Ertapen

• Complicated Intra-Abdominal Infections
• Complicated Skin and Skin Structure Infections (including diabetic foot infections)
• Community Acquired Pneumonia
• Complicated Urinary Tract Infections (including pyelonephritis)
• Acute Pelvic Infections (including postpartum endomyometritis, septic abortion, post-surgical gynecological infections)
• Bacterial Septicaemia
• 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. It exhibits a bactericidal mode of action.

Adult Dose (>12 years):

• Most infections: 1 g/day IV/IM for 3-14 days.
• Community-Acquired Pneumonia/Complicated UTI: 1 g/day IV/IM up to 14 days.
• Complicated Skin Infections: 1 g/day IV/IM for 7-14 days (diabetic foot up to 4 weeks).
• Acute Pelvic Infections: 1 g/day IV/IM for 3-10 days.
• Prophylaxis (Elective Colorectal Surgery): 1 g IV single dose 1 hour prior to incision.

Child Dose (3-12 years): 15 mg/kg IV/IM q12hr (max 1 g/day).

Renal Dose: CrCl >30 mL/min: No adjustment; CrCl <30 mL/min or ESRD: 500 mg/day IV; Dialysis: 500 mg/day IV (supplemental 150 mg if given within 6 hr of dialysis).

Common Side Effects:

• Injection site reactions (pain, swelling, redness)
• Diarrhea
• Nausea
• Vomiting
• Headache
• Infused vein complication/Phlebitis

Other Side Effects: Dizziness, somnolence, insomnia, seizure, confusion, hypotension, dyspnoea, oral candidiasis, C. difficile-associated diarrhea, abdominal pain, taste perversion, asthenia/fatigue, candidiasis, fever.

Use in Pregnancy: Category B. Animal studies revealed no evidence of harm to the fetus. No adequate studies in pregnant women. Should be used only if potential benefit justifies potential risk to mother and fetus.

Precautions:

• Ertapenem may cause side effects which could affect your ability to drive (dizziness and sleepiness).
• Usually only given in the hospital for serious infections.
• Inform your doctor if allergic to penicillin or taking seizure medication.
• Diarrhea, severe stomach pain or blood in stools: inform doctor.
• Your doctor may monitor your liver and kidney function during treatment.
• Prolonged use may result in overgrowth of non-susceptible organisms.
• Pseudomembranous colitis has been reported.

Overdose: No specific information on treatment of overdosage. 3 g daily for 8 days did not result in significant toxicity. In overdose, discontinue and give supportive treatment. Can be removed by haemodialysis.

Storage: For injection: Store at 2-8°C. Keep away from light.