Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Meropenem belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections.
Meropenem is used to treat the following in adults and children aged 3 months and older:
• Infection affecting the lungs (pneumonia)
• Lung and bronchial infections in patients suffering from cystic fibrosis
• Complicated urinary tract infections
• Complicated infections in the abdomen
• Infections that you can catch during or after the delivery
• Complicated skin and soft tissues infections
• Acute bacterial infection of the brain (meningitis).
Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Meropenem may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.
Do not use Meropenem if • you are allergic to meropenem or any of the other ingredients of this medicine (listed in section 6).
• you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to Meropenem
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Meropenem:
• if you have health problems, such as liver or kidney problems.
• if you have had severe diarrhoea after taking other antibiotics.
You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.
You may develop signs and symptoms of severe skin reactions (see section 4). If this happens talk to your doctor or nurse immediately so that they can treat the symptoms.
If you notice unexplained muscle pain, tenderness or weakness and/or dark coloured urine tell your doctor immediately. This may be a sign of muscle breakdown (called rhabdomyolysis) which may lead to kidney problems.
Liver problems
If you notice yellowing of the skin and eyes, itchy skin, dark-coloured urine or light-coloured stool tell your doctor. This may be a sign of liver problems which your doctor needs to check.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meropenem.
Other medicines and Meropenem Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
This is because Meropenem can affect the way some medicines work and some medicines can have an effect on Meropenem.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
• Probenecid (used to treat gout).
• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meropenem should not be used because it may decrease the effect of sodium valproate.
• Oral anti-coagulant agent (used to treat or prevent blood clots).
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is preferable to avoid the use of Meropenem during pregnancy.
Your doctor will decide whether you should use Meropenem.
It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving Meropenem. Small amounts of this medicine pass into the breast milk. Therefore, your doctor will decide whether you should use Meropenem while breast-feeding.
Driving and using machines No studies on the effect on the ability to drive and use machines have been performed. However, Meropenem has been associated with headache; tingling or pricking skin (paraesthesiae). Any of these side effects could affect your ability to drive or operate machines.
Meropenem may cause involuntary muscle movements, leading the person's body to shake rapidly and uncontrollably (convulsions) that are usually accompanied with a loss of consciousness.
Do not drive or use machines if you experience this side effect.
Meropenem contains sodium. Meropenem 500 mg: This medicine contains 45 mg sodium (main component of cooking/table salt) in each 500 mg dose. This is equivalent to 2.25% of the recommended maximum daily dietary intake of sodium for an adult.
Meropenem 1 g: This medicine contains 90 mg sodium (main component of cooking/table salt) in each 1 g dose. This is equivalent to 4.5% of the recommended maximum daily dietary intake of sodium for an adult.
If you have a condition which requires you to monitor your sodium intake please inform your doctor, pharmacist or nurse.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Use in adults • The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need.
• The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). You will usually receive a dose every 8 hours. However you may receive a dose less often if your kidneys do not work very well.
Use in children and adolescents • The dose for children over 3 months old and up to 11 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meropenem for each kilogram (kg) that the child weighs. A dose is usually given every 8 hours. Children who weigh over 50 kg will be given an adult dose.
How to use Meropenem • Meropenem will be given to you as an injection or infusion into a large vein.
• Your doctor or nurse will normally give Meropenem to you.
• However, some patients, parents and carers are trained to give Meropenem at home. Instructions for doing this are provided in this leaflet (in the section called 'Instructions for giving Meropenem to yourself or someone else at home'). Always use Meropenem exactly as your doctor has told you. You should check with your doctor if you are not sure.
• Your injection should not be mixed with or added to solutions that contain other medicines.
• The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meropenem.
• You should normally have your injections at the same times each day.
If you use more Meropenem than you should If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.
If you forget to use Meropenem If you miss an injection, you should have it as soon as possible.
However, if it is almost time for your next injection, skip the missed injection. Do not have a double dose (two injections at the same time) to make up for a forgotten dose.
If you stop using Meropenem Do not stop having Meropenem until your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions If you have a severe allergic reaction, stop having Meropenem and see a doctor straight away . You may need urgent medical treatment. The signs may include a sudden onset of:
• Severe rash, itching or hives on the skin.
• Swelling of the face, lips, tongue or other parts of the body.
• Shortness of breath, wheezing or trouble breathing.
• Serious skin reactions which include • Serious hypersensitivity reactions involving fever, skin rash, and changes in the blood tests that check how the liver is working (increased levels of liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
• Severe red scaly rash, skin bumps that contain pus, blisters or peeling of skin, which may be associated with a high fever and joint pains.
• Severe skin rashes that can appear as reddish circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).
Damage to red blood cells (not known) The signs include:
• Being breathless when you do not expect it.
• Red or brown urine.
If you notice any of the above, see a doctor straight away .
Muscle breakdown • Unexplained muscle pain, tenderness or weakness, and/or dark coloured urine.
If you notice these signs or symptoms, see a doctor straight away.
Other possible side effects: Common (may affect up to 1 in 10 people)
• Abdominal (stomach) pain.
• Feeling sick (nausea).
• Being sick (vomiting).
• Diarrhoea.
• Headache.
• Skin rash, itchy skin.
• Pain and inflammation.
• Increased numbers of platelets in your blood (shown in a blood test).
• Changes in blood tests, including tests that show how well your liver is working.
Uncommon (may affect up to 1 in 100 people)
• Changes in your blood. These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called 'bilirubin'. Your doctor may do blood tests from time to time.
• Changes in blood tests, including tests that show how well your kidneys are working.
• A tingling feeling (pins and needles).
• Infections of the mouth or the vagina that are caused by a fungus (thrush).
• Inflammation of the bowel with diarrhoea.
• Sore veins where Meropenem is injected.
• Other changes in your blood. The symptoms include frequent infections, high temperature and sore throat. Your doctor may do blood tests from time to time.
• Reduced levels of potassium in your blood (which can cause weakness, muscle cramps, tingling and heart rhythm disturbances).
• Liver problems. Yellowing of the skin and eyes, itchy skin, dark-coloured urine or light-coloured stool. If you notice these signs or symptoms, see a doctor straight away.
Rare (may affect up to 1 in 1,000 people)
• Fits (convulsions).
• Acute disorientation and confusion (delirium).
Sudden chest pain , which may be a sign of a potentially serious allergic reaction called Kounis syndrome has been noted with other medicines of the same type. If this happens talk to a doctor or nurse immediately.
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 at: 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C
After reconstitution: The reconstituted solutions for intravenous injection or infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour.
Do not freeze the reconstituted solution.
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 protect the environment.
What Meropenem Powder for Solution for Injection or Infusion contains The active substance is meropenem trihydrate.
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
The other ingredient is anhydrous sodium carbonate.
What Meropenem Powder for Solution for Injection or Infusion looks like and contents of the pack Meropenem is a white to pale yellow crystalline powder for solution for injection or infusion in vial. Pack sizes of 1 or 10 vials.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
SUN PHARMA UK LIMITED
6-9 The Square
Stockley Park
Uxbridge
UB11 1FW
United Kingdom
Manufacturer:
Terapia SA
124 Fabricii Street
400632 Cluj Napoca
Romania
Or
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This leaflet was last revised in June 2025.
Advice/medical education
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.
2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
4. You should not give antibiotics that were prescribed for you to other people.
5. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.
V038
Ranbaxy (UK) Limited a Sun Pharmaceutical Company
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Meropenem 500 mg Powder for Solution for Injection or Infusion comes as injection containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Meropenem 500 mg Powder for Solution for Injection or Infusion is meropenem trihydrate.
Medicines with the same active substance, strength and form include: Meronem IV 500mg Powder for solution for injection or infusion, Meropenem 500 mg powder for solution for injection or infusion, Meropenem 500 mg powder for solution for injection/infusion. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Meropenem 500 mg Powder for Solution for Injection or Infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Meropenem Powder for Solution for Injection or Infusion is indicated for the treatment of the following infections in adults and children over 3 months of age (see sections 4.4 and 5.1):
• Severe pneumonia, including hospital and ventilator-associated pneumonia
• Broncho-pulmonary infections in cystic fibrosis
• Complicated urinary tract infections
• Complicated intra-abdominal infections
• Intra- and post-partum infections
• Complicated skin and soft tissue infections
• Acute bacterial meningitis
Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The tables below provide general recommendations for dosing.
The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response.
A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as infections due to less susceptible bacterial species (eg Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp), or very severe infections.
Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below).
Adults and adolescents
Infection
Dose to be administered every 8 hours
Severe pneumonia including hospital and ventilator-associated pneumonia
500 mg or 1 g
Broncho-pulmonary infections in cystic fibrosis
2 g
Complicated urinary tract infections
500 mg or 1 g
Complicated intra-abdominal infections
500 mg or 1 g
Intra- and post-partum infections
500 mg or 1 g
Complicated skin and soft tissue infections
500 mg or 1 g
Acute bacterial meningitis
2 g
Management of febrile neutropenic patients
1 g
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6).
Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection.
Renal impairment
The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. There are limited data to support the application of these dose adjustments for a unit dose of 2 g.
Creatinine clearance (ml/min)
Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above)
Frequency
26-50
one unit dose
every 12 hours
10-25
half of one unit dose
every 12 hours
<10
half of one unit dose
every 24 hours
Meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered after completion of the haemodialysis cycle.
There are no established dose recommendations for patients receiving peritoneal dialysis.
Hepatic impairment
No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).
Dose in elderly patients
No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.
Paediatric population
Children under 3 months of age
The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2).
Children from 3 months to 11 years of age and up to 50 kg body weight
The recommended dose regimens are shown in the table below:
Infection
Dose to be administered every 8 hours
Severe pneumonia including hospital and ventilator-associated pneumonia
10 or 20 mg/kg
Broncho-pulmonary infections in cystic fibrosis
40 mg/kg
Complicated urinary tract infections
10 or 20 mg/kg
Complicated intra-abdominal infections
10 or 20 mg/kg
Complicated skin and soft tissue infections
10 or 20 mg/kg
Acute bacterial meningitis
40 mg/kg
Management of febrile neutropenic patients
20 mg/kg
Children over 50 kg body weight,
The adult dose should be administered.
There is no experience in children with renal impairment.
Method of administration
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypersensitivity to any other carbapenem antibacterial agent.
Severe hypersensitivity (eg anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. penicillins or cephalosporins).
The selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. Resistance
Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems.
Hypersensitivity reactions
As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8).
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalised exanthematous pustulosis (AGEP) have been reported in patients receiving meropenem (see section 4.8). If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered.
With other beta-lactam antibiotics there have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8).
Rhabdomyolysis
Rhabdomyolysis has been reported with the use of meropenem. If signs or symptoms of rhabdomyolysis are observed, meropenem should be discontinued and appropriate therapy initiated (see section 4.8).
Antibiotic-associated colitis
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents, including meropenem, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see section 4.8). Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Seizures
Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8).
Drug-induced liver injury (DILI)
Hepatic function should be closely monitored during treatment with meropenem due to the risk of DILI (see section 4.8). If severe DILI occurs, treatment discontinuation should be considered as clinically appropriate. Meropenem should be reintroduced only if assessed as essential for treatment.
Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. There is no dose adjustment necessary (see section 4.2).
Direct antiglobulin test (Coombs test) seroconversion
A positive direct or indirect Coombs test may develop during treatment with meropenem.
Concomitant use with valproic acid/sodium valproate/valpromide
The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5).
Meropenem contains sodium.
Meropenem 500 mg: This medicinal product contains 45 mg sodium per 500 mg vial, equivalent to 2.25% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
No specific medicinal product interaction studies other than probenecid were conducted.
Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. Caution is required if probenecid is co-administered with meropenem.
The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism.
Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days. Due to the rapid onset and the extent of the decrease, co-administration of valproic acid/sodium valproate/valpromide with carbapenem agents is not considered to be manageable and therefore should be avoided (see section 4.4).
Oral anti-coagulants
Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. There have been many reports of increases in the anti-coagulant effects of orally administered anti-coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalised ratio) is difficult to assess. It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent.
Paediatric population
Interaction studies have only been performed in adults.
Pregnancy
There are no or limited amount of data from the use of meropenem in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
Lactation
Small amounts of meropenem have been reported to be excreted in human milk. Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby.
No studies on the effect on the ability to drive and use machines have been performed. However, when driving or operating machines, it should be taken into account that headache, paraesthesiae and convulsions have been reported for meropenem.
Summary of the safety profile
In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3 %), rash (1.4 %), nausea/vomiting (1.4 %) and injection site inflammation (1.1 %). The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6 %) and increased hepatic enzymes (1.5-4.3 %).
Tabulated risk of adverse reactions
In the table below all adverse reactions are listed by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1
System Organ Class
Frequency
Event
Infections and infestations
Uncommon
oral and vaginal candidiasis
Blood and lymphatic system disorder
Common
thrombocythaemia
Uncommon
eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis, haemolytic anaemia
Immune system disorders
Uncommon
angioedema, anaphylaxis (see sections 4.3 and 4.4)
Metabolism and nutrition disorders
Uncommon
Hypokalaemia
Psychiatric disorders
Rare
delirium
Nervous system disorders
Common
headache
Uncommon
paraesthesiae
Rare
convulsions (see section 4.4)
Gastrointestinal disorders
Common
diarrhoea, vomiting, nausea, abdominal pain
Uncommon
antibiotic-associated colitis (see section 4.4)
Hepatobiliary disorders
Common
transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased.
Uncommon
blood bilirubin increased
drug-induced liver injury*
Skin and subcutaneous tissue disorders
Common
rash, pruritis
Uncommon
urticaria, toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme (see section 4.4).
Not known
drug reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome), generalised exanthematous pustulosis (see section 4.4)
Musculoskeletal and connective tissue disorders
Not known
rhabdomyolisis
Renal and urinary disorders
Uncommon
blood creatinine increased, blood urea increased
General disorders and administration site conditions
Common
inflammation, pain
Uncommon
thrombophlebitis, pain at the injection site
* DILI includes hepatitis and liver failure
Description of selected adverse reactions
Kounis Syndrome
Acute coronary syndrome associated with an allergic reaction (Kounis syndrome) has been reported with other beta-lactam antibiotics (see section 4.4).
Paediatric population
Meropenem is licensed for children over 3 months of age. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. All reports received were consistent with events observed in the adult population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction. Symptomatic treatments should be considered.
In individuals with normal renal function, rapid renal elimination will occur.
Haemodialysis will remove meropenem and its metabolite.
Ask anything about Meropenem 500 mg Powder for Solution for Injection or Infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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