imipenem and cilastatin Intravenous, Intramuscular

im-i-PEN-em, sye-la-STAT-in SOE-dee-um

Commonly used brand name(s)

In the U.S.

• Primaxin IM


• Primaxin IV

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: Beta-Lactam

Chemical Class: Carbapenem

Uses For imipenem and cilastatin

Imipenem and cilastatin combination is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth. imipenem and cilastatin 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.

imipenem and cilastatin is available only with your doctor's prescription.

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)

Before Using imipenem and cilastatin

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 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

imipenem and cilastatin 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.

Geriatric

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, imipenem and cilastatin is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 receiving imipenem and cilastatin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using imipenem and cilastatin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ganciclovir


• Theophylline


• Valganciclovir


• Valproic Acid

Using imipenem and cilastatin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• 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

Proper Use of imipenem and cilastatin

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, imipenem and cilastatin 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 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. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. 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 using the medicine.

• 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.
    
    
  
  

Precautions While Using imipenem and cilastatin

Some patients may develop tremors or seizures while receiving imipenem and cilastatin. 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.

imipenem and cilastatin Side Effects

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

• 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 imipenem and cilastatin)

Some 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

• Diarrhea


• nausea and vomiting

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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More imipenem and cilastatin Intravenous, Intramuscular resources

• Imipenem and cilastatin Intravenous, Intramuscular Use in Pregnancy & Breastfeeding
• Imipenem and cilastatin Intravenous, Intramuscular Drug Interactions
• Imipenem and cilastatin Intravenous, Intramuscular Support Group
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