SYNERCID Powder for solution for injection Ref.[10268] Active ingredients: Dalfopristin Quinupristin

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

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

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.)

Preparation and administration of solution

• Reconstitute the 500 mg single dose vial by slowly adding 5 mL of 5% Dextrose in Water or Sterile Water for injection.
• GENTLY swirl the vial by manual rotation without shaking to ensure dissolution of contents while LIMITING FOAM FORMATION.
• 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.
• 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.
• 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.
• 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:

Table 9. Y-Site Injection Compatibility of Synercid at 2 mg/mL Concentration:

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.

There are four reports of patients receiving Synercid doses at up to three times that recommended (7.5 mg/kg). No adverse events were considered possibly or probably related to Synercid overdose. Signs of acute overdosage may include dyspnea, emesis, tremors, and ataxia as seen in animals given extremely high doses (50 mg/kg) of Synercid. Patients who receive an overdose should be carefully observed and given supportive treatment. Synercid is not removed by peritoneal dialysis or by hemodialysis.

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.