In the U.S.—

• Antibacterial, systemic

Ertapenem (er-ta-PEN-em) is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections. Ertapenem is used to treat infections in many different parts of the body. It is sometimes given with other antibiotics.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ertapenem, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ertapenem. Also tell your health care professional if you have ever had any had any unusual or allergic reaction to penicillins, cephalosporins, beta-lactamase inhibitors, lidocaine, or local anesthetics of the amide type. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Ertapenem has not been studied in pregnant women. Ertapenem also has not been shown to cause birth defects or other problems in animal studies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Ertapenem passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast feeding. Mothers who are taking this medicine and who wish to breast feed should discuss this with their doctor.

Children—Studies on this medicine have only been done in adult patients, and there is no specific information comparing the use of ertapenem in children with use in other age groups. Use in children less than 18 years of age is not recommended.

Older adults—Ertapenem has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ertapenem, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Probenecid (e.g. Benemid)Use of this medicine with ertapenem may increase the amount of ertapenem in the body

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Gastrointestinal disease (for example, stomach or intestinal problems, especially diarrhea)—Patients with stomach or intestinal problems, especially diarrhea, may be more likely to have side effects

• Central nervous system (CNS) disorders (for example, brain disease or history of seizures)—Patients with nervous system disorders, including seizures, may be more likely to have side effects

• Kidney disease—Patients with kidney disease may be more likely to have side effects

To help clear up your infection completely, ertapenem must be given for the full time of treatment, even if you begin to feel better after a few days. Skipping doses or not completing the full course of therapy may decrease the usefulness of this medicine. It may also increase the likelihood that the bacteria causing your infection will develop resistance. If this happens, ertapenem and other medicines used to treat infections will not work in the future. Also, this medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, it must be given on a regular schedule.

Dosing—

The dose of ertapenem will be different for different patients. If you are receiving this medicine at home, follow your doctor's orders. The following information includes only the average doses of ertapenem. If your dose is different, do not change it unless your doctor tells you to do so.

. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking ertapenem

• For injection dosage form:
  • For bacterial infections:
    • Adults— 1 gram injected into a vein or injected into a muscle once a day. Your doctor will determine whether the medication is injected into a vein or injected into a muscle and the length of time that you will take it.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Some patients may develop tremors or seizures while receiving this medicine. If you already have a history of seizures and you are taking anticonvulsants, you should continue to take them unless otherwise directed by your doctor.

In some patients, ertapenem may cause diarrhea.

• Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor . Diarrhea medicines may make your diarrhea worse or make it last longer.
• For mild diarrhea, diarrhea medicine containing kaolin (e.g., Kaopectate liquid) or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or make it last longer.
• If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Bleeding;  blistering;  burning;  coldness;  discoloration of skin;  feeling of pressure;  hives ;  infection;  inflammation ;  itching skin;  lumps;  numbness ;  pain ;  skin rash;  redness of skin;  scarring;  soreness;  stinging ;  swelling;  tenderness;  tingling;  ulceration;  unusually warm skin 
  
  

• Less common
  • Bluish color changes in skin color;  pain, tenderness, swelling of foot or leg;  fast pounding or irregular heartbeat or pulse 
  
  

• Rare
  • Abdominal or stomach cramps;  abdominal tenderness;  bloating;  convulsions ;  diarrhea, watery and severe, which may also be bloody;  fainting or loss of consciousness;  fast or irregular breathing;  fever;  increased thirst;  loss of bladder control ;  muscle spasm or jerking of all extremities;  nausea;  sudden loss of consciousness ;  swelling of eyes or eyelids;  tightness in chest;  trouble in breathing;  unusual tiredness or weakness;  unusual weight loss;  vomiting;  wheezing 
  
  

• Incidence not known- occurred during clinical practice
  • Cough;  difficulty swallowing;  fast heartbeat;  hives;  itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue;  seeing, hearing, or feeling things that are not there;  shortness of breath;  skin rash;  tightness in chest;  unusual tiredness or weakness;  wheezing  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• More common
  • Agitation;  chest pain;  confusion about identity, place, and time;  drowsiness;  headache;  mental depression 
  
  

• Less common
  • Acid or sour stomach;  belching;  blurred vision;  body aches or pain;  congestion;  cough;  difficult or labored breathing;  difficulty having a bowel movement (stool);  dizziness;  dryness or soreness of throat;  fear ;  faintness or lightheadedness when getting up from a lying or sitting position;  flushing;  heartburn;  hoarseness;  indigestion;  itching of the vagina or genital area;  itching skin;  lack or loss of strength;  leg pain;  nervousness;  pain during sexual intercourse ;  pounding in the ears;  runny nose;  shortness of breath;  sleeplessness;  slow heartbeat;  sore mouth or tongue;  stomach discomfort, upset, or pain;  sudden sweating;  tender, swollen glands in neck;  thick, white vaginal discharge with no odor or with a mild odor;  tightness in chest;  trouble sleeping;  trouble in swallowing;  unable to sleep;  voice changes;  white patches in mouth and/or on tongue 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.