Source: Health Products and Food Branch (CA)
SYNERCID (quinupristin and dalfopristin in the ratio of 30:70) is indicated in adults for the treatment of the following infections when caused by susceptible strains of the designated microorganisms, for which intravenous therapy is appropriate.
Before instituting treatment with SYNERCID appropriate specimens should be obtained for isolation of the causative organism(s) and for determination of susceptibility to SYNERCID. If clinically indicated, treatment with SYNERCID may be started empirically before results of susceptibility testing are available. In infections where gram-negative or anaerobic pathogens are suspected or are shown to be present, SYNERCID should be used in combination with another antibiotic(s) to provide appropriate antimicrobial coverage. Once culture results are available, appropriate antibiotic therapy should be continued. Vancomycin-resistant Enterococcus faecium (VREF): SYNERCID is indicated for the treatment of the following serious and life-threatening infections when due to VREF:
Note: This indication for VREF is based entirely on data from uncontrolled, compassionate-use studies.
Complicated skin and skin structure infections caused by Staphylococcus aureus (methicillin susceptible) and Streptococcus pyogenes where intravenous therapy is considered appropriate.
Note: No cases of serious skin and skin structure infections, including necrotizing fasciitis, were studied in the clinical trials.
The recommended dose of SYNERCID (quinupristin and dalfopristin in the ratio of 30:70) in adults is 7.5 mg/kg of actual body weight administered by intravenous administration (See WARNINGS) in 5% dextrose injection over a 60-minute period, q8 hours or q12 hours. An infusion pump may be used to control the rate of infusion.
| Indications | Dose | Frequency | Recommended treatment duration |
|---|---|---|---|
| Complicated skin and skin structure infections | 7.5 mg/kg | q12h | 7 to 14 days. Minimum: 7 days. |
| Infections caused by Vancomycin-resistant Enterococcus faecium see INDICATIONS | 7.5 mg/kg | q8h | Depends on site and severity of infection. (Mean duration in clinical studies: 15 to 20 days.) |
Note: See WARNINGS, PRECAUTIONS: General, and PHARMACEUTICAL INFORMATION for detailed instructions on the administration of SYNERCID.
Synercid should not be administered as an intravenous bolus.
Do not dilute with saline solutions because SYNERCID is not compatible with saline.
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 the drug.
If moderate to severe venous irritation occurs following peripheral administration of SYNERCID diluted in 250 mL of 5% dextrose injection, consideration should be given to increasing the peripheral infusion volume to 500 or 750 mL of 5% dextrose injection, changing the infusion site, or infusing by a peripherally inserted central catheter or a central venous catheter.
Following completion of the infusion the vein should be flushed with 5% dextrose injection to minimize venous irritation. Do not flush with saline or heparin after SYNERCID administration because of concerns relating to incompatibility.
No dosage adjustment of SYNERCID is required for use in the elderly (see ACTION AND CLINICAL PHARMACOLOGY and PRECAUTIONS).
No dosage adjustment of SYNERCID is required for use in the elderly (see ACTION AND CLINICAL PHARMACOLOGY and PRECAUTIONS).
Data from clinical trials of SYNERCID suggest that the incidence of adverse reactions considered to be drug-related 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 scores A and B) suggest a dosage reduction may be necessary but exact recommendations cannot be made. Pharmacokinetic data in patients with severe hepatic involvement receiving SYNERCID have not been studied (see ACTION AND CLINICAL PHARMACOLOGY and PRECAUTIONS: Special populations: Patients with hepatic insufficiency).
No dosage adjustment of SYNERCID is required for use in obese patients (see ACTION AND CLINICAL PHARMACOLOGY and PRECAUTIONS).
Although limited numbers of paediatric patients have been treated with SYNERClD, its safety and efficacy have not been established for patients less than 16 years of age. Therefore there are insufficient data on which to base a dose recommendation (see PRECAUTIONS).
There were four cases of overdose with SYNERCID (quinupristin and dalfopristin in the ratio of 30:70). Patients received SYNERCID doses at up to three times that recommended (7.5 mg/kg). No adverse events were considered possibly or probably related to SYN ERCI D 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.
Before reconstitution: The unopened vials should be stored in a refrigerator at 2 to 8°C.
Reconstituted and infusions solutions: Since SYNERCID contains no antibacterial preservative, it should be reconstituted under strict aseptic conditions (e.g. Laminar Air Flow Hood). 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. The solution should not be frozen.
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