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 OR
- 300 mg PO x 2 doses
- Follow with maintenance dosing starting on Day 2
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
Nontuberculous Mycobacteria (Orphan)
Orphan designation for nontuberculous mycobacteria (NTM), including NTM pulmonary disease caused by Mycobacterium abscessus complex (MABc)
Sponsor
- Paratek Pharmaceuticals, Inc; 75 Park Plaza, 4th floor; Boston, Massachusetts 02116
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
Contraindicated (1)
- acitretin
acitretin increases toxicity of omadacycline by Mechanism: unknown. Contraindicated. Concomitant use of oral retinoids with tetracyclines may increase the risk of pseudotumor cerebri/intracranial hypertension. .
Serious - Use Alternative (25)
- amoxicillin
omadacycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- ampicillin
omadacycline decreases effects of ampicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- atracurium
omadacycline increases effects of atracurium by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- bexarotene
bexarotene increases toxicity of omadacycline by Mechanism: unknown. Avoid or Use Alternate Drug. Concomitant use of oral retinoids with tetracyclines may increase risk of pseudotumor cerebri/intracranial hypertension. .
- cholera vaccine
omadacycline, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.
- cisatracurium
omadacycline increases effects of cisatracurium by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- dicloxacillin
omadacycline decreases effects of dicloxacillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- isotretinoin
isotretinoin increases toxicity of omadacycline by Mechanism: unknown. Avoid or Use Alternate Drug. Concomitant use of oral retinoids with tetracyclines may increase risk of pseudotumor cerebri/intracranial hypertension. .
- microbiota oral
omadacycline decreases effects of microbiota oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Microbiota oral contains bacterial spores. Antibacterial agents may decrease efficacy if coadministered. Complete antibiotic regimens 2-4 days before initiating microbiota oral. .
- nafcillin
omadacycline decreases effects of nafcillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- oxacillin
omadacycline decreases effects of oxacillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- palovarotene
omadacycline, palovarotene. Other (see comment). Avoid or Use Alternate Drug. Comment: Systemic retinoid use has been associated with cases of benign intracranial hypertension (pseudotumor cerebri), some of which involved concomitant use of tetracyclines.
- pancuronium
omadacycline increases effects of pancuronium by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- penicillin G aqueous
omadacycline decreases effects of penicillin G aqueous by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- penicillin G benzathine
omadacycline decreases effects of penicillin G benzathine by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- penicillin G procaine
omadacycline decreases effects of penicillin G procaine by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- penicillin VK
omadacycline decreases effects of penicillin VK by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- piperacillin
omadacycline decreases effects of piperacillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- rocuronium
omadacycline increases effects of rocuronium by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride decreases levels of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Administer tetracyclines at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate decreases levels of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Administer tetracyclines at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .
- succinylcholine
omadacycline increases effects of succinylcholine by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- ticarcillin
omadacycline decreases effects of ticarcillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- tretinoin
tretinoin increases toxicity of omadacycline by Mechanism: unknown. Avoid or Use Alternate Drug. Concomitant use of oral retinoids with tetracyclines may increase risk of pseudotumor cerebri/intracranial hypertension. .
- vecuronium
omadacycline increases effects of vecuronium by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
Monitor Closely (61)
- aluminum hydroxide
aluminum hydroxide will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- aluminum hydroxide/magnesium carbonate
aluminum hydroxide/magnesium carbonate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- aluminum hydroxide/magnesium trisilicate
aluminum hydroxide/magnesium trisilicate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- aminobenzoate potassium
aminobenzoate potassium will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ascorbic acid
ascorbic acid will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- aspirin/citric acid/sodium bicarbonate
aspirin/citric acid/sodium bicarbonate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- bismuth subgallate
bismuth subgallate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- bismuth subsalicylate
bismuth subsalicylate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- calcium acetate
calcium acetate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- calcium carbonate
calcium carbonate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- calcium chloride
calcium chloride will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- calcium citrate
calcium citrate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- calcium gluconate
calcium gluconate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- calcium/vitamin D
calcium/vitamin D will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- carbonyl iron
carbonyl iron will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- cholestyramine
cholestyramine will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Monitor for decreased effects of tetracyclines if coadministered with a bile acid sequestrant. Separate doses 2 or more hours if these agents are used concomitantly.
- chromium
chromium will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- citric acid/sodium bicarbonate
citric acid/sodium bicarbonate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- colesevelam
colesevelam will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Monitor for decreased effects of tetracyclines if coadministered with a bile acid sequestrant. Separate doses 2 or more hours if these agents are used concomitantly.
- colestipol
colestipol will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Monitor for decreased effects of tetracyclines if coadministered with a bile acid sequestrant. Separate doses 2 or more hours if these agents are used concomitantly.
- copper
copper will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- cyanocobalamin
cyanocobalamin will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferric carboxymaltose
ferric carboxymaltose will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferric citrate
ferric citrate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferric gluconate
ferric gluconate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferric maltol
ferric maltol will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferric pyrophosphate DIALYSATE
ferric pyrophosphate DIALYSATE will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferrous fumarate
ferrous fumarate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferrous gluconate
ferrous gluconate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferrous sulfate
ferrous sulfate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- ferumoxytol
ferumoxytol will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- folic acid
folic acid will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- iodine
iodine will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- iron dextran complex
iron dextran complex will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- iron sucrose
iron sucrose will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- iron/folic acid/vitamin/mineral
iron/folic acid/vitamin/mineral will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- magnesium chloride
magnesium chloride will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- magnesium citrate
magnesium citrate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- magnesium gluconate
magnesium gluconate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- magnesium hydroxide
magnesium hydroxide will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- magnesium oxide
magnesium oxide will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- magnesium supplement
magnesium supplement will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products; administer magnesium 2hr before the tetracycline or 4hr after the tetracycline..
magnesium supplement will decrease the level or effect of omadacycline by Other (see comment). Modify Therapy/Monitor Closely. Formation of an insoluble complex reduces absorption of the drug through intestinal tract; administer magnesium 2hr before the tetracycline or 4hr after the tetracycline. - manganese
manganese will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- molybdenum
molybdenum will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- multivitamins
multivitamins will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- multivitamins, vision
multivitamins, vision will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- niacin
niacin will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- polysaccharide iron
polysaccharide iron will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- pyridoxine
pyridoxine will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- selenium
selenium will decrease the level or effect of omadacycline by cation binding in GI tract. Modify Therapy/Monitor Closely. Do not take polyvalent cations within 4 hr before or after omadacycline.
- sodium acid phosphate
sodium acid phosphate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- sodium bicarbonate
sodium bicarbonate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- sodium citrate/citric acid
sodium citrate/citric acid will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- sodium phosphate rectal
sodium phosphate rectal will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- sodium picosulfate/magnesium oxide/anhydrous citric acid
sodium picosulfate/magnesium oxide/anhydrous citric acid will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- thiamine
thiamine will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- trimagnesium citrate anhydrous
trimagnesium citrate anhydrous will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- tripotassium dicitratobismuthate
tripotassium dicitratobismuthate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- vitamin B2
vitamin B2 will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- warfarin
omadacycline increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
- zinc
zinc will decrease the level or effect of omadacycline by cation binding in GI tract. Modify Therapy/Monitor Closely. Separate administration of oral tetracycline derivatives and oral zinc salts by at least 2 hr.
Minor (0)
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
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Nuzyra oral - | 150 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
