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. 2019 Dec 31;7(4):e102. doi: 10.15190/d.2019.15

Table 1. Main characteristics of the described antibacterial drugs FDA approved in 201818-35.

Food and Drug Administration (FDA), European Medicines Agency (EMA), complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSI), intravenous (IV), oral administration/per oral (PO), hours (h); doses and duration have to be verified in the most recent prescriptions reglementations, according to the local laws before administration.

NAME (generic/brand/ class) Approval status Indication Administration Dose and duration
Plazomicin (Zemdri)/ aminoglycoside antibiotic COMPANY: Achaogen, Inc. (CA, USA) FDA: approved in June 2018 EMA: application submitted (2018) cUTIs; Enterobacteriaceae infections IV infusion, every 24 hours for 4-7 days. A. Dosage regimen (adults with CrCl>60ml/min): 15 mg/kg every 24 hours B. Dosage regimen (adults with CrCl>30 <60 ml/min): 10 mg/kg every 24h C. Dosage regimen (adults with CrCl>15 <30 ml/min): 10 mg/kg every 48h
Eravacycline (Xerava) / fully synthetic fluorocycline COMPANY: Tetraphase Pharmaceutical (MA, USA) FDA: approved in August 2018 EMA: approved in September 2018 cIAI IV 60 min infusion, given once every 12 hours for a total of 4 to 14 days; dose is patient’s weight dependent Adult patients (≥18 years of age) with cIAI: administer 1mg/kg, every 12h, by IV infusion (~ 60min); recommended duration of treatment is 4 to 14 days
Sarecycline (Seysara) / tetracycline-derived antibiotic COMPANY: Paratek Pharmaceuticals (MA, USA) and Allergan plc (USA) – acquired by Almirall SA (Spain) FDA: approved in October 2018 EMA: not yet approved non-nodular moderate to severe acne PO administration with food A. Adult <54 kg: 60 mg PO every Day 55-84 kg: 100 mg PO every Day 85-136 kg: 150 mg PO every Day B. Children ≥9 years 33-54 kg: 60 mg PO every Day 55-84 kg: 100 mg PO every Day 85-136 kg: 150 mg PO every Day If improvement after 12 weeks not observed, reassess treatment
Omadacycline (Nuzyra) / aminomethylcycline antibiotic, tetracycline class (inhibits 30S ribosomal subunit) COMPANY: Paratek Pharmaceuticals (MA, USA) FDA: approved in October 2018 EMA: not yet approved CABP, ABSSSI Both once-daily IV and PO formulations A. For patients with CABP, the loading dose on day 1 is 200 mg by IV infusion over 60 minutes, or 100 mg by IV infusion over 30 minutes, given twice; the maintenance dose is 100 mg by IV infusion over 30 minutes once daily, or 300 mg PO daily for a total of 7 to 14 days. B. For patients with ABSSSI, the loading dose on day 1 is 200 mg by IV infusion over 60 minutes; or 100 mg by IV infusion over 30 minutes, given twice; or, on days 1 and 2, 450 mg orally once daily. The maintenance dose is 100 mg by IV infusion over 30 minutes once daily, or 300 mg PO daily, for a total duration of 7 to 14 days
Rifamycin (Aemcolo) / bactericidal; inhibit bacterial DNA-dependent RNA polymerase, suppressing RNA synthesis COMPANY: Cosmo Pharmaceuticals (Ireland) FDA: approved in November 2018 EMA: not yet approved Travelers' diarrhea (noninvasive strains (E. coli) PO administration 388 mg (2 tablets) PO twice a day x 3 days