Pretomanid Tablets
Dosage form: tablet
Drug class:Miscellaneous antituberculosis agents
Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Clinical Studies
- Nonclinical Toxicology
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
Indications and Usage for Pretomanid Tablets
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:
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- 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.
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- 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 [seeDosage and Administration (2.2)].
Pretomanid Tablets Dosage and Administration
Important Administration Instructions
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- Pretomanid Tablets must be used only in combination with bedaquiline and linezolid as part of the recommended dosing regimen [seeDosage and Administration (2.2)].
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- Emphasize t..
