Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
TIGECYCLINE (UNII: 70JE2N95KR) (TIGECYCLINE - UNII:70JE2N95KR)
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
TIGECYCLINE
TIGECYCLINE 50 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
TYGACIL 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. TYGACIL 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 f
TYGACIL (tigecycline) for injection is supplied in a single-dose 10 mL glass vial, containing 50 mg tigecycline lyophilized powder for reconstitution. Supplied: NDC 0008-4990-20 Box containing 10 single-dose vials 50 mg/vial Prior to reconstitution, TYGACIL should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] The reconstituted solution of TYGACIL may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag) [see Dosage and Administration (2.5)] .
New Drug Application
TYGACIL- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TYGACIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TYGACIL. TYGACIL (TIGECYCLINE) FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2005 WARNING: ALL-CAUSE MORTALITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ALL-CAUSE MORTALITY WAS HIGHER IN PATIENTS TREATED WITH TYGACIL THAN COMPARATORS IN A META-ANALYSIS OF CLINICAL TRIALS. 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 _(1.4, 5.1, 5.2, 6.1)._ RECENT MAJOR CHANGES Dosage and Administration, Monitoring of Blood Coagulation Parameters (2.4) Warnings and Precautions, Monitoring of Blood Coagulation Parameters (5.6) INDICATIONS AND USAGE TYGACIL is a tetracycline class antibacterial indicated in patients 18 years of age and older for: • • • Limitations of Use: TYGACIL is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia (1.4). 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 that are proven or strongly suspected to be caused by bacteria (1.5). DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS For Injection: 50 mg, lyophilized powder for reconstitution in a single-dose 10 mL vial. (3) CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • ® 6/2020 6/2020 Complicated skin and skin structure infections (1.1) Complicated intra-abdominal infections (1.2) Community-acquired bacterial pneumonia (1.3) Initial dose of 100 mg followed by 50 mg every 12 hours administered intravenously over approximately 30 to 60 minutes. (2.1) Severe hepat read_full_document