Advise patients of reproductive toxicities seen in animal studies and that the potential effects on human male fertility have not been adequately evaluated.Lactic acidosis was reported with the combination regimen of pretomanid, bedaquiline, and linezolid. {* salutation *} The preparation of this review was not supported by any external funding.During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Myelosuppression is a known adverse reaction of linezolid. The Global Alliance for TB Drug Development (TB Alliance). Refer to the prescribing information for linezolid for additional counseling information for these serious adverse reactions.Counsel patients that linezolid dosing may be modified or interrupted during the therapy to manage the known linezolid adverse reactions of myelosuppression, peripheral neuropathy, and optic neuropathy.Inform patients that pretomanid must be taken as part of a combination regimen with bedaquiline and linezolid. Please try again. {* #forgotPasswordForm *} {* traditionalSignIn_signInButton *}

A small-molecule nitroimidazopyran drug candidate for the treatment of tuberculosis. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. The timetable you submitted on August 09, 2019, states that you will conduct this study according to the following schedule: Final Protocol Submission: Submitted Study Completion: 12/2020 Final Report Submission: 06/2021 . Obtain an ECG prior to initiation of treatment and ≥2, 12, and 24 weeks after starting treatment. Enhanced bactericidal activity of rifampin and/or pyrazinamide when combined with PA-824 in a murine model of tuberculosis. Monitor visual function.

If evidence of new or worsening liver dysfunction occurs, test for viral hepatitides and discontinue other hepatotoxic medications. {* #tradAuthenticateMergeForm *} Antimicrob Agents Chemother. {* designation_specialty_json *}
2011;6(1):27–37.Murray S, Mendel C, Spigelman M. TB Alliance regimen development for multidrug-resistant tuberculosis. The following may increase the risk for QT prolongation when patients are receiving bedaquiline as part of the combination regimen of pretomanid, bedaquiline, and linezolid: a history of torsades de pointes, congenital long QT syndrome, ongoing hypothyroidism, ongoing bradyarrhythmia, uncompensated heart failure, or serum calcium, magnesium, or potassium levels below the lower limits of normal. Excipient information presented when available (limited, particularly for generics); consult specific product labeling.Pretomanid is an antimycobacterial drug that kills actively replicating Multiple reductive and oxidative pathways; CYP3A4 accounts for up to ~20% of metabolism.Urine: 53% (primarily metabolites [~1% as unchanged drug]); Feces: 38%.Limitations of use: Not indicated for drug-sensitive tuberculosis, latent infection due to Use in patients for whom bedaquiline and/or linezolid are contraindicated.Oral: Administer with food. Pretomanid tablets: US prescribing information. Its long duration of action is a result of slow absorption from the injection site. Interrupt treatment with the entire regimen if aminotransferase elevations are accompanied by total bilirubin elevation >2 times ULN, aminotransferase elevations are >8 times ULN, or aminotransferase elevations are >5 times ULN and persist >2 weeks.• Lactic acidosis: Lactic acidosis has been reported with pretomanid in combination with bedaquiline and linezolid.

Its long duration of action is a result of slow absorption from the injection site.

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