Generic Name: cefepime (as hydrochloride)
Product Name: Cefepime Alphapharm
Indication: What cefepime is used for
Cefepime Alphapharm is an injectable antibiotic used for serious infections in adults caused by bacteria in the lungs (pneumonia and bronchitis), in the kidney and bladder (urinary tract infections), in the skin, inside the abdomen (peritonitis and biliary tract infections), in the womb or vagina, or in the blood (septicaemia). It may be given before surgery or if you have a lack of white blood cells with fever.
Cefepime Alphapharm is also used for serious infections in children over 2 months of age caused by bacteria in the lungs (pneumonia), in the kidney and bladder (urinary tract infections), or in the skin; or in the blood; or if the child has a lack of white blood cells with fever.
There may be other reasons why your doctor has prescribed Cefepime Alphapharm. Ask your doctor why Cefepime Alphapharm has been prescribed for you.
Action: How cefepime works
Cefepime Alphapharm contains cefepime which belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing the infection.
Cefepime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefepime has a broad spectrum of in vitro activity that encompasses a wide range of gram-positive and gram-negative bacteria. Cefepime has a low affinity for chromosomally encoded beta-lactamases. Cefepime is highly resistant to hydrolysis by most betalactamases and exhibits rapid penetration into gram-negative bacterial cells. Within bacterial cells, the molecular targets of cefepime are the penicillin binding proteins (PBP).
Cefepime has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections:
- Aerobic gram-negative microorganisms:
- Escherichia coli;
- Klebsiella pneumoniae;
- Proteus mirabilis;
- Pseudomonas aeruginosa;
- Aerobic gram-positive microorganisms:
- Staphylococcus aureus (methicillin-susceptible strains only);
- Streptococcus pneumoniae;
- Streptococcus pyrogenes (Lancefield’s Group A streptococci).
The following in vitro data are available, but the clinical significance is unknown. Cefepime has been shown to have in vitro activity against most strains of the following microorganisms; however, the safety and effectiveness of cefepime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials:
- Aerobic gram-positive microorganisms:
- Staphylococcus epidermidis (methicillin-susceptible strains only);
- Staphylococcus saprophyticus;
- Streptococcus agalactiae (Lancefield’s Group B streptococci);
- Viridans group streptococci.
NOTE: Most strains of entrococci, e.g. Enterococcus faecalis, and methicillin-resistant staphylococci are resistant to cefepime.
- Aerobic gram-negative microorganisms:
- Acinetobacter calcoaceticus subsp. lwoffi;
- Citrobacter diversus;
- Citrobacter freundii;
- Enterobacter agglomerans;
- Haemophilius influenzae (including beta-lactamase producing strains);
- Hafnia alvei;
- Klebsiella oxytoca;
- Moraxella catarrhalis (including beta-lactamase producting strains);
- Morganella morganii;
- Proteus vulgaris;
- Providencia rettgeri;
- Providencia stuartii;
- Serratia marcescens.
NOTE: Cefepime is inactive against many strains of Stenotrophomonas (formally Xanthomonas maltophilia and Pseudomonas maltophilia).
- Anaerobic microorganisms:
NOTE: Cefepime is inactive against most strains of Clostridium difficile.
The prevalence of acquired resistance may vary geographically and with time for selected species. Information about the local resistance pattern should be obtained from a local bacteriological laboratory and taken into account in the choice of empiric therapy.
Cefepime Alphapharm 1g contains 1g of the active ingredient cefepime (as hydrochloride). Cefepime Alphapharm 2g contains 2g of the active ingredient cefepime (as hydrochloride).
It also contains the inactive ingredients l-arginine.
The contents of each vial are dissolved in sterile water, 5% glucose or saline for injections before the injection is given.
Dose advice: How to use cefepime
Before you take Cefepime Alphapharm
When you must not take it
You should not be given Cefepime Alphapharm if:
- You have an allergy to cefepime, or to other cephalosporins or to any ingredient listed here. Some of the symptoms of an allergic reaction may include skin rash, difficulty breathing or fever;
- You have had a serious reaction to penicillin.
Before you start to take it
Before you are given Cefepime Alphapharm your doctor must know:
- If you have ever had any type of allergic reaction to penicillin medicines;
- If you have any allergies to other medicines or to any other substances such as foods, preservatives or dyes;
- If you have ever had any other health problems or medical conditions such as:
- Kidney disease;
- Severe bowel conditions or bowel disease;
- Frequent infections such as fever, severe chills, sore throat or mouth ulcer or lack of white blood cells;
- A recent bone marrow transplant;
- Cancer of the blood;
- Low blood pressure;
- If you have ever suffered diarrhoea as a result of taking medicine.
Pregnancy and breastfeeding
Tell your doctor if:
- You are pregnant or intend to become pregnant;
- Breastfeeding or plan to breastfeed.
Like most medicines, Cefepime Alphapharm is not recommended for women who are pregnant or breastfeeding. However, your doctor will discuss with you the possible risks and benefits of using Cefepime Alphapharm during pregnancy.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy or health food shop. Some medicines may interfere with cefepime. These include:
- Any other antibiotic;
- Fluid tablets (diuretics) such as Lasix, Midamor, or Moduretic.
These medicines may be affected by cefepime or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.
Cefepime Alphapharm may be given to infants (over 2 months old) and children; Cefepime Alphapharm is not recommended if the infant is less than 2 months old.
How to take Cefepime Alphapharm
Your doctor will decide what dose you will receive.
The usual adult dose is 1 gram given by injection every 12 hours (2 each day) for 7 to 10 days.
The dose of Cefepime Alphapharm for children aged 2 months to 12 years old will depend on the weight of the child, the severity of the infection and the medical condition of the child.
How it is given
Cefepime Alphapharm is given as a slow injection (or drip) directly into a vein or as a deep injection into a large muscle. The injection will be given to you by a nurse or doctor, you will not be giving the injection to yourself.
Usually, you will be in the hospital when receiving Cefepime Alphapharm. Your doctor has information on how to recognize and treat an overdose. Ask your doctor or nurse if you have any concerns when you are receiving Cefepime Alphapharm.
While you are taking Cefepime Alphapharm
Things you must do
- If the symptoms of your infection do not improve within a few days, or if they become worse, you must tell your doctor;
- If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately, even if it occurs several weeks after defepime has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without checking with your doctor first;
- If you get a sore white mouth or tongue while receiving or soon after stopping cefepime, tell your doctor. Also, tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of cefepime allows fungi to grow and the symptoms described above to occur. Cefepime does not work against fungi.
- If you become pregnant while you are being given Cefepime Alphapharm tell your doctor;
- If you are about to start taking any new medicine, tell your doctor and pharmacist that you are receiving Cefepime Alphapharm;
- If you have your urine tested for sugar while you are receiving Cefepime Alphapharm, make sure your doctor knows which test is used. Cefepime Alphapharm may affect the results of some of these tests;
- Tell all the doctors, dentists and pharmacists who are treating you that you are receiving Cefepime Alphapharm.
Things to be careful of
Be careful driving or operating machinery until you know how Cefepime Alphapharm affects you. Cefepime Alphapharm generally does not cause any problems with your ability to drive a car or operate machinery. However, as with other medicines, Cefepime Alphapharm may cause dizziness, drowsiness or tiredness in some people.
After taking Cefepime Alphapharm
Cefepime Alphapharm will be stored in the pharmacy or the ward. The powder for injection is usually kept in a cool dry place where the temperature stays below 25 degrees Celsius. Protect from light.
Schedule of cefepime
Cefepime Alphapharm is a Schedule 4 medicine.
Side effects of cefepime
It is important that you tell a nurse, doctor or pharmacist if you experience any problems when you are being treated with Cefepime Alphapharm. Cefepime Alphapharm helps most people with infections, but it may cause some unwanted side effects in a few people. All medicines have side effects, sometimes they are serious, most of the time they are not. You may need special medical treatment if you get some of the side effects.
If there are any germs present which is not sensitive to cefepime, they may flourish during cefepime therapy and cause other infections such as thrush.
Cefepime may cause adverse effects on the blood, liver or kidneys which are detected by laboratory testing. It may be necessary to monitor these effects by having your blood samples analysed regularly. Your doctor will advise if it is necessary for you to have these tests done.
Call for a nurse or doctor if you experience any of the following:
- Chest pain, increased heartbeat, feeling faint, breathing difficulty, chills, dizziness, asthma;
- Feel confused, suffer hallucinations, twitching muscles or experience a seizure.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- Oral thrush. White, furry, sore tongue and mouth;
- Vaginal thrush. Sore and itchy vagina and/or discharge;
- Itching or burning while passing urine;
- Cough, sore throat, mouth ulcers;
- Swelling, pain and inflammation at the site of the injection;
- Any change in your bowel habit. Diarrhoea or constipation;
- Pain in the gut, indigestion or upset stomach;
- Skin rash or itchiness, skin redness;
- Sweating, feeling unwell, fluid retention, headache, weakness, numbness;
- Insomnia, anxiety, nervousness, confusion
After treatment with cefepime is finished
Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after the treatment with cefepime has stopped:
- Severe abdominal cramps or stomach cramps;
- Watery and severe diarrhoea, which may also be bloody;
- Fever with one or both of the above symptoms.
These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore you may need urgent medical attention. Although this side effect is rare, do not take diarrhoea medicine without first checking with your doctor.
The list above is not a complete list of all possible side effects. Your doctor can tell you more about the safety of Cefepime Alphapharm. Also, as with any medicine, there are some side effects which are not yet known. Ask your doctor if you have any questions.
For further information talk to your doctor.