Watch More! Unlock the full videos with a FREE trial
Add to Study plan
Master
Included In This Lesson
Access More! View the full outline and transcript with a FREE trial
Outline
What is the generic name?
PRETOMANID
What is the Trade Name for PRETOMANID?
Pretomanid
What are the Indications for PRETOMANID?
- 1 INDICATIONS AND USAGE Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients. Limitations of Use: • Pretomanid Tablets are not indicated in patients with the following conditions: o Drug-sensitive (DS) tuberculosis o Latent infection due to Mycobacterium tuberculosis. o Extra-pulmonary infection due to Mycobacterium tuberculosis. o MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy. • Safety and effectiveness of Pretomanid Tablets have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen [see Dosage and Administration (2.2) ] . Limited Population: Pretomanid Tablet is an antimycobacterial indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug‑resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients. ( 1 ) Limitations of Use ( 1 ): • Pretomanid Tablets are not indicated for patients with: • Drug-sensitive (DS) tuberculosis • Latent infection due to Mycobacterium tuberculosis • Extra-pulmonary infection due to Mycobacterium tuberculosis • MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy • Safety and effectiveness of Pretomanid Tablets have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.
View Our Nursing Pharmacology Course
References: https://open.fda.gov/
Other Pharm Resources
View the FULL Outline
When you start a FREE trial you gain access to the full outline as well as:
- SIMCLEX (NCLEX Simulator)
- 6,500+ Practice NCLEX Questions
- 2,000+ HD Videos
- 300+ Nursing Cheatsheets
“Would suggest to all nursing students . . . Guaranteed to ease the stress!”
~Jordan