Ertapenem

Dosage Forms & Strengths

powder for injection

• 1g/vial

Community-Acquired Pneumonia

1 g/day IV/IM up to 14 days; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically

Complicated Urinary Tract Infections (Including Pyelonephritis)

1 g/day IV/IM up to 14 days; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically

Acute Pelvic Infections

1 g/day IV/IM for 3-10 days

Complicated Intra-abdominal Infections

1 g/day IV/IM for 5-14 days

Complicated Skin/Skin Structure Infections

1 g/day IV/IM for 7-14 days; may be continued up to 4 weeks for diabetic foot infections, depending on severity of infection and response to therapy (treatment excludes diabetic foot infections with osteomyelitis)

Dosing Modifications

Renal impairment

• CrCl >30 mL/min/1.73 m²: Dosage adjustment not necessary
• CrCl <30 mL/min/1.73 m² and end-stage renal disease (ESRD): 500 mg/day IV
• Dialysis: 500 mg/day IV; if given ≤6 hr before dialysis, supplemental dose of 150 mg afterward

Dosage Forms & Strengths

powder for injection

• 1g/vial

Community-Acquired Pneumonia

<3 years: Safety and efficacy not established

3-12 years: 15 mg/kg IV/IM q12hr up to 14 days; not to exceed 1 g q12hr; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically  

>12 years: 1 g/day IV/IM up to 14 days; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically

Complicated Urinary Tract Infections (Including Pyelonephritis)

<3 years: Safety and efficacy not established

3-12 years: 15 mg/kg IV/IM q12hr up to 14 days; not to exceed 1 g q12hr; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically  

>12 years: 1 g/day IV/IM up to 14 days; after ≥3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically

Acute Pelvic Infections

<3 years: Safety and efficacy not established

3-12 years: 15 mg IV/IM q12hr for 3-10 days

>12 years: 1 g/day IV/IM for 3-10 days

Complicated Intra-abdominal Infections

<3 years: Safety and efficacy not established

3-12 years: 15 mg IV/IM q12hr for 5-14 days

>12 years: 1 g/day IV/IM for 5-14 days

Complicated Skin/Skin Structure Infections

<3 years: Safety and efficacy not established

3-12 years: 15 mg IV/IM q12hr for 7-14 days; may be continued up to 4 weeks for diabetic foot infections, depending on severity of infection and response to therapy (treatment excludes diabetic foot infections with osteomyelitis)

>12 years: 1 g/day IV/IM for 7-14 days; may be continued up to 4 weeks for diabetic foot infections, depending on severity of infection and response to therapy (treatment excludes diabetic foot infections with osteomyelitis)

Ertapenem is a prescription medication used to treat serious bacterial infections of the abdomen, skin, urinary tract, kidney, pelvis, and pneumonia. Ertapenem treats diabetic foot infections and certain gynecological infections. It is also used to prevent infection following colorectal surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ertapenem is part of the drug class:

• Carbapenems

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• tremors, twitching, or rigid (very stiff) muscles;

• a seizure (convulsions); or

• unusual changes in your mood or behavior.

Common side effects include:

• nausea, vomiting;

• diarrhea;

• headache; or

• pain, redness, or mild swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have your blood work checked if you are on ertapenem for a long time. Talk with your doctor.
• Do not use longer than you have been told. A second infection may happen.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Do not give ertapenem to a child younger than 3 months of age.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Feeling confused.
• Feeling very tired or weak.
• Mood changes.
• Seizures.
• Shakiness.
• Trouble controlling body movements.
• Feeling very sleepy.
• Vaginal itching or discharge.
• It is common to have diarrhea when taking this medicine. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking ertapenem or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Headache.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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; known hypersensitivity to local anesthetics of the amide type due to the use of lidocaine as a diluent (IM use only).

Complicated: 1 gram IV or IM once daily for 5 to 14 days

Complicated: 1 gram IV or IM once daily
The recommended total duration of antibiotic treatment is 10 to 14 days, which includes a possible conversion to oral therapy after at least 3 days of parenteral therapy and once clinical improvement occurs.

Prophylaxis of surgical site infection following elective colorectal surgery: 1 gram IV one time, one hour prior to surgical incision

3 months to 12 years: 15 mg/kg IV or IM every 12 hours
Maximum dose: 1 g/day

13 years or older: 1 gram IV or IM once daily

Duration: 3 to 10 days

Substance Name

Ertapenem

CAS Registry Number

153832-46-3

Drug Class

Antiinfective Agents

Antibacterial Agents

Carbapenems

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem and other antibacterial drugs, Ertapenem 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.

Treatment

Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients  (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms [see Dosage and Administration (2)].

Complicated Intra-Abdominal Infections

Ertapenem for Injection is indicated for the treatment of 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.

Complicated Skin and Skin Structure Infections, Including Diabetic Foot Infections without Osteomyelitis

Ertapenem for Injection is indicated for the treatment of 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 osteomyelitis [see Clinical Studies (14)].

Community Acquired Pneumonia

Ertapenem for Injection is indicated for the treatment of 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.

Complicated Urinary Tract Infections Including Pyelonephritis

Ertapenem for Injection is indicated for the treatment of complicated urinary tract infections including pyelonephritis due to Escherichia coli, including cases with concurrent bacteremia, or Klebsiella pneumoniae.

Acute Pelvic Infections Including Postpartum Endomyometritis, Septic Abortion and Post Surgical Gynecologic Infections

Ertapenem for Injection is indicated for the treatment of 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.

Prevention

Ertapenem for Injection is indicated in adults for:

Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery

Ertapenem for Injection is indicated for the prevention of surgical site infection following elective colorectal surgery.

• 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 administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.

No specific information is available on the treatment of overdosage with Ertapenem. Intentional overdosing of Ertapenem is unlikely. Intravenous administration of Ertapenem at a dose of 2 g over 30 min or 3 g over 1 to 2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 g doses of Ertapenem in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity.

In the event of an overdose, Ertapenem should be discontinued and general supportive treatment given until renal elimination takes place.

Ertapenem can be removed by hemodialysis; the plasma clearance of the total fraction of Ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Ertapenem.

Ertapenem was neither mutagenic nor genotoxic in the following in vitro assays: alkaline elution/rat hepatocyte assay, chromosomal aberration assay in Chinese hamster ovary cells, and TK6 human lymphoblastoid cell mutagenesis assay; and in the in vivo mouse micronucleus assay.

In mice and rats, IV doses of up to 700 mg/kg/day (for mice, approximately 3 times the recommended human dose of 1 g based on body surface area and for rats, approximately 1.2 times the human exposure at the recommended dose of 1 g based on plasma AUCs) resulted in no effects on mating performance, fecundity, fertility, or embryonic survival.

Animal Toxicology and/or Pharmacology

In repeat-dose studies in rats, treatment-related neutropenia occurred at every dose-level tested, including the lowest dose of 2 mg/kg (approximately 2% of the human dose on a body surface area basis).

Studies in rabbits and Rhesus monkeys were inconclusive with regard to the effect on neutrophil counts.

How Supplied

Ertapenem for Injection is a sterile, white to off white lyophilized cake or powder in single dose vials containing Ertapenem for intravenous infusion or for intramuscular injection and is supplied as follows:

1 gram/vial

    Single Dose Vials in a Carton of 10              NDC 55150-282-20

Storage and Handling

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.

Discard Unused Portion.

The vial stoppers are not made with natural rubber latex.

Instructions for Patients

Patients should be advised that allergic reactions, including serious allergic reactions could occur and that serious reactions may require immediate treatment. Advise patients to report any previous hypersensitivity reactions to Ertapenem, other beta-lactams or other allergens.

Patients should be counseled to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with Ertapenem. If treatment with Ertapenem is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed.

Patients should be counseled that antibacterial drugs including Ertapenem should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ertapenem is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Ertapenem or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Distributed by:
AuroMedics Pharma LLC
279 Princeton-Hightstown Rd.
E. Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad – 500038
India