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TYGACIL®(tigecycline)

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TYGACIL® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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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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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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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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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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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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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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6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

  • All-Cause Mortality [see

    6.1 Clinical Trials Experience

    ...
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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

TYGACIL, like other...

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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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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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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Tigecycline is a tetracycline class antibacterial [see

12.2 Pharmacodynamics

...

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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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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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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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17 PATIENT COUNSELING INFORMATION

Tooth Discoloration and Inhibition of Bone Growth

Advise pregnant women that TYGACIL may cause permanent...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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