omeprazole/amoxicillin/clarithromycin (Rx)

Brand and Other Names:Omeclamox-Pak
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Dosing & Uses

AdultPediatric

Dosing Forms & Strengths

omeprazole/amoxicillin/clarithromycin

capsule/capsule/tablet prepack

  • 20mg/500mg/500mg
  • Amoxicillin dose consists of two 500mg capsules (ie, 1000mg/dose)

Duodenal Ulcer

Indicated for eradication of H pylori to reduce risk of duodenal ulcer recurrence

Omeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg coadministered PO BID (morning and evening) for 10 days

Renal & Hepatic Impairment

Renal impairment: No dose adjustment necessary

Hepatic impairment: Avoid use

Safety and efficacy not established

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Interactions

Interaction Checker

and omeprazole/amoxicillin/clarithromycin

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            Contraindicated (4)

            • erlotinib

              omeprazole decreases levels of erlotinib by Other (see comment). Contraindicated. Comment: Concomitant use of proton pump inhibitors with erlotinib should be avoided if possible. Drugs that alter pH of upper GI tract may alter the solubility of erlotinib and reduce its bioavailability. .

            • mavacamten

              omeprazole will increase the level or effect of mavacamten by affecting hepatic enzyme CYP2C19 metabolism. Contraindicated. Strong or moderate CYP2C19 inhibitors may increase mavacamten systemic exposure, resulting in heart failure due to systolic dysfunction.

            • nelfinavir

              omeprazole decreases levels of nelfinavir by unspecified interaction mechanism. Contraindicated. Coadministration may lead to loss of nelfinavir virologic response and development of resistance; mechanism may be CYP2C19 inhibition of nelfinavir conversion to active M8 metabolite, and also PPIs decreasing gastric pH resulting in decreased nelfinavir absorption.

            • rilpivirine

              omeprazole decreases levels of rilpivirine by increasing gastric pH. Applies only to oral form of both agents. Contraindicated. Concurrent use may cause treatment failure and/or the development of rilpivirine or NNRTI resistance owing to decreased levels.

            Serious - Use Alternative (43)

            • abametapir

              abametapir will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • abrocitinib

              omeprazole will increase the level or effect of abrocitinib by decreasing metabolism. Avoid or Use Alternate Drug. Abrocitinib is a CYP2C9 and CYP2C19 substrate. Drugs that are moderate-to-strong inhibitors of both CYP2C9 and CYP2C19 increase systemic exposure of abrocitinib and its active metabolites, which may increase adverse effects.

            • acalabrutinib

              omeprazole decreases levels of acalabrutinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Acalabrutinib solubility decreases with increasing gastric pH. Due to the long-lasting effect of PPIs, separation of doses may not eliminate the interaction.

            • apalutamide

              apalutamide will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP2C19 inducer, with drugs that are CYP2C19 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered.

              apalutamide will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • atazanavir

              omeprazole will decrease the level or effect of atazanavir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Atazanavir solubility decreases as pH increases. Substantially reduced plasma concentrations of atazanavir are expected if PPIs are coadministered. PPI dose should not exceed a dose comparable to omeprazole 20 mg and must be taken ~12 h before atazanavir/ritonavir in treatment naive-patients. PPIs are not recommended in treatment-experienced taking atazanavir.

            • carbamazepine

              carbamazepine will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug.

            • ceritinib

              omeprazole decreases effects of ceritinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • cilostazol

              omeprazole will increase the level or effect of cilostazol by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug.

            • clopidogrel

              omeprazole decreases effects of clopidogrel by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug. Clopidogrel efficacy may be reduced by drugs that inhibit CYP2C19. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. Clopidogrel is metabolized to this active metabolite in part by CYP2C19. .

            • dacomitinib

              omeprazole will increase the level or effect of dacomitinib by unspecified interaction mechanism. Avoid or Use Alternate Drug. Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy. Avoid use of PPIs with dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

            • dasatinib

              omeprazole will decrease the level or effect of dasatinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • digoxin

              omeprazole will increase the level or effect of digoxin by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • duloxetine

              omeprazole will decrease the level or effect of duloxetine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

            • enzalutamide

              enzalutamide will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erdafitinib

              omeprazole will increase the level or effect of erdafitinib by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. If coadministration of a strong CYP2C9 inhibitors is unavoidable, closely monitor adverse reactions and modify dose of erdafitinib accordingly. If strong CYP2C9 inhibitor is discontinued, consider increasing erdafitinib dose in the absence of any drug-related toxicities.

            • fedratinib

              omeprazole will increase the level or effect of fedratinib by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of fedratinib (a CYP3A4 and CYP2C19 substrate) with dual CYP3A4 and CYP2C19 inhibitor. Effect of coadministration of a dual CYP3A4 and CYP2C19 inhibitor with fedratinib has not been studied.

            • fexinidazole

              fexinidazole will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • fluvoxamine

              fluvoxamine will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug.

            • idelalisib

              idelalisib will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • indinavir

              omeprazole will decrease the level or effect of indinavir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • infigratinib

              omeprazole will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • isoniazid

              isoniazid will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug.

            • itraconazole

              omeprazole will decrease the level or effect of itraconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • ivosidenib

              ivosidenib will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • ketoconazole

              omeprazole will decrease the level or effect of ketoconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • levoketoconazole

              omeprazole will decrease the level or effect of levoketoconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • lonafarnib

              omeprazole will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              lonafarnib will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug. Lonafarnib may increase the AUC and peak concentration of CYP2C19 substrates. If coadministration unavoidable, monitor for adverse reactions and reduce the CYP2C19 substrate dose in accordance with its approved product labeling.

            • mesalamine

              omeprazole decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to sustained release dosage form.

            • neratinib

              omeprazole will decrease the level or effect of neratinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • nilotinib

              omeprazole will decrease the level or effect of nilotinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Nilotinib has a pH-dependent solubility and solubility is decreased at higher pH; separating doses may not eliminate this effect because of PPI extended duration of action

            • nisoldipine

              omeprazole will increase the level or effect of nisoldipine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • pazopanib

              omeprazole will decrease the level or effect of pazopanib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Avoid coadministration of pazopanib with drugs that raise gastric pH; consider short-acting antacids in place of PPIs and H2 antagonists; separate antacid and pazopanib dosing by several hours

            • pexidartinib

              omeprazole will decrease the level or effect of pexidartinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Avoid coadministration of proton pump inhibitors (PPIs) with pexidartinib. Use H2-receptor antagonists or antacids if needed. When using alternatives to PPIs, administer pexidartinib 2 hr before or after taking locally-acting antacids OR administer pexidartinib at least 2 hr before or 10 hr after taking an H2-receptor antagonist.

            • phenobarbital

              phenobarbital will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifampin

              rifampin will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifapentine

              rifapentine will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • secobarbital

              secobarbital will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • secretin

              omeprazole, secretin. Other (see comment). Avoid or Use Alternate Drug. Comment: Concomitant use of PPIs may cause a hyperresponse in gastrin secretion in response to stimulation testing with secretin, falsely suggesting gastrinoma. The time it takes for serum gastrin concentrations to return to baseline following discontinuation of PPIs is specific to the individual PPI. Temporarily stop omeprazole treatment at least 14 days before assessing to allow gastrin levels to return to baseline.

            • siponimod

              omeprazole will increase the level or effect of siponimod by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Coadministration of siponimod with drugs that cause moderate CYP2C9 AND a moderate or strong CYP3A4 inhibition is not recommended. Caution if siponimod coadministered with moderate CYP2C9 inhibitors alone.

            • sofosbuvir/velpatasvir

              omeprazole will decrease the level or effect of sofosbuvir/velpatasvir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Velpatasvir solubility decreases as gastric pH increases (practically insoluble at pH >5). Coadministration of sofosbuvir/velpatasvir with omeprazole or other PPIs is not recommended. If considered medically necessary, give sofosbuvir/velpatasvir with food 4 hr before omeprazole 20 mg. Use with other PPIs has not been studied.

            • sotorasib

              omeprazole will decrease the level or effect of sotorasib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer sotorasib 4 hr before or 10 hr after administration of a locally-acting antacid.

            • tucatinib

              tucatinib will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • voxelotor

              voxelotor will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (99)

            • abrocitinib

              omeprazole will increase the level or effect of abrocitinib by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Start abrocitinib 50 mg qDay when coadministered with CYP2C19 inhibitors. If adequate response not achieved after 12 weeks, may increase to 100 mg qDay. Discontinue if inadequate response after dosage increase.

            • amobarbital

              amobarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • ampicillin

              omeprazole will decrease the level or effect of ampicillin by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • armodafinil

              armodafinil will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • avapritinib

              omeprazole will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • axitinib

              omeprazole increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • belumosudil

              omeprazole will decrease the level or effect of belumosudil by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Increase belumosudil dosage to 200 mg PO BID when coadministered with proton pump inhibitors.

            • belzutifan

              omeprazole will increase the level or effect of belzutifan by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Belzutifan is a CYP2C19 substrate. Coadministration with CYP2C19 inhibitors may increase incidence or severity of adverse effects. Monitor for anemia and hypoxia and reduce belzutifan dose as recommended.

            • bendamustine

              omeprazole decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

            • bortezomib

              bortezomib will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • bosutinib

              omeprazole decreases levels of bosutinib by Other (see comment). Use Caution/Monitor. Comment: PPIs may decrease bosutinib concentration by ~45%; bosutinib displays pH-dependent solubility.

            • budesonide

              omeprazole decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • butabarbital

              butabarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • butalbital

              butalbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • cannabidiol

              omeprazole will increase the level or effect of cannabidiol by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider reducing the cannabidiol dose when coadministered with a strong CYP2C19 inhibitor.

              cannabidiol will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider reducing the dose of sensitive CYP2C19 substrates, as clinically appropriate, when coadministered with cannabidiol.

            • capecitabine

              omeprazole decreases effects of capecitabine by unknown mechanism. Use Caution/Monitor. Retrospective data suggest elevated gastric pH caused by PPI use may impair capecitabine tablet dissolution and/or reduce absorption.

            • carbamazepine

              carbamazepine will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • carbonyl iron

              omeprazole will decrease the level or effect of carbonyl iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • cefpodoxime

              omeprazole decreases effects of cefpodoxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • cefuroxime

              omeprazole decreases effects of cefuroxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • cenobamate

              cenobamate will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              cenobamate will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider a dose reduction of CYP2C19 substrates, as clinically appropriate, when used concomitantly with cenobamate.

            • ciprofloxacin

              omeprazole will decrease the level or effect of ciprofloxacin by unknown mechanism. Use Caution/Monitor. Absorption of the ciprofloxacin ER tablet was slightly diminished (20%) when coadministered with omeprazole.

            • citalopram

              omeprazole will increase the level or effect of citalopram by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Citalopram 20 mg/day is the maximum recommended dose for patients taking CYP2C19 inhibitors because of the risk of QT prolongation.

            • clobazam

              omeprazole will increase the level or effect of clobazam by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Dosage adjustment may be required; CYP2C19 inhibitors may result in increased exposure to N-desmethylclobazam (active metabolite).

            • clozapine

              omeprazole will decrease the level or effect of clozapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • cobicistat

              cobicistat will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • conivaptan

              conivaptan will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • crizotinib

              omeprazole will decrease the level or effect of crizotinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Drugs that elevate the gastric pH may decrease the solubility of crizotinib and subsequently reduce its bioavailability. However, no formal studies have been conducted.

            • cyclosporine

              omeprazole, cyclosporine. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Long-term use of PPIs may cause hypomagnesemia and increase this risk when coadministered with drugs that may also decrease magnesium levels.

            • dabrafenib

              omeprazole will decrease the level or effect of dabrafenib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Drugs that alter upper GI tract pH (eg, PPIs, H2-blockers, antacids) may decrease dabrafenib solubility and reduce its bioavailability

              dabrafenib will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Use alternative if available

            • dextroamphetamine

              omeprazole, dextroamphetamine. Other (see comment). Use Caution/Monitor. Comment: Reduced gastric acidity caused by proton pump inhibitors decreases time to Tmax for amphetamine and dextroamphetamine. AUC was unaffected. .

            • diazepam intranasal

              omeprazole will increase the level or effect of diazepam intranasal by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Strong or moderate CYP2C19 inhibitors may decrease rate of diazepam elimination, thereby increasing adverse reactions to diazepam.

            • dichlorphenamide

              dichlorphenamide and omeprazole both decrease serum potassium. Use Caution/Monitor.

            • digoxin

              omeprazole increases toxicity of digoxin by Other (see comment). Use Caution/Monitor. Comment: Prolonged use of PPIs may cause hypomagnesemia and increase risk for digoxin toxicity.

            • efavirenz

              efavirenz will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

              efavirenz will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • elagolix

              elagolix will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak inhibitor of CYP2C19. No dose adjustments are needed for omeprazole with 40 mg/day or less. Consider omeprazole dose reduction with higher omeprazole doses (eg, dose for Zollinger-Ellison) if coadministered with elagolix.

              elagolix decreases levels of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • eltrombopag

              omeprazole will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • eluxadoline

              omeprazole increases levels of eluxadoline by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. As a precautionary measure due to incomplete information on the metabolism of eluxadoline, use caution when coadministered with strong CYP2C19 inhibitors.

            • encorafenib

              encorafenib, omeprazole. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • escitalopram

              omeprazole will increase the level or effect of escitalopram by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • eslicarbazepine acetate

              eslicarbazepine acetate will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • etravirine

              etravirine will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • fedratinib

              fedratinib will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • ferric gluconate

              omeprazole will decrease the level or effect of ferric gluconate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferric maltol

              omeprazole will decrease the level or effect of ferric maltol by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferrous fumarate

              omeprazole will decrease the level or effect of ferrous fumarate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferrous gluconate

              omeprazole will decrease the level or effect of ferrous gluconate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferrous sulfate

              omeprazole will decrease the level or effect of ferrous sulfate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • fexinidazole

              fexinidazole will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • finerenone

              omeprazole will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

            • flibanserin

              omeprazole will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Coadministration of flibanserin with strong CYP2C19 inhibitors may increase flibanserin exposure and increase the risk of hypotension, syncope, and CNS depression.

              omeprazole will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

            • fluconazole

              fluconazole will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • fosamprenavir

              omeprazole will decrease the level or effect of fosamprenavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • fosphenytoin

              omeprazole will increase the level or effect of fosphenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              fosphenytoin will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • gefitinib

              omeprazole decreases levels of gefitinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Avoid coadministration of gefitinib with PPIs if possible. If treatment with a PPI is required, separate gefitinib and PPI doses by 12 hr.

            • glyburide

              omeprazole will increase the level or effect of glyburide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

            • iloperidone

              iloperidone increases levels of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

            • imipramine

              omeprazole will increase the level or effect of imipramine by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • iron dextran complex

              omeprazole will decrease the level or effect of iron dextran complex by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • iron sucrose

              omeprazole will decrease the level or effect of iron sucrose by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • isavuconazonium sulfate

              omeprazole will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • ledipasvir/sofosbuvir

              omeprazole decreases levels of ledipasvir/sofosbuvir by Other (see comment). Use Caution/Monitor. Comment: Ledipasvir solubility decreases as pH increases; drugs that increase gastric pH are expected to decrease levels of ledipasvir; proton-pump inhibitor doses comparable to omeprazole <20 mg can be administered simultaneously with ledipasvir/sofosbuvir under fasted conditions.

            • lemborexant

              omeprazole will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

            • letermovir

              letermovir increases levels of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor and dose adjustment may be necessary.

            • lomitapide

              omeprazole increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

            • losartan

              omeprazole will increase the level or effect of losartan by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. May inhibit the conversion of losartan to its active metabolite E-3174. Importance of interaction not established; monitor individual therapeutic response to determine losartan dosage.

            • lumacaftor/ivacaftor

              lumacaftor/ivacaftor, omeprazole. affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. In vitro studies suggest that lumacaftor may induce and ivacaftor may inhibit CYP2C19 substrates. .

              lumacaftor/ivacaftor will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lumacaftor/ivacaftor is a strong CYP3A4 inhibitor and also has the potential to induce CYP2C19 and both induce and inhibitor P-gp.

            • methotrexate

              omeprazole increases levels of methotrexate by decreasing renal clearance. Use Caution/Monitor. Temporary withdrawal of PPI may be considered in some patients.

            • methylphenidate

              omeprazole decreases effects of methylphenidate by enhancing GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Since the characteristics of methylphenidate extended release capsules (Ritalin LA) are pH dependent, coadministration of antacids or acid suppressants could alter the release of methylphenidate. Consider separating the administration of the antacid and the methylphenidate extended-release capsules may be avoided.

            • midazolam intranasal

              omeprazole will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

            • modafinil

              modafinil will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • mycophenolate

              omeprazole will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Potential interaction applies to mycophenolate mofetil. Enteric coated mycophenolate sodium formulation is less sensitive to this interaction. Clinical significance unclear.

            • nateglinide

              omeprazole will increase the level or effect of nateglinide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

            • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)

              ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) will decrease the level or effect of omeprazole by unspecified interaction mechanism. Use Caution/Monitor. Monitor for decreased omeprazole efficacy; consider increasing omeprazole dose in patients whose symptoms are not well controlled (not to exceed 40 mg/day)

            • oxcarbazepine

              oxcarbazepine will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • pentobarbital

              pentobarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • phenobarbital

              phenobarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • phenytoin

              omeprazole will increase the level or effect of phenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              phenytoin will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • polysaccharide iron

              omeprazole will decrease the level or effect of polysaccharide iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • posaconazole

              omeprazole will decrease the level or effect of posaconazole by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              posaconazole will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • primidone

              primidone will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

              primidone will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifampin

              rifampin will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • riociguat

              omeprazole will decrease the level or effect of riociguat by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • ritonavir

              ritonavir will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • roflumilast

              omeprazole will decrease the level or effect of roflumilast by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Concomitant therapy may reduce therapeutic effectiveness.

            • rose hips

              omeprazole will decrease the level or effect of rose hips by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • secobarbital

              secobarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • St John's Wort

              St John's Wort will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • stiripentol

              stiripentol, omeprazole. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              stiripentol will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider reducing the dose of CYP2C19 substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

            • tacrolimus

              omeprazole will increase the level or effect of tacrolimus by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Concomitant administration may increase tacrolimus whole blood concentrations, particularly in intermediate or poor metabolizers of CYP2C19

            • tamoxifen

              omeprazole will increase the level or effect of tamoxifen by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

            • tazemetostat

              tazemetostat will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              omeprazole will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tinidazole

              omeprazole will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tofacitinib

              omeprazole increases levels of tofacitinib by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. No specific dose adjustment recommended when tofacitinib coadministered with potent CYP2C19 inhibitors; decrease tofacitinib dose if coadministered with both moderate CYP3A4 and potent CYP2C19 inhibitors .

            • triclabendazole

              triclabendazole will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • vismodegib

              omeprazole will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

            • voriconazole

              voriconazole will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

              voriconazole will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • warfarin

              omeprazole will increase the level or effect of warfarin by Other (see comment). Use Caution/Monitor. Warfarin's less potent R-enantiomer is metabolized in part by CYP3A4 (and also CYP1A2 and CYP2C19). Monitor INR more frequently if coadministered with inhibitors of these isoenzymes and adjust warfarin dose if needed.

            Minor (55)

            • alosetron

              omeprazole will decrease the level or effect of alosetron by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

            • alprazolam

              omeprazole increases levels of alprazolam by decreasing metabolism. Minor/Significance Unknown.

            • ambrisentan

              omeprazole will increase the level or effect of ambrisentan by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.

            • bismuth subsalicylate

              omeprazole increases levels of bismuth subsalicylate by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • blessed thistle

              blessed thistle decreases effects of omeprazole by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical interaction.

            • bosentan

              omeprazole will increase the level or effect of bosentan by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              bosentan will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • carbamazepine

              omeprazole increases levels of carbamazepine by decreasing metabolism. Minor/Significance Unknown. Monitor plasma levels when used concomitantly.

            • carvedilol

              omeprazole will increase the level or effect of carvedilol by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • chlordiazepoxide

              omeprazole increases levels of chlordiazepoxide by decreasing metabolism. Minor/Significance Unknown.

            • clomipramine

              omeprazole will increase the level or effect of clomipramine by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.

            • clonazepam

              omeprazole increases levels of clonazepam by decreasing metabolism. Minor/Significance Unknown.

            • clorazepate

              omeprazole increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

            • cyanocobalamin

              omeprazole decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • darifenacin

              darifenacin will decrease the level or effect of omeprazole by Other (see comment). Minor/Significance Unknown. Effectiveness of proton pump inhibitors may be decreased theoretically if administered with other antisecretory agents

            • devil's claw

              devil's claw decreases effects of omeprazole by pharmacodynamic antagonism. Minor/Significance Unknown.

            • dexamethasone

              dexamethasone will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • diazepam

              omeprazole will increase the level or effect of diazepam by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.

            • dronedarone

              dronedarone will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF, omeprazole. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Based on drug interaction studies conducted with the components of Stribild, no clinically significant drug interactions have been either observed or are expected when coadministered with PPIs.

            • eslicarbazepine acetate

              eslicarbazepine acetate decreases effects of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Monitor for GI symptoms; net increased or decreased effect on PPI action unclear due to opposing CYP450 actions.

            • estazolam

              omeprazole increases levels of estazolam by decreasing metabolism. Minor/Significance Unknown.

            • etravirine

              omeprazole will increase the level or effect of etravirine by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.

              omeprazole will increase the level or effect of etravirine by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • ferric carboxymaltose

              omeprazole will decrease the level or effect of ferric carboxymaltose by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.

            • fluoxetine

              fluoxetine will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • flurazepam

              omeprazole increases levels of flurazepam by decreasing metabolism. Minor/Significance Unknown.

            • fluvastatin

              omeprazole will increase the level or effect of fluvastatin by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • glipizide

              omeprazole will increase the level or effect of glipizide by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.

            • ibuprofen IV

              omeprazole will increase the level or effect of ibuprofen IV by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • levoketoconazole

              levoketoconazole will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • levothyroxine

              omeprazole decreases levels of levothyroxine by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Conflicting evidence regarding this interaction exists.

            • lidocaine

              omeprazole will decrease the level or effect of lidocaine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

            • liothyronine

              omeprazole decreases levels of liothyronine by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Conflicting evidence regarding this interaction exists.

            • liotrix

              omeprazole decreases levels of liotrix by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Conflicting evidence regarding this interaction exists.

            • lisdexamfetamine

              omeprazole, lisdexamfetamine. Other (see comment). Minor/Significance Unknown. Comment: Reduced gastric acidity caused by proton pump inhibitors decreases time to Tmax for amphetamine and dextroamphetamine. AUC was unaffected. .

            • lorazepam

              omeprazole increases levels of lorazepam by decreasing metabolism. Minor/Significance Unknown.

            • methamphetamine

              omeprazole decreases levels of methamphetamine by Other (see comment). Minor/Significance Unknown. Comment: Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone; monitor patients for changes in clinical effect and adjust therapy based on clinical response.

            • mexiletine

              omeprazole will decrease the level or effect of mexiletine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

            • midazolam

              omeprazole increases levels of midazolam by decreasing metabolism. Minor/Significance Unknown.

            • mitotane

              mitotane decreases levels of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • olanzapine

              omeprazole will decrease the level or effect of olanzapine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

            • ospemifene

              omeprazole increases levels of ospemifene by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.

            • phytoestrogens

              omeprazole decreases levels of phytoestrogens by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • ponatinib

              omeprazole decreases levels of ponatinib by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.

            • quazepam

              omeprazole increases levels of quazepam by decreasing metabolism. Minor/Significance Unknown.

            • ribociclib

              ribociclib will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • riluzole

              omeprazole will decrease the level or effect of riluzole by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

            • ruxolitinib

              omeprazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ruxolitinib topical

              omeprazole will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • sulfamethoxazole

              omeprazole will increase the level or effect of sulfamethoxazole by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • theophylline

              omeprazole will decrease the level or effect of theophylline by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

              omeprazole increases toxicity of theophylline by Other (see comment). Minor/Significance Unknown. Comment: Prolonged use of proton pump inhibitors can cause hypochlorhydria, which in turn causes peristalsis in small intestine to increase and peristalsis in the proximal colon to decrease; monitor for toxicity.

            • thyroid desiccated

              omeprazole decreases levels of thyroid desiccated by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Conflicting evidence regarding this interaction exists.

            • tizanidine

              omeprazole will decrease the level or effect of tizanidine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

            • tolbutamide

              omeprazole will increase the level or effect of tolbutamide by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

            • triazolam

              omeprazole increases levels of triazolam by decreasing metabolism. Minor/Significance Unknown.

            • voriconazole

              omeprazole will increase the level or effect of voriconazole by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Clarithromycin

            • GI effects, general (13%)

            1-10%

            Clarithromycin

            • Headache (2%)
            • Abdominal pain (2%)
            • Abnormal taste (3-7%)
            • Diarrhea (3-6%)
            • Dyspepsia (2%)
            • Heartburn (2%)
            • Nausea (3-6%)
            • Increased BUN (4%)
            • Increased PT (1%)
            • Vomiting (1%)
            • GI intolerance
            • Decrease WBC Rash

            Omeprazole

            • Acid regurgitation (1.9%)
            • Upper respiratory infection (1.9%)
            • Constipation (1.5%)
            • Dizziness (1.5%)
            • Rash (1.5%)
            • Asthenia (1.3%)
            • Back pain (1.1%)
            • Cough (1.1%)

            <1%

            Clarithromycin

            • QT prolongation
            • Neurology/Psychiatric: Anxiety, dizziness, hallucinations, manic behavior, neuromuscular blockade, psychosis, seizures
            • Gastrointestinal: Anorexia, glossitis, pancreatitis, jaundice, hepatitis/hepatic dysfunction, C difficile colitis
            • Laboratory: Bilirubin increased, elevated AST, LFTs, alkaline phosphate, serum creatinine; hypoglycemia, leukopenia, neutropenia, thrombocytopenia
            • Anaphylaxis, dyspnea, Stevens-Johnson syndrome

            Frequency Not Defined

            Omeprazole

            • Fracture of bone, osteoporosis-related
            • Hepatotoxicity (rare)
            • Hip fracture
            • Interstitial nephritis (rare)
            • Pancreatitis (rare)
            • Rhabdomyolysis
            • Toxic epidermal necrolysis (rare)

            Amoxicillin

            • Headache
            • Rash
            • Diarrhea, nausea, vomiting
            • Anemia
            • AST/ALT elevation
            • Anaphylaxis
            • Candidiasis (mucocutaneous), pseudomembranous colitis, serum sickness

            Clarithromycin

            • Torsade de pointes (rare)
            • Allergic reactions: urticaria & skin eruptions, leukocytoclastic vasculitis, toxic epidermal necrolysis, pruritus, rash
            • Transient CNS effects: psychosis, anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, nightmares, tinnitus, tremor, and vertigo
            • Hepatic failure
            • Stomatitis
            • Acute renal failure
            • Reversible hearing loss (hypoacusis)

            Postmarketing Reports

            Acute tubulointerstitial nephritis

            See individual drug monographs for more information

            Omeprazole

            • Hypocalcemia
            • Severe cutaneous adverse reactions (SCAR): Drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), erythema multiforme, photosensitivity, urticaria, rash, skin inflammation, pruritus, petechiae; purpura, alopecia, hyperhidrosis

            Amoxicillin

            • SCAR, including TEN, SJS, DRESS, and AGEP

            Clarithromycin

            • SCAR, including TEN, DRESS, and AGEP
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            Warnings

            Contraindications

            Coadministration with pimozide, ergotamine or dihydroergotamine

            Omeprazole

            • • Hypersensitivity to omeprazole, benzimidazoles or other proton pump inhibitors

            Amoxicillin

            • Allergy to penicillins, cephalosporins, imipenem
            • Infectious mononucleosis (relative)
            • Concomitant live bacterial vaccines

            Clarithromycin

            • Clarithromycin/ranitidine bicitrate contraindicated in: severe renal impairment (CrCl<25 mL/min); history of acute porphyria

            Cautions

            Omeprazole

            • Liver disease may require dosage reduction
            • Published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (>1 yr), high-dose therapy
            • Hypomagnesemia may occur with prolonged use (ie, >1 year); adverse effects may result and include tetany, arrhythmias, or seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued
            • Symptomatic response does not preclude concomitant underlying malignancy
            • Acute tubulointerstitial nephritis (TIN) reported in patients taking PPIs; TIN may occur at any point during PPI therapy; patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions, to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (eg, fever, rash or arthralgia); discontinue drug and evaluate patients with suspected acute TIN
            • Cutaneous and systemic lupus
              • Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; these events have occurred as both new onset and exacerbation of existing autoimmune disease; majority of PPI-induced lupus erythematosus cases were CLE; the most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly; generally, histological findings were observed without organ involvement
              • Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs; PPI associated SLE is usually milder than non-drug induced SLE; onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly; the majority of patients presented with rash; however, arthralgia and cytopenia were also reported
              • Avoid administration of PPIs for longer than medically indicated; if signs or symptoms consistent with CLE or SLE are noted in patients receiving therapy, discontinue the drug and refer the patient to appropriate specialist for evaluation
              • Most patients improve with discontinuation of PPI alone in 4 to 12 weeks; serological testing (eg, ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestation

            Amoxicillin

            • Allergy to cephalosporins, carbapenems
            • Endocarditis prophylaxis: use only for high-risk patients, per recent AHA Guidelines
            • High doses may cause false urine glucose test by some methods

            Clarithromycin

            • Severe renal impairment
            • Do not refrigerate oral solution
            • Endocarditis prophylaxis: use only for high-risk patients, per recent AHA Guidelines
            • Exacerbation of symptoms of myasthenia gravis and new onset of symptoms reported with clarithromycin; monitor patients for symptoms
            • Colchicine toxicity, some fatal, reported with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency; monitor patients for clinical symptoms of colchicine toxicity

            Bacterial resistance and superinfection

            • Possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy due to clarithromycin and amoxicillin components; if superinfections occur, discontinue therapy and institute appropriate therapy
            • Prescribing clarithromycin or amoxicillin component in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

            Clostridioides difficile-associated diarrhea (CDAD)

            • CDAD reported with use of clarithromycin and amoxicillin; may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters the normal flora of colon leading to overgrowth of C. difficile
            • C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy
            • CDAD must be considered in all patients who present with diarrhea following antibiotic use; careful medical history is necessary since CDAD has been reported to occur over two months after administration of antibacterial agents; if CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued
            • Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
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            Pregnancy & Lactation

            Pregnancy

            Based on findings in animal studies for omeprazole and clarithromycin during pregnancy may cause fetal harm; therapy is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate; Ii therapy is administered during pregnancy, or if pregnancy occurs while receiving therapy, the patient should be apprised of the potential hazard to fetus; there are no adequate and well controlled studies of omeprazole, clarithromycin, or amoxicillin (used separately or together) in pregnant women

            Animal data

            • Clarithromycin demonstrated adverse developmental effects in four animal species at clinically relevant doses; omeprazole increased embryo-fetal loss in rabbits, but animal studies and multiple human studies do not show an increased risk for major malformations; there was no evidence of harm to fetus in mice and rats due to amoxicillin

            Lactation

            Based on limited human data, clarithromycin and its active metabolite 14-OH clarithromycin are present in human milk at less than 2% of maternal weight-adjusted dose; in a separate observational study, reported adverse effects on breast-fed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin

            No data are available to assess effects of clarithromycin or 14-OH clarithromycin on milk production

            Limited data from a single case report suggest omeprazole may be present in human milk; there are no clinical data on effects of omeprazole on breastfed infant or on milk production

            Data from a published clinical lactation study indicate that amoxicillin is present in human milk; published adverse effects with amoxicillin exposure in breast-fed infant include diarrhea; there are no data on effects of amoxicillin on milk production

            Development and health benefits of breastfeeding should be considered along with mother’s clinical need for omeprazole or clarithromycin or amoxicillin and any potential adverse effects on breast-fed child from clarithromycin or from underlying maternal condition.

            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

            Omeprazole

            • Proton pump inhibitor; binds to H+/K+-exchange ATPase (proton pump) in gastric parietal cells resulting in blocking acid secretion

            Amoxicillin

            • Ampicillin derivative; elicits antibacterial effect by inhibiting biosynthesis of cell wall mucopeptide

            Clarithromycin

            • Semisynthetic macrolide antibiotic that reversibly binds to P site of 50S ribosomal subunit of susceptible organisms and may inhibit RNA-dependent protein synthesis by stimulating dissociation of peptidyl t-RNA from ribosomes, causing bacterial growth inhibition

            Pharmacokinetics

            Omeprazole

            • Half-Life: 0.5-1 hr; increases to 3 hr with hepatic impairment
            • Bioavailability: 30-40%
            • Peak Plasma Time: 0.5-3.5 hr
            • Protein Bound: 95-96%
            • Total Body Clearance: 500-600 mL/min
            • Metabolism: hepatic
            • Excretion: 77% urine; 16-19% feces (mainly in bile)

            Amoxicillin

            • Half-Life: 1.5 hr
            • Absorption: 74-92%
            • Distribution: most body fluids and bone, CSF<1%
            • Peak Plasma Time: 1-2 hr
            • Protein Bound: 17-20%
            • Metabolism: hepatic
            • Excretion: urine

            Clarithromycin

            • Half-Life: 3-7 hr
            • Peak Plasma Time: 2-4 hr
            • Absorption: highly stable in presence of gastric acid (unlike erythromycin); food delays but does not affect extent of absorption
            • Distribution: widely into most body tissues except CNS Metabolism: partially hepatic (P450 enzyme CYP3A4); converted to 14-OH clarithromycin (active metabolite)
            • Renal Clearance: approximates normal GFR
            • Excretion: primarily urine
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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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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
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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.