Synercid
- Generic Name: quinupristin and dalfopristin
- Brand Name: Synercid
- Drug Class: Streptogramins
Synercid (Quinupristin and Dalfopristin) side effects drug center
Synercid I.V. (quinupristin and dalfopristin) for Injection is a combination antibiotic used to treat severe infections in the blood and other body systems. Common side effects of Synercid I.V. include:
- nausea,
- vomiting,
- diarrhea,
- constipation,
- headache,
- joint or muscle pain,
- skin rash or itching,
- dizziness,
- sleep problems (insomnia),
- vaginal itching or discharge, or
- local reactions where the IV needle is placed (pain, swelling, or irritation).
Tell your doctor if you have serious side effects of Synercid I.V. including:
- diarrhea that is watery or bloody;
- yellowing skin or eyes (jaundice);
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
- confusion, seizures (convulsions);
- lightheadedness, fainting;
- pale skin, easy bruising or bleeding, unusual weakness; or
- chills, body aches, flu symptoms.
Synercid should be administered by intravenous infusion in 5% Dextrose in Water solution over a 60-minute period. The recommended dosage for the treatment of complicated skin and skin structure infections is 7.5 mg/kg every 12 hours. Synercid I.V. may interact with cisapride, digoxin, diazepam, midazolam, methylprednisolone, cyclosporine, tacrolimus, cancer medications, calcium channel blockers, HIV or AIDS medications, or heart rhythm medications. Tell your doctor all medications you use. During pregnancy, Synercid I.V. should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Synercid I.V. (quinupristin and dalfopristin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe stomach pain, diarrhea that is watery or bloody;
- pain, bruising, swelling, or severe irritation around the IV needle;
- jaundice (yellowing of the skin or eyes);
- a seizure (convulsions);
- irregular heart rate; or
- sudden numbness or weakness, severe headache, slurred speech, problems with balance.
Common side effects may include:
- mild irritation around the IV needle;
- rash; or
- nausea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Synercid (Quinupristin and Dalfopristin)
SIDE EFFECTS
The safety of Synercid was evaluated in 1099 patients enrolled in 5 comparative clinical trials. Additionally, 4 non-comparative clinical trials (3 prospective and 1 retrospective in design) were conducted in which 1199 patients received Synercid for infections due to Gram-positive pathogens for which no other treatment option was available. In non-comparative trials, the patients were severely ill, often with multiple co-morbidities or physiological impairments, and may have been intolerant to or failed other antibacterial therapies.
Comparative Trials
Adverse Reactions Summary– All Comparative Studies
Safety data are available from five comparative clinical studies (n= 1099 Synercid; n= 1095 comparator). One of the deaths in the comparative studies was assessed as possibly related to Synercid. The most frequent reasons for discontinuation due to drug-related adverse reactions were as follows:
Table 5: Percent (%) of Patients Discontinuing Therapy by Reaction Type
Type | Synercid | Comparator |
Venous | 9.2 | 2.0 |
Non-venous | 9.6 | 4.3 |
-Rash | 1.0 | 0.5 |
-Nausea | 0.9 | 0.6 |
-Vomiting | 0.5 | 0.5 |
-Pain | 0.5 | 0.0 |
-Pruritus | 0.5 | 0.3 |
Clinical Reactions– All Comparative Studies
Adverse reactions with an incidence of ≥1% and possibly or probably related to Synercid administration include:
Table 6: Adverse Reactions with an Incidence of ≥1% and Possibly or Probably Related to Synercid Administration
Adverse Reactions | % of patients with adverse reactions | |
Synercid | Comparator | |
Inflammation at infusion site | 42.0 | 25.0 |
Pain at infusion site | 40.0 | 23.7 |
Edema at infusion site | 17.3 | 9.5 |
Infusion site reaction | 13.4 | 10.1 |
Nausea | 4.6 | 7.2 |
Thrombophlebitis | 2.4 | 0.3 |
Diarrhea | 2.7 | 3.2 |
Vomiting | 2.7 | 3.8 |
Rash | 2.5 | 1.4 |
Headache | 1.6 | 0.9 |
Pruritus | 1.5 | 1.1 |
Pain | 1.5 | 0.1 |
Additional adverse reactions that were possibly or probably related to Synercid with an incidence less than 1% within each body system are listed below:
Body as a Whole: abdominal pain, worsening of underlying illness, allergic reaction, chest pain, fever, infection;
Cardiovascular: palpitation, phlebitis;
Digestive: constipation, dyspepsia, oral moniliasis, pancreatitis, pseudomembranous enterocolitis, stomatitis;
Metabolic: gout, peripheral edema;
Musculoskeletal: arthralgia, myalgia, myasthenia;
Nervous: anxiety, confusion, dizziness, hypertonia, insomnia, leg cramps, paresthesia, vasodilation;
Respiratory: dyspnea, pleural effusion;
Skin and Appendages: maculopapular rash, sweating, urticaria;
Urogenital: hematuria, vaginitis
Clinical Reactions– Skin And Structural Studies
In two of the five comparative clinical trials Synercid (n=450) and comparator regimens (e.g., oxacillin/vancomycin or cefazolin/vancomycin; n=443) were studied for safety and efficacy in the treatment of complicated skin and skin structure infections. The adverse event profile seen in the Synercid patients in these two studies differed significantly from that seen in the other comparative studies. What follows is safety data from these two studies.
Discontinuation of therapy was most frequently due to the following drug related events:
Table 7: Drug Related Events Most Frequently Leading to Discontinuation of Therapy
% of patients discontinuing therapy by reaction type | ||
Type | Synercid | Comparator |
Venous | 12.0 | 2.0 |
Non-venous | 11.8 | 4.0 |
-Rash | 2.0 | 0.9 |
-Nausea | 1.1 | 0.0 |
-Vomiting | 0.9 | 0.0 |
-Pain | 0.9 | 0.0 |
-Pruritus | 0.9 | 0.5 |
Venous adverse events were seen predominately in patients who had peripheral infusions. The most frequently reported venous and non-venous adverse reactions possibly or probably related to study drug were:
Table 8: The Most Frequently Reported Venous and Non-Venous Adverse Reactions Possibly or Probably Related to Study Drug
% of patients with adverse reactions | ||
Synercid | Comparator | |
Venous | 68.0 | 32.7 |
-Pain at infusion site | 44.7 | 17.8 |
-Inflammation at infusion site | 38.2 | 14.7 |
-Edema at infusion site | 18.0 | 7.2 |
-Infusion site reaction | 11.6 | 3.6 |
Non-venous | 24.7 | 13.1 |
-Nausea | 4.0 | 2.0 |
-Vomiting | 3.7 | 1.0 |
-Rash | 3.1 | 1.3 |
-Pain | 3.1 | 0.2 |
There were eight (1.7%) episodes of thrombus or thrombophlebitis in the Synercid arms and none in the comparator arms.
Laboratory Events-All Comparative Studies
Table 9 shows the number (%) of patients exhibiting laboratory values above or below the clinically relevant “critical” values during treatment phase (with an incidence of 0.1% or greater in either treatment group).
Table 9: Laboratory Events
Parameter | Critically High or Low Value | Synercid Critically High or Low | Comparator Critically High or Low |
AST | > 10 x ULN | 9 (0.9) | 2 (0.2) |
ALT | > 10 x ULN | 4 (0.4) | 4 (0.4) |
Total Bilirubin | > 5 x ULN | 9 (0.9) | 2 (0.2) |
Conjugated Bilirubin | > 5 x ULN | 29 (3.1) | 12 (1.3) |
LDH | > 5 x ULN | 10 (2.6) | 8 (2.1) |
Alk Phosphatase | > 5 x ULN | 3 (0.3) | 7 (0.7) |
Gamma-GT | > 10 x ULN | 19 (1.9) | 10 (1.0) |
CPK | > 10 x ULN | 6 (1.6) | 5 (1.4) |
Creatinine | ≥ 440 μmoL/L | 1 (0.1) | 1 (0.1) |
BUN | ≥ 35.5 mmoL/L | 2 (0.3) | 9 (1.2) |
Blood Glucose | > 22.2 mmoL/L | 11 (1.3) | 11 (1.3) |
< 2.2 mmoL/L | 1 (0.1) | 1 (0.1) | |
Bicarbonates | > 40 mmoL/L | 2 (0.3) | 3 (0.5) |
< 10 mmoL/L | 3 (0.5) | 3 (0.5) | |
CO2 | > 50 mmoL/L | 0 (0.0) | 0 (0.0) |
< 15 mmoL/L | 1 (0.2) | 0 (0.0) | |
Sodium | > 160 mmoL/L | 0 (0.0) | 0 (0.0) |
< 120 mmoL/L | 5 (0.5) | 3 (0.3) | |
Potassium | > 6.0 mmoL/L | 3 (0.3) | 6 (0.6) |
< 2.0 mmoL/L | 0 (0.0) | 1 (0.1) | |
Hemoglobin | < 8 g/dL | 25 (2.6) | 16 (1.6) |
Hematocrit | > 60% | 2 (0.2) | 0 (0.0) |
Platelets | > 1,000,000/mm3 | 2 (0.2) | 2 (0.2) |
< 50,000/mm3 | 6 (0.6) | 7 (0.7) |
Non- Comparative Trials
Clinical Adverse Reactions
Approximately one-third of patients discontinued therapy in these trials due to adverse events. However, the discontinuation rate due to adverse reactions assessed by the investigator as possibly or probably related to Synercid therapy was approximately 5.0%.
There were three prospectively designed non-comparative clinical trials in patients (n = 972) treated with Synercid. One of these studies (301), had more complete documentation than the other two (398A and 398B). The most common events probably or possibly related to therapy are presented in Table 10:
Table 10: The Most Common Events Probably or Possibly Related to Therapy
Adverse Reactions | % of patients with adverse reaction | ||
Study 301 | Study 398A | Study 398B | |
Arthralgia | 7.8 | 5.2 | 4.3 |
Myalgia | 5.1 | 0.95 | 3.1 |
Arthralgia and Myalgia | 7.4 | 3.3 | 6.8 |
Nausea | 3.8 | 2.8 | 4.9 |
The percentage of patients who experienced severe related arthralgia and myalgia was 3.3% and 3.1%, respectively. The percentage of patients who discontinued treatment due to related arthralgia and myalgia was 2.3% and 1.8%, respectively.
Laboratory Events
The most frequently observed abnormalities in laboratory studies were in total and conjugated bilirubin, with increases greater than 5 times upper limit of normal, irrespective of relationship to Synercid, reported in 25.0% and 34.6% of patients, respectively. The percentage of patients who discontinued treatment due to increased total and conjugated bilirubin was 2.7% and 2.3%, respectively. Of note, 46.5% and 59.0% of patients had high baseline total and conjugated bilirubin levels before study entry.
Other
Serious adverse reactions in clinical trials, including non-comparative studies, considered possibly or probably related to Synercid administration with an incidence < 0.1% include: acidosis, anaphylactoid reaction, apnea, arrhythmia, bone pain, cerebral hemorrhage, cerebrovascular accident, coagulation disorder, convulsion, dysautonomia, encephalopathy, grand mal convulsion, hemolysis, hemolytic anemia, heart arrest, hepatitis, hypoglycemia, hyponatremia, hypoplastic anemia, hypoventilation, hypovolemia, hypoxia, jaundice, mesenteric arterial occlusion, neck rigidity, neuropathy, pancytopenia, paraplegia, pericardial effusion, pericarditis, respiratory distress syndrome, shock, skin ulcer, supraventricular tachycardia, syncope, tremor, ventricular extrasystoles and ventricular fibrillation. Cases of hypotension and gastrointestinal hemorrhage were reported in less than 0.2% of patients.
Post-Marketing Experiences
In addition to adverse events reported from clinical trials, reports of angioedema and anaphylactic shock have been identified during post approval use of Synercid.
Read the entire FDA prescribing information for Synercid (Quinupristin and Dalfopristin)
© Synercid Patient Information is supplied by Cerner Multum, Inc. and Synercid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.