Pretomanid Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—14, 26, 182
Manufacturer
Pretomanid Indications
Indications
As part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug or those with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy.
Limitations of Use
Not for treating drug-sensitive TB, latent infection, or extra-pulmonary infection due to Mycobacterium tuberculosis, or TB resistant to isoniazid and rifampin in those who are responsive to standard therapy and not treatment-intolerant. The safety and efficacy for use in combination with drugs other than bedaquiline and linezolid have not been established.
Pretomanid Dosage and Administration
Adult
Children
Pretomanid Contraindications
Not Applicable
Pretomanid Boxed Warnings
Not Applicable
Pretomanid Warnings/Precautions
Warnings/Precautions
Pretomanid Pharmacokinetics
See Literature
Pretomanid Interactions
Interactions
Avoid concomitant strong or moderate CYP3A4 inducers (eg, rifampin, efavirenz), alcohol, hepatotoxic agents (including herbal supplements). Concomitant organic anion transporter-3 substrates (eg, methotrexate, indomethacin, ciprofloxacin); monitor frequently and consider dose reduction of substrates.
Pretomanid Adverse Reactions
Adverse Reactions
Pretomanid Clinical Trials
See Literature
Pretomanid Note
Not Applicable
Pretomanid Patient Counseling
See Literature