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:

Sandoz Inc

INN (International Name):

TIGECYCLINE

Sammensætning:

TIGECYCLINE 50 mg in 10 mL

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. intermedius,

Produkt oversigt:

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 )].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TIGECYCLINE- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SANDOZ INC
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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
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:
•
•
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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
•
•
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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
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WARNINGS AND PRECAUTIONS
•
•
Complicated skin and skin structure infections (1.1)
Comp