Erpen1 gm/vial

Erpen is a carbapenem antibiotic used to treat certain moderate-to-severe bacterial infections caused by susceptible organisms.

Established / FDA-approved uses (adults and pediatric patients 3 months and older, unless noted)

• Complicated intra-abdominal infections
• Complicated skin and skin-structure infections, including diabetic foot infections without osteomyelitis
• Community-acquired pneumonia
• Complicated urinary tract infections, including pyelonephritis
• Acute pelvic infections (e.g. post-partum endomyometritis, septic abortion, post-surgical gynecologic infections)

Adults only

• Prophylaxis of surgical site infection following elective colorectal surgery (single pre-operative dose)

Note: Erpen is not active against Pseudomonas aeruginosa, Acinetobacter species, or methicillin-resistant staphylococci, and should not be used for infections caused by these organisms. As with all antibacterial agents, Erpen should be reserved for infections proven or strongly suspected to be caused by susceptible bacteria, and culture/sensitivity data should guide therapy whenever possible.

Each single-use vial contains Ertapenem (as ertapenem sodium) equivalent to 1 g of ertapenem, supplied as a sterile lyophilized powder for reconstitution into an intravenous or intramuscular injectable solution.

Erpen is a synthetic, broad-spectrum carbapenem (beta-lactam) antibacterial agent for parenteral use. It is supplied as a white to pale-yellow lyophilized powder that is reconstituted before intravenous infusion or intramuscular injection.

Erpen is active against a wide range of gram-positive and gram-negative aerobic and anaerobic bacteria, but notably lacks activity against Pseudomonas aeruginosa and Acinetobacter species, distinguishing it from other carbapenems such as meropenem and imipenem.

Carbapenem antibiotics (broad-spectrum beta-lactam antibacterial agents).

Ertapenem exerts its bactericidal effect by inhibiting bacterial cell wall synthesis. It penetrates the outer membrane of most gram-negative and gram-positive bacteria and binds to penicillin-binding proteins (PBPs), disrupting the cross-linking of peptidoglycan needed for a stable cell wall, which leads to cell lysis and bacterial death.

Ertapenem is stable against hydrolysis by most beta-lactamases, including penicillinases, cephalosporinases, and extended-spectrum beta-lactamases, but is hydrolyzed by metallo-beta-lactamases.

Pharmacokinetics: Ertapenem is highly protein-bound (concentration-dependent), achieves therapeutic concentrations in plasma after IV or IM administration, is minimally metabolized, and is eliminated primarily by the kidneys, with a plasma half-life of approximately 4 hours in adults with normal renal function, supporting once-daily dosing.

Erpen may be given by intravenous (IV) infusion or by deep intramuscular (IM) injection into a large muscle mass (e.g. gluteal muscle or lateral thigh); it must not be given as an IV bolus injection.

• IV infusion: infuse the reconstituted and diluted solution over approximately 30 minutes.
• IM injection: give as a deep injection; not intended for IV use once mixed with lidocaine.
• Complete IV infusion within 6 hours of reconstitution at room temperature (or within 24 hours if refrigerated and then brought to room temperature before use).
• Use IM solution within 1 hour of preparation.
• Do not mix or co-infuse Erpen with other medications in the same IV line.

See Reconstitution for exact preparation steps.

Valproic acid / divalproex sodium

Concomitant use of Erpen with valproic acid or divalproex sodium is generally not recommended. Carbapenems, including Erpen, can reduce serum valproic acid concentrations to sub-therapeutic levels, increasing the risk of breakthrough seizures. If co-administration cannot be avoided, valproic acid levels should be monitored closely and supplemental anticonvulsant therapy considered.

Probenecid

Probenecid competes with Erpen for active tubular secretion, reducing renal clearance and increasing the half-life and plasma concentration of Erpen. Co-administration with probenecid to prolong the effect of Erpen is not recommended.

Other beta-lactams / local anesthetics

For intramuscular use, Erpen is reconstituted with lidocaine; this route carries the interaction/contraindication risks of amide-type local anesthetics (see Contraindications).

As with other broad-spectrum antibiotics, Erpen may reduce the efficacy of live attenuated bacterial vaccines (e.g. oral typhoid vaccine); avoid such vaccines during therapy.

Common (adults)

• Diarrhea
• Nausea
• Headache
• Infused-vein complications (phlebitis, infusion site pain/swelling)

Common (pediatric patients)

• Diarrhea
• Vomiting
• Infusion/injection site pain

Serious (uncommon but important)

• Hypersensitivity reactions, including anaphylaxis (see Contraindications and Precautions and Warnings).
• Seizures and other CNS effects, more common with renal impairment or pre-existing CNS disorders (see Precautions and Warnings).
• Clostridioides difficile-associated diarrhea (CDAD), ranging from mild diarrhea to severe colitis (see Precautions and Warnings).

Pregnancy

Erpen should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; always consult a physician. Data from animal reproduction studies did not show evidence of developmental malformations, but adequate and well-controlled studies in pregnant women are limited.

Lactation

Erpen passes into human breast milk in low concentrations. A nursing mother should discuss with her physician whether to continue breastfeeding or the medication, weighing the developmental and health benefits of breastfeeding against the mother's clinical need for Erpen and any potential effects on the breastfed infant.

Take Erpen exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice.

Hypersensitivity reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibiotics, including Erpen. Before starting therapy, inform your physician of any prior allergic reactions to penicillins, cephalosporins, other beta-lactams, or other allergens. If an allergic reaction occurs, discontinue Erpen immediately and seek emergency medical care.

Seizures and other CNS effects

Seizures and other central nervous system adverse effects have been reported during treatment with Erpen, particularly in patients with renal impairment or existing CNS disorders (e.g. brain lesions, history of seizures). Anticonvulsant therapy should be continued in patients with a known seizure disorder.

Clostridioides difficile-associated diarrhea (CDAD)

CDAD has been reported with nearly all antibacterial agents, including Erpen, and may range from mild diarrhea to fatal colitis. Evaluate promptly if diarrhea develops during or after treatment.

Development of drug-resistant bacteria

Prescribing Erpen in the absence of a proven or strongly suspected bacterial infection is unlikely to benefit the patient and increases the risk of development of drug-resistant bacteria.

Limited information is available on overdose with Erpen; in studies, excessive doses have caused nausea in healthy volunteers. There is no specific antidote for Erpen overdose. In case of suspected overdose, seek immediate medical attention or contact a poison control center/emergency services. Management is supportive; Erpen can be removed from the body by hemodialysis if needed.

Store unopened vials of Erpen at room temperature, below 30°C, protected from light and moisture. Do not freeze. Keep out of reach of children.

After reconstitution: use the diluted IV solution within 6 hours at room temperature or within 24 hours if refrigerated (bring to room temperature before infusing); use the reconstituted intramuscular solution within 1 hour of preparation. Discard any unused reconstituted solution.

Renal impairment

Dose reduction is required when creatinine clearance is ≤30 mL/min/1.73m² (see Dosage and Administration); a supplemental dose is needed after hemodialysis performed within 6 hours of a dose.

Hepatic impairment

No dose adjustment has been established; formal studies in hepatic impairment are limited, so Erpen should be used with caution and clinical monitoring in patients with significant liver disease.

Elderly patients

No dosage adjustment is required based on age alone, but elderly patients should be monitored for renal function, as this population has a higher likelihood of decreased renal function.

Pediatric patients

Erpen is approved for use in pediatric patients 3 months of age and older for the treatment indications listed; safety and efficacy in infants under 3 months have not been established. It is not approved for surgical prophylaxis in pediatric patients. See Pediatric Uses for details.

Pregnancy and lactation

See Pregnancy and Lactation for detailed guidance.

Patients with seizure disorders or CNS disease

Use with caution; see Precautions and Warnings for seizure risk information.

Duration of Erpen therapy depends on the indication and clinical response, typically ranging from 3 to 14 days (see the table under Dosage and Administration). Intravenous therapy with Erpen may be given for up to 14 days total; intramuscular therapy is generally limited to up to 7 days. For surgical prophylaxis, only a single pre-operative dose is used. Always complete the full course as prescribed even if symptoms improve, unless your physician advises otherwise.

For intravenous (IV) use

1. Reconstitute the 1 g vial of Erpen with 10 mL of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or Bacteriostatic Water for Injection.
2. Shake well to dissolve completely.
3. Immediately transfer the reconstituted solution into 50 mL of 0.9% Sodium Chloride Injection.
4. Infuse intravenously over approximately 30 minutes.
5. Complete the infusion within 6 hours of reconstitution (room temperature) or within 24 hours if refrigerated (then equilibrate to room temperature before use).

For intramuscular (IM) use

1. Reconstitute the 1 g vial with 3.2 mL of 1% lidocaine hydrochloride injection (without epinephrine), as directed by a physician or pharmacist.
2. Shake well and allow to stand until the solution is clear.
3. Use within 1 hour of preparation; administer by deep intramuscular injection into a large muscle mass.

Reconstitution should be performed by a trained healthcare professional under appropriate aseptic conditions.

Carbapenems; broad-spectrum beta-lactam antibiotics.

Ertapenem is a bactericidal carbapenem that inhibits bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) on the bacterial cell wall, blocking the cross-linking of peptidoglycan strands. This weakens the cell wall, causing bacterial cell lysis and death. Ertapenem resists breakdown by most common bacterial beta-lactamases, giving it activity against many organisms resistant to older beta-lactam antibiotics, though it is not active against Pseudomonas aeruginosa or Acinetobacter species.

B

Erpen is approved for use in pediatric patients 3 months of age and older for complicated intra-abdominal infections, complicated skin/skin-structure infections, community-acquired pneumonia, complicated urinary tract infections, and acute pelvic infections, at a dose of 15 mg/kg every 12 hours (not to exceed 1 g/day).

Safety and efficacy of Erpen in infants younger than 3 months have not been established, and it is not approved for surgical prophylaxis in pediatric patients. Pediatric patients should be monitored for the same adverse effects as adults, including seizures, hypersensitivity reactions, and C. difficile-associated diarrhea (see Precautions and Warnings).