What is Quinupristin and Dalfopristin?

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 .

Quinupristin and dalfopristin injection is used to treat infections of the skin and 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 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.

This medicine is available only with your doctor's prescription.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 60 minutes.

To help clear up your infection completely, this medicine 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.

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 this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Appropriate studies have not been performed on the relationship of age to the effects of quinupristin and dalfopristin injection in children younger than 16 years of age. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of quinupristin and dalfopristin injection in the elderly.

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.

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 this medicine, 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 this medicine 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.

• Astemizole
• Atorvastatin
• Cerivastatin
• Cholera Vaccine, Live
• Fluvastatin
• Haloperidol
• Lovastatin
• Pravastatin
• Simvastatin
• Tacrolimus
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinorelbine

Using this medicine 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.

• Carbamazepine
• Cyclosporine
• Delavirdine
• Diazepam
• Diltiazem
• Disopyramide
• Docetaxel
• Felodipine
• Indinavir
• Isradipine
• Lacidipine
• Lidocaine
• Manidipine
• Methylprednisolone
• Midazolam
• Nevirapine
• Nicardipine
• Nifedipine
• Nilvadipine
• Nimodipine
• Nisoldipine
• Paclitaxel
• Quinidine
• Ritonavir
• Verapamil

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis (inflammation of the colon) or
• Diarrhea, severe—Use with caution. May make these conditions worse.

• Liver disease—Liver disease may increase blood levels of this medicine, increasing the chance of side effects.

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve or if they become worse, call your doctor.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.