Pharmacokinetics and Pharmacodynamics of Oral and Intravenous Omadacycline

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Keith A Rodvold, Manjunath P Pai

Abstract

Oral and intravenous (IV) omadacycline formulations are approved in the United States for treating acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adults. Oral omadacycline bioavailability is 34.5%; similar exposures are obtained following 300 mg oral and 100 mg IV doses. Oral administration should be in a fasted state, with dairy products, antacids, or multivitamins avoided for ≥4 hours after dosing. Low protein binding (21%), large volume of distribution (190 L), low systemic clearance (10 L/hour), and long elimination half-life (16-17 hours) support once-daily dosing. Omadacycline is excreted unchanged in feces (81.1%) and urine (14.4%), with low potential for drug-drug interactions. Dose adjustments are unnecessary for age, sex, and renal or hepatic impairment. Pharmacokinetic-pharmacodynamic studies identify fAUC0-24/MIC ratio as the parameter that correlates with in vivo efficacy. Systemic exposure of omadacycline in epithelial lining fluid is greater than/equal to plasma concentrations in healthy adults.

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Citations

Aug 2, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Jason C Gallagher
Aug 21, 2019·Microorganisms·Despoina KoulentiUNKNOWN SotiriosTsiodras
Nov 13, 2019·Antimicrobial Agents and Chemotherapy·Alexander J LepakDavid R Andes
Jun 10, 2020·Antimicrobial Agents and Chemotherapy·Khurshida BegumKevin W Garey
Jan 24, 2020·Drugs·George G ZhanelJames A Karlowsky
Dec 10, 2020·The Journal of Antimicrobial Chemotherapy·A R NoelA P MacGowan
Jun 2, 2021·Antimicrobial Agents and Chemotherapy·Bethany R QuadeLucas S Blanton
Jun 15, 2021·Antimicrobial Agents and Chemotherapy·Kavindra V SinghBarbara E Murray

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NCT02877927
NCT02378480
NCT02531438

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