Version May 2024
Plague (Y. pestis) (alternative agent):
Postexposure prophylaxis: Oral: 300 mg every 24 hours for 7 days (Ref).
Treatment, bubonic or pharyngeal:
Note: Consult public health officials for event-specific recommendations.
IV: Loading dose: 200 mg once, followed by maintenance dose of 100 mg every 24 hours (Ref).
Oral: Loading dose: 450 mg every 24 hours for 2 days, followed by maintenance dose of 300 mg every 24 hours (Ref).
Duration of therapy: 10 to 14 days and for at least a few days after clinical resolution (Ref).
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 skin structure 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.
No dosage adjustment necessary.
No dosage adjustment necessary.
Refer to adult dosing.
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%)
Hypersensitivity to omadacycline, tetracycline-class antibacterial drugs, or any component of the formulation.
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.
• 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. Monitor CABP patients, particularly those with higher mortality risk, closely for clinical response.
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. Monitor closely for clinical response.
• 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.
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]
No
Solution (reconstituted) (Nuzyra Intravenous)
100 mg (per each): $524.44
Tablets (Nuzyra Oral)
150 mg (per each): $306.59
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.
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.
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 skin structure infections: Treatment of acute bacterial skin and skin structure infections (ABSSSI) 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.
Plague (Yersinia pestis)
Substrate of P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Antacids: May decrease the 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 diminish the therapeutic effect 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 diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Bile Acid Sequestrants: May decrease the absorption of Tetracyclines. Risk C: Monitor therapy
Bismuth Subcitrate: May decrease the 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 the 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 the 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 diminish the therapeutic effect 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 combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Iron Preparations: Tetracyclines may decrease the absorption of Iron Preparations. Iron Preparations may decrease the 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 diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Lanthanum: May decrease the 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 the serum concentration of Lithium. Risk C: Monitor therapy
Magnesium Dimecrotate: May interact via an unknown mechanism with Tetracyclines. Risk C: Monitor therapy
Magnesium Salts: May decrease the 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 enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Methoxyflurane: Tetracyclines may enhance the nephrotoxic effect of Methoxyflurane. Risk X: Avoid combination
Mipomersen: Tetracyclines may enhance the hepatotoxic effect of Mipomersen. Risk C: Monitor therapy
Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the 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 the 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
Neuromuscular-Blocking Agents: Tetracyclines may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Penicillins: Tetracyclines may diminish the therapeutic effect of Penicillins. Risk C: Monitor therapy
Polyethylene Glycol-Electrolyte Solution: May decrease the 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 enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Quinapril: May decrease the serum concentration of Tetracyclines. Risk C: Monitor therapy
Retinoic Acid Derivatives: Tetracyclines may enhance the adverse/toxic effect of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect 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 the 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 combination
Sucralfate: May decrease the 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 the 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 enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect 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 enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Tetracyclines may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Zinc Salts: May decrease the 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
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.
Due to the potential for adverse pregnancy outcomes, the manufacturer recommends effective contraception for females of reproductive potential during omadacycline therapy.
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]).
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.
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.
Periodic renal and hepatic function tests
Omadacycline inhibits protein synthesis by binding with the 30S ribosomal subunit of susceptible bacteria.
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%)
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