Synercid

Dalfopristin and quinupristin is a combination antibiotic that fights severe or life-threatening infection caused by bacteria.

Dalfopristin and quinupristin is used to treat severe infections in the blood and other body systems.

Dalfopristin and quinupristin may also be used for other purposes not listed in this medication guide.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause vomiting, trouble breathing, tremors, shaking, and loss of balance or coordination.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

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.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Synercid should be administered by intravenous infusion in 5% Dextrose in Water solution over a 60-minute period. (See WARNINGS.) An infusion pump or device may be used to control the rate of infusion. If necessary, central venous access (e.g., PICC) can be used to administer Synercid to decrease the incidence of venous irritation. The recommended dosage for the treatment of complicated skin and skin structure infections is 7.5 mg/kg q12h. The minimum recommended treatment duration for complicated skin and skin structure infections is seven days.

Special Populations

No dosage adjustment of Synercid is required for use in the elderly. (See CLINICAL PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: Geriatric Use.)

No dosage adjustment of Synercid is required for use in patients with renal impairment or patients undergoing peritoneal dialysis. (See CLINICAL PHARMACOLOGY: Pharmacokinetics.)

Data from clinical trials of Synercid suggest that the incidence of adverse effects in patients with chronic liver insufficiency or cirrhosis was comparable to that in patients with normal hepatic function. Pharmacokinetic data in patients with hepatic cirrhosis (Child Pugh A or B) suggest that dosage reduction may be necessary but exact recommendations cannot be made at this time. (See CLINICAL PHARMACOLOGY: Special Populations and PRECAUTIONS: General: Hepatic Insufficiency sections.)

The recommended dose of Synercid for pediatric patients (12 to < 18 years of age) is 7.5 mg/kg q12h. No dosing recommendations are available in pediatric patients less than 12 years of age. (See PRECAUTIONS: Pediatric Use.)

1. Reconstitute the 500 mg single dose vial by slowly adding 5 mL of 5% Dextrose in Water or Sterile Water for injection.
2. GENTLY swirl the vial by manual rotation without shaking to ensure dissolution of contents while LIMITING FOAM FORMATION.
3. Allow the solution to sit for a few minutes until all the foam has disappeared. The resulting solution should be clear. Vials reconstituted in this manner will give a solution of 100 mg/mL. CAUTION: FURTHER DILUTION REQUIRED BEFORE INFUSION.
4. According to the patient's weight, the reconstituted Synercid solution should be added to 250 mL of 5% Dextrose solution. An infusion volume of 100 mL may be used for central line infusions.
5. If moderate to severe venous irritation occurs following peripheral administration of Synercid diluted in 250 mL of Dextrose 5% in water, consideration should be given to increasing the infusion volume to 500 or 750 mL, changing the infusion site, or infusing by a peripherally inserted central catheter (PICC) or a central venous catheter.
6. The desired dose should be administered by intravenous infusion over 60 minutes.

NOTE: As for other parenteral drug products, Synercid should be inspected visually for particulate matter prior to administration.

Because Synercid contains no antibacterial preservative, it should be reconstituted under strict aseptic conditions (e.g., Laminar Air Flow Hood). The reconstituted solution should be diluted within 30 minutes. Vials are for single use. The storage time of the diluted solution should be as short as possible to minimize the risk of microbial contamination. Stability of the diluted solution prior to the infusion is established as 5 hours at room temperature or 54 hours if stored under refrigeration 2 to 8°C (36 to 46°F). The solution should not be frozen.

NDC 61570-260-10
Contains 10 of NDC 61570-260-01

REFRIGERATE

Synercid® I.V.

(quinupristin 150mg and
dalfopristin 350mg) for Injection

500 mg

For I.V. Use Only. Prior to Reconstitution:
Store in a refrigerator 2–8° C (36–46° F).
10 Single Dose Vials

Pfizer
Injectables

Rx only