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Synercid (Quinupristin / Dalfopristin Injection) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug Interactions: In vitro drug interaction studies have shown that Synercid significantly inhibits cytochrome P450 3A4. (See WARNINGS.)

Synercid does not significantly inhibit human cytochrome P450 1A2, 2A6, 2C9, 2C19, 2D6, or 2E1. Therefore, clinical interactions with drugs metabolized by these cytochrome P450 isoenzymes are not expected.

A drug interaction between Synercid and digoxin cannot be excluded but is unlikely to occur via CYP3A4 enzyme inhibition. Synercid has shown in vitro activity (MICs of 0.25 mcg/mL when tested on two strains) against Eubacterium lentum. Digoxin is metabolized in part by bacteria in the gut and as such, a drug interaction based on Synercid 's inhibition of digoxin's gut metabolism (by Eubacterium lentum) may be possible.

In vitro combination testing of Synercid with aztreonam, cefotaxime, ciprofloxacin, and gentamicin, against Enterobacteriaceae and Pseudomonas aeruginosa did not show antagonism.

In vitro combination testing of Synercid with prototype drugs of the following classes: aminoglycosides (gentamicin), β-lactams (cefepime, ampicillin, and amoxicillin), glycopeptides (vancomycin), quinolones (ciprofloxacin), tetracyclines (doxycycline) and also chloramphenicol against enterococci and staphylococci did not show antagonism.

OVERDOSAGE

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.

CONTRAINDICATIONS

Synercid is contraindicated in patients with known hypersensitivity to Synercid, or with prior hypersensitivity to other streptogramins (e.g., pristinamycin or virginiamycin).

REFERENCES

  1. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fourth Edition; Approved Standard. NCCLS Document M7-A4 (ISBN 1-56238-309-4). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 1997.
  2. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition; Approved Standard. NCCLS document M2-A6 (ISBN 1-56238-308-6). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 1997.

Rx Only

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834

Prescribing Information as of November 2007

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