Medically reviewed by Drugs.com. Last updated on Aug 20, 2020.
(oh MAD a SYE kleen)
- Omadacycline Tosylate
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]
Brand Names: U.S.
- Antibiotic, Tetracycline Derivative
Omadacycline inhibits protein synthesis by binding with the 30S ribosomal subunit of susceptible bacteria.
Food decreases rate and extent of absorption
IV: Vdss: 190 L; tissue concentrations exceed plasma concentrations in alveolar cells and epithelial lining fluid
IV: Urine (27% as unchanged drug)
Oral: Feces: (77.5% to 84.0%); Urine: ~14.4 % (range 10.8% to 17.4%)
Time to Peak
IV: ~0.5 hours; Oral: 2.5 hours
IV: ~16 hours; Oral: 13.45 to 16.83 hours
20%; not concentration dependent
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 skin structure infections: Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adult patients caused by susceptible Staphylococcus 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 Klebsiella pneumoniae.
Hypersensitivity to omadacycline, tetracycline-class antibacterial drugs, or any component of the formulation.
Pneumonia, community acquired:
Loading dose: IV: 200 mg as a single dose on day 1 or 100 mg twice daily on day 1
IV: 100 mg once daily
Oral: 300 mg once daily
Duration of therapy: 7 to 14 days
Skin and skin structure infections:
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
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.
Refer to adult dosing.
IV: Reconstitute 100 mg vial with 5 mL of SWFI, NS, or D5W. Gently swirl and let vial stand until cake dissolves and any foam disperses; do not shake vial. Reconstituted solution should be yellow to dark orange; if not, discard. Prior to further dilution, invert vial to dissolve any remaining powder and gently swirl to prevent foaming, if necessary. Immediately (within 1 hour) withdraw 5 or 10 mL of the reconstituted solution and further dilute to a 100 mL of NS or D5W for final infusion concentration of 1 mg/mL or 2 mg/mL, respectively.
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.
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.
Store intact vials and tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Diluted infusion solutions are stable for 24 hours at room temperature (≤25°C) or for 7 days when refrigerated (2°C to 8°C). Do not freeze.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). 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 therapeuctic effects of tetracyclines. Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Bile Acid Sequestrants: May decrease the absorption of Tetracyclines. 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. 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. 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. 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. Avoid combination
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. Consider therapy modification
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Lanthanum: May decrease the serum concentration of Tetracyclines. Management: Administer oral tetracycline antibiotics at least two hours before or after lanthanum. Consider therapy modification
Lithium: Tetracyclines may increase the serum concentration of Lithium. Monitor therapy
Magnesium Dimecrotate: May interact via an unknown mechanism with Tetracyclines. 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. Consider therapy modification
Mecamylamine: Tetracyclines may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination
Methoxyflurane: Tetracyclines may enhance the nephrotoxic effect of Methoxyflurane. Avoid combination
Mipomersen: Tetracyclines may enhance the hepatotoxic effect of Mipomersen. 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. 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. Consider therapy modification
Neuromuscular-Blocking Agents: Tetracyclines may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Penicillins: Tetracyclines may diminish the therapeutic effect of Penicillins. Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy
Quinapril: May decrease the serum concentration of Tetracyclines. 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. 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. 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. 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. 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. Consider therapy modification
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. Consider therapy modification
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy
Vitamin K Antagonists (eg, warfarin): Tetracyclines may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Zinc Salts: May decrease the absorption of Tetracyclines. Only a concern when both products are administered orally. Management: Consider doxycycline as a noninteracting tetracycline derivative. Separate dose administration of oral tetracycline derivative and oral zinc salts by at least 2 hours to minimize interaction. Consider therapy modification
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%)
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 (formerly Clostridium) difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• 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.
• Elderly: 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.
Periodic renal and hepatic function tests
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.
What is this drug used for?
• It is used to treat bacterial infections.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin
• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting
• Acidosis like confusion, fast breathing, fast heartbeat, abnormal heartbeat, severe abdominal pain, nausea, vomiting, fatigue, shortness of breath, or loss of strength and energy
• Unable to pass urine
• Change in amount of urine passed
• Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools
• Blurred vision
• Double vision
• Injection site pain or irritation
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Frequently asked questions
More about omadacycline
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
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- Drug class: tetracyclines
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- Omadacycline (Advanced Reading)
- Omadacycline Intravenous (Advanced Reading)
- Omadacycline Tablets
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