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TYGACIL®(tigecycline)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
TYGACIL® Quick Finder
Highlights
Boxed Warning
WARNING: ALL-CAUSE MORTALITY
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in TYGACIL-treated patients versus comparator. The cause of this...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Complicated Skin and Skin Structure Infections
TYGACIL is indicated in patients 18 years of age and older for the treatment of complicated...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Adult Dosage
The recommended dosage regimen for TYGACIL is an initial dose of 100 mg, followed by 50 mg every 12 hours....
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For Injection: Each single-dose 10 mL glass vial contain 50 mg of tigecycline as an orange lyophilized powder for reconstitution.
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Contraindications
4 CONTRAINDICATIONS
TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline. Reactions have included anaphylactic reactions [see Warnings and...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 All-Cause Mortality
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in TYGACIL...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- All-Cause Mortality [see Boxed Warning and...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Warfarin
Prothrombin time or other suitable anticoagulation test should be monitored if TYGACIL is administered with warfarin...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
TYGACIL, like other...
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Overdosage
10 OVERDOSAGE
No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of TYGACIL at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an...
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Description
11 DESCRIPTION
TYGACIL (tigecycline) is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4S,4aS,5a...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Tigecycline is a tetracycline class antibacterial [see Microbiology (12.4)...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Lifetime studies in animals have not been performed to evaluate the carcinogenic...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Complicated Skin and Skin Structure Infections
TYGACIL was evaluated in adults for the treatment of complicated skin and skin structure...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
TYGACIL (tigecycline) for injection is supplied in a single-dose 10 mL glass vial, containing 50 mg tigecycline lyophilized powder for reconstitution.
Supplied:
...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Tooth Discoloration and Inhibition of Bone Growth
Advise pregnant women that TYGACIL may cause permanent...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.