PRIMAXIN IV 500 mg Injection
(Imipenem/cilastatin sodium)
Read all of this leaflet carefully before you start to have this medicine.
- Keep this leaflet. You may want to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even it their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What 'Primaxin' is and what it is used for
- 2. Before you have 'Primaxin'
- 3. How to take 'Primaxin'
- 4. Possible side effects
- 5. How to store 'Primaxin'
- 6. Further information.
What 'Primaxin' is and what it is used for
The name of this medicine is 'Primaxin' IV 500mg injection, but in the rest of the leaflet it will be referred to as 'Primaxin'.
What 'Primaxin' is
'Primaxin' contains two different medicines called imipenem and cilastatin sodium.
- Imipenem belongs to a group of medicines called ‘beta-lactam’ antibiotics. Imipenem is able to kill a wide range of bacteria. Bacteria are germs that may cause infection.
- Imipenem can be stopped from working (made inactive) by a reaction that occurs in the kidneys.
- Cilastatin sodium stops this reaction occurring. Cilastatin is known as a ‘specific enzyme inhibitor’.
- Imipenem is usually given with cilastatin sodium to increase the levels of ‘active’ imipenem available in the blood and urinary tract to kill bacteria.
What 'Primaxin' is used for
'Primaxin' is used
- To treat an infection caused by bacteria.
- To prevent an infection when you have had surgery.
'Primaxin' is used to treat infections which may affect:
- the urinary system
- the reproductive organs (men and women)
- the respiratory tract (such as your lungs, throat, or chest)
- bones and joints
- skin and other tissues
- blood and infections in your stomach (abdomen).
'Primaxin' is not recommended for the treatment of infections affecting the brain, spinal cord or nerve endings, such as meningitis, which is inflammation of the membranes surrounding the brain and spinal cord.
Before you have 'Primaxin'
Do not use 'Primaxin':
- if you are allergic (hypersensitive) to imipenem, cilastatin sodium or any of the other ingredients of 'Primaxin' (listed in section 6: Further information)
- in children under 3 months old
- in babies or children with kidney problems
- if you have severe kidney problems.
Take special care with 'Primaxin':
Check with your doctor or pharmacist before having your medicine:
- if you have ever had bad reaction to any other antibiotic such as a ‘penicillin’ or a ‘cephalosporin’
- if you have inflammation of the colon (colitis) or other stomach problems
- if you have any nervous system problems such as tremors or fits (seizures)
- if you are having dialysis, your doctor should monitor you carefully.
If you are not sure of any of the above apply to you talk to your doctor or pharmacist before having Primaxin.
Tell your doctor if you are taking medicines called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia).
Using other medicines
- Please tell your doctor if you are taking or have recently taken any medicines, including medicines obtained without a prescription.
- There are a few medicines that cannot be taken at the same time as ‘Primaxin’.
- It is particularly important to tell your doctor if you are taking ganciclovir which is used to treat some viral infections, as taking this with ‘Primaxin’ can lead to an increased risk of convulsions.
- It is also important to tell your doctor if you are taking valproic acid or sodium valproate(used to treat epilepsy, bipolar disorder, migraine or schizophrenia) Primaxin can reduce the amount of valproic acid in your blood which may cause seizures to occur.
Your doctor will decide whether you should use 'Primaxin' in combination with these medicines.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine. Do not use ‘Primaxin’ if you are or think you may be pregnant, you are planning to become pregnant or you are breast-feeding
Driving and using machines
As this medicine may cause dizziness and sleepiness you should not perform tasks that require special attention, e.g. driving a car or operating dangerous machinery until you know how you tolerate your medicine.”
How to have 'Primaxin'
How your injection is given
- You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.
- This injection should only be given into a vein (intravenous injection).
- The number of injections you require will depend upon your condition.
To treat an infection
- The usual dose for ADULT patients weighing more than 70 kg is 250 mg or 500 mg.
- If the infection is severe a dose of 1000mg (1g) may be used. This dose is repeated every six or eight hours."
- The Maximum total daily dose of 4 g should not be exceeded.
- For patients weighing less than 70 kg the dosage should be reduced proportionally.
For the prevention of infection after an operation: The usual adult dose is 1 g after receiving anaesthetic and a further 1 g three hours later.- If you are having surgery in the lower bowel area you may be given two additional 500 mg doses at eight and 16 hours after being put to sleep.
Use in children (weighing less than 40 kg)
- Do not use Primaxin in children less than 3 months old.
- If a child weighs less than 40 kg (about 6 st 4 lb) the dose is based on his/her weight and is usually 15 mg/kg given every six hours to give a daily dose of 60 mg/kg.
Kidney problems and patients on dialysis
- If you have kidney problems your dose should be reduced.
- If you are having a type of dialysis called haemodialysis, the usual adult dose is 250 or 500 mg given immediately after your dialysis and then at 12 hour intervals thereafter.
- If you are receiving dialysis you should be carefully monitored by your doctor or healthcare professional.
If you take too much 'Primaxin' or forget to take it
You should be given your injections at the correct times by a person qualified to do so. If you think you may have missed a dose, or have been given too much, talk to you doctor or nurse straight away.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines ‘Primaxin’ can cause side effects, although not everybody gets them. Most side effects are mild and not permanent.
The following side effects may happen with this medicine:
Allergic reactions
If you have an allergic reaction, stop taking this medicine and see a doctor straight away. The signs may include:
- swelling of your face, lips, tongue or throat, which may cause problems breathing or swallowing.
- fever
- rash over your body and itching.
Local reactions
- reddening of your skin
- local pain and hardening of tissue
- inflammation of the wall of a vein.
Stomach and gut
- feeling sick (nausea) and being sick (vomiting). These are more likely to occur in patients who have a low number of white cells in their blood)
- diarrhoea , taste disturbance
- staining of your teeth or tongue
- inflammation of your colon (signs may be stomach (abdominal) pain, fever and diarrhoea).
Blood
- some people have had problems which effect the contents of the blood. Signs may be sore throat, tiredness, paleness. These problems can be found by taking blood tests.
Liver
- some people have had problems with their liver. Signs include yellowing of the skin and eyes. These problems are found by taking blood tests.
Kidney
- changes in the amount of urine you produce
- rarely renal failure caused by kidneys not functioning properly
- harmless changes in urine colour (discolouration) may occur.
Nervous system
- tremors, twitching or uncontrolled movements of a part of the body
- seeing, hearing or feeling something that is not there (hallucinations)
- pins and needles, confusion or fits.
Other side effects have been reported, but it is unknown if these were caused by taking 'Primaxin'.
Stomach and gut
- gastro-enteritis (signs may be loss of appetite, feeling sick (nausea), being sick (vomiting), diarrhoea, stomach cramps)
- haemorrhagic colitis, a type of gastro-enteritis (signs may be sudden severe stomach (abdominal) cramps, with watery diarrhoea which becomes bloody, raised temperature)
- red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy appearance, heartburn, sore throat, increase in the production of saliva.
Nervous system
- dizziness, sleepiness, brain disturbances
- tingling sensation, vertigo (a spinning sensation), headache
- tinnitus (ringing in the ears), temporary hearing loss in patients with impaired hearing.
Joints and Muscles
- pain in several joints, weakness.
Heart and circulation
- low blood pressure, signs may be dizziness and fainting
- irregular heartbeat,the heart beating forcefully or rapidly.
Lungs
- chest discomfort, difficulty breathing, a type of pain called ‘thoracic spinal pain’.
Skin
- sudden appearance of reddened patches and blisters on the palms of the hands, soles of the feet and on the face
- swelling of the face, flushing, bluish discoloration of the face and lips, skin texture changes, excessive sweating,
- in women itching of the vulva, fungal infection which may occur in the mouth (signs may be creamy white painful patches inside the mouth), in women the vagina (signs include itching or irritation of the vagina and vulva and white cheese-like discharge from the vagina), or in men the penis (signs may be soreness or irritation at the end of the penis and occasionally a slight discharge from the penis).
Blood
- changes in the amounts of blood cells, signs may be fever or chills, tiredness, bruising or bleeding.
If you experience any of these symptoms or have any other unusual symptoms or feelings, consult your doctor as soon as possible.
How to store Primaxin
Keep out of the reach and sight of children.
Do not use 'Primaxin' after the expiry date which is stated on the carton after the letters EXP. The expiry date refers to the last day of that month.
'Primaxin' should be stored in a dry place below 25°C. The container should be kept in the outer carton until immediately before use.
After 'Primaxin' has been made up it can be kept at room temperature for up to 3 hours or in the fridge for up to 24 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Primaxin IV 500mg injection contains
- The active substances are 500mg imipenem (as the monohydrate) and cilastatin sodium (as the sodium salt).
- The other ingredient in 'Primaxin' IV 500mg injection is sodium bicarbonate.
What Primaxin IV 500mg injection looks like and the contents of the pack
'Primaxin' IV 500mg injection is a powder for solution for injection.
It is available as vials containg sterile white to light yellow powder.
It is available as a single 20ml vial.
Marketing Authorisation Holder and Manufacturer.
The Marketing Authorisation Holder is
‘Primaxin’ IV Injection is made by
and
Riom
This leaflet was last approved in April 2010
This leaflet gives you some important patient information about ‘Primaxin’ Injection. If you have questions after you read it ask your doctor or pharmacist, who will give you further information.
denotes registered trademark of Merck Sharp & Dohme Corp, a subsidiary of
© Merck Sharp & Dohme Limited 2010. All rights reserved.
PIL.TENIV.09.UK.3171
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