Treatment : Erpen is indicated for the treatment of patients with moderate to severe infections caused by susceptible strains of microorganisms, as well as initial empiric therapy prior to the identification of causative organisms in the infections listed below: Complicated Intra-Abdominal Infections ... Read more Treatment : Erpen is indicated for the treatment of patients with moderate to severe infections caused by susceptible strains of microorganisms, as well as initial empiric therapy prior to the identification of causative organisms in the infections listed below: Complicated Intra-Abdominal Infections Complicated Skin and Skin Structure Infections including diabetic lower extremity and diabetic foot infections Community Acquired Pneumonia Complicated Urinary Tract Infections including pyelonephritis Acute Pelvic Infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections Bacterial Septicaemia Prevention : Erpen is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
Ertapenem for Injection is a sterile, synthetic, long-acting, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics, such as penicillins and cephalosporins, with activity against a wide range of Gram-positive and Gram-negative aerobic and anaerobic bacteria. Ertapenem exhibits a bactericidal mode of action. It works by binding to and inhibiting bacterial penicillin-binding proteins (PBPs). In Escherichia coli, it has a strong affinity toward PBPs 1a, 1b, 2, 3, 4 and 5 with preferential binding to PBPs 2 and 3. Upon binding to PBPs, ertapenem inhibits bacterial cell wall synthesis by interfering with the lengthening and strengthening of the peptidoglycan portion of the cell wall, thereby inhibiting cell wall synthesis.
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Adults (>12 years) : 1 gm given once a day. Pediatric (3 months to 12 years) : 15 mg/kg twice daily (not to exceed 1 g/day). Ertapenem may be administered by IV infusion or IM injection. When administered intravenously, it should be infused over a period of 30 minutes. IM administration of Ertapenem may be used as an alternative to IV administration in the treatment of those infections for which intramuscular therapy is appropriate. The usual duration of therapy with Ertapenem is 3 to 14 days but varies by the type of infection and causative pathogen(s). When clinically indicated, a switch to an appropriate oral antimicrobial maybe implemented if clinical improvement has been observed. Prophylaxis of surgical site infection following elective colorectal surgery : To prevent surgical site infections following surgery in adults, the recommended dosage is 1 g IV administered as a single intravenous dose given 1 hour prior to the surgical incision. Patients with renal insufficiency : Ertapenem may be used for the treatment of infections in adult patients with renal insufficiency. In patients whose creatinine clearance is >30 mL/min no dosage adjustment is necessary. Adult patients with advanced renal insufficiency (creatinine clearance ≤30 mL/min), including those on haemodialysis, should receive 500 mg daily. There are no data in paediatric patients with renal insufficiency. Patients on Haemodialysis : If Ertapenem is given at least 6 hours prior to haemodialysis, no supplementary dose is needed. When adult patients on haemodialysis are given Ertapenem within 6 hours prior to haemodialysis, a supplementary 30% dose is recommended following the haemodialysis session. There are no data in patients undergoing peritoneal dialysis or haemofiltration. There are no data in paediatric patients on haemodialysis. No dosage adjustment is recommended in patients with impaired hepatic function
Most adverse experiences reported in these clinical studies were described as mild to moderate in severity. The most common drug-related adverse experiences reported during parenteral therapy with Erpen include Headache, Infused vein complication, phlebitis/ thrombophlebitis, Diarrhoea, nausea and vomiting. Other uncommon side effects include- Dizziness, somnolence, insomnia, seizure, confusion, Extravasation, hypotension, Dyspnoea, Oral candidiasis, constipation, acid regurgitation, C. difficile-associated diarrhoea, dry mouth, dyspepsia, anorexia, Erythema, pruritus, Abdominal pain, taste perversion, asthenia/fatigue, candidiasis, oedema/swelling, fever, pain, chest pain, Vaginal pruritus.
Ertapenem is contraindicated in patients with 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. Due to the use of lidocaine HCl as a diluent, intramuscular administration of Ertapenem is contraindicated in patients with a known hypersensitivity to local anaesthetics of the amide type and in patients with severe shock or heart block.
When Erpen is administered with probenecid, probenecid competes for active tubular secretion and thus inhibits the renal excretion of Erpen. This leads to small but statistically significant increases in the elimination half-life (19%) and in the extent of systemic exposure (25%). No dosage adjustment is necessary when Erpen is given with probenecid. Because of the small effect on half-life, the co-administration with probenecid to extend the half-life of Erpen is not recommended. Other than with probenecid, no specific clinical drug interaction studies have been conducted. Decreased serum levels of valproic acid with co-administration of Erpen have been reported. Careful monitoring of serum levels of valproic acid should be considered if Erpen is to be co-administered with valproic acid.
Before initiating therapy with Erpen, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. If an allergic reaction to Erpen occurs, discontinue the drug immediately. Serious anaphylactic reactions require immediate emergency treatment. As with other antibiotics, prolonged use of Erpen may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Erpen, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis".