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Omadacycline

Brand and Other Names: Nuzyra
Mechanism of Action:
NUZYRA is an antibacterial drug [see MICROBIOLOGY (12.4)]
Indications:
NUZYRA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae
Route: Intravenous and Oral
Dose:
NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orally once daily.
Adverse Reactions:
Mortality Imbalance in Patients with Community-Acquired Bacterial Pneumonia, Tooth Development and Enamel Hypoplasia, Inhibition of Bone Growth, Hypersensitivity Reactions, Tetracycline Class Effects
Contraindication:
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients.
Warnings and Precautions:
Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established.
See package insert for full prescribing information.