Indications for TYGACIL:
Susceptible complicated skin and skin structure and intra-abdominal infections. Community-acquired bacterial pneumonia (CABP).
Limitations of Use:
Not for treating diabetic foot infection, hospital-acquired or ventilator-associated pneumonia.
≥18yrs: Give by IV infusion over 30–60 mins. 100mg once, then 50mg every 12hrs. Skin, skin structure, and intra-abdominal infections: treat for 5–14 days. CABP: treat for 7–14 days. Severe hepatic impairment (Child Pugh C): 100mg once, then 25mg every 12hrs.
<18yrs: not recommended. See full labeling for suggested dosages when no alternative antibacterial drugs are available.
Risk of increase in all-cause mortality; reserve for use when alternatives are not suitable. Monitor for hepatic dysfunction and pancreatitis; consider discontinuing if occurs. Ventilator-associated pneumonia. Complicated intra-abdominal infections secondary to intestinal perforation: avoid monotherapy (sepsis/septic shock may develop). Monitor blood coagulation parameters (including fibrinogen) at baseline and during treatment. Severe hepatic impairment. Risk of tooth discoloration, enamel hypoplasia, and reversible bone growth inhibition (during 2nd/3rd trimester of pregnancy, infancy, and childhood up to age 8yrs). Pregnancy (2nd/3rd trimester). Nursing mothers (avoid if therapy >3 weeks): may consider interrupting breastfeeding and pumping and discarding breastmilk during and for 9 days after the last dose.
Monitor warfarin. May potentiate calcineurin inhibitors (eg, cyclosporine, tacrolimus); monitor. May antagonize oral contraceptives.
Nausea, vomiting, diarrhea, abdominal pain, headache, increased SGPT; pancreatitis, anaphylaxis, hypofibrinogenemia, C. difficile-associated diarrhea.
Generic Drug Availability:
Single-use vials (5mL, 10mL)—10