1.Diabetic foot infection, moderate to severe
2.Skin and soft tissue infection, moderate to severe
3.Urinary tract infection, complicated
4.Intra-abdominal infection, mild to moderate
5.Pelvic infections, acute
6.Pneumonia
7.Surgical prophylaxis (colorectal surgery)
藥理
Antibiotic, Carbapenem
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins; which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
藥動學
Absorption:
IM: Almost complete
Distribution:
■ Vdss:
Infants 3 months and Children: ~0.2 L/kg
Adolescents 13 to 17 years: ~0.16 L/kg
Adults: ~0.12 L/kg
■ Protein binding (concentration dependent, primarily to albumin):
85% at 300 mcg/mL, 95% at <100 mcg/mL
Metabolism:
■ Non-CYP-mediated hydrolysis to inactive metabolite
■ Bioavailability: IM: ~90%
■ Half-life elimination:
Infants 3 months and Children: ~2.5 hours
Adolescents and Adults: ~4 hours
■ Time to peak: IM: ~2.3 hours
Excretion:
Urine (~80% as unchanged drug and metabolite); feces (~10%)
禁忌症
Known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams; known hypersensitivity to local anesthetics of the amide type due to the use of lidocaine as a diluent (IM use only).
懷孕分類
B
Ertapenem is approved for the treatment of postpartum endomyometritis, septic abortion, and postsurgical infections. Ertapenem may be considered for use as an alternative antibiotic in the treatment of intraamniotic infection (ACOG 712 2017).
哺乳分類
Ertapenem is present in human milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. In general, antibiotics that are present in breast milk may cause non-dose-related modification of bowel flora. Monitor infants for GI disturbances, such as thrush or diarrhea (WHO 2002).
副作用
1. Adults (treatment trials):
Most common drug-related adverse reactions included diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), and vaginitis in females (2.1%).
Seizures occurred in 0.5% of adult patients during therapy + 14-day follow-up (regardless of causality).
2. Pediatrics (treatment trials):
Most common drug-related adverse reactions included diarrhea (6.5%), infusion site pain (5.5%), infusion site erythema (2.6%), vomiting (2.1%).
劑量和給藥方法
1. General / administration notes:
(1)For IV or IM use. Do not mix or co-infuse with other medications.
(2)Do not use diluents containing dextrose (α-D-glucose).
(3)IV infusion over 30 minutes; may be administered IV up to 14 days or IM up to 7 days (when appropriate).
2. Treatment regimen:
(1) 13 years old : 1 g once daily.
(2) 3 months to 12 years old : 15 mg/kg twice daily (max 1 g/day).
(3) Prophylaxis (elective colorectal surgery, adults) : 1 g IV single dose given 1 hour prior to surgical incision.
3.Preparation highlights:
(1) Adult IV: reconstitute 1 g vial with 10 mL (SWFI / 0.9% NaCl / bacteriostatic water), then transfer to 50 mL 0.9% NaCl; complete infusion within 6 hours of reconstitution.
(2) IM: reconstitute 1 g vial with 3.2 mL of 1% lidocaine HCl (without epinephrine); use within 1 hour; do not administer the IM solution IV.
小兒調整劑量
3 months–12 years: 15 mg/kg twice daily, not to exceed 1 g/day
腎功能調整劑量
Adults:
CrCl >30 mL/min/1.73 mm: no dosage adjustment.
CrCl 30 mL/min/1.73 mm or ESRD (CrCl 10 mL/min/1.73 mm): 500 mg daily.
Hemodialysis : if 500 mg dose is given within 6 hours prior to HD, give supplemental 150 mg after HD; if given 6 hours before HD, no supplemental dose needed.
Pediatrics : no dosing recommendation
肝功能調整劑量
No dose adjustment recommendations
安定性
After preparation with the appropriate diluent :
1. Maintains potency for 6 hours at room temperature (25°C) OR 24 hours refrigerated (5°C), and must be used within 4 hours after removal from refrigeration.
2. Do not freeze prepared solutions.