omadacycline (Rx)

Brand and Other Names:Nuzyra
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Dosing & Uses

AdultPediatricGeriatric

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

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Interactions

Interaction Checker

and omadacycline

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            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 (23)

            • 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. .

            • 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.

            • 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 toxicity of warfarin by anticoagulation. Modify Therapy/Monitor Closely. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

            • 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)

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              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%)

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              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
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              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.

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              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%
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              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
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Nuzyra oral
              -
              150 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.