ertapenem sodium 1 g/1
ertapenem sodium · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Hikma Pharmaceuticals USA, Inc.
ertapenem sodium is a injection, powder, lyophilized, for solution containing ertapenem sodium at 1 g/1, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- ertapenem sodium
- Generic Name
- ertapenem sodium
- NDC Code (Product)
0143-9398- Manufacturer
- Hikma Pharmaceuticals USA, Inc.
- Strength
- 1 g/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA208790
- Marketing Start
- 08/02/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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) 1.1 Complicated Intra-Abdominal Infections Ertapenem for injection is indicated for the treatment of complicated…
Dosage & Administration
2 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 ) Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 g/day intravenously or intramuscularly.) ( 2.2 ) Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days. ( 2.1 ) Prophylaxis regimen for adults: 1 gram single dose given 1 hour prior to elective colorectal surgery. ( 2.3 ) 2.1 Instructions for Use in All Patients For Intravenous or Intramuscular Use DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE ( α -D-GLUCOSE). Ertapenem for injection may b…
Contraindications
4 CONTRAINDICATIONS Ertapenem for injection 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, Ertapenem for injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. Known hypersensitivity to product components or anaphylactic reactions to β-lactams. ( 4 ) Due to the use of lidocaine HCl as a diluent, Ertapenem for injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Co-administration with probenecid inhibits the renal excretion of ertapenem and is therefore not recommended. ( 7.1 ) The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. ( 5.2 , 7.2 ) 7.1 Probenecid Probenecid interferes with the active tubular secretion of ertapenem, resulting in increased plasma concentrations of ertapenem [see Clinical Pharmacology ( 12.3 )]. Co-administration of probenecid with ertapenem is not recommended. 7.2 Valproic Acid Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggest that carbapenems may inhibit the hydrolysi…
Adverse Reactions
6 ADVERSE REACTIONS The following are described in greater detail in the Warnings and Precautions section Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Seizure Potential [see Warnings and Precautions (5.2)]Interaction with Valproic Acid [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] Caution with Intramuscular Administration [see Warnings and Precautions ( 5.5 )] Development of Drug-Resistant Bacteria [see Warnings and Precautions ( 5.6 )] Laboratory Tests [see Warnings and Precautions ( 5.7 )] Adults: The most common adverse reactions (≥5%) in patients treated with Ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication. ( 6.1 ) In the prophylaxis indication the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials. ( 6.1 ) Pediatrics: Adverse reactions in this population were comparable to adults. The most common adverse reactions (≥5%) in pediatric patients treated with Ertapenem for injection, including those who …
Frequently Asked Questions
What is ertapenem sodium used for?
ertapenem sodium contains ertapenem sodium. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is ertapenem sodium a controlled substance?
ertapenem sodium is not classified as a controlled substance by the DEA.
What is the generic name for ertapenem sodium?
The generic name for ertapenem sodium is ertapenem sodium. There are 11 other brand versions of ertapenem sodium.
What is the NDC code for ertapenem sodium 1 g/1?
The NDC (National Drug Code) for ertapenem sodium 1 g/1 is 0143-9398, listed by Hikma Pharmaceuticals USA, Inc..