INVANZ
INVANZ- ertapenem sodium injection, powder, lyophilized, for solution
Merck Sharp & Dohme LLC
1 INDICATIONS AND USAGE
1.1 Complicated Intra-Abdominal Infections
INVANZ 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.
1.2 Complicated Skin and Skin Structure Infections, Including Diabetic Foot Infections without Osteomyelitis
INVANZ 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. INVANZ has not been studied in diabetic foot infections with concomitant osteomyelitis [see Clinical Studies (14)].
1.3 Community Acquired Pneumonia
INVANZ is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with community acquired pneumonia due to Streptococcus pneumoniae (penicillin susceptible isolates only) including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates only), or Moraxella catarrhalis.
1.4 Complicated Urinary Tract Infections Including Pyelonephritis
INVANZ is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated urinary tract infections including pyelonephritis due to Escherichia coli , including cases with concurrent bacteremia, or Klebsiella pneumoniae.
1.5 Acute Pelvic Infections Including Postpartum Endomyometritis, Septic Abortion and Post-Surgical Gynecologic Infections
INVANZ is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecological infections due to Streptococcus agalactiae, Escherichia coli , Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia.
1.6 Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery
INVANZ is indicated in adults for the prevention of surgical site infection following elective colorectal surgery.
1.7 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and other antibacterial drugs, INVANZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Instructions for Use in All Patients
For Intravenous or Intramuscular Use
DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
INVANZ may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, INVANZ should be infused over a period of 30 minutes. Intramuscular administration of INVANZ may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.
2.2 Treatment Regimen
13 years of age and older
The dose of INVANZ in patients 13 years of age and older is 1 gram (g) given once a day [see Clinical Pharmacology (12.3)].
3 months to 12 years of age
The dose of INVANZ in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day).
Table 1 presents treatment guidelines for INVANZ.
Infection † | Daily Dose(IV or IM)Adults and Pediatric Patients 13 years of age and older | Daily Dose(IV or IM)Pediatric Patients 3 months to 12 years of age | Recommended Duration of Total Antimicrobial Treatment |
| |||
Complicated intra-abdominal infections | 1 g | 15 mg/kg twice daily ‡ | 5 to 14 days |
Complicated skin and skin structure infections, including diabetic foot infections § | 1 g | 15 mg/kgtwice daily ‡ | 7 to 14 days ¶ |
Community acquired pneumonia | 1 g | 15 mg/kgtwice daily ‡ | 10 to 14 days # |
Complicated urinary tract infections, including pyelonephritis | 1 g | 15 mg/kgtwice daily ‡ | 10 to 14 days # |
Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections | 1 g | 15 mg/kg twice daily ‡ | 3 to 10 days |
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