Uses of Ernem-1 Powder for Infusion: - Bacterial infections Intra-abdominal infections, Community-acquired pneumonia, Skin and skin structure infections, Urinary tract infections, Pyelonephritis, Surgical infections, Diabetic foot infections, Septic abortion Hypersensitivity; lactation.

Other beta-lactam Antibiotics

The bactericidal activity of ertapenem results from the inhibition of cell wall synthesis and is mediated through ertapenem binding to penicillin binding proteins (PBPs). In Escherichia coli, it has strong affinity toward PBPs 1a, 1b, 2, 3, 4 and 5 with preference for PBPs 2 and 3. Ertapenem is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended spectrum beta-lactamases. Ertapenem is hydrolyzed by metallo-beta-lactamases.

How to use Ertapenem: Your doctor or nurse will give you this medicine. Kindly do not self administer. Administration: IV Preparation Reconstitute 1 g vial with 10 mL SWI, NS, or BWI; shake well; transfer to 50 mL NS IV Administration Infuse over 30 minutes IM Preparation Reconstitute 1 g vial with 3.2 mL of 1% lidocaine injection (without epinephrine); shake well; use within 1 hour after preparation IM Administration Make sure patient does not have allergy to lidocaine or another amide anesthetic Administer by deep IM injection into large muscle mass (eg, gluteal muscle or lateral part of thigh) Do not administer IM preparation or drug reconstituted for IM administration IV Adult Dose: Community-Acquired Pneumonia 1 g/day IV/IM up to 14 days; after ?3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically Complicated Urinary Tract Infections (Including Pyelonephritis) 1 g/day IV/IM up to 14 days; after ?3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically Acute Pelvic Infections 1 g/day IV/IM for 3-10 days Complicated Intra-abdominal Infections 1 g/day IV/IM for 5-14 days Complicated Skin/Skin Structure Infections 1 g/day IV/IM for 7-14 days; may be continued up to 4 weeks for diabetic foot infections, depending on severity of infection and response to therapy (treatment excludes diabetic foot infections with osteomyelitis) Child Dose: Community-Acquired Pneumonia, Complicated Urinary Tract Infections (Including Pyelonephritis) 3-12 years: 15 mg/kg IV/IM q12hr up to 14 days; not to exceed 1 g q12hr; after ?3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically >12 years: 1 g/day IV/IM up to 14 days; after ?3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically Complicated Intra-abdominal Infections, Complicated Skin/Skin Structure Infections 3-12 years: 15 mg IV/IM q12hr for 7-14 days >12 years: 1 g/day IV/IM for 7-14 days <3 years: Safety and efficacy not established Renal Dose: Renal impairment CrCl >30 mL/min/1.73 m²: Dosage adjustment not necessary CrCl <30 mL/min/1.73 m² and end-stage renal disease (ESRD): 500 mg/day IV Dialysis: 500 mg/day IV; if given ?6 hr before dialysis, supplemental dose of 150 mg afterward

May decrease plasma levels of valproic acid thus, increasing the risk of seizures. Increased plasma concentrations w/ probenecid.

Hypersensitivity; lactation.

Common - Injection site reactions (pain, swelling, redness) - Vomiting - Nausea >10% Diarrhea (2-12%) 1-10% Elevated liver function tests (LFTs) (7-9%),Nausea (6-9%),Headache (6-7%),Infused vein complications (5-7%),Increased platelet count (4-7%),Increased alkaline phosphatase (4-7%),Altered mental status (3-5%),Fever (2-5%),Abdominal pain (4%),Vomiting (4%),Constipation (3-4%),Insomnia (3%),Swelling or edema (3%),Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) (2-3%),Rash (2-3%),Vaginitis (1-3%),Dizziness (2%),Phlebitis or thrombophlebitis (1.5-2%),Pruritus (1-2%),Tachycardia (1-2%),Acid regurgitation (1-2%),Eosinophilia (1-2%),Hypotension (1-2%),Erythema (1-2%),Hypertension (0.7-2%),Chest pain (1%),Dyspepsia (1%),Fatigue (1%),Anxiety (0.8-1%),Oral candidiasis (0.1-1%) Potentially Fatal: Pseudomembranous colitis, Stevens-Johnson syndrome.

Pregnancy Category B. There are, however, no adequate and well-controlled trials in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ertapenem is excreted in human breast milk. Caution should be exercised when Ertapenem is administered to a nursing woman. Ertapenem should be administered to nursing mothers only when the expected benefit outweighs the risk.

Precaution: Hypersensitivity to penicillins, cephalosporins or other beta-lactams (possibility of cross-sensitivity). Renal impairment; CNS disorders e.g. epilepsy. Pregnancy. Lactation: Drug distributed in breast milk; use with caution

No specific information is available on the treatment of overdosage with Ertapenem. Intentional overdosing of Ertapenem is unlikely. Intravenous administration of Ertapenem at a dose of 2 g over 30 min or 3 g over 1-2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 g doses of Ertapenem in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity. In the event of an overdose, Ertapenem should be discontinued and general supportive treatment given until renal elimination takes place. Ertapenem can be removed by hemodialysis; the plasma clearance of the total fraction of ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.

Ertapenem 1 g single dose should be prepared with diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection. When prepared with this diluent, Ertapenem for Injection maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Ertapenem should not be frozen.

Other beta-lactam Antibiotics

Ertapenem acts similarly to penicillins by bacterial cell wall inhibition. It is active against many gram-negative and aerobic and anaerobic organisms. It is stable to hydrolysis by beta-lactamases.

Pregnancy Available data from a small number of postmarketing cases with use in pregnancy are insufficient to inform any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes Animal data In animal reproduction studies after intravenous administration of ertapenem during period of organogenesis, there was no evidence of developmental malformations in rats at systemic exposures (AUC) up to approximately 1.2 times the human exposure at maximum recommended human dose (MRHD) and in mice at doses up to approximately 3 times MRHD based on body surface area comparison; in pregnant rats administered ertapenem during organogenesis through lactation, fetal toxicity, developmental delays, and impaired reproduction did not occur in first generation offspring at systemic exposures (AUC) approximately 1.2 times the human exposure at MRHD Lactation Ertapenem is present in human milk; there are no data on effects on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition