IMIPENEMAND CILASTATIN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Primaxin IM
• Primaxin IV

In Canada?

• Primaxin

Category

• Antibacterial, systemic

Description

Imipenem and cilastatin (i-mi-PEN-em and sye-la-STAT-in) combinationis used in the treatment of infections caused by bacteria. It works by killingbacteria 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 manydifferent parts of the body. It is sometimes given with other antibiotics.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Parenteral
• Injection (U.S. and Canada)

Before Receiving This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic 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, imipenemand cilastatin combination has not been reported to cause birth defects orother problems in animal studies.

Breast-feeding?It is not known whether imipenem or cilastatinpasses into the breast milk. However, this medicine has not been reportedto cause problems in nursing babies.

Children?This medicine has been tested in a limited numberof children 12 years of age and older and, in effective doses, has not beenreported to cause different side effects or problems in children than it doesin adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of imipenem and cilastatin in the elderly with use in otherage groups, this medicine is not expected to cause different side effectsor problems in older people than it does in younger adults.

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

Other medical problems?The presence of other medicalproblems may affect the use of imipenem and cilastatin. Make sure you tellyour doctor if you have any other medical problems, especially:

• Central nervous system (CNS) disorders (for example, brain diseaseor history of seizures)?Patients with nervous system disorders, includingseizures, may be more likely to have side effects

• Kidney disease?Patients with kidney disease may be more likelyto have side effects

Proper Use of This Medicine

To help clearup your infection completely, imipenem and cilastatincombination must be given for the full time of treatment, even if youbegin to feel better after a few days. Also, this medicine works best whenthere is a constant amount in the blood or urine. To help keep the amountconstant, it must be given on a regular schedule.

Dosing?The dose of imipenem and cilastatin combinationwill be different for different patients. Follow yourdoctor's orders or the directions on the label. The following informationincludes only the average doses of imipenem and cilastatin combination. If your dose is different, do not change it unless yourdoctor 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 750mg injected into a muscle every twelve hours, depending on how severe yourinfection is.
    • Children up to 12 years of age?Use and dose must be determinedby your doctor.

Precautions While Using This Medicine

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 yourdoctor.

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., Kaopectateliquid) or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However,other kinds of diarrhea medicine should not be taken. They may make your diarrheaworse or make it last longer.
• If you have any questions about this or if mild diarrhea continuesor gets worse, check with your health care professional.

Side Effects of This Medicine

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 mayneed 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 tirednessor weakness

Rare

Fever; severe abdominal or stomach crampsand pain; watery and severe diarrhea, which may alsobe bloody (these side effects may also occur up to several weeks after youstop receiving this medicine)

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if thefollowing side effects continue or are bothersome:

More common

Diarrhea; nausea and vomiting

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.

Additional Information

Once a medicine has been approved for marketingfor a certain use, experience may show that it is also useful for other medicalproblems. Although these uses are not included in product labeling, imipenemand cilastatin combination is used in certain patients with thefollowing medical conditions:

• Febrile neutropenia (treatment)
• Melioidosis (treatment)

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