Omadacycline Oral Dosing and Pharmacokinetics in Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infection.

ABSTRACT: Omadacycline, a first-in-class aminomethylcycline antibiotic, is approved in the USA as intravenous (IV) and/or oral therapy for treatment of adults with community-acquired bacterial pneumonia (CABP) or acute bacterial skin and skin structure infections (ABSSSI). Phase 1 and 3 studies indicate that omadacycline dose adjustments are not required for any patient group based on age, sex, race, weight, renal impairment, end-stage renal disease, or hepatic impairment. Equivalency of exposure has also been demonstrated for 300 mg oral and 100 mg IV doses. Using an oral loading-dose regimen results in drug exposures exceeding established efficacy targets against the most common CABP and ABSSSI pathogens by Day 2 of treatment, and omadacycline has demonstrated clinical efficacy and is well tolerat

SUBMITTER: Leviton IM 

PROVIDER: S-EPMC8861994 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature