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Omadacycline: Drug information

Omadacycline: Drug information
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For additional information see "Omadacycline: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Nuzyra
Pharmacologic Category
  • Antibiotic, Tetracycline Derivative
Dosing: Adult
Mycobacterial infection

Mycobacterial (nontuberculous, rapidly growing) infection (alternative agent) (off-label use): Note: Patients should be under the care of a clinician with expertise in managing mycobacterial infection (Ref).

Oral: 300 mg once daily as part of an appropriate combination regimen (Ref). Some experts administer a loading dose of 450 mg once daily for the first 2 days of therapy (Ref).

Pneumonia, community acquired

Pneumonia, community acquired (without risk factors for Pseudomonas) (alternative agent):

IV: 200 mg as a single dose (Ref) or 100 mg twice daily on day 1, then 100 mg once daily (Ref).

Oral: 300 mg twice daily on day 1 (Ref), then 300 mg once daily (Ref).

Duration of therapy: Minimum of 5 days; patients should be clinically stable with normal vital signs before therapy is discontinued (Ref).

Skin and soft tissue infection

Skin and soft tissue infection:

Loading dose:

IV: 200 mg as a single dose on day 1 or 100 mg twice daily on day 1.

Oral: 450 mg once daily on days 1 and 2.

Maintenance dose:

IV: 100 mg once daily.

Oral: 300 mg once daily.

Duration of therapy: 7 to 14 days.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Liver Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Nausea (2% to 22%), vomiting (3% to 11%)

1% to 10%:

Cardiovascular: Hypertension (3%), insomnia (3%), atrial fibrillation (<2%), tachycardia (<2%)

Central nervous system: Headache (2% to 3%), fatigue (<2%), lethargy (<2%), vertigo (<2%)

Dermatologic: Erythema (<2%), hyperhidrosis (<2%), pruritus (<2%), urticaria (<2%)

Endocrine & metabolic: Increased gamma-glutamyl transferase (3%)

Gastrointestinal: Diarrhea (3%), constipation (2%), abdominal pain (<2%), dysgeusia (<2%), dyspepsia (<2%), increased serum lipase (<2%), oral candidiasis (<2%)

Genitourinary: Vulvovaginal candidiasis (<2%)

Hematologic & oncologic: Anemia (<2%), thrombocythemia (<2%)

Hepatic: Increased serum alanine aminotransferase (4%), increased serum aspartate aminotransferase (2% to 4%), increased serum alkaline phosphatase (<2%), increased serum bilirubin (<2%)

Hypersensitivity: Hypersensitivity reaction (<2%)

Local: Infusion site reaction (5%)

Neuromuscular & skeletal: Increased creatine phosphokinase (<2%)

Respiratory: Oropharyngeal pain (<2%)

Contraindications

Hypersensitivity to omadacycline, tetracycline-class antibacterial drugs, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic/Hypersensitivity reactions: Hypersensitivity reactions have been reported; life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracyclines. Discontinue if an allergic reaction occurs. Avoid use in patients with known hypersensitivity to tetracyclines.

• Antianabolic effects: May be associated with antianabolic effects observed with the tetracycline class (including increased BUN, azotemia, acidosis, and hyperphosphatemia); discontinue use if suspected.

• Fixed drug eruption: May be associated with fixed drug eruption due to structural similarities with tetracyclines; discontinue use if suspected.

• Hepatotoxicity: May be associated with abnormal liver function tests due to structural similarities with tetracyclines; discontinue use when suspected.

• Pancreatitis: May be associated with pancreatitis due to structural similarities with tetracyclines; discontinue use if suspected.

• Photosensitivity: May be associated with photosensitivity due to structural similarities with tetracyclines. Use skin protection and avoid prolonged exposure to sunlight and ultraviolet light. Discontinue use if skin erythema occurs.

• Pseudotumor cerebri: May be associated with pseudotumor cerebri due to structural similarities with tetracyclines; discontinue use if suspected.

• Superinfection: Use may result in fungal or bacterial superinfection, including Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Community-acquired bacterial pneumonia: Mortality rate was higher in patients treated with omadacycline for community-acquired bacterial pneumonia (CABP) compared to patients treated with moxifloxacin. All deaths occurred in patients >65 years of age with multiple comorbidities.

Special populations:

• Older adult: Numerically lower clinical success rates at the early clinical response timepoint were observed in CABP patients ≥65 years of age compared to patients <65 years of age. In addition, all deaths in the CABP trial occurred in patients >65 years of age.

• Pediatric: May cause reversible inhibition of bone growth when used during the second and third trimesters of pregnancy, infancy, and childhood ≤8 years of age. May cause tooth enamel hypoplasia or permanent tooth discoloration (more common with long-term use, but observed with repeated, short courses) when used during tooth development (last half of pregnancy, infancy, and childhood ≤8 years of age). Avoid use in children <8 years of age.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous, as tosylate [preservative free]:

Nuzyra: 100 mg (1 ea)

Tablet, Oral, as tosylate:

Nuzyra: 150 mg [contains sodium bisulfite]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Nuzyra Intravenous)

100 mg (per each): $556.38

Tablets (Nuzyra Oral)

150 mg (per each): $315.79

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: If stored under refrigeration, allow diluted infusion solution to reach room temperature prior to infusion. Infuse 200 mg dose over a total of 60 minutes and 100 mg dose over a total of 30 minutes through a dedicated line or Y-site; if no dedicated line available, flush line with NS or D5W before and after infusion of omadacycline.

Oral: Administer with water on an empty stomach (after fasting ≥4 hours); avoid food and drink (except water) for 2 hours after administration and avoid dairy and other products with multivalent cations (eg, antacids, multivitamins) for 4 hours after administration.

Use: Labeled Indications

Pneumonia, community-acquired: Treatment of community-acquired bacterial pneumonia (CABP) in adult patients caused by susceptible Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, H. parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Skin and soft tissue infection: Treatment of acute bacterial skin and soft tissue infections in adult patients caused by susceptible S. aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and K. pneumoniae.

Use: Off-Label: Adult

Mycobacterial (nontuberculous, rapidly growing) infection

Metabolism/Transport Effects

Substrate of P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Antacids: May decrease absorption of Tetracyclines. Management: Separate administration of antacids and oral tetracycline derivatives by several hours when possible to minimize the extent of this potential interaction. Monitor for decreased therapeutic effects of tetracyclines. Risk D: Consider Therapy Modification

Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification

BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Bile Acid Sequestrants: May decrease absorption of Tetracyclines. Risk C: Monitor

Bismuth Subcitrate: May decrease serum concentration of Tetracyclines. Management: Avoid administration of oral tetracyclines within 30 minutes of bismuth subcitrate administration. This is of questionable significance for at least some regimens intended to treat H. pylori infections. Risk D: Consider Therapy Modification

Bismuth Subsalicylate: May decrease serum concentration of Tetracyclines. Management: Consider dosing tetracyclines 2 hours before or 6 hours after bismuth. The need to separate doses during Helicobacter pylori eradication regimens is questionable. Risk D: Consider Therapy Modification

Calcium Salts: May decrease serum concentration of Tetracyclines. Management: If coadministration of oral calcium with oral tetracyclines cannot be avoided, consider separating administration of each agent by several hours. Risk D: Consider Therapy Modification

Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Iron Preparations: Tetracyclines may decrease absorption of Iron Preparations. Iron Preparations may decrease serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Risk D: Consider Therapy Modification

Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Lanthanum: May decrease serum concentration of Tetracyclines. Management: Administer oral tetracycline antibiotics at least 2 hours before or after lanthanum. Risk D: Consider Therapy Modification

Lithium: Tetracyclines may increase serum concentration of Lithium. Risk C: Monitor

Magnesium Dimecrotate: And Tetracyclines may interact via an unclear mechanism. Risk C: Monitor

Magnesium Salts: May decrease absorption of Tetracyclines. Only applicable to oral preparations of each agent. Management: Avoid coadministration of oral magnesium salts and oral tetracyclines. If coadministration cannot be avoided, administer oral magnesium at least 2 hours before, or 4 hours after, oral tetracyclines. Monitor for decreased tetracycline therapeutic effects. Risk D: Consider Therapy Modification

Mecamylamine: Tetracyclines may increase neuromuscular-blocking effects of Mecamylamine. Risk X: Avoid

Methotrexate: Tetracyclines may increase serum concentration of Methotrexate. Risk C: Monitor

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Methoxyflurane: Tetracyclines may increase nephrotoxic effects of Methoxyflurane. Risk X: Avoid

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease serum concentration of Tetracyclines. Management: Avoid this combination if possible. If coadministration cannot be avoided, administer the polyvalent cation-containing multivitamin at least 2 hours before or 4 hours after the tetracycline derivative. Monitor for decreased tetracycline effects. Risk D: Consider Therapy Modification

Multivitamins/Minerals (with AE, No Iron): May decrease serum concentration of Tetracyclines. Management: If coadministration of a polyvalent cation-containing multivitamin with oral tetracyclines cannot be avoided, administer the polyvalent cation-containing multivitamin either 2 hours before or 4 hours after the tetracycline product. Risk D: Consider Therapy Modification

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Neuromuscular-Blocking Agents: Tetracyclines may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents. Risk C: Monitor

Penicillins: Tetracyclines may decrease therapeutic effects of Penicillins. Risk C: Monitor

Polyethylene Glycol-Electrolyte Solution: May decrease absorption of Tetracyclines. Management: Give oral tetracyclines at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider Therapy Modification

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Quinapril: May decrease serum concentration of Tetracyclines. Risk C: Monitor

Retinoic Acid Derivatives: Tetracyclines may increase adverse/toxic effects of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid

Sodium Bicarbonate (Systemic): May decrease serum concentration of Tetracyclines. Risk C: Monitor

Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification

Strontium Ranelate: May decrease serum concentration of Tetracyclines. Management: In order to minimize any potential impact of strontium ranelate on tetracycline antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during tetracycline therapy. Risk X: Avoid

Sucralfate: May decrease absorption of Tetracyclines. Management: Administer most tetracycline derivatives at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Administer oral omadacycline 4 hours prior to sucralfate. Risk D: Consider Therapy Modification

Sucroferric Oxyhydroxide: May decrease serum concentration of Tetracyclines. Management: Administer oral/enteral doxycycline at least 1 hour before sucroferric oxyhydroxide. Specific dose separation guidelines for other tetracyclines are not presently available. No interaction is anticipated with parenteral administration of tetracyclines. Risk D: Consider Therapy Modification

Sulfonylureas: Tetracyclines may increase hypoglycemic effects of Sulfonylureas. Risk C: Monitor

Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vitamin K Antagonists: Tetracyclines may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

Zinc Salts: May decrease absorption of Tetracyclines. Only a concern when both products are administered orally. Management: Separate administration of oral tetracycline derivatives and oral zinc salts by at least 2 hours to minimize this interaction. Risk D: Consider Therapy Modification

Food Interactions

Oral omadacycline serum levels may be decreased if taken with high-fat meal or dairy. Management: Administer oral omadacycline after fasting for ≥4 hours, avoid food and drink (except water) for 2 hours after administration, and avoid dairy products for 4 hours after administration.

Reproductive Considerations

Due to the potential for adverse pregnancy outcomes, the manufacturer recommends effective contraception for patients who could become pregnant during omadacycline therapy.

Pregnancy Considerations

Tetracyclines accumulate in developing teeth and long tubular bones. Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur in the second or third trimesters and following long-term or repeated exposure. Reversible inhibition of bone growth may occur following maternal use of tetracyclines in the second and third trimesters.

Omadacycline is not one of the recommended antibiotics for the treatment of plague (Y. pestis) in pregnant patients (CDC [Nelson 2021]).

Breastfeeding Considerations

It is not known if omadacycline is present in breast milk.

As a class, tetracyclines have generally been avoided in breastfeeding patients due to concerns that they may cause adverse events in the breastfeeding infant, including tooth discoloration and inhibition of bone growth. Due to the potential for adverse events, the manufacturer does not recommend breastfeeding during therapy or for 4 days after the last omadacycline dose.

Dietary Considerations

Tablets: Take with water on an empty stomach (after ≥4 hours of fasting); avoid food and drink (except water) for 2 hours after taking and avoid dairy products for 4 hours after taking.

Monitoring Parameters

Periodic renal and hepatic function tests; clinical response in patients with community-acquired bacterial pneumonia, particularly those with higher mortality risk (eg, patients ≥65 years of age).

Mechanism of Action

Omadacycline inhibits protein synthesis by binding with the 30S ribosomal subunit of susceptible bacteria.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Food decreases rate and extent of absorption

Distribution: IV: Vdss: 190 L; tissue concentrations exceed plasma concentrations in alveolar cells and epithelial lining fluid

Protein binding: 20%; not concentration dependent

Metabolism: Not metabolized

Bioavailability: Oral: 34.5% following a single 300 mg dose

Half-life elimination: IV: ~16 hours; Oral: 13.45 to 16.83 hours

Time to peak: IV: ~0.5 hours; Oral: 2.5 hours

Excretion:

IV: Urine (27% as unchanged drug)

Oral: Feces: (77.5% to 84.0%); Urine: ~14.4 % (range 10.8% to 17.4%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Anti-infective considerations:

Parameters associated with efficacy: Limited data available: AUC24/minimum inhibitory concentration (MIC): Goal AUC24/MIC targets are highly variable and may depend on specific pathogen and inoculum, site of infection, and other host factors (Lepak 2017; Lepak 2020; Rodvold 2019; VanScoy 2020).

Organism specific:

S. pneumoniae: Goal: AUC24/MIC not well defined; reported AUC24/MIC values are highly variable, ranging from 6.06 to 179.98 (1-log kill) (Lepak 2017).

S. aureus: Goal: AUC24/MIC <1.06 to 16.97 (1-log kill) (Lepak 2020).

Mycobacterium kansasii: Goal: AUC24/MIC: 1.96 (50% of the maximal effect; EC50), AUC24/MIC: 3.05 (80% of the maximal effect; EC80) (Singh 2022).

Expected drug exposure:

Adults:

Cmax (peak):

Single dose:

Oral: 300 mg: 0.5 ± 0.15 mg/L.

Oral: 450 mg: 0.9 ± 0.2 mg/L.

IV: 100 mg: 1.5 ± 0.58 mg/L.

Steady state:

Oral: 300 mg once daily: 0.95 ± 0.42 mg/L.

Oral: 450 mg once daily: 1.1 ± 0.27 mg/L.

IV: 100 mg once daily: 2.1 ± 0.68 mg/L.

AUC:

Single dose, AUC0-∞:

Oral: 300 mg: 9.4 ± 2.6 mg•hour/L.

Oral: 450 mg: 13.5 ± 3.6 mg•hour/L.

IV: 100 mg: 9.4 ± 2.1 mg•hour/L.

Steady state, AUC0-24:

Oral: 300 mg once daily: 11.2 ± 5 mg•hour/L.

Oral: 450 mg once daily: 13.4 ± 3.5 mg•hour/L.

IV: 100 mg once daily: 12.1 ± 3.2 mg•hour/L.

Postantibiotic effect: Bacterial killing continues after omadacycline concentration falls below the MIC of targeted pathogen; generally ~1 to 3 hours, varies based on organism (Rodvold 2019).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PR) Puerto Rico: Nuzyra
  1. Daley CL, Iaccarino JM, Lange C, et al. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Clin Infect Dis. 2020;71(4):905-913. doi:10.1093/cid/ciaa1125 [PubMed 32797222]
  2. El Ghali A, Morrisette T, Alosaimy S, et al. Long-term evaluation of clinical success and safety of omadacycline in nontuberculous mycobacteria infections: a retrospective, multicenter cohort of real-world health outcomes. Antimicrob Agents Chemother. 2023;67(10):e0082423. doi:10.1128/aac.00824-23 [PubMed 37768312]
  3. Ingram PR, Jones EE, Allen B, Murray RJ, Keehner TJ, Whitmore TJ. Omadacycline therapy for Mycobacterium abscessus species infections. Intern Med J. 2023;53(12):2257-2263. doi:10.1111/imj.16071 [PubMed 36917124]
  4. Lepak AJ, Zhao M, Marchillo K, VanHecker J, Andes DR. In vivo pharmacodynamic evaluation of omadacycline (PTK 0796) against Streptococcus pneumoniae in the murine pneumonia model. Antimicrob Agents Chemother. 2017;61(5):e02368-16. doi:10.1128/AAC.02368-16 [PubMed 28193651]
  5. Lepak AJ, Zhao M, Marchillo K, VanHecker J, Andes DR. In vivo pharmacodynamic evaluation of omadacycline against Staphylococcus aureus in the neutropenic mouse pneumonia model. Antimicrob Agents Chemother. 2020;64(2):e02058-19. doi:10.1128/AAC.02058-19 [PubMed 31712210]
  6. Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019;200(7):e45-e67. doi:10.1164/rccm.201908-1581ST [PubMed 31573350]
  7. Mingora CM, Bullington W, Faasuamalie PE, et al. Long-term safety and tolerability of omadacycline for the treatment of Mycobacterium abscessus infections. Open Forum Infect Dis. 2023;10(7):ofad335. doi:10.1093/ofid/ofad335 [PubMed 37476076]
  8. Nelson CA, Meaney-Delman D, Fleck-Derderian S, et al; Contributors. Antimicrobial treatment and prophylaxis of plague: recommendations for naturally acquired infections and bioterrorism response. MMWR Recomm Rep. 2021;70(3):1-27. doi:10.15585/mmwr.rr7003a1 [PubMed 34264565]
  9. Nuzyra (omadacycline) injection and tablets [prescribing information]. Boston, MA: Paratek Pharmaceuticals Inc; March 2025.
  10. Refer to manufacturer's labeling.
  11. Rodvold KA, Pai MP. Pharmacokinetics and pharmacodynamics of oral and intravenous omadacycline. Clin Infect Dis. 2019;69(suppl 1):S16-S22. doi:10.1093/cid/ciz30o [PubMed 31367744]
  12. Singh S, Gumbo T, Boorgula GD, Shankar P, Heysell SK, Srivastava S. Omadacycline pharmacokinetics/pharmacodynamics in the hollow fiber system model and potential combination regimen for short course treatment of Mycobacterium kansasii pulmonary disease. Antimicrob Agents Chemother. 2022;66(9):e0068722. doi:10.1128/aac.00687-22 [PubMed 35976006]
  13. Stets R, Popescu M, Gonong JR, et al. Omadacycline for community-acquired bacterial pneumonia. N Engl J Med. 2019;380(6):517-527. doi:10.1056/NEJMoa1800201 [PubMed 30726692]
  14. VanScoy BD, Lakota EA, Conde H, et al. Pharmacokinetic-pharmacodynamic characterization of omadacycline against Haemophilus influenzae using a one-compartment in vitro infection model. Antimicrob Agents Chemother. 2020;64(6):e02265-19. doi:10.1128/AAC.02265-19 [PubMed 32284378]
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