Tygacil

Generic name: Tigecycline
Drug class: Glycylcyclines

Usage of Tygacil

Tygacil is an antibiotic that fights bacteria in the body.

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

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

Tygacil side effects

Get emergency medical help if you have signs of an allergic reaction to Tygacil: hives; difficulty 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;

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 Tygacil side effects may include:

nausea, vomiting, stomach pain;

diarrhea;

headache; or

abnormal liver function tests.

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.

Before taking Tygacil

You should not use Tygacil if you are allergic to tigecycline.

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

you have liver disease;

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

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

Death has occurred more often in people using Tygacil 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 Tygacil.

Do not use Tygacil 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.

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

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 Tygacil. Tigecycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Relate drugs

How to use Tygacil

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: -Tygacil 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 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: -Tygacil 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: -Tygacil 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 Tygacil-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:

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: -Tygacil 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 Tygacil-treated adult patients. -Proposed doses based on exposures seen in pharmacokinetic trials (small numbers of pediatric patients included).

Warnings

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.

Do not use Tygacil if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Tygacil can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using this medicine.

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

What other drugs will affect Tygacil

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.

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