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TIGECYCLINE (UNII: 70JE2N95KR) (TIGECYCLINE - UNII:70JE2N95KR)
Sandoz Inc
TIGECYCLINE
TIGECYCLINE 50 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
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. 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,
Tigecycline for injection, USP is supplied in a single-dose 5 mL glass vial or 10 mL glass vial, each containing 50 mg tigecycline lyophilized powder for reconstitution. Supplied: NDC 0781-3481-95 box of ten 50 mg 5 mL vials NDC 0781-3481-92 box of ten 50 mg 10 mL vials Prior to reconstitution, tigecycline 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 tigecycline 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 )].
Abbreviated New Drug Application
TIGECYCLINE- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TIGECYCLINE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TIGECYCLINE FOR INJECTION. 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 TIGECYCLINE 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. TIGECYCLINE 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) 6/2020 Warnings and Precautions, Monitoring of Blood Coagulation parameters (5.6) 6/2020 Warnings and Precautions, Tooth Discoloration and Enamel Hypoplasia (5.7) 1/2020 Warnings and Precautions, Inhibition of Bone Growth (5.8) 1/2020 INDICATIONS AND USAGE Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: • • • Limitations of Use: Tigecycline for injection 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 Tigecycline for injection and other antibacterial drugs, Tigecycline for injection 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 5 mL vial or 10 mL vial. (3) CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • Complicated skin and skin structure infections (1.1) Comp 전체 문서 읽기