Brand Name
Nuzyra
Generic Name
Omadacycline
View Brand Information FDA approval date: February 01, 2019
Classification: Tetracycline-class Antibacterial
Form: Injection, Tablet
What is Nuzyra (Omadacycline)?
NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms : Community-acquired bacterial pneumonia .
Approved To Treat
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Brand Information
NUZYRA (omadacycline)
1CONTRAINDICATIONS
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients
2ADVERSE REACTIONS
The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling:
- Tooth Development and Enamel Hypoplasia
- Inhibition of Bone Growth
- Hypersensitivity Reactions
- Tetracycline Class Effects
2.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
2.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of NUZYRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Subcutaneous Tissue Disorders: rash
3OVERDOSAGE
No specific information is available on the treatment of overdosage with NUZYRA. Following a 100 mg single dose intravenous administration of omadacycline, 8.9% of dose is recovered in the dialysate.
4DESCRIPTION
NUZYRA contains omadacycline tosylate, an aminomethylcycline which is a semisynthetic derivative of the tetracycline class of antibacterial drugs, for intravenous or oral administration. The chemical name of omadacycline tosylate is (4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-9-(2,2-dimethylpropylaminomethyl)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide, 4-methylbenzenesulfonate.
The molecular formula is C
NUZYRA (omadacycline) for injection is a yellow to dark orange sterile lyophilized powder. Each vial of NUZYRA for injection contains 100 mg of omadacycline (equivalent to 131 mg omadacycline tosylate). Inactive ingredients: Sucrose (100 mg); may include hydrochloric acid and/or sodium hydroxide for pH adjustment.
NUZYRA (omadacycline) tablets for oral administration are yellow film coated tablets containing 150 mg of omadacycline (equivalent to 196 mg omadacycline tosylate), and the following inactive ingredients: Colloidal silicon dioxide, crospovidone, glycerol monocaprylocaprate, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol, sodium bisulfite, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide.
5PRINCIPAL DISPLAY PANEL - 6 Tablet Blister Pack Carton
NDC 71715-002-21
once-daily
Contains 6 tablets
6PRINCIPAL DISPLAY PANEL - 10 Vial Carton
NDC 71715-001-02
RX ONLY
NUZYRA
100 mg per single-dose vial.
100 mg
Contains 10 vials
7PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
NDC 71715-002-27
once-daily
Contains 30 tablets
