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)

Misc. beta-lactams

1.Absorption (IM): After IM administration (reconstituted with 1% lidocaine), ertapenem is almost completely absorbed; mean bioavailability ~90%, with Tmax ~2.3 hours after 1 g IM. 2.Distribution: (1)Highly protein bound (primarily albumin); binding decreases from ~95% (<100 mcg/mL) to ~85% (~300 mcg/mL). (2)Apparent Vss: adults ~0.12 L/kg; pediatrics 3 months–12 years ~0.2 L/kg; pediatrics 13–17 years ~0.16 L/kg. 3.Metabolism: Major metabolite is an inactive ring-opened derivative (beta-lactam hydrolysis). 4.Elimination / Excretion: (1)Eliminated primarily by kidneys; mean plasma t? ~4 hours in healthy adults; ~4 hours in pediatrics 13–17 years; ~2.5 hours in pediatrics 3 months–12 years. (2)After 1 g IV radiolabeled dose: ~80% urine, ~10% feces; in urine ~38% unchanged and ~37% ring-opened metabolite.

1.Contraindicated in patients with known hypersensitivity to any component, other drugs in the same class, or those with anaphylactic reactions to beta-lactams. 2.For intramuscular administration (due to lidocaine diluent): contraindicated in patients with known hypersensitivity to amide-type local anesthetics.

1.FDA “Pregnancy Category” is not used in this labeling (PLLR format). 2.Pregnancy Risk Summary: available human data are insufficient to inform drug-associated risk; animal studies showed no malformations in rats (AUC ~1.2× human exposure at MRHD) and in mice (up to ~3× MRHD by BSA comparison).

1.Ertapenem is present in human milk. 2.No data on effects on the breastfed infant or milk production; weigh benefits of breastfeeding with maternal need and potential risks.

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%).

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: 1 g once daily.(2)3 months to 12 years: 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.

3 months–12 years: 15 mg/kg twice daily, not to exceed 1 g/day

Adults: CrCl >30 mL/min/1.73 m2: no dosage adjustment. CrCl ?30 mL/min/1.73 m2 or ESRD (CrCl ?10 mL/min/1.73 m2): 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

No dose adjustment recommendations

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.