Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ertapenem CIPLA 1 g powder for concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ertapenem sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Ertapenem CIPLA contains ertapenem which is an antibiotic of the beta-lactam group. It has the ability to kill a wide range of bacteria (germs) that cause infections in various parts of the body. Ertapenem CIPLA can be given to persons 3 months of age and older. This medicine is used for: •
Treatment: Your doctor has prescribed Ertapenem CIPLA because you or your child has one (or more) of the following types of infection: − Infection in the abdomen (stomach) − Infection affecting the lungs (pneumonia) − Gynaecological infections − Skin infections of the foot in diabetic patients.
•
Prevention − Prevention of surgical site infections in adults following surgery of the colon or rectum.
2.
What you need to know before you take it
Ertapenem CIPLA
Ertapenem CIPLA must not be given • if you are allergic to ertapenem or any of the other ingredients of this medicine (listed in section 6) • if you are allergic to antibiotics such as penicillins, cephalosporins or carbapenems (which are used to treat various infections). Warnings and precautions Talk to your doctor or pharmacist or nurse before you are given Ertapenem CIPLA. 7
During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), tell your doctor straight away as you may need urgent medical treatment. It is important that you tell your doctor if you have diarrhoea before, during or after your treatment with Ertapenem CIPLA. This is because you may have a condition known as colitis (an inflammation of the bowel). Do not take any medicine to treat diarrhoea without first checking with your doctor. Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see 'Other medicines and Ertapenem CIPLA' below). Tell your doctor about any medical condition you have or have had including: • Kidney disease. It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment. • Allergies to any medicines, including antibiotics • Central nervous system disorders, such as localized tremors, or seizures (fits). While antibiotics including ertapenem kill certain bacteria, other bacteria and fungi may continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and treat you if necessary. Children and adolescents (3 months to 17 years of age) Experience with Ertapenem CIPLA is limited in children less than two years of age. In this age group your doctor will decide on the potential benefit of its use. There is no experience in children under 3 months of age. Other medicines and Ertapenem CIPLA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. Tell your doctor, nurse or pharmacist if you are taking medicines called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is because Ertapenem CIPLA can affect the way some other medicines work. Your doctor will decide whether you should use Ertapenem CIPLA in combination with these medicines. 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 receiving this medicine. Ertapenem CIPLA has not been studied in pregnant women. Ertapenem CIPLA should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus. Women who are receiving Ertapenem CIPLA should not breast-feed, because it has been found in human milk and the breast-fed baby may therefore be affected. Driving and using machines Do not drive or use any tools or machines until you know how you react to the medicine. Certain side effects, such as dizziness and sleepiness, have been reported with Ertapenem CIPLA, which may affect some patients' ability to drive or operate machinery. Ertapenem CIPLA contains sodium This medicine contains approximately 137 mg sodium (main component of cooking/table salt) in each 1 g dose. This is equivalent to 6.85% of the recommended maximum daily dietary intake of sodium for 7
an adult. 3.
How to take it
Ertapenem CIPLA will always be prepared and given to you intravenously (into a vein) by a doctor or another healthcare professional. The recommended dose of Ertapenem CIPLA: •
For adults and adolescents 13 years of age and older: 1 gram (g) given once a day.
•
For children 3 months to 12 years of age: 15 mg/kg given twice daily (not to exceed 1 g/day).
•
For prevention of surgical site infections following surgery of the colon or rectum: 1 g administered as a single intravenous dose 1 hour before surgery.
Your doctor will decide the duration of your treatment. It is very important that you continue receiving Ertapenem CIPLA for as long as your doctor prescribes it. If you are given more Ertapenem CIPLA than you should If you are concerned that you may have been given too much Ertapenem CIPLA, contact your doctor or another healthcare professional immediately. If you miss a dose of Ertapenem CIPLA If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Adults 18 years of age and older: Since the drug has been marketed, severe allergic reactions (anaphylaxis), hypersensitivity syndromes (allergic reactions including rash, fever, abnormal blood tests) have been reported. The first signs of a severe allergic reaction may include swelling of the face and/or throat. If these symptoms occur tell your doctor straight away as you may need urgent medical treatment. Common (may affect up to 1 in 10 people) side effects are: • Headache • Diarrhoea, nausea, vomiting • Rash, itching • Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site, or leaking of fluid into the tissue and skin around the injection site) • Increase in platelet count • Changes in liver function tests Uncommon (may affect up to 1 in 100 people) side effects are: • Dizziness, sleepiness, sleeplessness, confusion, seizures • Low blood pressure, slow heart rate • Shortness of breath, sore throat 7
• • • • •
Constipation, yeast infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation, dry mouth, indigestion, loss of appetite Skin redness Vaginal discharge and irritation Abdominal pain, fatigue, fungal infection, fever, oedema/swelling, chest pain, abnormal taste Changes in some laboratory blood and urine tests
Rare (may affect up to 1 in 1,000 people) side effects are: • Decrease in white blood cells, decrease in blood platelet count • Low blood sugar • Agitation, anxiety, depression, tremor • Irregular heart rate, increased blood pressure, bleeding, fast heart rate • Nasal congestion, cough, bleeding from the nose, pneumonia, abnormal breathing sounds, wheezing • Inflammation of the gall bladder, difficulty in swallowing, faecal incontinence, jaundice, liver disorder • Inflammation of the skin, fungal infection of the skin, skin peeling, infection of the wound after an operation • Muscle cramp, shoulder pain • Urinary tract infection, kidney impairment • Miscarriage, genital bleeding • Allergy, feeling unwell, pelvic peritonitis, changes to the white part of the eye, fainting • The skin may become hard at the site of injection. • Swelling of the skin blood vessels. Side effects reported with frequency not known (frequency cannot be estimated from the available data) are: • Hallucinations • Decreased consciousness • Altered mental status (including aggression, delirium, disorientation, mental status changes) • Abnormal movements • Muscle weakness • Unsteady walking • Teeth staining There have also been reports of changes in some laboratory blood tests. If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away. Children and adolescents (3 months to 17 years of age): Common (may affect up to 1 in 10 people) side effects are: • Diarrhoea • Diaper rash • Pain at the infusion site • Changes in white blood cell count • Changes in liver function tests Uncommon (may affect up to 1 in 100 people) side effects are: • Headache • Hot flush, high blood pressure, red or purple, flat, pinhead spots under the skin • Discoloured faeces, black tar-like faeces • Skin redness, skin rash • Burning, itching, redness and warmth at infusion site, redness at injection site 7
• •
Increase in platelet count Changes in some laboratory blood tests
Possible side effects
reported with frequency not known (frequency cannot be estimated from the available data) are: • Hallucinations • Altered mental status (including aggression) 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 Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/ 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 it
Ertapenem CIPLA
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 after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. 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. 6.
Contents of the pack and other information
What Ertapenem CIPLA contains • The active ingredient is ertapenem 1 g. • The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524). What Ertapenem CIPLA looks like and contents of the pack Ertapenem is a white to light yellow, freeze-dried powder for concentrate for solution for infusion. Solutions of Ertapenem range from colourless to pale yellow. Variations of colour within this range do not affect potency of the medicine. Ertapenem CIPLA is supplied in a pack containing 10 vials. Marketing Authorisation Holder and Manufacturer CIPLA (EU) Limited, Dixcart House, Addlestone road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom. This leaflet was last revised in 04/2026
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The following information is intended for medical or healthcare professionals only: Instructions of how to reconstitute and dilute Ertapenem CIPLA: For single use only. Preparation for intravenous administration: Ertapenem CIPLA must be reconstituted and then diluted prior to administration. Adult and adolescents (13 to 17 years of age) Reconstitution Reconstitute the contents of a 1 g vial of Ertapenem CIPLA with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution to yield a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve. Dilution For a 50 mL bag of diluent: For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 mL bag of sodium chloride 9 mg/mL (0.9 %) solution; or For a 50 mL vial of diluent: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution and discard. Transfer the contents of the reconstituted 1 g vial of Ertapenem CIPLA to the 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution. Infusion Infuse over a period of 30 minutes. Children (3 months to 12 years of age) Reconstitution Reconstitute the contents of a 1 g vial of Ertapenem CIPLA with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution to yield a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve. Dilution For a bag of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a bag of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less; or For a vial of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a vial of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less. Infusion Infuse over a period of 30 minutes The reconstituted solution should be diluted in sodium chloride 9 mg/mL (0.9 %) solution immediately after preparation. Diluted solutions should be used immediately. If not used immediately, in use storage times are the responsibility of the user. Diluted solutions (approximately 20 mg/mL ertapenem) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours at 2 to 8°C (in a refrigerator). Solutions should be used within 4 hours of their removal from the refrigerator. Do not freeze the reconstituted solutions. The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration, whenever the container permits. Solutions of Ertapenem CIPLA range from colourless to pale yellow. Variations of colour within this range do not affect potency. Any antibiotic residual solution as well as all materials that have been used for administration should be disposed of in accordance with local requirements.
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Frequently asked questions about Ertapenem CIPLA 1 g powder for concentrate for solution for infusion
How do I take Ertapenem CIPLA 1 g powder for concentrate for solution for infusion?
Ertapenem CIPLA 1 g powder for concentrate for solution for infusion comes as infusion containing 1g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ertapenem CIPLA 1 g powder for concentrate for solution for infusion?
The active substance in Ertapenem CIPLA 1 g powder for concentrate for solution for infusion is ertapenem sodium.
Are there equivalent medicines to Ertapenem CIPLA 1 g powder for concentrate for solution for infusion?
Medicines with the same active substance, strength and form include: INVANZ® 1g powder for concentrate for solution for infusion, Ertapenem 1g Powder for Concentrate for Solution for Infusion, Ertapenem 1g powder for concentrate for solution for infusion vials. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ertapenem CIPLA 1 g powder for concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ertapenem CIPLA 1 g powder for concentrate for solution for infusion without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ertapenem sodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment
Ertapenem is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1):
• Intra-abdominal infections
• Community acquired pneumonia
• Acute gynaecological infections
• Diabetic foot infections of the skin and soft tissue (see section 4.4)
Prevention
Ertapenem is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Posology
Treatment
Adults and adolescents (13 to 17 years of age): The dose of ertapenem is 1 gram (g) given once a day by the intravenous route (see section 6.6).
Infants and children (3 months to 12 years of age): The dose of ertapenem is 15 mg/kg given twice daily (not to exceed 1 g/day) by the intravenous route (see section 6.6).
Prevention
Adults: To prevent surgical site infections following elective colorectal surgery, the recommended dosage is 1 g administered as a single intravenous dose to be completed within 1 hour prior to the surgical incision.
Paediatric population
The safety and efficacy of ertapenem in children below 3 months of age have not yet been established.
No data are available.
Renal impairment
Ertapenem may be used for the treatment of infections in adult patients with mild to moderate renal impairment. In patients whose creatinine clearance is > 30 mL/min/1.73 m2, no dosage adjustment is necessary. There are inadequate data on the safety and efficacy of ertapenem in patients with severe renal impairment to support a dose recommendation. Therefore, ertapenem should not be used in these patients (see section 5.2). There are no data in children and adolescents with renal impairment.
Haemodialysis
There are inadequate data on the safety and efficacy of ertapenem in patients on haemodialysis to support a dose recommendation. Therefore, ertapenem should not be used in these patients.
Hepatic impairment
No dosage adjustment is recommended in patients with impaired hepatic function (see section 5.2).
Elderly
The recommended dose of ertapenem should be administered, except in cases of severe renal impairment (see Renal impairment).
Method of administration
Intravenous administration: Ertapenem should be infused over a period of 30 minutes.
The usual duration of therapy with ertapenem is 3 to 14 days but may vary depending on the type and severity of infection and causative pathogen(s). When clinically indicated, a switch to an appropriate oral antibacterial agent may be implemented if clinical improvement has been observed.
For instructions on preparation of the medicinal product before administration, see section 6.6.
4.3. Contraindications
• 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 (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins).
4.4. Special warnings and precautions for use
Hypersensitivity
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. Before initiating therapy with ertapenem, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens (see section 4.3). If an allergic reaction to ertapenem occurs (see section 4.8), discontinue the therapy immediately. Serious anaphylactic reactions require immediate emergency treatment.
Superinfection
Prolonged use of ertapenem may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Antibiotic-associated colitis
Antibiotic-associated colitis and pseudomembranous colitis have been reported with ertapenem and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents. Discontinuation of therapy with ertapenem and the administration of specific treatment for Clostridioides difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Seizures
Seizures have been reported during clinical investigation in adult patients treated with ertapenem (1 g once a day) during therapy or in the 14-day follow-up period. Seizures occurred most commonly in elderly patients and those with pre-existing central nervous system (CNS) disorders (e.g. brain lesions or history of seizures) and/or compromised renal function. Similar observations have been made in the post-marketing environment.
Encephalopathy
Encephalopathy has been reported with the use of ertapenem (see section 4.8). If ertapenem-induced encephalopathy is suspected (e.g. myoclonus, seizures, altered mental status, depressed level of consciousness), discontinuation of ertapenem should be considered. Patients with renal impairment are at higher risk of ertapenem-induced encephalopathy and the resolution may be prolonged.
Concomitant use with valproic acid
The concomitant use of ertapenem and valproic acid/sodium valproate is not recommended (see section 4.5).
Sub-optimal exposure
Based on the data available it cannot be excluded that in the few cases of surgical interventions exceeding 4 hours, patients could be exposed to sub-optimal ertapenem concentrations and consequently to a risk of potential treatment failure. Therefore, caution should be exercised in such unusual cases.
Excipient
This medicinal product contains 137 mg sodium per 1g, Ertapenem for Injection, equivalent to 6.85% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Considerations for use in particular populations
Experience in the use of ertapenem in the treatment of severe infections is limited. In clinical studies for the treatment of community-acquired pneumonia, in adults, 25 % of evaluable patients treated with ertapenem had severe disease (defined as pneumonia severity index > III). In a clinical study for the treatment of acute gynaecologic infections, in adults, 26 % of evaluable patients treated with ertapenem had severe disease (defined as temperature ≥ 39°C and/or bacteraemia); ten patients had bacteraemia. Of evaluable patients treated with ertapenem in a clinical study for the treatment of intra-abdominal infections, in adults, 30 % had generalized peritonitis and 39 % had infections involving sites other than the appendix including the stomach, duodenum, small bowel, colon, and gallbladder; there were limited numbers of evaluable patients who were enrolled with APACHE II scores ≥ 15 and efficacy in these patients has not been established.
The efficacy of ertapenem in the treatment of community acquired pneumonia due to penicillin-resistant Streptococcus pneumoniae has not been established.
Efficacy of ertapenem in the treatment of diabetic foot infections with concurrent osteomyelitis has not been established.
There is relatively little experience with ertapenem in children less than two years of age. In this age group, particular care should be taken to establish the susceptibility of the infecting organism(s) to ertapenem. No data are available in children under 3 months of age.
4.5. Interaction with other medicinal products and other forms of interaction
Interactions caused by inhibition of P-glycoprotein-mediated clearance or CYP-mediated clearance of medicinal products are unlikely (see section 5.2).
Decreases in valproic acid levels that may fall below the therapeutic range have been reported when valproic acid was co-administered with carbapenem agents. The lowered valproic acid levels can lead to inadequate seizure control; therefore, concomitant use of ertapenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered.
4.6. Fertility, pregnancy and lactation
Pregnancy
Adequate and well-controlled studies have not been performed in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, parturition or post-natal development. However, ertapenem should not be used during pregnancy unless the potential benefit outweighs the possible risk to the foetus.
Breast-feeding
Ertapenem is excreted in human milk. Because of the potential for adverse reactions on the infant, mothers should not breast-feed their infants while receiving ertapenem.
Fertility
There are no adequate and well-controlled studies regarding the effect of ertapenem use on fertility in men and women. Preclinical studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Ertapenem may influence patient's ability to drive and use machines. Patients should be informed that dizziness and somnolence have been reported with ertapenem (see section 4.8).
4.8. Undesirable effects
Summary of the safety profile
Adults
The total number of patients treated with ertapenem in clinical studies was over 2,200 of which over 2,150 received a 1 g dose of ertapenem. Adverse reactions (i.e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20 % of patients treated with ertapenem. Treatment was discontinued due to adverse reactions in 1.3 % of patients. An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery.
For patients who received only ertapenem, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (4.8 %), infused vein complication (4.5 %) and nausea (2.8 %).
For patients who received only ertapenem, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: elevations in ALT (4.6 %), AST (4.6 %), alkaline phosphatase (3.8 %) and platelet count (3.0 %).
Paediatric population (3 months to 17 years of age):
The total number of patients treated with ertapenem in clinical studies was 384. The overall safety profile is comparable to that in adult patients. Adverse reactions (i.e .considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20.8 % of patients treated with ertapenem. Treatment was discontinued due to adverse reactions in 0.5 % of patients.
For patients who received only ertapenem, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (5.2 %) and infusion site pain (6.1 %).
For patients who received only ertapenem, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: decreases in neutrophil count (3.0 %), and elevations in ALT (2.9 %) and AST (2.8 %).
Tabulated list of adverse reactions
For patients who received only ertapenem, the following adverse reactions were reported during therapy plus follow-up for 14 days after treatment was stopped:
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); Not known (cannot be estimated from the available data).
Adults 18 years of age and older
Children and adolescents (3 months to 17 years of age)
Infections and infestations
Uncommon: Oral candidiasis, candidiasis, fungal infection, pseudomembranous enterocolitis, vaginitis
Rare: Pneumonia, dermatomycosis, postoperative wound infection, urinary tract infection
Blood and lymphatic system disorders
Rare: Neutropenia, thrombocytopenia
Immune system disorders
Rare: Allergy
Not known: Anaphylaxis including anaphylactoid reactions
Metabolism and nutrition disorders
Uncommon: Anorexia
Rare: Hypoglycaemia
Psychiatric disorders
Uncommon: Insomnia, confusion
Rare: Agitation, anxiety, depression
Not known: Altered mental status (including aggression, delirium, disorientation, mental status changes)
Not known: Altered mental status (including aggression)
Nervous system disorders
Common: Headache
Uncommon: Dizziness, somnolence, taste perversion, seizure (see section 4.4)
Rare: Tremor, syncope
Not known: Hallucinations, depressed level of consciousness, dyskinesia, myoclonus, gait disturbance, encephalopathy (see section 4.4)
Uncommon: Headache
Not known: Hallucinations
Eye disorders
Rare: Scleral disorder
Cardiac disorders
Uncommon: Sinus bradycardia
Rare: Arrhythmia, tachycardia
Vascular disorders
Common: Infused vein complication, phlebitis/thrombophlebitis
Uncommon: Hypotension
Rare: Haemorrhage, increased blood pressure
Uncommon: Hot flush, hypertension
Respiratory, thoracic and mediastinal disorders
Uncommon: Dyspnoea, pharyngeal discomfort
Rare: Nasal congestion, cough, epistaxis, rales/rhonchi, wheezing
Gastrointestinal disorders
Common: Diarrhoea, nausea, vomiting
Uncommon: Constipation, acid regurgitation, dry mouth, dyspepsia, abdominal pain
Rare: Dysphagia, faecal incontinence, pelvic peritonitis
Not known: teeth staining
Common: Diarrhoea
Uncommon: Faeces discoloured, melaena
Hepato-biliary disorders
Rare: Cholecystitis, jaundice, liver disorder
Skin and subcutaneous tissue disorders
Common: Rash, pruritus
Uncommon: Erythema, urticaria
Rare: Dermatitis, desquamation, hypersensitivity vasculitis
Not known: Acute Generalised Exanthematous Pustulosis (AGEP), Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)
Common: Diaper dermatitis
Uncommon: Erythema, rash, petechiae
Musculoskeletal and connective tissue disorders
Rare: Muscle cramp, shoulder pain
Not known: Muscular weakness
Renal and urinary disorders
Rare: Renal insufficiency, acute renal insufficiency
Pregnancy, puerperium and perinatal conditions
Rare: Abortion
Reproductive system and breast disorders
Rare: Genital bleeding
General disorders and administration site conditions
Uncommon: Extravasation, asthenia/fatigue, fever, oedema/swelling, chest pain
Rare: Injection-site induration, malaise
Common: Infusion site pain
Uncommon: Infusion site burning, infusion site pruritus, infusion site erythema, injection site erythema, infusion site warmth
Investigations
Chemistry
Common: Elevations in ALT, AST, alkaline phosphatase
Uncommon: Increases in total serum bilirubin, direct serum bilirubin, indirect serum bilirubin, serum creatinine, serum urea, serum glucose
Rare: Decreases in serum bicarbonate, serum creatinine and serum potassium; increases in serum LDH, serum phosphorus, serum potassium
Common: Elevations in ALT and AST
Haematology
Common: Elevation in platelet count
Uncommon: Decreases in white blood cells, platelet count, segmented neutrophils, haemoglobin and haematocrit; increases in eosinophils, activated partial thromboplastin time, prothrombin time, segmented neutrophils and white blood cells
Rare: Decrease in lymphocytes; increases in band neutrophils, lymphocytes, metamyelocytes, monocytes, myelocytes; atypical lymphocytes
Common: Decreases in neutrophil count
Uncommon: Increases in platelet count, activated partial thromboplastin time, prothrombin time, decreases in haemoglobin
Urinalysis
Uncommon: Increases in urine bacteria, urine white blood cells, urine epithelial cells and urine red blood cells; urine yeast present
Rare: Increase in urobilinogen
Miscellaneous
Uncommon: Positive Clostridioides difficile toxin
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 Yellow Card Scheme
Website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No specific information is available on the treatment of overdose with ertapenem. Overdosing of ertapenem is unlikely. Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity. In clinical studies in adults inadvertent administration of up to 3 g in a day did not result in clinically important adverse reactions. In paediatric clinical studies, a single intravenous (IV) dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity.
However, in the event of an overdose, treatment with ertapenem should be discontinued and general supportive treatment given until renal elimination takes place.
Ertapenem can be removed to some extent by haemodialysis (see section 5.2); however, no information is available on the use of haemodialysis to treat overdose.
💬 Ask about this leaflet
Ask anything about Ertapenem CIPLA 1 g powder for concentrate for solution for 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.