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Synercid (Quinupristin / Dalfopristin Injection) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Synercid is indicated in adults for the treatment of the following infections when caused by susceptible strains of the designated microorganisms.

Vancomycin-resistant Enterococcus faecium (VREF)

Synercid is indicated for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia. (See CLINICAL STUDIES.)

One of Synercid 's approved indications is for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia. Synercid has been approved for marketing in the United States for this indication 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 drugs for marketing under these regulations is based upon a demonstrated effect on a surrogate endpoint that is likely to predict clinical benefit.

Approval of this indication is based upon Synercid '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. However, a study to verify the clinical benefit of therapy with Synercid on traditional clinical endpoints (such as cure of the underlying infection) is presently underway.

Complicated skin and skin structure infections caused by Staphylococcus aureus (methicillin susceptible) or Streptococcus pyogenes. (See CLINICAL STUDIES.)

DOSAGE AND ADMINISTRATION

Synercid should be administered by intravenous infusion in 5% Dextrose in Water solution over a 60-minute period. (See WARNINGS.) The recommended dosage for the treatment of infections is described in the table below. 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.

Dose
Vancomycin-Resistant Enterococcus faecium 7.5 mg/kg q8h
Complicated Skin and Skin Structure Infection 7.5 mg/kg q12h

The minimum recommended treatment duration for Complicated Skin and Skin Structure Infections is seven days. For Vancomycin-Resistant Enterococcus faecium infection, the treatment duration should be determined based on the site and severity of the infection.

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

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

Hepatic Insufficiency: 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 .)

Pediatric Patients (less than 16 years of age): Based on a limited number of pediatric patients treated under emergency-use conditions, no dosage adjustment of Synercid is required. (See PRECAUTIONS: Pediatric Use.)

Preparation and administration of solution:

  1. Reconstitute the 500 mg single dose vial by slowly adding 5 mL of 5% Dextrose in Water or Sterile Water for injection.

    Reconstitute the 600 mg single dose vial by slowly adding 6 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.

COMPATIBILITY:

DO NOT DILUTE WITH SALINE SOLUTIONS BECAUSE SYNERCID IS NOT COMPATIBLE WITH THESE AGENTS. Synercid should not be mixed with, or physically added to, other drugs except for the following drugs where compatibility by Y-site injection has been established:

Y-Site Injection Compatibility of Synercid at 2 mg/mL Concentration
Admixture and Concentration IV Infusion Solutions for Admixture
Aztreonam 20 mg/mL D5W
Ciprofloxacin 1 mg/mL D5W
Fluconazole 2 mg/mL Used as the undiluted solution
Haloperidol 0.2 mg/mL D5W
Metoclopramide 5 mg/mL D5W
Potassium Chloride 40 mEq/L D5W
D5W = 5% Dextrose Injection

If Synercid is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.

With intermittent infusion of Synercid and other drugs through a common intravenous line, the line should be flushed before and after administration with 5% Dextrose in Water solution.

Stability and Storage: Before Reconstitution: The unopened vials should be stored in a refrigerator at 2 to 8°C (36 to 46°F).

Reconstituted and Infusions Solutions: 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.

HOW SUPPLIED

Synercid is supplied as a sterile lyophilized pyrogen-free preparation in single-dose 10 mL type I glass vials with gray elastomeric closure, and aluminum seal with a dark blue flip-off cap for the 500 mg vial and a red flip-off cap for the 600 mg vial.

NDC 61570-260-10 Synercid IV 500 mg 150 mg quinupristin and 10 vials
350 mg dalfoptistin
NDC 61570-261-10 Synercid IV 600 mg 180 mg quinupristin and 10 vials
420 mg dalfoptistin

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