Mechanism of effect
Omadacycline inhibits protein synthesis by binding with the 30S ribosomal subunit of susceptible bacteria.
Pharmacodynamic
Antibiotic, Tetracycline Derivative
Pharmacokinetics
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
Metabolism
Not metabolized
Excretion
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
Half-Life Elimination
IV: ~16 hours; Oral: 13.45 to 16.83 hours
Protein Binding
20%; not concentration dependent
Drug 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.
Dosage
Usual Adult Dose for Pneumonia
Loading Dose: 200 mg via IV infusion (over 60 minutes) on day 1 OR 100 mg via IV infusion (over 30 minutes) twice on day 1
Maintenance Dose:
-IV: 100 mg via IV infusion (over 30 minutes) once a day
-Oral: 300 mg orally once a day
Duration of Therapy: 7 to 14 days
Use: For the treatment of patients with community-acquired bacterial pneumonia due to the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, H parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Chlamydophila pneumoniae
Usual Adult Dose for Skin and Structure Infection
Loading Dose:
-IV: 200 mg via IV infusion (over 60 minutes) on day 1 OR 100 mg via IV infusion (over 30 minutes) twice on day 1
-Oral: 450 mg orally once a day on day 1 and day 2
Maintenance Dose:
-IV: 100 mg via IV infusion (over 30 minutes) once a day
-Oral: 300 mg orally once a day
Duration of Therapy: 7 to 14 days
Use: For the treatment of patients with acute bacterial skin and skin structure infections due to the following susceptible microorganisms: S aureus (methicillin-susceptible and -resistant isolates), S lugdunensis, S pyogenes, S anginosus group (includes S anginosus, S intermedius, and S constellatus), Enterococcus faecalis, Enterobacter cloacae, K pneumoniae
Drug contraindications
Hypersensitivity to omadacycline, tetracycline-class antibacterial drugs, or any component of the formulation.
Side effects
Check with your doctor immediately if any of the following side effects occur while taking omadacycline:
Less common
Blurred vision
dizziness
fainting
fast, pounding, or irregular heartbeat or pulse
fever
headache
hives, itching, skin rash
hoarseness
irritation
itching of the vagina or genitals
joint pain, stiffness, or swelling
nervousness
pale skin
pounding in the ears
redness of the skin
sore mouth or tongue
stomach pain
swelling of the eyelids, face, lips, hands, or feet
thick, white vaginal discharge with mild or no odor
tightness in the chest
troubled breathing or swallowing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
white patches in the mouth or on the tongue
Side effects not requiring immediate medical attention
Some side effects of omadacycline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Nausea
vomiting
Less common
Belching
change or loss in taste
constipation
diarrhea
feeling of constant movement of self or surroundings
heartburn
increased sweating
indigestion
mouth or throat pain
sensation of spinning
stomach discomfort or upset
trouble sleeping
unusual drowsiness, dullness, or feeling of sluggishness
Interactions
ampicillin , Amoxicillin , Enoxaparin , Isotretinoin , benzathine penicillin , Penicillin G , fondaparinux , ceprotin , temocillin , Betrixaban , dicloxacillin , Edoxaban , Phenprocoumon , nafcillin , Dalteparin , Bexarotene , Tinzaparin , Danaparoid , Ardeparin , Porfimer , Bivalirudin , Argatroban , Lepirudin , Acenocoumarol , Oxacillin , Meticillin , Warfarin , Rivaroxaban , Dabigatran , Apixaban , Procaine , Desirudin , Penicillin V , Piperacillin , Tretinoin , Magnesium sulfate , acitretin , Heparinacitretin
aluminum carbonate
aluminum hydroxide
aminolevulinic acid
aminolevulinic acid topical
anisindione
attapulgite
bcg
bifidobacterium infantis
bismuth subcitrate potassium
bismuth subgallate
bismuth subsalicylate
calcium acetate
calcium carbonate
calcium chloride
calcium citrate
calcium glubionate
calcium gluceptate
calcium gluconate
calcium lactate
calcium phosphate, tribasic
carbonyl iron
cholera vaccine, live
dicumarol
dihydroxyaluminum sodium carbonate
ethinyl estradiol
etretinate
ferric citrate
ferrous fumarate
ferrous gluconate
ferrous sulfate
heme iron polypeptide
iron polysaccharide
iron protein succinylate
isotretinoin
kaolin
lactobacillus acidophilus
lactobacillus reuteri
lactobacillus rhamnosus
lactobacillus rhamnosus gg
lanthanum carbonate
lithium
magaldrate
magnesium amino acids chelate
magnesium aspartate
magnesium carbonate
magnesium chloride
magnesium citrate
magnesium gluconate
magnesium glycinate
magnesium hydroxide
magnesium lactate
magnesium oxide
magnesium salicylate
magnesium sulfate
methoxsalen
methyl aminolevulinate topical
multivitamin with iron
multivitamin with iron and fluoride
multivitamin with minerals
multivitamin, prenatal
porfimer
quinapril
ranitidine bismuth citrate
sucralfate
sucroferric oxyhydroxide
tretinoin
typhoid vaccine, live
verteporfin
vitamin a
warfarin
zinc acetate
zinc chloride
zinc gluconate
zinc sulfate
Alerts
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.
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
Points of recommendation
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.
Pregnancy level
US FDA pregnancy category: Not assigned.
Risk summary: This drug may cause harm to the embryo or fetus; like other tetracycline-class agents, it may cause deciduous tooth discoloration and reversible bone growth inhibition when used during the second and third trimester of pregnancy; insufficient data available on use of this drug in pregnant women to inform a drug-related risk.
Breast feeding warning
No information is available on the use of omadacycline during breastfeeding. It is unknown how much omadacycline is excreted into breastmilk, but the drug is only about 35% absorbed orally under optimal circumstances, and is probably less from milk because of its calcium content. The manufacturer states that breastfeeding is not recommended during treatment and for 4 days after the last dose. If an infant is breastfed, monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (e.g., thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. As a theoretical precaution, avoid prolonged or repeat courses during nursing.
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