NUZYRA Omadacycline Application Scope

An aminomethylcycline antibiotic used to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults caused by susceptible pathogens.

NUZYRA Omadacycline Characteristics

Ingredients: Omadacycline (as omadacycline tosylate)
Properties: Broad-spectrum tetracycline-class antibiotic; inhibits bacterial protein synthesis; effective against common Gram-positive, Gram-negative, and atypical pathogens.
Packaging Specification:
- Injection: 100 mg single-dose lyophilized vial
- Tablets: 150 mg film-coated tablets (bottles of 30)
Storage: Store at 20–25 °C (USP room temperature); do NOT freeze
Expiry Date: Refer to vial or bottle label (typically up to 30 months when stored correctly)
Executive Standard: Compliant with FDA and EMA requirements; meets pharmaceutical and USP standards for antibiotics
Approval Number:
FDA-approved Oct 2 2018 (NDA 209816 and 209817) for tablet and injection formulations
Date of Revision: Update
Manufacturer: Paratek Pharmaceuticals, Inc. (USA)

Guidelines for the Use of NUZYRA

Dosage and Administration:
- Day 1: 200 mg IV over 60 min or 100 mg IV over 30 min twice
- Maintenance: 100 mg IV daily or 300 mg orally daily for 7–14 days
Adverse Reactions:
- Nausea, vomiting, infusion‑site reactions, elevated liver enzymes, hypertension, headache, diarrhea, insomnia, constipation
- Serious Adverse Reactions:
  - C. difficile-associated diarrhea, photosensitivity, tooth discoloration, bone growth inhibition (in children/pregnancy), allergic/anaphylactic reactions
Contraindications: Known hypersensitivity to omadacycline, tetracycline-class antibiotics, or excipients
Precautions:
- - Monitor for C. difficile-associated diarrhea and hypersensitivity
  - Avoid use in pregnant women and children <8 years due to effects on teeth/bone
  - Monitor elderly patients due to observed mortality imbalance in CABP trial (>65 years)

NUZYRA Interactions

May require adjustments for anticoagulants
Oral absorption reduced by antacids with aluminum, calcium, magnesium, iron, and bismuth

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.