Dosing & Uses
Dosage Forms & Strengths
tablet
- 150mg (equivalent to 196mg omadacycline tosylate)
injectable, lyophilized powder for reconstitution
- 100mg/single-dose vial (equivalent to 131mg omadacycline tosylate)
Community-Acquired Bacterial Pneumonia
Indicated for treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms
Loading dose (Day 1): 200 mg IV once OR 100 mg IV x 2 doses
Maintenance dose: 100 mg IV qDay OR 300 mg PO qDay
Treatment duration: 7-14 days
Bacterial Skin and Skin Structure Infections
Indicated for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible microorganisms
Treatment duration: 7-14 days
Loading dose
- IV (Day 1): 200 mg IV once OR 100 mg IV x 2 doses OR
- PO (Days 1 and 2): 450 mg PO qDay x 2 days
Maintenance dose
- IV: 100 mg IV qDay OR
- PO: 300 mg PO qDay
Dosage Modifications
Renal or hepatic impairment
- No dosage adjustment required with any severity of renal or hepatic impairment, including patients with ESRD or those receiving dialysis
Dosing Considerations
Bacterial-resistance
- To reduce development of drug-resistant bacteria and maintain effectiveness of omadacycline and other antibacterial drugs, use only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
- In absence of susceptibility data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy
Susceptible microorganisms
CABP
- Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae
ABSSSI
- Staphylococcus aureus (methicillin-susceptible and methacillin-resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp (includes Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae
<18 years: Safety and efficacy not established
Mortality imbalance observed in the CABP clinical trial, with 8 deaths (2%) occurring in patients treated with omadacycline compared with 4 deaths (1%) in patients treated with moxifloxacin
The cause of the mortality imbalance has not been established
All deaths, in both treatment arms, occurred in patients aged >65 yr; most patients had multiple comorbidities
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10% (ABSSSI)
Nausea (21.9%)
Vomiting (11.4%)
1-10% (ABSSI)
Infusion site reactions (5.2%)
Increased ALT (4.1%)
Increased AST (3.6%)
Headache (3.3%)
Diarrhea (3.2%)
1-10% (CABP)
Increased ALT (3.7%)
Hypertension (3.4%)
Increased GGT (2.6%)
Insomnia (2.6%)
Vomiting (2.6%)
Constipation (2.4%)
Nausea (2.4%)
Increased AST (2.1%)
Headache (2.1%)
Warnings
Contraindications
Hypersensitivity to any tetracyclines
Cautions
Mortality imbalance observed in the CABP clinical trial, with 8 deaths (2%) occurring in patients treated with omadacycline compared with 4 deaths (1%) in patients treated with moxifloxacin; cause not established; all deaths, in both treatment arms, occurred in patients aged >65 years and most patients had multiple comorbidities
Clostridium difficile-associated diarrhea (CDAD) reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, consider discontinuing ongoing antibacterial drug use not directed against C difficile and initiating treatment-appropriate measures
Bacterial resistance to tetracyclines may develop; because of this, use only as indicated
As with other antibiotics, use may result in overgrowth of nonsusceptible organisms, including fungi
Hypersensitivity reactions reported; life-threatening hypersensitivity (anaphylactic) reactions reported with other tetracyclines (see Contraindications)
Tetracycline class effects
- Intracranial hypertension, pseudotumor cerebri, antianabolic action reported in adults and adolescents associated with tetracycline use; clinical manifestations include headache, blurred vision, and papilledema
- Photosensitivity manifested by an exaggerated sunburn reaction observed with tetracyclines; instruct patients to minimize or avoid exposure to natural or artificial sunlight
- Increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests may occur
- Discontinue if these adverse effects suspected
Teratogenic effects
- Can cause fetal harm if used during pregnancy
Use during tooth and bone development
- Use during tooth development (last half of pregnancy, infancy, and childhood to age 8 years) may cause permanent discoloration of the teeth (yellow-grey-brown); enamel hypoplasia reported with tetracyclines; advise patient of potential risk
- May cause reversible inhibition of bone growth during pregnancy, infancy, and early childhood
- All tetracyclines form a stable calcium complex in any bone-forming tissue
- Decreased fibula growth rate observed in premature infants given PO tetracycline in doses of 25 mg/kg q6hr; reversible when drug discontinued
- Also see Pregnancy
Drug interaction overview
- Avoid coadministration with oral retinoids; may have additive effects on increasing intracranial pressure
- Coadministration with antacids containing aluminum, calcium, or magnesium; bismuth subsalicylate; and iron-containing preparations decrease tetracycline absorption, which may decrease efficacy; separate doses
- May interfere with bacteriocidal action of penicillin; avoid coadministration
- May depress plasma prothrombin activity, which may increase bleeding risk in patients who are on anticoagulant therapy
Pregnancy
Pregnancy
Like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during second and third trimesters of pregnancy
Pregnant women should discontinue omadacycline as soon as pregnancy is recognized
Animal data
- Administration during organogenesis resulted in fetal loss and/or congenital malformations in pregnant rats and rabbits at 7 times and 3 times the mean AUC exposure, respectively, of the clinical IV dose of 100 mg and the oral dose of 300 mg; reductions in fetal weight occurred in rats at all administered doses
Infertility
- Males: Based on animal studies, can lead to impaired spermiation and sperm maturation, resulting in abnormal sperm morphology and poor motility
- Females: Based on animal studies, omadacycline affected fertility parameters, resulting in reduced ovulation and increased embryonic loss at intended human exposures
Contraception
- Advise women of reproductive potential to use highly effective form of contraception
Lactation
Tetracyclines are excreted in human milk
Because of the potential for serious adverse reactions on bone and tooth development in nursing infants, omadacycline is not recommended in breastfeeding women
Advise women not to breastfeed during treatment and for 4 days after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Aminomethylcycline antibacterial within the tetracycline drug class
Binds to the 30S ribosomal subunit and blocks protein synthesis
Active in vitro against gram-positive bacteria expressing tetracycline resistance active efflux pumps (tetK and tet L) and ribosomal protection proteins (tet M)
In general, considered bacteriostatic; however, has demonstrated bactericidal activity against some isolates of S pneumoniae and H influenzae
Absorption
Bioavailability: 34.5% (single 300-mg dose)
Peak plasma time, steady-state: 0.5 hr (IV); 2.5 hr (PO)
Peak plasma concentration, steady-state: 2120 ng/mL (IV); 952-1077 ng/mL (PO)
AUC, steady-state: 12,140 hr·ng/mL (IV); 11,156-13,367 hr·ng/mL (PO)
Distribution
Protein bound: 20%
Vd, steady-state: 190 L (IV)
Metabolism
Not metabolized
Elimination
Half-life, steady-state: 16 hr (IV); 15.5-16.8 hr (PO)
Systemic clearance, steady-state: 8.8 L/hr (IV)
Renal clearance: 2.4-3.3 L/hr
Excretion
Urine
- IV: 27%
- PO: 14.4%
Feces
- PO: 81.1%
Administration
Oral Administration
Instruct patients not to eat or drink (other than water) 4 hr before or 2 hr after taking omadacycline tablets
Do not to consume dairy products, antacids, or multivitamins for 4 hr after taking tablets
IV Compatibilities
0.9% NaCl
D5W
IV Preparation
Lyophilized powder must be reconstituted and then further diluted
Reconstitution
- Calculate dose and number of vials needed
- Reconstitute each 100-mg vial with 5 mL of sterile water for injection
- Do not shake; gently swirl vial contents and let stand until the lyophilized cake has completely dissolved and any foam disperses
- Reconstituted solution should appear yellow to dark orange; if not, discard solution
- Visually inspect for particulate matter and discoloration before further dilution and administration; if needed, invert vial to dissolve any remaining powder and swirl gently to prevent foaming
Dilution
- Within 1 hr of reconstitution, withdraw solution from vial(s) and further dilute by adding to 100-mL bag of 0.9% NaCl or D5W
- If diluted infusion bag is refrigerated, remove from refrigeration, place in upright vertical position, and allow bag to come to room temperature 60 minutes before use
IV Administration
Infuse through dedicated IV line or Y-site
If same IV line is used for sequential infusion of several drugs, flush with 0.9% NaCl or D5W before and after omadacycline
100-mg dose: Infuse over 30 minutes
200-mg dose: infuse over 60 minutes
Storage
Vials of lyophilized power or tablets
- Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
- Do not freeze
Diluted IV solution
- Room temperature: Use within 24 hr when stored at ≤77°F (≤25°C)
- Refrigerated: Use within 48 hr when refrigerated 36-46°F (2-8°C); do not freeze
Images
Patient Handout
Formulary
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