One of quinupristin/dalfopristin’s approved indications is for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia. Quinupristin/dalfopristin has been approved for marketing in the United States for this indication under FDA's accelerated approval regulations that allow marketing of products for use in life-threatening conditions when other therapies are not available. Approval of drugs for marketing under these regulations is based upon a demonstrated effect on a surrogate endpoint that is likely to predict clinical benefit.
Approval of this indication is based upon quinupristin/dalfopristin’s ability to clear VREF from the bloodstream, with clearance of bacteremia considered to be a surrogate endpoint. There are no results from well-controlled clinical studies that confirm the validity of this surrogate marker. However, a study to verify the clinical benefit of therapy with quinupristin/dalfopristin on traditional clinical endpoints (such as cure of the underlying infection) is presently underway .
Quinupristin/dalfopristin has been approved for marketing in the United States for vancomycin-resistant Enterococcus faecium (VREF) bacteremia under FDA's accelerated approval regulations that allow marketing of products for use in life-threatening conditions when other therapies are not available. Approval of this indication is based upon quinupristin/dalfopristin’s ability to clear VREF from the bloodstream, with clearance of bacteremia considered to be a surrogate endpoint. There are no results from well-controlled clinical studies that confirm the validity of this surrogate marker .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antibiotic
Chemical Class: Streptogramin
Quinupristin and dalfopristin belong to the family of medicine called antibiotics. Antibiotics are medicines used in the treatment of infections caused by bacteria. They work by killing bacteria or preventing their growth. Quinupristin and dalfopristin will not work for colds, flu, or other virus infections.
Quinupristin and dalfopristin injection is used to treat infection of the skin or the blood. It may also be used for other conditions as determined by your doctor. It is given by injection and is used mainly for serious infection for which other medicine may not work.
Quinupristin and dalfopristin injection is available only with your doctor's prescription.
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 quinupristin and dalfopristin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to quinupristin and dalfopristin 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.
Studies on quinupristin and dalfopristin have been done only in adult patients, and there is no specific information comparing use of quinupristin and dalfopristin in children under 16 years old with use in other age groups.
In studies of patients 65 years or older, quinupristin and dalfopristin have not been shown to cause different side effects or problems than they do in younger adults.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
Using quinupristin and dalfopristin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using quinupristin and dalfopristin 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.
Using quinupristin and dalfopristin 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.
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.
The presence of other medical problems may affect the use of quinupristin and dalfopristin. Make sure you tell your doctor if you have any other medical problems, especially:
Some medicine given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using quinupristin and dalfopristin at home, make sure you clearly understand and carefully follow your doctor's instructions.
To help clear up your infection completely, quinupristin and dalfopristin must be given for the full time of treatment, even if you begin to feel better after a few days. Also, it works best when there is a constant amount in the blood. To help keep the amount constant, quinupristin and dalfopristin must be given on a regular schedule.
The dose of quinupristin and dalfopristin 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 quinupristin and dalfopristin. 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.
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 as soon as possible if any of the following side effects occur:More common
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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