In the U.S.—

In Canada—

• Antibacterial, systemic

Imipenem and cilastatin (i-mi-PEN-em and sye-la-STAT-in) combination 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.

Imipenem and cilastatin combination 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 form:

Parenteral
• Injection (U.S. and Canada)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to imipenem and cilastatin, penicillins or cephalosporins. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in humans. However, imipenem and cilastatin combination has not been reported to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether imipenem or cilastatin passes into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—This medicine has been tested in a limited number of children 12 years of age and older and, in effective doses, has not been reported to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of imipenem and cilastatin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people 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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• 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, imipenem and cilastatin combination must be given for the full time of treatment, even if you begin to feel better after a few days. 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 imipenem and cilastatin combination will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of imipenem and cilastatin combination. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form:
  • For bacterial infections:
    • Adults and children 12 years of age and over—250 milligrams (mg) to 1 gram injected into a vein every six to eight hours; or 500 to 750 mg injected into a muscle every twelve hours, depending on how severe your infection is.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

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, imipenem and cilastatin combination 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.

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 health care professional immediately if any of the following side effects occur:

• More common
  • Confusion;  convulsions (seizures);  dizziness;  pain at place of injection ;  skin rash, hives, itching, fever, or wheezing;  tremors 
  
  

• Less common
  • Dizziness;  increased sweating;  nausea or vomiting;  unusual tiredness or weakness 
  
  

• Rare
  • Fever;  severe abdominal or stomach cramps and pain;  watery and severe diarrhea, which may also be bloody (these side effects may also occur up to several weeks after you stop receiving this medicine) 
  
  

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. However, check with your doctor if the following side effects continue or are bothersome:

• More common
  • Diarrhea;  nausea and vomiting 
  
  

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, imipenem and cilastatin combination is used in certain patients with the following medical conditions:

• Febrile neutropenia (treatment)
• Melioidosis (treatment)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for its use.