Ertapenem Fresenius Kabi
Ertapenem – Broad-Spectrum Carbapenem Antibiotic
Ertapenem Fresenius Kabi is a broad-spectrum carbapenem antibiotic administered by intravenous infusion. It is used to treat serious bacterial infections including intra-abdominal infections, pneumonia, gynecological infections, and diabetic foot infections. Ertapenem is also approved for surgical prophylaxis before colorectal procedures. This prescription-only medicine requires preparation and administration by healthcare professionals.
Quick Facts
Key Takeaways
- Ertapenem is a once-daily carbapenem antibiotic effective against a wide range of Gram-positive and Gram-negative bacteria, including anaerobes.
- It is administered only by intravenous infusion over 30 minutes in a healthcare setting and is not available in oral form.
- Do not use ertapenem if you are allergic to carbapenems, penicillins, or cephalosporins – cross-reactivity can occur between beta-lactam antibiotics.
- Ertapenem significantly reduces blood levels of valproic acid (sodium valproate), which may lead to loss of seizure control in patients with epilepsy.
- Unlike other carbapenems such as meropenem and imipenem, ertapenem lacks activity against Pseudomonas aeruginosa and Acinetobacter species.
What Is Ertapenem Fresenius Kabi and What Is It Used For?
Ertapenem is a member of the carbapenem class of antibiotics, which are among the most broad-spectrum antimicrobial agents available in clinical practice. Carbapenems are structurally related to penicillins and cephalosporins, sharing a common beta-lactam ring, but they possess enhanced stability against many bacterial enzymes (beta-lactamases) that can inactivate other beta-lactam antibiotics. This makes ertapenem particularly valuable for treating infections caused by bacteria that are resistant to more commonly used antibiotics.
The mechanism of action of ertapenem involves binding to penicillin-binding proteins (PBPs) within the bacterial cell wall. This binding inhibits the final transpeptidation step of peptidoglycan synthesis, which is essential for maintaining the structural integrity of the bacterial cell wall. Without a functional cell wall, bacteria undergo osmotic lysis and die. Ertapenem has high affinity for PBPs 1a, 1b, 2, 3, 4, and 5, providing its broad-spectrum activity.
Ertapenem is effective against a wide variety of pathogens, including many Gram-positive organisms such as Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pneumoniae, and Streptococcus pyogenes. It also covers Gram-negative bacteria including Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, as well as many anaerobic bacteria such as Bacteroides fragilis. However, unlike broader carbapenems such as meropenem and imipenem, ertapenem does not have clinically useful activity against Pseudomonas aeruginosa, Acinetobacter species, or Enterococcus species.
Approved Indications
Your doctor may prescribe Ertapenem Fresenius Kabi for one or more of the following types of infections:
- Intra-abdominal infections – complicated infections within the abdomen, including peritonitis, intra-abdominal abscesses, and post-surgical infections.
- Community-acquired pneumonia – lung infections acquired outside of hospital settings, when caused by susceptible organisms.
- Gynecological infections – including acute pelvic infections, post-partum endomyometritis, and septic abortion.
- Diabetic foot infections – skin and soft tissue infections of the foot in patients with diabetes mellitus, which are often polymicrobial in nature.
Surgical Prophylaxis
In addition to treating established infections, ertapenem is approved for prophylactic use in adults to prevent surgical site infections following elective colorectal surgery. A single 1 g dose is administered intravenously one hour before the surgical incision. Clinical trials have demonstrated that ertapenem prophylaxis significantly reduces the incidence of post-operative wound infections compared with other prophylactic regimens in this surgical setting.
Ertapenem Fresenius Kabi is manufactured by Fresenius Kabi and is bioequivalent to other ertapenem-containing products. The choice of ertapenem over other antibiotics is typically guided by local antimicrobial susceptibility patterns, the site and severity of infection, and the patient's clinical status.
What Should You Know Before Taking Ertapenem Fresenius Kabi?
Contraindications
Ertapenem Fresenius Kabi must not be used in the following situations:
- Hypersensitivity to ertapenem or any of the excipients (sodium bicarbonate, sodium hydroxide).
- Allergy to other beta-lactam antibiotics – if you have experienced a severe allergic reaction (anaphylaxis, severe urticaria, angioedema) to penicillins, cephalosporins, or other carbapenems, you should not receive ertapenem. Cross-reactivity between beta-lactam classes exists, and while the rate of cross-allergy between penicillins and carbapenems is relatively low (approximately 1%), severe reactions have been reported.
If you develop signs of a severe allergic reaction during treatment – such as swelling of the face, tongue, or throat, difficulty breathing or swallowing, widespread skin rash, or feeling faint – seek emergency medical attention immediately. Anaphylaxis can be life-threatening and requires immediate treatment with epinephrine.
Warnings and Precautions
Before starting treatment with ertapenem, tell your doctor if you have or have had any of the following conditions:
- Kidney disease – Ertapenem is primarily eliminated by the kidneys. Patients with moderate to severe renal impairment (creatinine clearance below 30 mL/min) and those receiving haemodialysis may require dose adjustments. It is essential that your doctor knows about your kidney function before prescribing ertapenem.
- Central nervous system (CNS) disorders – Patients with a history of seizures, brain lesions, or other CNS conditions may be at increased risk of seizures during carbapenem therapy. Ertapenem has been associated with seizure activity, particularly in patients with pre-existing CNS conditions or compromised renal function.
- Drug allergies – Report all known drug allergies, particularly to antibiotics, even if the reactions were mild.
As with all antibiotics, ertapenem can disrupt the normal gut flora, potentially leading to overgrowth of resistant organisms including Clostridioides difficile (formerly Clostridium difficile). If you develop persistent or bloody diarrhoea during or after your treatment, inform your doctor immediately. Do not take anti-diarrhoeal medications without first consulting your healthcare provider, as this condition requires specific treatment.
Pregnancy and Breastfeeding
Ertapenem has not been adequately studied in pregnant women. Animal reproductive studies have not demonstrated teratogenic effects, but animal studies are not always predictive of human response. Ertapenem should only be used during pregnancy if the potential benefit to the mother clearly outweighs the potential risk to the fetus. If you are pregnant, planning to become pregnant, or suspect you may be pregnant, inform your doctor before receiving this medication.
Ertapenem is excreted in human breast milk. Because of the potential for adverse effects in nursing infants – including disruption of the infant's gut flora and possible sensitisation to beta-lactam antibiotics – breastfeeding is not recommended during treatment with ertapenem. Discuss with your doctor whether to discontinue breastfeeding or to use an alternative antibiotic if breastfeeding is important to you.
Driving and Operating Machinery
Ertapenem may cause side effects such as dizziness, drowsiness, and confusion that could impair your ability to drive or operate machinery. Do not drive or use machines until you know how this medicine affects you. If you experience any of these symptoms, avoid activities that require alertness until the effects have resolved.
Sodium Content
Each vial of Ertapenem Fresenius Kabi contains approximately 137 mg of sodium, equivalent to 6.9% of the WHO-recommended maximum daily sodium intake for adults (2 g/day). This should be taken into consideration by patients on a controlled sodium diet, such as those with heart failure or hypertension.
How Does Ertapenem Fresenius Kabi Interact with Other Drugs?
Drug interactions can alter how medications work or increase the risk of serious side effects. While ertapenem has relatively few clinically significant drug interactions compared with some other antibiotic classes, there is one critical interaction that requires careful attention.
Major Interactions
Carbapenems, including ertapenem, can dramatically reduce serum concentrations of valproic acid. This reduction can be as large as 60–100% within 24 hours of starting carbapenem therapy. The mechanism involves increased glucuronidation and reduced enterohepatic recirculation of valproic acid. This can lead to loss of seizure control, which is particularly dangerous for patients with epilepsy. If you are taking valproic acid or sodium valproate for epilepsy, bipolar disorder, migraine prophylaxis, or any other indication, your doctor will carefully weigh the risks and benefits before prescribing ertapenem, and may choose an alternative antibiotic or alternative anticonvulsant.
| Interacting Drug | Effect | Severity | Clinical Advice |
|---|---|---|---|
| Valproic acid / Sodium valproate | Significantly reduced valproic acid blood levels (up to 60–100%) | Major | Avoid co-administration; consider alternative antibiotic or alternative anticonvulsant. Monitor valproic acid levels closely if combination is unavoidable. |
| Probenecid | Inhibits renal tubular secretion of ertapenem, increasing its half-life and AUC | Minor | Co-administration with probenecid is not recommended due to only modest increases in exposure with minimal clinical benefit. |
| Oral anticoagulants (warfarin) | Potential for altered INR due to antibiotic-related disruption of gut flora and vitamin K synthesis | Moderate | Monitor INR closely during and shortly after ertapenem treatment. Dose adjustment of warfarin may be necessary. |
Minor Interactions
Ertapenem does not inhibit the major cytochrome P450 enzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4) at clinically relevant concentrations. This means it is unlikely to affect the metabolism of most other medications that are processed through these liver enzymes. In formal pharmacokinetic studies, ertapenem did not significantly alter the pharmacokinetics of digoxin or oral contraceptives (ethinyl estradiol and levonorgestrel).
Ertapenem is compatible with intravenous solutions containing heparin sodium and potassium chloride. However, it should not be reconstituted or diluted with dextrose-containing solutions, as these are incompatible with the formulation. Only 0.9% sodium chloride solution or water for injection should be used for reconstitution and dilution.
What Is the Correct Dosage of Ertapenem Fresenius Kabi?
Ertapenem Fresenius Kabi is always prepared and administered by a healthcare professional. The powder must be reconstituted with water for injection or 0.9% sodium chloride solution, then further diluted before intravenous infusion. The infusion is delivered over 30 minutes.
Adults and Adolescents (13 Years and Older)
Standard Treatment Dose
1 g (one vial) administered intravenously once daily over a 30-minute infusion period. The total daily dose should not exceed 1 g. Treatment duration typically ranges from 3 to 14 days depending on the type and severity of infection and the clinical response.
Surgical Prophylaxis (Colorectal Surgery)
1 g administered as a single intravenous dose approximately one hour before the surgical incision. This single dose provides adequate antimicrobial coverage for the perioperative period.
Children (3 Months to 12 Years)
Paediatric Treatment Dose
15 mg per kg body weight administered twice daily (every 12 hours) by intravenous infusion over 30 minutes. The total daily dose must not exceed 1 g. Experience in children under 2 years of age is limited, and the prescribing physician will carefully assess the benefit-risk balance for this age group. Ertapenem is not recommended for use in infants under 3 months of age due to lack of clinical data.
| Patient Group | Dose | Frequency | Route | Infusion Duration |
|---|---|---|---|---|
| Adults & adolescents (≥13 years) | 1 g | Once daily | IV infusion | 30 minutes |
| Children (3 months – 12 years) | 15 mg/kg (max 1 g/day) | Twice daily | IV infusion | 30 minutes |
| Surgical prophylaxis (adults) | 1 g | Single dose | IV infusion | 30 min, 1 hr pre-op |
| Renal impairment (CrCl ≤30 mL/min) | Dose adjustment may be needed | As directed | IV infusion | 30 minutes |
Elderly Patients
No dose adjustment is required for elderly patients with normal renal function. However, because kidney function naturally declines with age, renal function should be assessed before and during treatment. Elderly patients are also more likely to have underlying conditions that may increase the risk of adverse effects, including CNS events such as confusion or seizures.
Missed Dose
Since ertapenem is administered by healthcare professionals in a clinical setting, missed doses are uncommon. If you believe a dose may have been missed or delayed, contact your healthcare team immediately. It is very important that you continue to receive ertapenem for the full course prescribed by your doctor, even if you start to feel better. Stopping antibiotic treatment prematurely can lead to recurrence of the infection and may contribute to antibiotic resistance.
Overdose
In the event of an overdose, ertapenem treatment should be discontinued and supportive care provided. Ertapenem can be removed from the bloodstream by haemodialysis, although there is limited clinical experience with this approach. In clinical studies, single intravenous doses of up to 3 g and daily doses of up to 2 g have been administered without significant dose-related adverse effects. However, intentional overdose with any antibiotic should be managed under medical supervision.
What Are the Side Effects of Ertapenem Fresenius Kabi?
Like all medicines, Ertapenem Fresenius Kabi can cause side effects, although not everybody gets them. The side effects listed below are organised by frequency based on data from clinical trials and post-marketing surveillance. If you experience any side effects, particularly those listed as serious, inform your healthcare provider immediately.
Adults (18 Years and Older)
Common
May affect up to 1 in 10 people
- Headache
- Diarrhoea, nausea, vomiting
- Skin rash, itching
- Infusion site reactions (inflammation, phlebitis, swelling, fluid leakage into surrounding tissue)
- Increased platelet count
- Abnormal liver function tests
Uncommon
May affect up to 1 in 100 people
- Dizziness, drowsiness, insomnia, confusion, seizures
- Low blood pressure, slow heart rate
- Shortness of breath, sore throat
- Constipation, oral thrush, acid reflux, dry mouth, indigestion, loss of appetite
- Antibiotic-associated diarrhoea (C. difficile colitis)
- Skin redness, vaginal discharge and irritation
- Abdominal pain, fatigue, fungal infection, fever, oedema, chest pain, altered taste
- Changes in blood and urine test results
Rare
May affect up to 1 in 1,000 people
- Decreased white blood cell count, decreased platelet count
- Low blood sugar (hypoglycaemia)
- Agitation, anxiety, depression, tremor
- Irregular heartbeat, high blood pressure, bleeding, rapid heart rate
- Nasal congestion, cough, nosebleed, pneumonia, wheezing
- Gallbladder inflammation, difficulty swallowing, faecal incontinence, jaundice, liver disease
- Skin inflammation, fungal skin infection, skin peeling, surgical wound infection
- Muscle cramp, shoulder pain
- Urinary tract infection, kidney problems
- Miscarriage, vaginal bleeding
- Allergic reactions, malaise, pelvic peritonitis, changes in eye whites, fainting
- Induration at injection site, superficial venous inflammation
Not Known
Frequency cannot be estimated from available data
- Hallucinations
- Decreased level of consciousness
- Altered mental state (including aggression, delirium, disorientation, mood changes)
- Abnormal involuntary movements (dyskinesia)
- Muscle weakness
- Unsteady gait (ataxia)
- Tooth discolouration
Children and Adolescents (3 Months to 17 Years)
Common
May affect up to 1 in 10 children
- Diarrhoea
- Nappy rash
- Infusion site pain
- Changes in white blood cell count
- Abnormal liver function tests
Uncommon
May affect up to 1 in 100 children
- Headache
- Hot flushes, high blood pressure, petechiae (small red or purple spots)
- Discoloured stool, black tarry stool
- Skin redness, itching
- Burning, itching, redness, warmth at infusion site
- Increased platelet count, changes in blood test results
Not Known
Frequency cannot be estimated from available data
- Hallucinations
- Altered mental state (including aggression)
Contact your doctor or seek emergency care immediately if you experience raised, fluid-filled skin lesions over a large area of the body, signs of a severe allergic reaction (facial or throat swelling, difficulty breathing, severe rash), or severe, persistent, or bloody diarrhoea during or after treatment. These may require urgent medical intervention.
How Should You Store Ertapenem Fresenius Kabi?
Proper storage of Ertapenem Fresenius Kabi is essential to maintain its efficacy and safety. Although this medication is typically handled by healthcare professionals in hospitals and clinics, understanding its storage requirements helps ensure the quality of the medicine you receive.
- Unopened vials: Store at or below 25°C (77°F). Keep in the original packaging to protect from light.
- After reconstitution: The reconstituted solution (approximately 100 mg/mL) should be used immediately. If not used immediately, it should be diluted promptly.
- After dilution: Diluted solutions (approximately 20 mg/mL ertapenem in 0.9% sodium chloride) are physically and chemically stable for 6 hours at 25°C or 24 hours when stored at 2–8°C (refrigerated).
- After removal from refrigerator: Use within 4 hours.
- Do not freeze the reconstituted or diluted solution.
- Visual inspection: Before administration, solutions should be inspected for particulate matter and discolouration. The normal colour ranges from colourless to pale yellow. Variations within this range do not affect potency. Do not use if particles are visible or the solution is discoloured outside this range.
Keep all medicines out of sight and reach of children. Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of that month. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use, in order to help protect the environment.
What Does Ertapenem Fresenius Kabi Contain?
Ertapenem Fresenius Kabi is supplied as a white to yellowish freeze-dried (lyophilised) powder in glass vials. When reconstituted and diluted correctly, the solution is colourless to pale yellow. Colour variations within this range are normal and do not affect the potency or safety of the medicine.
| Component | Role | Amount |
|---|---|---|
| Ertapenem | Active substance | 1 g |
| Sodium bicarbonate (E500) | Buffering agent | As required for pH |
| Sodium hydroxide (E524) | pH adjustment | As required for pH |
Ertapenem Fresenius Kabi is available in packs of 10 vials. Not all pack sizes may be marketed in every country. The vials are for single use only; any unused solution or waste material should be disposed of in accordance with local regulations.
Preparation Instructions (Healthcare Professionals Only)
For adults and adolescents (13–17 years): Reconstitute the contents of one 1 g vial with 10 mL of water for injection or 0.9% sodium chloride to obtain a concentration of approximately 100 mg/mL. Shake well to dissolve. Transfer the entire reconstituted contents to a 50 mL infusion bag of 0.9% sodium chloride. Infuse over 30 minutes.
For children (3 months to 12 years): Reconstitute as above. Withdraw a volume corresponding to 15 mg/kg body weight and transfer to an infusion bag of 0.9% sodium chloride to achieve a final concentration of 20 mg/mL or lower. Infuse over 30 minutes. The total daily dose must not exceed 1 g.
Frequently Asked Questions About Ertapenem
References and Sources
This article is based on the following evidence-based sources and international medical guidelines:
- European Medicines Agency (EMA). Ertapenem – Summary of Product Characteristics (SmPC). Available at: www.ema.europa.eu
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: WHO; 2023.
- Zhanel GG, Wiebe R, Dilay L, et al. Comparative review of the carbapenems. Drugs. 2007;67(7):1027–1052. doi:10.2165/00003495-200767070-00006
- Chahine EB, Ferrill MJ, Poulakos MN. Ertapenem: a group 1 carbapenem. American Journal of Health-System Pharmacy. 2003;60(22):2374–2381.
- Infectious Diseases Society of America (IDSA). Practice Guidelines for the Diagnosis and Management of Complicated Intra-Abdominal Infection in Adults and Children. Clinical Infectious Diseases. 2010;50(2):133–164.
- Lipsky BA, Berendt AR, Deery HG, et al. Diagnosis and Treatment of Diabetic Foot Infections. IDSA Guidelines. Clinical Infectious Diseases. 2012;54(12):e132–e173.
- British National Formulary (BNF). Ertapenem. Available at: bnf.nice.org.uk
- U.S. Food and Drug Administration (FDA). INVANZ (ertapenem) Prescribing Information. Available at: www.fda.gov
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians and clinical pharmacologists with expertise in infectious diseases and antimicrobial therapy.
Written by iMedic's medical editorial staff with clinical expertise in infectious diseases and evidence-based medicine.
Reviewed by the iMedic Medical Review Board according to international guidelines from WHO, EMA, FDA, and IDSA.
Evidence Level: 1A – Based on systematic reviews, randomised controlled trials, and international prescribing guidelines including the EMA SmPC, FDA Prescribing Information, WHO Essential Medicines List, and IDSA clinical practice guidelines.
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