Pfizer Medical Information

Health Care Professionals Log In

Sign up for TYGACIL Updates

Registering for PfizerPro.com is easy and gives you access to:

  • The 5-Minute Clinical Consult
    2008
  • Epocrates® Online Premium
  • A.D.A.M. QuickSheets
Register with Wyeth.com

Expanded broad-spectrum IV antibiotic indicated for adults with cSSSI, cIAI, and CABP due to the indicated pathogens*
(Please see Indications and Important Safety Information)

Convenient q12h dosing1

No dosage adjustments required for patients with renal impairment regardless of severity1

  • TYGACIL is eliminated unchanged primarily by the biliary/fecal route

No dosage adjustments required for patients with mild-to-moderate hepatic impairment (Child Pugh A and Child Pugh B)1

  • In patients with severe hepatic impairment (Child Pugh C), the dose of TYGACIL should be reduced. Patients should be treated with caution and monitored appropriately

No significant drug interactions when administered with digoxin or warfarin1

Convenient q12h dosing1

  • Recommended dosage regimen
    • 100 mg initial dose
    • 50 mg every 12 hours
  • In severe hepatic impairment (Child Pugh C), the initial dose
    should be 100 mg followed by a reduced dose of 25 mg every 12 hours
  • IV infusions should be administered over approximately 30 to 60 minutes every 12 hours

Duration of TYGACIL Treatment1

  • The recommended duration of treatment with TYGACIL for adults with complicated skin and skin structure infections or complicated intra-abdominal infections is 5 to 14 days, and for community-acquired bacterial pneumonia is 7 to 14 days
  • The duration of therapy should be guided by the severity and site of the infection and the patient’s clinical and bacteriological progress

Special Populations

Hepatic Impairment1

  • No dosage adjustments required for patients with mild-to-moderate hepatic impairment (Child Pugh A and Child Pugh B)
  • In patients with severe hepatic impairment (Child Pugh C), the dose of TYGACIL should be reduced. Patients should be treated with caution and monitored appropriately

Renal Impairment1

  • No dosage adjustments required for patients with renal impairment regardless of severity
  • TYGACIL is eliminated unchanged primarily by the biliary/fecal route

Hemodialysis1

  • No dosage adjustments in patients undergoing hemodialysis

Age, Gender, Race1

  • No dosage adjustment necessary based on patient age (in adult patients), gender, or race

Children1

  • The safety and effectiveness of TYGACIL have not been established in patients younger than 18 years; therefore, use of TYGACIL in patients younger than 18 years is not recommended1

Drug Interactions1

  • No significant drug interactions when administered with digoxin or warfarin
  • TYGACIL was coadministered with digoxin or warfarin to healthy patients in drug interaction studies
  • While no dosage adjustment is necessary, prothrombin time or other suitable anticoagulation test should be monitored if TYGACIL is administered with warfarin
  • Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective

How Supplied1

TYGACIL for injection is supplied in a single-dose 5 mL glass vial or 10 mL glass vial, each containing
50 mg tigecycline lyophilized powder for reconstitution. Learn more about reconstituting TYGACIL

Administration1

TYGACIL may be administered intravenously through a dedicated line or through a Y-site.
If the same intravenous line is used for sequential infusion of several drugs, the line should
be flushed before and after infusion of TYGACIL with 0.9% Sodium Chloride Injection, USP,
5% Dextrose Injection, USP, or Lactated Ringer’s Injection, USP. Injection should be made
with an infusion solution compatible with tigecycline and with any other drug(s) administered
via this common line.

Y–site compatibility1

Compatibilities

TYGACIL is compatible with the following drugs or diluents when used with either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer’s, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin

Incompatibilities

The following drugs should not be administered simultaneously through the same Y-site as TYGACIL:
amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole, and omeprazole.

Related Resources

Dosing Card (2.1mb)
Use the convenient dosing card for TYGACIL for information on dosage and administration,
special populations, Y-site compatibility, dosage adjustment requirements, and drug interactions.

Indications and Important Safety Information

*Indications

TYGACIL® (tigecycline) is indicated for the treatment of adults with:

  • Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis
  • Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus,
    S. intermedius,
    and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros
  • Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila

Important Safety Information

  • TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline
  • Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline-class antibiotics
  • Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline. Some of these patients were receiving multiple concomitant medications. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function. Adverse events may occur after the drug has been discontinued
  • The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established
  • An increase in all-cause mortality has been observed across phase 3 and 4 clinical studies in TYGACIL-treated patients versus comparator-treated patients. The cause of this increase has not been established.  This increase in all-cause mortality should be considered when selecting among treatment options
  • TYGACIL may cause fetal harm when administered to a pregnant woman
  • The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated
  • Acute pancreatitis, including fatal cases, has occurred in association with tigecycline treatment. Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis
  • Monotherapy should be used with caution in patients with clinically apparent intestinal perforation
  • TYGACIL is structurally similar to tetracycline-class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria. As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi
  • The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, infection, headache, and abdominal pain
  • Prothrombin time or other suitable anticoagulant test should be monitored if TYGACIL is administered with warfarin
  • Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective
  • The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established

Please see full Prescribing Information.