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tigecycline

Pronunciation

Generic Name: tigecycline (tye ge SYE kleen)
Brand Name: Tygacil

What is tigecycline?

Tigecycline is an antibiotic that fights bacteria in the body.

Tigecycline is used to treat many different bacterial infections of the skin or the digestive system, as well as pneumonia.

Tigecycline should be used only for infections that cannot be treated with other medicines.

Tigecycline may also be used for purposes not listed in this medication guide.

What is the most important information I should know about tigecycline?

Death has occurred more often in people using tigecycline when compared with people using other antibiotics. Deaths were usually caused by complications from the infection or by other medical conditions. It is not known whether tigecycline treatment causes death.

Slideshow: Flashback: FDA Drug Approvals 2013

What should I discuss with my healthcare provider before using tigecycline?

You should not use this medicine if you are allergic to tigecycline.

To make sure tigecycline is safe for you, tell your doctor if you have:

  • liver disease;

  • if you are using a blood thinner (warfarin, Coumadin, Jantoven); or

  • if you are allergic to a tetracycline antibiotic (demeclocycline, doxycycline, minocycline, tetracycline).

Death has occurred more often in people using tigecycline when compared with people using other antibiotics. Many deaths were caused by complications from the infection being treated. Some deaths were caused by the patients' other medical conditions. It is not known whether tigecycline treatment causes death. Talk to your doctor about the risks and benefits of using tigecycline.

FDA pregnancy category D. Do not use tigecycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Use effective birth control, and tell your doctor right away if you become pregnant during treatment.

Tigecycline can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking tigecycline.

It is not known whether tigecycline passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Children should not use tigecycline. Tigecycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

How is tigecycline given?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not share this medicine with another person, even if they have the same symptoms you have.

Tigecycline is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Tigecycline must be given slowly, and the IV infusion can take up to 60 minutes to complete.

Tigecycline is a powder medicine that must be mixed with a liquid (diluent) in an IV bag before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Prepare your dose only when you are ready to give yourself an injection. After mixing, the liquid should appear as a yellow or orange color. Do not use the medication if it has changed to green or black, or if it has any particles in it. Call your doctor for a new prescription.

Do not give any of the following drugs through the same IV line used to give your tigecycline injection:

  • amphotericin (Amphocin, Fungizone);

  • amphotericin B lipid complex (Abelcet);

  • diazepam (Valium); or

  • esomeprazole (Nexium I.V.).

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Tigecycline will not treat a viral infection such as the common cold or flu.

Store unmixed powder at room temperature away from moisture and heat.

Mixed medicine in an IV bag must be used within 24 hours if you keep it at room temperature.

Tigecycline mixed in an IV bag with sodium chloride or dextrose solution may be stored in a refrigerator and used within 48 hours.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using tigecycline?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using tigecycline and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Tigecycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Tigecycline side effects

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:

  • diarrhea that is watery or bloody;

  • increased pressure inside the brain--severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;

  • pancreas problems-severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, mild stomach pain;

  • mild diarrhea; or

  • headache.

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.

See also: Side effects (in more detail)

Tigecycline dosing information

Usual Adult Dose for Intraabdominal Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration of therapy: 5 to 14 days

Approved indication: For the treatment of complicated intraabdominal infections due to susceptible isolates of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus group (includes S anginosus, S intermedius, and S constellatus), Bacteroides fragilis, B thetaiotaomicron, B uniformis, B vulgatus, Clostridium perfringens, and Peptostreptococcus micros

Usual Adult Dose for Skin or Soft Tissue Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration of therapy: 5 to 14 days

Comments:
-Tigecycline is not for the treatment of diabetic foot infections; clinical trial failed to show its non-inferiority.

Approved indication: For the treatment of complicated skin and skin structure infections due to susceptible isolates of E coli, E faecalis (vancomycin-susceptible isolates), S aureus (methicillin-susceptible and -resistant isolates), S agalactiae, S anginosus group (includes S anginosus, S intermedius, and S constellatus), S pyogenes, E cloacae, K pneumoniae, and B fragilis

Usual Adult Dose for Skin and Structure Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration of therapy: 5 to 14 days

Comments:
-Tigecycline is not for the treatment of diabetic foot infections; clinical trial failed to show its non-inferiority.

Approved indication: For the treatment of complicated skin and skin structure infections due to susceptible isolates of E coli, E faecalis (vancomycin-susceptible isolates), S aureus (methicillin-susceptible and -resistant isolates), S agalactiae, S anginosus group (includes S anginosus, S intermedius, and S constellatus), S pyogenes, E cloacae, K pneumoniae, and B fragilis

Usual Adult Dose for Pneumonia:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration of therapy: 7 to 14 days

Comments:
-Tigecycline is not for the treatment of hospital-acquired or ventilator-associated pneumonia; greater mortality and decreased efficacy reported in comparative clinical trial.

Approved indication: For the treatment of community-acquired bacterial pneumonia due to susceptible isolates of S pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila

Usual Pediatric Dose for Intraabdominal Infection:

Proposed for complicated infections:
8 to 11 years: 1.2 mg/kg IV every 12 hours
Maximum dose: 50 mg/dose

12 to 17 years: 50 mg IV every 12 hours

Comments:
-Tigecycline should not be used unless no alternative antibacterial agents are available.
-Safety and efficacy of the suggested regimens have not been evaluated due to the increase in mortality observed in tigecycline-treated adult patients.
-Proposed doses based on exposures seen in pharmacokinetic trials (small numbers of pediatric patients included).

Usual Pediatric Dose for Skin and Structure Infection:

Proposed for complicated infections:
8 to 11 years: 1.2 mg/kg IV every 12 hours
Maximum dose: 50 mg/dose

12 to 17 years: 50 mg IV every 12 hours

Comments:
-Tigecycline should not be used unless no alternative antibacterial agents are available.
-Safety and efficacy of the suggested regimens have not been evaluated due to the increase in mortality observed in tigecycline-treated adult patients.
-Proposed doses based on exposures seen in pharmacokinetic trials (small numbers of pediatric patients included).

Usual Pediatric Dose for Pneumonia:

Proposed for community-acquired bacterial pneumonia:
8 to 11 years: 1.2 mg/kg IV every 12 hours
Maximum dose: 50 mg/dose

12 to 17 years: 50 mg IV every 12 hours

Comments:
-Tigecycline should not be used unless no alternative antibacterial agents are available.
-Safety and efficacy of the suggested regimens have not been evaluated due to the increase in mortality observed in tigecycline-treated adult patients.
-Proposed doses based on exposures seen in pharmacokinetic trials (small numbers of pediatric patients included).

What other drugs will affect tigecycline?

Other drugs may interact with tigecycline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about tigecycline.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01. Revision Date: 2014-02-04, 9:24:40 PM.

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