Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
ERTAPENEM SODIUM (UNII: 2T90KE67L0) (ERTAPENEM - UNII:G32F6EID2H)
Par Pharmaceutical Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated intra-abdominal infections due to Escherichia coli , Clostridium clostridioforme , Eubacterium lentum , Peptostreptococcus species, Bacteroides fragilis , Bacteroides distasonis , Bacteroides ovatus , Bacteroides thetaiotaomicron , or Bacteroides uniformis . Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae , Streptococcus pyogenes , Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , Bacteroides fragilis , Peptostreptococcus species, Porphyromonas asaccharolytica , or Prevotella bivia . Ertapenem for injection has not been studied in diabetic foot infections with concomitant osteomy
Ertapenem for injection is supplied as a sterile lyophilized powder in single-dose vials containing ertapenem for intravenous infusion or for intramuscular injection as follows: NDC 42023-221-85 in packages of 10 vials. Before reconstitution Do not store lyophilized powder above 25°C (77°F). Reconstituted and infusion solutions The reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection [see Dosage and Administration (2.7)], may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of ertapenem for injection should not be frozen.
New Drug Application
ERTAPENEM- ERTAPENEM SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PAR PHARMACEUTICAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ERTAPENEM FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ERTAPENEM FOR INJECTION. ERTAPENEM FOR INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. (1.1) Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. (1.2) Community-acquired pneumonia. (1.3) Complicated urinary tract infections including pyelonephritis. (1.4) Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. (1.5) Ertapenem for injection is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. (1.6) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ertapenem for injection and other antibacterial drugs, ertapenem for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.7) DOSAGE AND ADMINISTRATION DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (Α–D–GLUCOSE). (2.1) Ertapenem for injection should be infused over 30 minutes in both the Treatment and Prophylactic regimens. (2.1) Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis. (2.4, 2.5) Treatment regimen: Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly. (2.2) P Διαβάστε το πλήρες έγγραφο