TIGECYCLINE injection, powder, lyophilized, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

TIGECYCLINE (UNII: 70JE2N95KR) (TIGECYCLINE - UNII:70JE2N95KR)

Tilgængelig fra:

Xellia Pharmaceuticals USA LLC

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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. int

Produkt oversigt:

Tigecycline for Injection, USP, is supplied in a single-dose 10 mL glass vial, each containing 50 mg tigecycline lyophilized powder for reconstitution. Supplied: 10 × 50 mg Single Use Vials in one carton. NDC 70594-035-021 Prior to reconstitution, Tigecycline for Injection, USP, 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 for Injection, USP 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(2.1)] .

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TIGECYCLINE- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
XELLIA PHARMACEUTICALS USA LLC
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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
Warnings and Precautions, Tooth Discoloration and Enamel Hypoplasia
(5.6)
1/2020
Warnings and Precautions, Inhibition of Bone Growth (5.7)
1/2020
INDICATIONS AND USAGE
Tigecycline is a tetracycline class antibacterial indicated in
patients 18 years of age and older for:
Complicated skin and skin structure infections (1.1)
Complicated intra-abdominal infections (1.2)
Community-acquired bacterial pneumonia (1.3)
Limitations of Use: Tigecycline 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 and other antibacterial
drugs, Tigecycline should be used only to treat infections that are
proven or strongly suspected to be caused by bacteria.
DOSAGE AND ADMINISTRATION
Initial dose of 100 mg, followed by 50 mg every 12 hours administered
intravenously over approximately 30 to 60
minutes. (2.1)
Severe hepatic impairment (Child Pugh C): Initial dose of 100 mg
followed by 25 mg every 12 hours. (2.2)
DOSAGE FORMS AND STRENGTHS
For Injection: 50 mg, lyophilized powder for reconstitution in a
single-d