Indicated for:

Complicated Skin and Skin Structure Infections:

• Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of 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:

• Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of 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:

• Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae, and Legionella pneumophila.

TYGACIL is not indicated for treatment of diabetic foot infection.

TYGACIL is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia. In a comparative clinical trial, greater mortality and decreased efficacy were reported in TYGACIL-treated patients.

An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in TYGACIL-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. TYGACIL should be reserved for use in situations when alternative treatments are not suitable.

Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with TYGACIL.

Hypofibrinogenemia has been reported in patients treated with TYGACIL. Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with TYGACIL.

Anaphylactic reactions have been reported with nearly all antibacterial agents, including TYGACIL, and may be life-threatening. TYGACIL is structurally similar to tetracycline-class antibiotics and should be avoided in patients with known hypersensitivity to tetracycline-class antibiotics.

Avoid use of TYGACIL in pediatric patients unless no alternative antibacterial drugs are available.

Acute pancreatitis, including fatal cases, has occurred in association with tigecycline treatment.

The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Enamel hypoplasia has also been reported. Advise the patient of the potential risk to the fetus if TYGACIL is used during the second or third trimester of pregnancy.

The use of TYGACIL during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the tetracycline was discontinued. Advise the patient of the potential risk to the fetus if TYGACIL is used during the second or third trimester of pregnancy.

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.

Increases in total bilirubin concentration, prothrombin time and transaminases have been seen in patients treated with tigecycline. Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline.

TYGACIL is structurally similar to tetracycline-class antibacterial drugs 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).

Monotherapy with tigecycline should be avoided in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation.

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.

Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective.

TYGACIL may cause fetal harm when administered to a pregnant woman. The patient should be apprised of the potential hazard to the fetus.TYGACIL, like other tetracycline class antibacterial drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy.

There are no data on the presence of tigecycline in human milk; however, tetracycline-class antibacterial drugs are present in breast milk.

GoToSource

• Use in patients under the age of 18. GoToSource 

• Osteomyelitis. GoToSource

• Multi drug-resistant tuberculosis. GoToSource

• Clostridium difficile infection. GoToSource

• Febrile neutropenia. GoToSource

• Hospital-acquired or ventilator-associated pneumonia. GoToSource

• Rapidly growing mycobacteria. GoToSource

Tygacil has a higher mortality rate than other antibiotics. GoToSource

Clostridium difficile associated diarrhea, anaphylaxis (potentially life-threatening allergic reaction) and pancreatitis (inflammation of the pancreas). GoToSource

Anorexia, nausea, vomiting, increased hepatic enzymes and bilirubin, liver injury, inhibition of bone growth in children and dental staining. GoToSource

Lawsuits filed for deaths.