vonoprazan/amoxicillin (Rx)

Brand and Other Names:Voquezna Dual Pak
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

copackaged tablets and capsules

  • tablets: vonoprazan 20 mg
  • capsules: amoxicillin 500 mg
  • Carton contains 14 daily administration packs for twice daily dosing of vonoprazan and 3 times daily dosing of amoxicillin

Helicobacter pylori Infection

Indicated for treatment of Helicobacter pylori (H pylori) infection

Dose: vonoprazan 20 mg PO BID plus amoxicillin 1000 mg PO TID x 14 days

Dosage Modifications

Renal impairment

  • Mild-to-moderate (eGFR 30-89 mL/min): No dosage adjustment required
  • Severe (eGFR <30 mL/min): Avoid

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment required
  • Moderate-to-severe (Child-Pugh B-C): Avoid

Dosing Considerations

Preventing bacterial resistance

  • To reduce the development of drug-resistant bacteria and maintain the effectiveness, use only to treat or prevent infections that are proved or strongly suspected to be caused by susceptible bacteria
  • Consider selecting or modifying therapy when culture and susceptibility information are available; if this information is unavailable, base empiric therapy on local epidemiology and susceptibility patterns

Safety and efficacy not established

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Interactions

Interaction Checker

and vonoprazan/amoxicillin

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            Contraindicated (1)

            • rilpivirine

              vonoprazan will decrease the level or effect of rilpivirine by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated.

            Serious - Use Alternative (52)

            • BCG vaccine live

              amoxicillin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.

            • amobarbital

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

            • apalutamide

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

            • armodafinil

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

            • atazanavir

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

            • belzutifan

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

            • bexarotene

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

            • bosentan

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

            • butabarbital

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

            • butalbital

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

            • carbamazepine

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

            • cenobamate

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

            • cholera vaccine

              amoxicillin, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

            • dabrafenib

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

            • dasatinib

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

            • demeclocycline

              demeclocycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

            • doxycycline

              doxycycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

            • efavirenz

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

            • elagolix

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

            • encorafenib

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

            • enzalutamide

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

            • eravacycline

              eravacycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

            • erlotinib

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

            • eslicarbazepine acetate

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

            • etravirine

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

            • fosphenytoin

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

            • ivosidenib

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

            • lorlatinib

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

            • lumacaftor/ivacaftor

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

            • mavacamten

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

            • minocycline

              minocycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

            • mitapivat

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

            • mitotane

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

            • modafinil

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

            • mycophenolate

              amoxicillin will decrease the level or effect of mycophenolate by Other (see comment). Avoid or Use Alternate Drug. Effect may be due to impairment of enterohepatic recirculation

            • nafcillin

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

            • nelfinavir

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

            • omadacycline

              omadacycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

            • pentobarbital

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

            • pexidartinib

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

              amoxicillin and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

            • phenobarbital

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

            • pretomanid

              amoxicillin, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

            • phenytoin

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

            • primidone

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

            • rifabutin

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

            • rifampin

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

            • rifapentine

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

            • sarecycline

              sarecycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

            • secobarbital

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

            • sotorasib

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

            • St John's Wort

              St John's Wort will decrease the level or effect of vonoprazan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • tetracycline

              tetracycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

            Monitor Closely (38)

            • acyclovir

              amoxicillin, acyclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • allopurinol

              allopurinol decreases toxicity of amoxicillin by Other (see comment). Use Caution/Monitor. Comment: Allopurinol may increase potential for allergic or hypersensitivity reactions to amoxicillin.

            • aspirin

              amoxicillin, aspirin. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor.

              amoxicillin, aspirin. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • aspirin rectal

              amoxicillin, aspirin rectal. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              amoxicillin, aspirin rectal. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor.

            • aspirin/citric acid/sodium bicarbonate

              amoxicillin, aspirin/citric acid/sodium bicarbonate. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              amoxicillin, aspirin/citric acid/sodium bicarbonate. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor.

            • bazedoxifene/conjugated estrogens

              amoxicillin will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

            • bendroflumethiazide

              amoxicillin, bendroflumethiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • carbonyl iron

              vonoprazan will decrease the level or effect of carbonyl iron by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • chlorothiazide

              amoxicillin, chlorothiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • choline magnesium trisalicylate

              amoxicillin, choline magnesium trisalicylate. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              amoxicillin, choline magnesium trisalicylate. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor.

            • cyclopenthiazide

              amoxicillin, cyclopenthiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • dienogest/estradiol valerate

              amoxicillin will decrease the level or effect of dienogest/estradiol valerate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. An alternate or additional form of birth control may be advisable during concomitant use.

            • estradiol

              amoxicillin will decrease the level or effect of estradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

            • ethinylestradiol

              amoxicillin will decrease the level or effect of ethinylestradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.

            • ferric carboxymaltose

              vonoprazan will decrease the level or effect of ferric carboxymaltose by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferric citrate

              vonoprazan will decrease the level or effect of ferric citrate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferric derisomaltose

              vonoprazan will decrease the level or effect of ferric derisomaltose by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferric gluconate

              vonoprazan will decrease the level or effect of ferric gluconate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferric maltol

              vonoprazan will decrease the level or effect of ferric maltol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferric pyrophosphate DIALYSATE

              vonoprazan will decrease the level or effect of ferric pyrophosphate DIALYSATE by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferric pyrophosphate IV

              vonoprazan will decrease the level or effect of ferric pyrophosphate IV by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferrous fumarate

              vonoprazan will decrease the level or effect of ferrous fumarate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferrous gluconate

              vonoprazan will decrease the level or effect of ferrous gluconate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferrous sulfate

              vonoprazan will decrease the level or effect of ferrous sulfate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • ferumoxytol

              vonoprazan will decrease the level or effect of ferumoxytol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • hydrochlorothiazide

              amoxicillin, hydrochlorothiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • iron dextran complex

              vonoprazan will decrease the level or effect of iron dextran complex by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • iron sucrose

              vonoprazan will decrease the level or effect of iron sucrose by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • itraconazole

              vonoprazan will decrease the level or effect of itraconazole by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Closely monitor for reduced itraconazole efficacy if combined. Itraconazole capsules only: Separate administration by at least 1 hr before or 2 hr after ketoconazole.

            • ketoconazole

              vonoprazan will decrease the level or effect of ketoconazole by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Separate administration by at least 1 hr before or 2 hr after ketoconazole.

            • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate

              amoxicillin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.

            • mestranol

              amoxicillin will decrease the level or effect of mestranol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

            • methotrexate

              amoxicillin increases levels of methotrexate by decreasing renal clearance. Use Caution/Monitor. Increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with concurrent administration of high or low doses of methotrexate and penicillins.

            • methyclothiazide

              amoxicillin, methyclothiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • metolazone

              amoxicillin, metolazone. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • mycophenolate

              vonoprazan will decrease the level or effect of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Enteric-coated mycophenolate sodium may be less sensitive to this interaction.

            • polysaccharide iron

              vonoprazan will decrease the level or effect of polysaccharide iron by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • rose hips

              amoxicillin, rose hips. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            Minor (10)

            • amiloride

              amiloride decreases levels of amoxicillin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Administer each drug at least 2 hours apart from each other; monitor for reduced antibiotic efficacy.

            • azithromycin

              azithromycin decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • aztreonam

              aztreonam, amoxicillin. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Combination may be used synergistically against Enterobacteriaceae.

            • chloramphenicol

              chloramphenicol decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • clarithromycin

              clarithromycin decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • erythromycin base

              erythromycin base decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • erythromycin lactobionate

              erythromycin lactobionate decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • erythromycin stearate

              erythromycin stearate decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • pyridoxine (Antidote)

              amoxicillin will decrease the level or effect of pyridoxine (Antidote) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

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            Adverse Effects

            1-10%

            Diarrhea (5.2%)

            Abdominal pain (2.6%)

            Vulvovaginal candidiasis (2%)

            Nasopharyngitis (2%)

            Headache (1.4%)

            Hypertension (1.1%)

            <2%

            • Blood and lymphatic system disorders: Anemia, leukocytosis, leukopenia, neutropenia
            • Cardiac disorders: QT prolongation, tachycardia
            • Eye disorders: Orbital edema
            • Gastrointestinal disorders: Abdominal distention, constipation, dry mouth, duodenal polyp, duodenal ulcer, dyspepsia, flatulence, gastric ulcer, gastroesophageal reflux disease, hematochezia, large intestine polyp, nausea, rectal polyp, stomatitis, tongue discomfort, vomiting
            • General disorders and administration site conditions: Fatigue, pyrexia
            • Immune system disorders: Drug hypersensitivity
            • Infections and infestations: Anal fungal infection, gastrointestinal viral infection, oral fungal infection, pneumonia, tongue fungal infection, upper respiratory tract infection, urinary tract infection, viral infection
            • Investigations: Liver function test abnormal
            • Metabolism and nutrition disorders: Decreased appetite
            • Musculoskeletal system: Bone fracture
            • Nervous system disorders: Ageusia, dizziness, tension headache
            • Psychiatric disorders: Anxiety, depression, insomnia
            • Renal and urinary disorders: Renal hypertrophy, tubulointerstitial nephritis
            • Reproductive system and breast disorders: Vaginal discharge
            • Respiratory, thoracic, and mediastinal disorders: Cough, nasal polyps, oropharyngeal pain
            • Skin and subcutaneous tissue disorders: Dermatitis, dry skin, rash

            <1%

            Dysgeusia (0.6%)

            Postmarketing Reports

            Vonoprazan

            • Immune system disorders: Anaphylactic shock, urticaria, drug eruption
            • Hepatobiliary disorders: Hepatic injury, hepatic failure, jaundice
            • Skin and subcutaneous tissue disorders: Erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)

            Amoxicillin

            • Infections and infestations: Mucocutaneous candidiasis
            • Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis; onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment
            • Hypersensitivity reactions: Anaphylaxis, serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, exfoliative dermatitis, hypersensitivity vasculitis, and urticaria
            • Renal: Crystalluria
            • Hemic and lymphatic systems: Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, and agranulocytosis; reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena
            • Central nervous system: Reversible hyperactivity, agitation, confusion, convulsions, aseptic meningitis, and behavioral changes
            • Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) reported; most occurred in pediatric patients; discoloration reduced or eliminated with brushing or dental cleaning in most cases
            • Skin and subcutaneous tissue disorders: TEN, SJS, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)
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            Warnings

            Contraindications

            Known hypersensitivity to any component – vonoprazan, or amoxicillin (or other beta-lactam antibacterials [eg, penicillins, cephalosporins])

            Rilpivirine-containing products, owing to inhibition of gastric pH by vonoprazan

            Cautions

            Serious and occasionally fatal hypersensitivity reactions (eg, anaphylaxis, anaphylactic shock, rash, erythema multiforme, and Henoch-Schonlein purpura) reported with components; discontinue immediately and institute appropriate treatment if hypersensitivity occurs

            Severe cutaneous adverse reactions (SCAR), including SJS and TEN, reported with all components; additionally, DRESS and AGEP have been reported with amoxicillin; discontinue at first signs of SCAR

            Clostridioides difficile–associated diarrhea (CDAD) reported with acid-suppressing therapies and nearly all antibacterial agents; CDAD must be considered in all patients who present with diarrhea following antibacterial use; careful medical history necessary since CDAD reported to occur over 2 months after administration of antibacterial agents; if CDAD confirmed, discontinue, and implement appropriate management

            High percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash; avoid in patients with mononucleosis

            Prescribing this regimen in absence of proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit and increases risk for drug-resistant bacteria

            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; assess CgA levels at least 14 days after treatment, and consider repeating test if initial CgA levels are high

            Glucose tests: High urine concentrations of amoxicillin may cause false-positive results when using glucose tests based on the Benedict copper reduction reaction that determines the amount of reducing substances, like glucose, in the urine; use enzymatic glucose oxidase reactions instead while taking amoxicillin

            Drug interaction overview

            • Vonoprazan: CYP3A substrate; weak CYP3A inhibitor; CYP2C19 inhibitor
            • Strong or moderate CYP3A inducers
              • Avoid coadministration
              • Strong or moderate CYP3A inducers may decrease exposure of vonoprazan, which may reduce effectiveness
            • Probenecid
              • Closely monitor
              • Amoxicillin undergoes tubular secretion; probenecid may increase amoxicillin systemic exposure by blocking renal tubular secretion, which may increase risk of adverse reactions
            • Allopurinol
              • Discontinue if skin rash occurs
              • Increase incidence of rashes reported with coadministration of allopurinol and amoxicillin
            • Drugs dependent on gastric pH for absorption
              • Rilpivirine: Contraindicated
              • Atazanavir, nelfinavir: Avoid
              • Other antiretroviral drugs: See prescribing for reliance on gastric pH for absorption
              • Other drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole); Check prescribing information for modifying time of dosage or avoidance
              • Vonoprazan reduces intragastric acidity, which may alter absorption of certain drugs
            • Sensitive CYP3A4 substrates
              • See prescribing information for sensitive CYP3A substrates
              • Tacrolimus, cyclosporine: Dosage modification (dose reduction) may be needed; monitor closely
              • Vonoprazan (a weak CYP3A inhibitor) may increase exposure of CYP3A4 substrates, which may increase risk of adverse reactions related to these substrates
            • CYP2C19 substrates
              • Clopidogrel: Carefully monitor the efficacy of clopidogrel, and consider alternative anti-platelet therapy
              • Citaprolam, cilostazol: Carefully monitor for adverse reactions
              • Vonoprazan is a CYP2C19 inhibitor; may reduce plasma concentration of the active metabolite of clopidogrel, resulting in reduced platelet inhibition; may increase exposure of CYP2C19 substrate drugs
            • Oral anticoagulants
              • Monitor INR, and adjust dose accordingly
              • Abnormal prolongation of prothrombin time (increased INR) reported in patients receiving amoxicillin and oral anticoagulants
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            Pregnancy & Lactation

            Pregnancy

            Available data from pharmacovigilance reports with vonoprazan use in pregnant females are not sufficient to evaluate for drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes

            Report pregnancies to the Phathom Pharmaceuticals, Inc. Adverse Event reporting line at 1-800-775- PHAT (7428)

            Animal studies

            • Vonoprazan: Pups from dams orally administered vonoprazan during organogenesis and through lactation exhibited liver discoloration that was associated with necrosis, fibrosis, and hemorrhage at a dose ~22x the maximum recommended human dose (MRHD)
            • Amoxicillin: No evidence of harm to the fetus found

            Lactation

            Vonoprazan

            • There are no data regarding the presence of vonoprazan in human milk, the effects on the breastfed infant or the effects on milk production
            • Vonoprazan and its metabolites are present in rat milk; liver injury occurred in offspring from pregnant and lactating rats administered oral vonoprazan at AUC exposures approximately equal to and greater than the MRHD

            Amoxicillin

            • Data from published clinical lactation study indicate that amoxicillin is present in human milk
            • There are no data on the effects of amoxicillin on milk production

            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

            Vonoprazan

            • Potassium-competitive acid blocker (PCAB)
            • Suppresses basal and stimulated gastric acid secretion at secretory surface of gastric parietal cell through inhibition of the H+,K+-ATPase enzyme system in a potassium-competitive manner
            • Because this enzyme is regarded as the acid (proton) pump within the parietal cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, as it blocks the final step of acid production
            • Does not require activation by acid; may selectively concentrate in parietal cells in both resting and stimulated states
            • Binds to active proton pumps in noncovalent and reversible manner

            Amoxicillin

            • Ampicillin derivative; elicits antibacterial effect by binding to penicillin-binding proteins and inhibiting biosynthesis of cell wall

            Pharmacokinetics

            Vonoprazan

            • Absorption
              • Onset of antisecretory activity: 2-3 hr; elevated intragastric pH maintained for >24 hr
              • Steady-state achieved: 3-4 days
              • Peak plasma time: 2.5 hr (single-dose); 3 hr (steady-state)
              • Peak plasma concentration: 25.2 ng/mL (single-dose); 37.8 ng/mL (steady-state)
              • AUC: 154.8 nghr/mL (single-dose); 272.5 nghr/mL (steady-state)
            • Distribution
              • Vd: 1001 L (single-dose); 782.7 L (steady-state)
              • Protein bound: 85-88%
            • Metabolism
              • Metabolized to inactive metabolites via multiple pathways by combination of CYP450 isoforms (CYP3A4/5, CYP2B6, CYP2C19, CYP2C9 and CYP2D6) along with sulfo- and glucuronosyl-transferases
            • Elimination
              • Half-life: 7.1 hr (single-dose); 6.8 hr (steady-state)
              • Clearance: 97.3 L/hr (single-dose); 81.3 L/hr (steady-state)
              • Excretion: 67% urine (8% unchanged); 31% feces (1.4% unchanged)

            Amoxicillin

            • Half-life: 1.02 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 (60%)
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            Administration

            Oral Administration

            May take with or without food

            Missed dose

            • Within 4 hr of missed dose: Take as soon as possible
            • >4 hr of missed dose: Skip missed dose, and administer next dose at regularly scheduled time
            • Continue with normal dosing schedule until medication is completed

            Storage

            Store at 20-25ºC (68-77ºF); brief exposure to 15-30ºC (59-86ºF) permitted

            Protect from light

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            Patient Handout

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