Quinupristin and dalfopristin (Intravenous)

Quinupristin and dalfopristin injection is used to treat infections of the skin and blood. It may also be used for other conditions as decided by your doctor. It is given by injection and is mainly used for serious infections when other medicines may not work.

Quinupristin and dalfopristin are part of a group of medicines called antibiotics. Antibiotics are used to treat infections caused by bacteria. They work by killing bacteria or stopping their growth. Quinupristin and dalfopristin will not work for colds, flu, or other viral infections.

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

Your doctor will monitor your progress closely while you are receiving this medicine. This will help your doctor see if the medicine is working properly and to determine if you should keep receiving it. Blood tests may be needed to check for side effects.

If your symptoms do not improve or get worse, contact your doctor.

This medicine may cause diarrhea, which can be severe in some cases. It may happen 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 worsens, consult your doctor.

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

In deciding to use a medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medications. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

Studies have not been done on the effects of quinupristin and dalfopristin injection in children younger than 16 years. Safety and effectiveness have not been established for this age group.

Geriatric

Studies conducted so far have not found any specific problems in older adults that would limit the use of quinupristin and dalfopristin injection in this age group.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medicine if you are breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there could be an interaction. In such cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the following medicines while receiving this treatment. The interactions listed below are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both are prescribed, your doctor may adjust the dose or frequency for one or both 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 increase the risk of certain side effects, but using both may still be the best treatment for you. If both are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Drinking alcohol or using tobacco with specific medicines can also cause interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Colitis (inflammation of the colon) or
• Severe diarrhea—Use with caution. This may worsen these conditions.

• Liver disease—Having liver disease may raise blood levels of this medicine, increasing the risk of side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Swelling, redness, or pain at the injection site

Less common

• Changes in skin color
• Dry, red, hot, or irritated skin
• Joint pain
• Muscle pain
• Pain
• Redness, burning sensation, or pain under the skin, usually at the injection site
• Swelling of the foot or leg
• Tenderness

Rare

• Agitation
• Anxiety
• Back, leg, or stomach pains
• Black, tarry stools
• Bleeding gums
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Blood in the urine
• Bloody, black, or tarry stools
• Blue lips, fingernails, or skin
• Blurred vision
• Bone pain
• Burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• Chest pain or discomfort
• Chest pain, possibly moving to the left arm, neck, or shoulder
• Chills
• Coma
• Confusion
• Constipation
• Convulsions or seizures
• Cough or hoarseness
• Darkened urine
• Decreased urine output
• Difficult, fast, or labored breathing
• Difficult or painful urination
• Difficulty moving
• Difficulty swallowing
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Drowsiness
• Extremely shallow or slow breathing
• Fainting
• Fast, slow, irregular, pounding, or racing heartbeat or pulse
• Feeling of warmth or heat
• Flushing or redness of the skin, especially on the face and neck
• General body swelling
• General tiredness and weakness
• Hallucinations
• Headache
• High fever
• Hives
• Inability to speak
• Increased thirst
• Indigestion
• Irritability
• Itching
• Light-colored stools
• Loss of appetite
• Loss of bladder control
• Loss of consciousness
• Loss of strength or energy
• Lower back or side pain
• Muscle pain or cramps
• Muscle stiffness or weakness
• Nausea or vomiting
• No blood pressure or pulse
• Nosebleeds
• Not breathing
• Pain in the joints
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Pale skin
• Problems with bleeding or clotting
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Redness, burning sensation, or pain in the vagina
• Sensation of pins and needles
• Severe bloody diarrhea
• Severe or sudden headache
• Shakiness in the legs, arms, hands, or feet
• Shortness of breath
• Skin rash
• Skin rash with red patches
• Slurred speech
• Sore throat
• Sores on the skin
• Sores, ulcers, or white spots on the lips or in the mouth
• Stabbing pain
• Stiff neck
• Stopping of the heart
• Sweating
• Swelling of the face, ankles, or hands
• Swollen glands
• Temporary blindness
• Tightness in the chest
• Tingling of the hands or feet
• Total body jerking
• Trembling or shaking of the hands or feet
• Troubled breathing
• Unconsciousness
• Unexplained bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Upper right abdominal or stomach pain
• Vomiting
• Vomiting of blood or material that looks like coffee grounds
• Weakness in the arm or leg on one side of the body, sudden and severe
• Wheezing
• Worsening of the underlying disease
• Yellowing of the eyes or skin

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen 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:

Rare

• Acid or sour stomach
• Ankle, knee, or great toe joint pain
• Belching
• Cold sweats
• Cool, pale skin
• Cramps in the legs
• Depression
• Excessive muscle tone
• Heartburn
• Hives or welts
• Increased hunger
• Itching of the vagina or genital area
• Joint stiffness or swelling
• Lower back or side pain
• Muscle tension or tightness
• Nightmares
• Pain during sexual intercourse
• Redness of the skin
• Shakiness
• Sleeplessness
• Stomach discomfort, upset, or pain
• Sweating
• Swelling or inflammation of the mouth
• Thick, white vaginal discharge with no odor or with a mild odor
• Trouble sleeping
• Unable to sleep
• White patches in the mouth, tongue, or throat

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.

In the U.S.

• Synercid

Chemical Class: Streptogramin

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.