dexlansoprazole (Rx)

Brand and Other Names:Dexilant, Kapidex, more...Dexilant SoluTab
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

delayed-release capsule

  • 30mg
  • 60mg

delayed-release oral disintegrating tablet (ODT)

  • 30mg

Erosive Esophagitis

Capsule: Indicated for healing of all grades of erosive esophagitis (EE) and maintaining healing of EE

ODT: Indicated for maintaining healing of EE

Healing (capsule): 60 mg PO qDay for up to 8 weeks

Maintenance (capsule or ODT): 30 mg PO qDay for up to 6 months

Gastroesophageal Reflux Disease

Indicated for treating heartburn associated with symptomatic nonerosive GERD

Capsule or ODT: 30 mg PO qDay for 4 weeks

Dosage Modifications

Hepatic impairment

  • Milde (Child-Pugh A): Dose adjustment not necessary
  • Moderate (Child-Pugh B): Not to exceed 30 mg/day
  • Severe (Child-Pugh C): Not recommended

Dosage Forms & Strengths

delayed-release capsule

  • 30mg
  • 60mg

delayed-release oral disintegrating tablet (ODT)

  • 30mg

Erosive Esophagitis

<12 years

  • Safety and efficacy not established

>12 years

  • Capsule: Indicated for healing of all grades of erosive esophagitis (EE) and maintaining healing of EE
  • ODT: Indicated for maintaining healing of EE
  • Healing (capsule): 60 mg PO qDay for up to 8 weeks
  • Maintenance (capsule or ODT): 30 mg PO qDay for up to 6 months

Gastroesophageal Reflux Disease

<12 years

  • Safety and efficacy not established

>12 years

  • Indicated for treating heartburn associated with symptomatic nonerosive GERD
  • Capsule or ODT: 30 mg PO qDay for 4 weeks
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Interactions

Interaction Checker

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            Contraindicated (3)

            • erlotinib

              dexlansoprazole 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. .

            • nelfinavir

              dexlansoprazole 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

              dexlansoprazole 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 (28)

            • abametapir

              abametapir will increase the level or effect of dexlansoprazole 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.

            • acalabrutinib

              dexlansoprazole 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 dexlansoprazole 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 dexlansoprazole 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

              dexlansoprazole 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.

            • dacomitinib

              dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole 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.

            • enzalutamide

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

            • fedratinib

              dexlansoprazole 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.

            • idelalisib

              idelalisib will increase the level or effect of dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole 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.

            • itraconazole

              dexlansoprazole 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.

            • ketoconazole

              dexlansoprazole 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.

            • lonafarnib

              dexlansoprazole 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 dexlansoprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

              lonafarnib will increase the level or effect of dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole 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

            • pazopanib

              dexlansoprazole 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

              dexlansoprazole 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 dexlansoprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ponatinib

              dexlansoprazole decreases levels of ponatinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • rifapentine

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

            • secretin

              dexlansoprazole, secretin. Other (see comment). Avoid or Use Alternate Drug. Comment: Concomitant use of H2-receptor antagonists may cause a hyperresponse in gastrin secretion in response to stimulation testing with secretin, falsely suggesting gastrinoma. Discontinue H2-receptor antagonists at least 2 days before administering secretin to aid in the diagnosis of gastrinoma. Temporarily stop dexlansoprazole treatment at least 30 days before assessing to allow gastrin levels to return to baseline.

            • sofosbuvir/velpatasvir

              dexlansoprazole 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

              dexlansoprazole 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 dexlansoprazole 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 dexlansoprazole 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 (59)

            • ampicillin

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

            • avapritinib

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

            • bosutinib

              dexlansoprazole 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

              dexlansoprazole 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.

            • cannabidiol

              dexlansoprazole will increase the level or effect of cannabidiol by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider reducing the cannabidiol dose when coadministered with a moderate CYP2C19 inhibitor.

              cannabidiol will increase the level or effect of dexlansoprazole 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.

            • carbamazepine

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

            • carbonyl iron

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

            • cefditoren

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

            • cenobamate

              cenobamate will decrease the level or effect of dexlansoprazole 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 dexlansoprazole 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.

            • clopidogrel

              dexlansoprazole decreases effects of clopidogrel by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Mean AUC of clopidogrel active metabolite was reduced by ~9% when dexlansoprazole was coadministered compared to administration of clopidogrel alone in healthy subjects who were CYP2C19 extensive metabolizers. Clopidogrel efficacy may be reduced by drugs that inhibit CYP2C19. Inhibition of platelet aggregation by clopidogrel is entirely due to the active clopidogrel metabolite. Clopidogrel is metabolized in part by CYP2C19.

            • cobicistat

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

            • crizotinib

              dexlansoprazole decreases levels 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

              cyclosporine, dexlansoprazole. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: When used for prolonged periods of time PPIs may cause hypomagnesemia and the risk is further increased when used concomitantly with drugs that also have the same effects.

            • dabrafenib

              dexlansoprazole 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

            • dextroamphetamine

              dexlansoprazole, 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

              dexlansoprazole 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 dexlansoprazole both decrease serum potassium. Use Caution/Monitor.

            • digoxin

              dexlansoprazole 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.

            • elagolix

              elagolix will increase the level or effect of dexlansoprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak CYP2C19 inhibitor. Caution with sensitive CYP2C19 substrates.

              elagolix will decrease the level or effect of dexlansoprazole 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.

            • eslicarbazepine acetate

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

            • fedratinib

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

              fedratinib will increase the level or effect of dexlansoprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP2C19 substrates as necessary.

            • ferric gluconate

              dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole 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 dexlansoprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • flibanserin

              dexlansoprazole 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.

            • fosamprenavir

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

            • fosphenytoin

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

            • gefitinib

              dexlansoprazole 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.

            • iron dextran complex

              dexlansoprazole 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

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

            • istradefylline

              istradefylline will increase the level or effect of dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole 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.

            • lumacaftor/ivacaftor

              lumacaftor/ivacaftor, dexlansoprazole. 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 dexlansoprazole 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

              dexlansoprazole increases levels of methotrexate by decreasing renal clearance. Use Caution/Monitor. Increased risk of toxicity with higher doses.

            • methylphenidate

              dexlansoprazole 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

              dexlansoprazole 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.

            • mitotane

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

            • mycophenolate

              dexlansoprazole 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.

            • phenytoin

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

            • polysaccharide iron

              dexlansoprazole 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

              dexlansoprazole 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 dexlansoprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • primidone

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

            • rifampin

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

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

            • ritonavir

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

            • rose hips

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

            • saquinavir

              dexlansoprazole increases levels of saquinavir by unknown mechanism. Use Caution/Monitor. Potential for increased toxicity. .

            • St John's Wort

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

              St John's Wort will decrease the level or effect of dexlansoprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • stiripentol

              stiripentol, dexlansoprazole. 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 decrease the level or effect of dexlansoprazole 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

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

            • tazemetostat

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

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

            • tecovirimat

              tecovirimat will increase the level or effect of dexlansoprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Tecovirimat is a weak inhibitor of CYP2C8 and CYP2C19. Monitor for adverse effects if coadministered with sensitive substrates of these enzymes.

              tecovirimat will decrease the level or effect of dexlansoprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • tinidazole

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

            • triclabendazole

              triclabendazole will increase the level or effect of dexlansoprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. If plasma concentrations of the CYP2C19 substrates are elevated during triclabendazole, recheck plasma concentration of the CYP2C19 substrates after discontinuation of triclabendazole.

            • vismodegib

              dexlansoprazole 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 dexlansoprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            Minor (16)

            • axitinib

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

            • blessed thistle

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

            • cyanocobalamin

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

            • devil's claw

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

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF, dexlansoprazole. 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.

            • ferric carboxymaltose

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

            • levothyroxine

              dexlansoprazole 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.

            • liothyronine

              dexlansoprazole 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

              dexlansoprazole 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

              dexlansoprazole, 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. .

            • methamphetamine

              dexlansoprazole 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.

            • phytoestrogens

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

            • ribociclib

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

            • risedronate

              dexlansoprazole will increase the level or effect of risedronate by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies only to delayed release form; increase in pH may enhance the release of the drug from the delayed release formulation and increases availability

            • theophylline

              dexlansoprazole 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

              dexlansoprazole 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.

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            Adverse Effects

            1-10%

            Diarrhea (5%)

            Abdominal pain (4%)

            Nausea (3%)

            URI (2-3%)

            Vomiting (1-2%)

            Flatulence (1%)

            <1% (Selected)

            Arrhythmia

            Bradycardia

            Barrett's esophagus

            DVT

            Dyspnea

            Hepatomegaly

            Hypertension

            Paresthesia

            Rectal hemorrhage

            Vulvovaginal infection

            Postmarketing Reports

            Blurred vision

            Oral edema

            Facial edema

            Anaphylactic shock (requiring emergency intervention)

            Stevens-Johnsons syndrome

            Toxic epidermal necrolysis (sometimes fatal)

            Pharyngeal edema, throat tightness

            Generalized rash

            Leukocytoclastic vasculitis

            Bone fracture

            Cutaneous and systemic lupus erythematosus

            Cyanocobalamin (vitamin B-12) deficiency

            Fundic gland polyps

            Acute tubulointerstitial nephritis

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            Warnings

            Contraindications

            Hypersensitivity reactions, including anaphylaxis and acute interstitial nephritis reported

            PPIs are contraindicated with rilpivirine-containing products

            Cautions

            Proton pump inhibitors (PPIs) are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve

            May interfere with absorption of drugs for which pH is a determinant of oral bioavailability (eg, atazanavir)

            Proton pump inhibitors may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite

            Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4- 12 weeks; serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations

            Published observational studies suggest that 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

            Relief of symptoms does not eliminate the possibility of a gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI

            Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels

            Therapy increases risk of Salmonella, Campylobacter, and other infections

            Hypomagnesemia may occur with prolonged use (ie, >1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued; consider monitoring magnesium levels prior to initiation of PPI treatment and periodically

            Brand name changed from Kapidex to Dexilant

            Daily long-term use (eg, >3 yr) may lead to malabsorption or a deficiency of cyanocobalamin

            Acute interstitial nephritis reported in patients taking proton pump inhibitors (see Contraindications)

            Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity; increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors; temporarily stop dexlansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high

            May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered concomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of dexlansoprazole therapy with high dose methotrexate administration

            Significant increase in systemic exposure of dexlansoprazole reported in patients with moderate hepatic impairment (Child-Pugh Class B) who received a single dose of 60 mg compared to healthy subjects with normal hepatic function

            PPI therapy is associated with increased risk of fundic gland polyp; risk increases with long-term use >1 year; patient may be asymptomatic; problem usually identified incidentally on endoscopy; use shortest duration of therapy appropriate to condition being treated

            Not recommended in pediatric patients < 2 years; nonclinical studies in juvenile rats with lansoprazole have demonstrated adverse effect of heart valve thickening

            Acute tubulointerstitial nephritis (TIN) reported in patients taking PPIs; 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 (e.g., malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in absence of extra-renal manifestations (eg, fever, rash or arthralgia); discontinue therapy and evaluate patients with suspected acute TIN

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            Pregnancy & Lactation

            Pregnancy

            There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk; dexlansoprazole is R-enantiomer of lansoprazole, and published observational studies of lansoprazole use during pregnancy did not demonstrate an association of adverse pregnancy-related outcomes with lansoprazole

            In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 1.8 times the maximum recommended human dexlansoprazole dose; produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal day 21; these effects were associated with reduction in body weight gain; advise pregnant women of potential risk to fetus

            Lactation

            There is no information regarding presence of dexlansoprazole in human milk, effects on breastfed infant, or on milk production; however, lansoprazole and its metabolites are present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed child from therapy or from the 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

            R-enantiomer of lansoprazole; PPI; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in blockage of acid secretion

            Dual release formulation

            Absorption

            Peak plasma time: 1-2 hr and 4-5 hr (dual release)

            Distribution

            Protein bound: >96%

            Vd: 40.3 L

            Metabolism

            Hydroxylation mainly by CYP2C19 and oxidation to sulfone by CYP3A4

            Elimination

            Half-life elimination: 1-2 hr

            Excretion: Feces (48% as metabolites), urine (51% as metabolites)

            Pharmacogenomics

            Extensively metabolized in the liver by oxidation and reduction; oxidative metabolites are formed mainly by CYP2C19

            Dexlansoprazole is the major circulating component regardless of CYP2C19 allele status

            In extensive (*1/*1) and intermediate (*1/mutant) CYP2C19 metabolizers, 5-hydroxy dexlansoprazole is the major metabolite

            In CYP2C19 poor metabolizers (mutant/mutant), dexlansoprazole sulfone is the major plasma metabolite (because of an increase in the alternate metabolic pathway via CYP3A4)

            Systemic exposure of dexlansoprazole is generally higher in intermediate and poor metabolizers

            Intermediate metabolizers: Mean dexlansoprazole Cmax and AUC values were up to 2 times higher than they were in extensive metabolizers

            Poor metabolizers: Mean Cmax was up to 4 times higher and mean AUC was up to 12 times higher than they were in extensive metabolizers

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            Administration

            Oral Administration

            Capsule

            • May take with or without food
            • Swallow whole; do not chew
            • May sprinkle capsule contents on applesauce
              • 1. Place 1 TBSP of applesauce into a clean container
              • 2. Open capsule and sprinkle intact granules on applesauce
              • 3. Swallow applesauce and granules immediately, do not chew granules
              • 4. Do not save applesauce and granules for later use
            • Preparing capsule contents with water in oral syringe
              • 1. Open the capsule and empty the granules into a clean container with 20 mL of water
              • 2. Withdraw the entire mixture into a syringe
              • 3. Gently swirl the syringe in order to keep granules from settling
              • 4. Administer the mixture immediately into the mouth; do not save the water and granule mixture for later use
              • 5. Refill the syringe with 10 mL of water, swirl gently, and administer
              • 6. Refill the syringe again with 10 mL of water, swirl gently, and administer
            • Preparing capsule contents with water for NG tube administration
              • NG tube (≥16 French)
              • 1. Open the capsule and empty the granules into a clean container with 20 mL of water
              • 2. Withdraw the entire mixture into a catheter-tip syringe
              • 3. Swirl the catheter-tip syringe gently in order to keep the granules from settling, and immediately inject the mixture through the NG tube into the stomach; do not save the water and granule mixture for later use
              • 4. Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube
              • 5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer

            Oral disintegrating tablet

            • Take at least 30 minutes before a meal
            • Do not break or cut
            • Place the tablet on the tongue, allow to disintegrate and swallow without water
            • Do not chew microgranules
            • May also be swallowed whole with water
            • Avoid use of alcohol
            • ODT with water in oral syringe
              • 1. Place one tablet in an oral syringe and draw up 20 mL of water
              • 2. Swirl gently to allow for a quick dispersal
              • 3. After the tablet has dispersed, administer the contents immediately into the mouth; do not save the water and microgranule mixture for later use
              • 4. Refill the syringe with approximately 10 mL of water, swirl gently, and administer any remaining contents
              • 5. Refill the syringe again with approximately 10 mL of water, swirl gently, and administer any remaining contents
            • Preparing ODT with water for NG tube administration
              • 1. Place one tablet in a catheter-tip syringe and draw up 20 mL of water
              • 2. Shake gently to allow for a quick dispersal
              • 3. After the tablet has dispersed, swirl the catheter-tip syringe gently in order to keep the microgranules from settling, and immediately inject the mixture through the NG tube into the stomach; do not save the water and microgranule mixture for later use
              • 4. Refill the catheter-tip syringe with approximately 10 mL of water, shake gently, and flush the tube
              • 5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer

            Missed doses

            • If a dose is missed, administer as soon as possible; however, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time
            • Do not take 2 doses at one time to make up for a missed dose
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Dexilant oral
            -
            60 mg capsule
            Dexilant oral
            -
            30 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            dexlansoprazole oral

            DEXLANSOPRAZOLE - ORAL

            (DEX-lan-SOE-pra-zole)

            COMMON BRAND NAME(S): Dexilant

            USES: Dexlansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Dexlansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).Dexlansoprazole is not recommended for use in children younger than 2 years due to an increased risk of serious side effects. Ask the doctor or pharmacist for details.

            HOW TO USE: Read the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking dexlansoprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once daily with or without food. If your symptoms usually occur after a meal, your doctor may direct you to take your dose every day before the same meal for best results. Dosage and length of treatment are based on your medical condition and response to treatment.Do not crush or chew the capsules. Swallow this medication whole. If you have trouble swallowing this medication whole, you may open the capsule and sprinkle the contents onto 1 tablespoon (15 milliliters) of applesauce. Swallow all of the drug/food mixture right away without chewing it. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug.If you are giving this drug with a liquid medication measuring device/syringe, or through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take dexlansoprazole at least 30 minutes before sucralfate.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.Tell your doctor if your condition persists or worsens. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.

            SIDE EFFECTS: Diarrhea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain).This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Rarely, proton pump inhibitors (such as dexlansoprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine).This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking dexlansoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as lansoprazole, omeprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lupus.Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating), unexplained weight loss.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Proton pump inhibitors (such as dexlansoprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements.Older adults may be more sensitive to the side effects of this drug, especially bone loss and fractures (see above), and C. difficile infection (see Side Effects section).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. The effects on a nursing infant are unknown. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: methotrexate (especially high-dose treatment).Some products need stomach acid so that the body can absorb them properly. Dexlansoprazole decreases stomach acid, so it may change how well these products work. Some affected products include ampicillin, atazanavir, erlotinib, nelfinavir, pazopanib, rilpivirine, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others.Dexlansoprazole is very similar to lansoprazole. Do not use medications containing lansoprazole while using dexlansoprazole.This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.If your doctor instructs you to use this medication regularly for a long time, laboratory and medical tests (such as a magnesium blood test, vitamin B-12 levels) may be performed periodically to monitor your progress or check for side effects. Keep all regular medical and laboratory appointments.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised October 2020. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
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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.