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Nuzyra Injection Generic Name & Formulations
Legal Class
Rx
General Description
Omadacycline 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains sucrose.
Pharmacological Class
Tetracycline antibiotic.
See Also
How Supplied
Single-dose vials—10; Tabs—6, 30
Manufacturer
Generic Availability
NO
Nuzyra Injection Indications
Indications
Susceptible infections including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI).
Nuzyra Injection Dosage and Administration
Adult
≥18yrs: Day 1: Initially 200mg IV over 60mins or 100mg IV over 30mins twice. Maintenance: 100mg IV over 30mins once daily. Treat for 7–14 days.
Children
<8yrs: not recommended (see full labeling); <18yrs: not established.
Nuzyra Injection Contraindications
Not Applicable
Nuzyra Injection Boxed Warnings
Not Applicable
Nuzyra Injection Warnings/Precautions
Warnings/Precautions
Mortality imbalance in CABP; closely monitor response esp. those at higher risk (eg, >65yrs, comorbidities). Discontinue if allergic reaction occurs. Evaluate if diarrhea occurs; discontinue if C. difficile-associated diarrhea is suspected or confirmed. Advise females of reproductive potential to use effective contraception during treatment. Pregnancy (during 2nd & 3rd trimester): may cause permanent discoloration of the teeth or reversible inhibition of bone growth. Nursing mothers: not recommended (during and for 4 days after the last dose).
Nuzyra Injection Pharmacokinetics
See Literature
Nuzyra Injection Interactions
Interactions
May need to reduce concomitant anticoagulant dose. Inj: do not give with multivalent cation-containing solutions (eg, Ca, Mg, Al) through same IV line. Tabs: after dosing, avoid food or drink (except water) for 2hrs; and avoid dairy, antacids, iron preparations, multivitamins for 4hrs.
Nuzyra Injection Adverse Reactions
Adverse Reactions
Nausea, vomiting, infusion site reactions, AST/ALT/GGT increased, hypertension, headache, diarrhea, insomnia, constipation; hypersensitivity reactions, C. difficile-associated diarrhea, tetracycline class effects (eg, photosensitivity, pseudotumor cerebri, increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis); also Children (up to 8yrs of age): tooth discoloration, enamel hypoplasia, inhibition of bone growth.
Nuzyra Injection Clinical Trials
See Literature
Nuzyra Injection Note
Not Applicable
Nuzyra Injection Patient Counseling
See Literature
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