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More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL
Date:4/23/2008

nada, Switzerland and India.

Indications

TYGACIL(R) (tigecycline) is indicated for the treatment of adults with:

-- Complicated skin and skin structure infections caused by Escherichia

coli, Enterococcus faecalis (vancomycin-susceptible isolates only),

Staphylococcus aureus (methicillin-susceptible and -resistant

isolates), Streptococcus agalactiae, Streptococcus anginosus group

(includes S. anginosus, S. intermedius, and S. constellatus),

Streptococcus pyogenes, and Bacteroides fragilis

-- Complicated intra-abdominal infections caused by Citrobacter freundii,

Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella

pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates

only), Staphylococcus aureus (methicillin-susceptible isolates only),

Streptococcus anginosus group (includes S. anginosus, S. intermedius,

and S. constellatus), Bacteroides fragilis, Bacteroides

thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus,

Clostridium perfringens, and Peptostreptococcus micros

Important Safety Information

-- 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 proven or strongly suspected to be

caused by susceptible bacteria

-- Anaphylaxis/anaphylactoid reactions have been reported with nearly all

antibacterial agents, including tigecycline, and may be life-

threatening

-- TYGACIL is contraindicated in patients with known hypersensitivity to

tigecycline

-- TYGACIL should be administered with caution in patients with known

hypersensitivity to tetracycline class antibiotics

-- Glycylcycline class antibiotics are structurally similar to

tetracycline class antibiotics and may hav
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SOURCE Wyeth Pharmaceuticals
Copyright©2008 PR Newswire.
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