cribing information are not listed
1 INDICATIONS AND USAGE
1.1 Complicated Skin and Skin Structure Infections
1.2 Complicated Intra-abdominal Infections
1.3 Community-Acquired Bacterial Pneumonia
1.4 Usage
2 DOSAGE AND ADMINISTRATION
2.1 General Dosage and Administration
2.2 Patients With Hepatic Impairment
2.3 Preparation and Handling
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 All-Cause Mortality
5.2 Anaphylaxis/Anaphylactoid Reactions
5.3 Hepatic Effects
5.4 Mortality Imbalance and Lower Cure Rates in Ventilator-Associated Pneumonia
5.5 Use During Pregnancy
5.6 Tooth Development
5.7 Clostridium difficile Associated Diarrhea
5.8 Patients With Intestinal Perforation
5.9 Tetracycline-Class Effects
5.10 Superinfection
5.11 Development of Drug-Resistant Bacteria
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 Warfarin
7.2 Oral Contraceptives
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Complicated Skin and Skin Structure Infections
14.2 Complicated Intra-abdominal Infections
14.3 Community-Acquired Bacterial Pneumonia
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
TYGACIL is a tetracycline-class antibacterial indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions listed below for patients 18 years of age and older:
1.1 Complicated Skin and Skin Structure Infections
Complicated skin and skin structure infections caused by 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.
1.2 Complicated Intra-abdominal Infections
Complicated intra-abdominal infections caused by 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 fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.
1.3 Community-Acquired Bacterial Pneumonia
Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haem |
