Trade Names:Invanz- Powder for injection, lyophilized 1.046 g ertapenem sodium (equivalent to 1 g ertapenem)
Inhibits cell wall synthesis.
Bioavailability for IM dose is approximately 90%. T max is approximately 2.3 h (IM).
Approximately 85% to 95% protein bound (concentration dependent). Vd is approximately 0.12 L/kg in adults; 0.2 L/kg in children 3 mo to 12 yr of age; 0.16 L/kg in children 13 to 17 yr of age (at steady state).
Major metabolite is the inactive ring-opened derivative formed by hydrolysis of the beta-lactam ring.
The t ½ is approximately 4 h. Approximately 80% excreted in urine (approximately 38% as unchanged drug) and 10% in feces.
Unbound AUC increased 1.5- and 2.3-fold in those with mild and moderate renal function impairment, respectively. No dosage adjustment necessary. Unbound AUC increased 4.4- and 7.6-fold in those with advanced and end-stage renal function impairment, respectively. Dosage adjustment required.Hepatic Function Impairment
Pharmacokinetics have not been established.Elderly
The total and unbound AUC increased 37% and 67%, respectively.
Treatment of moderate to severe complicated intra-abdominal infections, complicated skin and skin structure infections, community-acquired pneumonia, complicated UTIs (eg, pyelonephritis), and acute pelvic infections (eg, postpartum endomyometritis, septic abortion, postsurgical gynecologic infections) caused by susceptible microorganisms; prophylaxis of surgical-site infection following elective colorectal surgery.
Hypersensitivity to any component of this product or to other drugs in the same class; patients who have demonstrated anaphylactic reactions to beta-lactams; because of the lidocaine diluent, patients with known sensitivity to local anesthetics of the amide type.
IV/IM 1 g/day for 7 to 14 days.Children 3 mo to 12 yr of age
IV/IM 15 mg/kg twice daily for 5 to 14 days.Complicated Skin and Skin Structure InfectionsAdults and Children 13 yr of age and older
IV/IM 1 g/day for 7 to 14 days.Children 3 mo to 12 yr of age
IV/IM 15 mg/kg twice daily for 7 to 14 days.Community-Acquired Pneumonia or Complicated UTIs (eg, Pyelonephritis)Adults and Children 13 yr of age and older
IV/IM 1 g/day for 10 to 14 days.Children 3 mo to 12 yr of age
IV/IM 15 mg/kg twice daily for 10 to 14 days.Acute Pelvic InfectionsAdults and Children 13 yr of age and older
IV/IM 1 g/day for 3 to 10 days.Children 3 mo to 12 yr of age
IV/IM 15 mg/kg twice daily for 3 to 10 days.Renal Function ImpairmentAdults and Children 13 yr of age and older
IV/IM Ccr 30 mL/min or less: 500 mg/day.Children 3 mo to 12 yr of age
IV/IM No data available.HemodialysisAdults
IV/IM 500 mg within 6 h prior to hemodialysis and a supplemental dose of 150 mg following the hemodialysis session.Children 3 mo to 12 yr of age
IV/IM No data available.Prophylaxis of Surgical SiteAdults
IV 1 g 1 h prior to surgical incision.
Store lyophilized powder below 77°F. Reconstituted solution for IV administration, diluted in sodium chloride 0.9% injection, may be stored at room temperature and used within 6 h or stored under refrigeration for 24 h and used within 4 h after removal from refrigeration. Protect from freezing. Use reconstituted solution for IM administration within 1 h of preparation.
Inhibits renal excretion of ertapenem; coadministration not recommended.
None well documented.
Hypertension, hypotension, tachycardia (2%).
Headache (7%); altered mental status (5%); insomnia (3%); dizziness (2%); anxiety, asthenia/fatigue (1%).Children
Pyrexia (5%); headache (4%); dizziness (2%).Postmarketing
Erythema, pruritus, rash (2%).Children
Diaper dermatitis (5%); rash (3%); pruritus (2%); dermatitis (1%).
Nasopharyngitis (2%); viral pharyngitis (1%).
Diarrhea (10%); nausea (8%); abdominal swelling, constipation, vomiting (4%); acid regurgitation, small intestine obstruction (2%); dyspepsia, oral candidiasis (1%).Children
Diarrhea (12%); vomiting (10%); abdominal pain (5%); constipation, loose stools, nausea (2%); abdominal abscess, upper abdominal pain (1%).
UTIs (4%); vaginitis (3%).
Increased ALT (9%); increased AST (8%); increased platelet count, increased serum alkaline phosphatase (7%); decreased Hgb (5%); decreased Hct (3%); decreased segmented neutrophils, decreased serum albumin, decreased serum potassium, decreased WBC, increased eosinophils, increased serum glucose, increased total serum bilirubin, increased urine RBC and WBC (2%); decreased platelet count, increased PT, increased serum creatinine, increased serum potassium (1%).Children
Decreased neutrophil count (6%); increased ALT, increased AST (4%); increased alkaline phosphatase, increased eosinophil count, increased platelet count (1%).
Infused vein complication (7%); extravasation, phlebitis/thrombophlebitis (2%).Children
Pain (7%); erythema (4%); phlebitis, swelling (2%); induration, warmth (1%).
Leg pain (1%).
Dyspnea (3%); cough, pneumonia (2%); rales/rhonchi, respiratory distress (1%).Children
Cough (4%); upper respiratory tract infection (2%); wheezing (1%).
Wound infections (6%); fever (5%); edema/swelling (3%); anastomotic leak, C. difficile infection/colitis, cellulitis, chest pain, death, postoperative infection (2%); seroma (1%).Children
Hypothermia (2%); herpes simplex (1%).Postmarketing
Periodic assessment of organ system function, including renal, hepatic, and hematopoietic, is advised during prolonged therapy. Monitor patient's response to therapy.
Category B .
Excreted in breast milk.
Safety and efficacy not established in children younger than 3 mo of age.
Because elderly patients are more likely to have decreased renal function, select dose with caution.
Hypersensitivity reactions may occur; do not administer to patients who have demonstrated anaphylactic reactions to beta-lactams, carbapenams, or penicillin.
Adjust dose accordingly.
May result in bacterial or fungal overgrowth of nonsusceptible organisms.
Seizures and other CNS adverse reactions may occur.
Consider possibility in patients with diarrhea.
Diarrhea, dizziness, nausea.
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