Quinupristin and dalfopristin (Intravenous route)
- Powder for Solution
Warnings:Intravenous route(Powder for Solution)
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 .
Uses of This Medicine:
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.
Before Using This Medicine:
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.
|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.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
- Vincristine Sulfate Liposome
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.
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 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.
Proper Use of This Medicine:
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.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- 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
- redness, burning sensation, or pain under the skin usually in the injection site
- swelling of the foot or leg
- 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
- convulsions or seizures
- cough or hoarseness
- darkened urine
- decreased urine output
- difficult, fast, or labored breathing
- difficult or painful urination
- difficulty with moving
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extremely shallow or slow breathing
- 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
- high fever
- inability to speak
- increased thirst
- 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
- 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
- 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
- unexplained bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- upper right abdominal or stomach pain
- 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
- 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
- Acid or sour stomach
- ankle, knee, or great toe joint pain
- cold sweats
- cool, pale skin
- cramps in the legs
- excessive muscle tone
- 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
- pain during sexual intercourse
- redness of the skin
- stomach discomfort, upset, or pain
- 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
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 or nurse immediately if any of the following side effects occur:
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:
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.
Last Updated: 11/4/2014