Ertapenem

Common Uses

Ertapenem is prescribed to treat moderate to severe infections caused by specific types of bacteria. These include:

• Abdominal infections: Complicated infections within the stomach or intestinal area.
• Skin infections: Serious skin and soft tissue infections, including those related to diabetic foot ulcers.
• Lung infections: Community-acquired pneumonia.
• Urinary tract infections: Complicated infections of the bladder or kidneys.
• Pelvic infections: Acute infections of the female reproductive system, including those occurring after surgery or childbirth.

Surgical Prevention

In addition to treating active infections, healthcare providers use ertapenem to prevent infections from developing after elective colorectal surgery. It is typically administered shortly before the procedure begins.

Important Considerations

Ertapenem is only effective against bacterial infections. It will not work for viral infections, such as the common cold, flu, or COVID-19. Using antibiotics when they are not needed increases the risk of developing an infection later that resists antibiotic treatment.

Mechanism of Action

Ertapenem belongs to a class of medications known as carbapenem antibiotics. It works by interfering with the ability of bacteria to build their cell walls. Bacteria require a stable cell wall to survive and protect themselves from their environment. By preventing the bacteria from properly forming these walls, ertapenem causes the bacteria to weaken and eventually burst, which clears the infection.

Spectrum of Activity

This medication is considered a broad-spectrum antibiotic, meaning it is effective against a wide variety of bacteria. It is typically used to treat serious or complex infections, including:

• Abdominal infections
• Pneumonia (lung infections)
• Urinary tract infections
• Skin and soft tissue infections
• Pelvic infections

Ertapenem is specifically designed to target bacteria that may be resistant to other types of antibiotics. However, it is only effective against bacterial infections. It will not work for viral infections, such as the common cold or the flu. Using antibiotics when they are not needed increases the risk of developing an infection later that resists antibiotic treatment.

Common Side Effects

Some people may experience mild side effects while receiving ertapenem. Common symptoms include:

• Diarrhea
• Nausea or vomiting
• Headache
• Dizziness
• Pain, redness, or swelling where the medication was injected
• Confusion
• Cough

Serious Side Effects

Seek medical attention immediately if you experience any of the following serious side effects:

• Allergic reactions: Skin rash, hives, itching, or swelling of the face, throat, or tongue.
• Severe intestinal issues: Watery or bloody diarrhea and stomach cramps, which may indicate a serious infection.
• Nervous system changes: Seizures, tremors, or involuntary muscle movements.
• Breathing difficulties: Shortness of breath or trouble swallowing.
• Liver problems: Yellowing of the skin or eyes and dark urine.

If you experience any unusual symptoms, consult your healthcare provider for guidance.

Allergic Reactions

Serious and occasionally fatal allergic reactions (anaphylaxis) have been reported with ertapenem. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens or those who have had previous reactions to penicillins, cephalosporins, or other beta-lactam antibiotics.

Central Nervous System Effects

Ertapenem may cause central nervous system side effects, including seizures, confusion, dizziness, and hallucinations. The risk of seizures is higher in patients with decreased kidney function or pre-existing brain disorders, such as a history of seizures or head injuries. If central nervous system symptoms occur, medical evaluation is necessary to determine if the medication should be continued.

Diarrhea and Superinfection

Like many antibiotics, ertapenem can cause Clostridioides difficile-associated diarrhea (CDAD). This condition can range from mild diarrhea to life-threatening inflammation of the colon. It may occur during treatment or up to several months after the last dose is administered. Prolonged use of the medication may also result in the overgrowth of non-susceptible organisms, such as fungi.

Drug Interactions

Ertapenem can significantly lower the levels of valproic acid or sodium valproate in the blood. These are medications commonly used to treat seizures or bipolar disorder. This interaction may lead to a loss of seizure control. Generally, the concurrent use of these medications is not recommended unless the benefits outweigh the risks.

Kidney Impairment

Because ertapenem is primarily cleared by the kidneys, patients with kidney disease require careful monitoring. Dosage adjustments are typically necessary for those with moderate to severe kidney impairment to prevent the drug from accumulating to toxic levels.

Intramuscular Injection Precautions

If ertapenem is administered via intramuscular injection, it is typically mixed with lidocaine. In these instances, the warnings and precautions associated with lidocaine must also be followed. This includes avoiding use in patients with a known allergy to amide-type local anesthetics or those in severe shock.

Pregnancy

There are no adequate and well-controlled studies of ertapenem use in pregnant women. Research in animals has not shown evidence of harm to the fetus at doses significantly higher than those used in humans; however, animal studies do not always predict how a human will respond. Because of the lack of human data, this medication should be used during pregnancy only if clearly needed and under the guidance of a healthcare provider.

Breastfeeding

Ertapenem is known to pass into human breast milk. While the effects on a nursing infant are not fully known, there is a possibility that the medication could affect the infant's natural gut bacteria or cause an allergic reaction. Decisions regarding whether to continue breastfeeding or to stop the medication should be made in consultation with a healthcare professional, weighing the importance of the drug to the mother against the benefits of breastfeeding for the child.

Available Forms

Ertapenem is provided as a sterile powder in single-dose vials. It must be reconstituted (mixed with a liquid) by a healthcare provider before it can be administered.

Administration Methods

• Intravenous (IV) Infusion: When given into a vein, the medication is typically infused over a period of 30 minutes.
• Intramuscular (IM) Injection: When given into a muscle, the powder is usually mixed with a liquid anesthetic to reduce discomfort at the injection site.

Strengths

This medication is typically available in a single strength for adult and pediatric use, provided in vials designed for one-time use.

FDA Approval and Indications

Ertapenem was first approved by the U.S. Food and Drug Administration (FDA) in 2001. It is indicated for the treatment of adults and pediatric patients (3 months of age and older) with several types of moderate to severe infections caused by susceptible bacteria, including:

• Complicated intra-abdominal infections
• Complicated skin and skin structure infections, including diabetic foot infections
• Community-acquired pneumonia
• Complicated urinary tract infections
• Acute pelvic infections

Additionally, the FDA has approved ertapenem for the prevention of surgical site infections following elective colorectal surgery in adults.

Regulatory Safety Information

The FDA-approved labeling for ertapenem does not include a boxed warning. However, regulatory information highlights important safety considerations, such as the risk of serious allergic reactions and potential central nervous system effects, including seizures. These risks are monitored through standard post-marketing surveillance. There are currently no Risk Evaluation and Mitigation Strategies (REMS) required for this medication.

FDA-Approved Uses

The U.S. Food and Drug Administration (FDA) has approved ertapenem for the treatment of several types of moderate to severe infections caused by susceptible bacteria. These indications include:

• Complicated intra-abdominal infections.
• Complicated skin and skin structure infections, including diabetic foot infections without bone infection (osteomyelitis).
• Community-acquired pneumonia.
• Complicated urinary tract infections, including kidney infections (pyelonephritis).
• Acute pelvic infections, including infections following childbirth, septic abortion, or gynecologic surgery.

Surgical Prophylaxis

Ertapenem is also FDA-approved for the prevention of surgical site infections in adults following elective colorectal surgery.

Approved Populations

This medication is approved for use in both adults and pediatric patients who are 3 months of age or older. It is a prescription-only medication administered by a healthcare professional as an injection into a muscle or as an infusion into a vein.