Pronunciation:

kwin-ue-PRIS-tin, dal-foe-PRIS-tin

Brand Names:

• Synercid

Classifications:

Chemical—

Streptogramin

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:

Allergies—

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.

Children—

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.

Older adults—

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

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.

Other 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 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
• Felodipine
• Indinavir
• Isradipine
• Lacidipine
• Lidocaine
• Manidipine
• Methylprednisolone
• Midazolam
• Nevirapine
• Nicardipine
• Nifedipine
• Nilvadipine
• Nimodipine
• Nisoldipine
• Paclitaxel
• Quinidine
• Ritonavir
• Verapamil

Other interactions—

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:

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:

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 in 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 with moving

difficulty with 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 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:

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.