Synercid

DRUG DESCRIPTION

Synercid® (quinupristin and dalfopristin powder for injection) I.V., a streptogramin antibacterial agent for intravenous administration, is a sterile lyophilized formulation of two semisynthetic pristinamycin derivatives, quinupristin (derived from pristinamycin I) and dalfopristin (derived from pristinamycin IIA) in the ratio of 30:70 (w/w).

Quinupristin is a white to very slightly yellow, hygroscopic powder. It is a combination of three peptide macrolactones. The main component of quinupristin ( > 88.0%) has the following chemical name: N[(6R,9S,10R,13S,15aS,18R,22S,24aS)-22-[p-(dimethylamino)benzyl]-6-ethyldocosahydro-10,23-dimethyl5,8,12,15,17,21,24-heptaoxo-13-phenyl-18-[[(3S)-3-quinuclidinylthio] methyl]-12H-pyrido[2,1-f]pyrrolo-[2,1l][1,4,7,10,13,16] oxapentaazacyclononadecin-9-yl]-3-hydroxypicolinamide.

The main component of quinupristin has an empirical formula of C53H67N9O10S, a molecular weight of 1022.24 and the following structural formula:

Quinupristin Structural Formula Illustration

Dalfopristin is a slightly yellow to yellow, hygroscopic, powder. The chemical name for dalfopristin is: (3R,4R,5E,10E,12E,14S,26R,26aS)-26-[[2-(diethylamino)ethyl]sulfonyl]-8,9,14,15,24,25,26,26a-octahydro-14hydroxy-3-isopropyl-4,12-dimethyl-3H-21,18-nitrilo-1H,22H-pyrrolo[2,1-c][1,8,4,19]dioxadiazacyclotetracosine-1,7,16,22(4H,17H)-tetrone.

Dalfopristin has an empirical formula of C34H50N4O9S, a molecular weight of 690.85 and the following structural formula:

What are the possible side effects of dalfopristin and quinupristin (Synercid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • confusion, seizure (convulsions);
  • feeling light-headed,...

Read All Potential Side Effects and See Pictures of Synercid »

What are the precautions when taking quinupristin and dalfopristin (Synercid)?

Before using quinupristin/dalfopristin, tell your doctor or pharmacist if you are allergic to it; or to other streptogramin antibiotics (e.g., pristinamycin, virginiamycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, high levels of bilirubin in the blood (hyperbilirubinemia).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Synercid »


Synercid Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: joint/muscle pain, redness/swelling/pain/warming of the skin at the injection site, yellowing eyes/skin, blood in the urine.

Get medical help right away if you experience this rare but very serious side effect: chest pain.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using quinupristin/dalfopristin, tell your doctor or pharmacist if you are allergic to it; or to other streptogramin antibiotics (e.g., pristinamycin, virginiamycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, high levels of bilirubin in the blood (hyperbilirubinemia).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Synercid Patient Information Including Side Effects

Brand Names: Synercid

Generic Name: dalfopristin and quinupristin (Pronunciation: dal FOE pris tin and kwi NYOO pris tin)

  • What is dalfopristin and quinupristin (Synercid)?
  • What are the possible side effects of dalfopristin and quinupristin (Synercid)?
  • What is the most important information I should know about dalfopristin and quinupristin (Synercid)?
  • What should I discuss with my health care provider before receiving dalfopristin and quinupristin (Synercid)?
  • How is dalfopristin and quinupristin given (Synercid)?
  • What happens if I miss a dose (Synercid)?
  • What happens if I overdose (Synercid)?
  • What should I avoid while taking dalfopristin and quinupristin (Synercid)?
  • What other drugs will affect dalfopristin and quinupristin (Synercid)?
  • Where can I get more information?

What is dalfopristin and quinupristin (Synercid)?

Dalfopristin and quinupristin is a combination antibiotic that fights severe or life-threatening infection caused by bacteria.

Dalfopristin and quinupristin is used to treat severe infections in the blood and other body systems.

Dalfopristin and quinupristin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dalfopristin and quinupristin (Synercid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • confusion, seizure (convulsions);
  • feeling light-headed, fainting;
  • pale skin, easy bruising or bleeding, unusual weakness; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • joint or muscle pain;
  • mild skin rash or itching;
  • nausea, vomiting, constipation;
  • headache, dizziness;
  • sleep problems (insomnia);
  • vaginal itching or discharge; or
  • pain, swelling, or irritation where the IV needle is placed.

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.

What is the most important information I should know about dalfopristin and quinupristin (Synercid)?

You should not receive this medication if you are allergic to dalfopristin and quinupristin.

Before receiving dalfopristin and quinupristin, tell your doctor if you have liver or kidney disease, or a history of any type of allergy.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

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