial (Ph.Eur. Type I) stopped with Chlorinated butyl rubber stopper partly coated with PTFE film and sealed with aluminium plastic cap prior to storage and transport.

Each pack contains 10 vials.

‘Cefoxitin 2g Powder for Solution for Injection or Infusion’ is supplied in 20 ml Neutral borosilicate clear glass tubular injection vial (Ph.Eur. Type I) stopped with Chlorinated butyl rubber stopper partly coated with PTFE film and sealed with aluminium plastic cap prior to storage and transport.

Each pack contains 10 vials.

Marketing Authorisation Holder

Marketing Authorisation Holder:

AFT Pharma UK Limited

Olympia House,

Unit 13 2nd Floor, Armitage Road,

London, NW11 8RQ

England

Manufacturer:

Quercus Labo BV.

Wijmenstraat 21P, Mariakerke, 9030, Belgium.

This leaflet was last revised in October 2025.