TYGACIL- tigecycline injection, powder, lyophilized, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

TYGACIL (tigecycline) for injection is supplied in a single-dose 10 mL glass vial, containing 50 mg tigecycline lyophilized powder for reconstitution. Supplied: 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)] .

Autorisasjon status:

New Drug Application

Preparatomtale

TYGACIL- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
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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)
6/2020
Warnings and Precautions, Monitoring of Blood Coagulation Parameters
(5.6)
6/2020
INDICATIONS AND USAGE
TYGACIL 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: 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
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)
Obtain baseline blood coagulation parameters, including fibrinogen,
and continue to monitor regularly
dur