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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

Vonoprazan and amoxicillin (co-packaged): Drug information

Vonoprazan and amoxicillin (co-packaged): Drug information
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For additional information see "Vonoprazan and amoxicillin (co-packaged): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Voquezna Dual Pak
Pharmacologic Category
  • Antibiotic, Penicillin;
  • Potassium-Competitive Acid Blocker
Dosing: Adult
Helicobacter pylori infection

Helicobacter pylori infection: Oral: Vonoprazan 20 mg twice daily plus amoxicillin 1 g three times daily for 14 days.

Missed dose: Administer missed dose as soon as possible within 4 hours of scheduled dose. If >4 hours have passed, skip the missed dose and resume dosing at regular scheduled time.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Mild to moderate impairment (eGFR 30 to 89 mL/minute): No dosage adjustment necessary.

Severe impairment (eGFR <30 mL/minute): Avoid use.

Dosing: Liver Impairment: Adult

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate to severe impairment (Child-Pugh class B or C): Avoid use.

Dosing: Adjustment for Toxicity: Adult

Drug-induced enterocolitis syndrome: Discontinue vonoprazan and amoxicillin and initiate appropriate therapy.

Hypersensitivity: Discontinue vonoprazan and amoxicillin and initiate appropriate therapy.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults and may also include concomitant clarithromycin therapy. Also see Amoxicillin.

1% to 10%:

Cardiovascular: Hypertension (1%), prolonged QT interval on ECG (<2%), tachycardia (<2%)

Dermatologic: Dermatitis (<2%), skin rash (<2%), xeroderma (<2%)

Gastrointestinal: Abdominal distension (<2%), abdominal pain (3%), ageusia (<2%), constipation (<2%), decreased appetite (<2%), diarrhea (5%), duodenal ulcer (<2%), dyspepsia (<2%), flatulence (<2%), gastric ulcer (<2%), gastroesophageal reflux disease (<2%), hematochezia (<2%), intestinal polyps (<2%; including duodenal and large intestine), nausea (<2%), rectal polyp (<2%), stomatitis (<2%), tongue changes (discomfort: <2%), viral gastrointestinal infection (<2%), vomiting (<2%), xerostomia (<2%)

Genitourinary: Urinary tract infection (<2%), vaginal discharge (<2%), vulvovaginal candidiasis (2%)

Hematologic & oncologic: Anemia (<2%), leukocytosis (<2%), leukopenia (<2%), neutropenia (<2%)

Hepatic: Abnormal hepatic function tests (<2%)

Hypersensitivity: Hypersensitivity reaction (<2%)

Infection: Fungal infection (<2%; including anal fungal infection, oral and tongue fungal infection), viral infection (<2%)

Nervous system: Anxiety (<2%), depression (<2%), dizziness (<2%), fatigue (<2%), headache (1%; tension headache: <2%), insomnia (<2%)

Neuromuscular & skeletal: Bone fracture (<2%)

Ophthalmic: Periorbital edema (<2%)

Renal: Interstitial nephritis (<2%), renal disease (hypertrophy: <2%)

Respiratory: Cough (<2%), nasal polyposis (<2%), nasopharyngitis (2%), oropharyngeal pain (<2%), pneumonia (<2%), upper respiratory tract infection (<2%)

Miscellaneous: Fever (<2%)

<1%: Gastrointestinal: Dysgeusia

Contraindications

Hypersensitivity to vonoprazan, amoxicillin (or any other beta-lactams), or any component of the formulation; rilpivirine-containing products.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity, history of sensitivity to multiple allergens, or previous IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria). Use with caution in asthmatic patients.

Clostridioides difficile–associated diarrhea: Prolonged use of amoxicillin may result in fungal or bacterial superinfection, including Clostridioides difficile–associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

• Dermatologic reactions: Severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Discontinue therapy if signs or symptoms SCAR occur.

• Drug-induced enterocolitis syndrome: Cases of drug-induced enterocolitis syndrome (mostly in patients ≤18 years of age) have been reported with amoxicillin treatment; signs and symptoms may include diarrhea (within 24 hours after administration), hypotension, lethargy, leukocytosis with neutrophilia, pallor, shock, and vomiting (1 to 4 hours after administration).

Disease-related concerns:

• Infectious mononucleosis: A high percentage of patients with infectious mononucleosis have developed rash during amoxicillin therapy; ampicillin-class antibiotics are not recommended in these patients.

• Neuroendocrine tumors: False positive results in diagnostic testing for neuroendocrine tumors may occur; serum chromogranin A (CgA) levels may increase due to drug-induced decreases in gastric acidity. Assess CgA levels ≥14 days after treatment and consider repeating test if initial levels are high.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Therapy Pack, Oral:

Voquezna Dual Pak: Amoxicillin 500 mg and vonoprazan fumarate 20 mg (112 ea)

Generic Equivalent Available: US

No

Pricing: US

Therapy Pack (Voquezna Dual Pak Oral)

500-20 mg (per each): $9.14

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: Administer with or without food. Administer vonoprazan in the morning and evening. Administer amoxicillin in the morning, midday, and evening.

Use: Labeled Indications

Helicobacter pylori infection: Treatment of H. pylori infection in adults.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Acalabrutinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Acalabrutinib. This interaction is only applicable to acalabrutinib capsules. Risk X: Avoid

Acemetacin: May increase serum concentration of Penicillins. Risk C: Monitor

Afatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Afatinib. Risk C: Monitor

Allopurinol: May increase hypersensitivity effects of Amoxicillin. Risk C: Monitor

ALPRAZolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of ALPRAZolam. Risk C: Monitor

Aminoglycosides: Penicillins may decrease serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Risk C: Monitor

Amphetamines: Inhibitors of the Proton Pump (PPIs and PCABs) may increase absorption of Amphetamines. Specifically, the amphetamine absorption rate may be increased in the first hours after dosing. Risk C: Monitor

Atazanavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Atazanavir. Management: Avoid use in treatment-experienced patients. In treatment-naive patients, administer boosted atazanavir 12 hours after the PPI and the PPI dose should not exceed the equivalent of 20 mg omeprazole. Monitor for reduced atazanavir efficacy. Risk D: Consider Therapy Modification

Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification

BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Belumosudil: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Belumosudil. Management: Increase the dose of belumosudil to 200 mg twice daily when coadministered with inhibitors of the proton pump (PPIs and PCABs). Risk D: Consider Therapy Modification

Bisphosphonate Derivatives: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Bisphosphonate Derivatives. Risk C: Monitor

Bosutinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors and potassium-competitive acid blockers, such as short-acting antacids or histamine-2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Risk D: Consider Therapy Modification

Capecitabine: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Capecitabine. Risk C: Monitor

Cefditoren: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Cefditoren. Risk X: Avoid

Cefpodoxime: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Cefpodoxime. Risk C: Monitor

Cefuroxime: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease absorption of Cefuroxime. Management: Avoid concomitant use of oral cefuroxime axetil and proton pump inhibitors (PPIs) or potassium-competitive acid blockers (PCABs) when possible. If combined, ensure oral cefuroxime axetil is taken with food to minimize the magnitude of this interaction. Risk D: Consider Therapy Modification

Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid

Cilostazol: Vonoprazan may increase serum concentration of Cilostazol. Risk C: Monitor

Citalopram: Vonoprazan may increase serum concentration of Citalopram. Risk C: Monitor

CloBAZam: CYP2C19 Inhibitors (Weak) may increase serum concentration of CloBAZam. CYP2C19 Inhibitors (Weak) may increase active metabolite exposure of CloBAZam. Risk C: Monitor

Clopidogrel: Vonoprazan may decrease therapeutic effects of Clopidogrel. Risk C: Monitor

CycloSPORINE (Systemic): CYP3A4 Inhibitors (Weak) may increase serum concentration of CycloSPORINE (Systemic). Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease serum concentration of Vonoprazan. Risk X: Avoid

CYP3A4 Inducers (Strong): May decrease serum concentration of Vonoprazan. Risk X: Avoid

Cysteamine (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Cysteamine (Systemic). Risk C: Monitor

Dacomitinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with PPIs and PCABs. Antacids may be used. Histamine H2-receptor antagonists (HR2A) may be used if dacomitinib is given at least 6 hours before or 10 hours after the H2RA. Risk X: Avoid

Dasatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Dasatinib. Management: Do not administer PPIs/PCABs with dasatinib. Antacids (taken 2 hours before or after dasatinib) can be used instead if some acid-reducing therapy is needed. No interaction is expected with the Phyrago brand of dasatinib. Risk X: Avoid

Dichlorphenamide: Penicillins may increase hypokalemic effects of Dichlorphenamide. Risk C: Monitor

Dofetilide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Dofetilide. Risk C: Monitor

Doxycycline: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease bioavailability of Doxycycline. Risk C: Monitor

Erlotinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Erlotinib. Risk X: Avoid

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Finerenone: CYP3A4 Inhibitors (Weak) may increase serum concentration of Finerenone. Risk C: Monitor

Flibanserin: CYP3A4 Inhibitors (Weak) may increase serum concentration of Flibanserin. Risk C: Monitor

Gefitinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Gefitinib. Management: Avoid use of inhibitors of the proton pump (PPIs or PCABs) with gefitinib when possible. If required, administer gefitinib 12 hours after the PPI/PCAB or 12 hours before the next dose of the PPI/PCAB. Closely monitor clinical response to gefitinib. Risk D: Consider Therapy Modification

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Indinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Indinavir. Risk C: Monitor

Itraconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Itraconazole. This specifically applies to the super bioavailable itraconazole products (eg, Tolsura brand). Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Itraconazole. This specifically applies to the non-super bioavailable itraconazole products (eg, Sporanox brand and its generics). Management: Exposure to Tolsura brand itraconazole may be increased by PPIs or PCABs ; consider itraconazole dose reduction. Exposure to Sporanox brand itraconazole may be decreased. Give Sporanox brand itraconazole at least 2 hrs before or 2 hrs after PPIs or PCABs. Risk D: Consider Therapy Modification

Ixabepilone: CYP3A4 Inhibitors (Weak) may increase serum concentration of Ixabepilone. Risk C: Monitor

Ketoconazole (Systemic): May increase serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Inhibitors of the Proton Pump (PPIs and PCABs) may decrease absorption of Ketoconazole (Systemic). Management: Administer ketoconazole with an acidic beverage, such as non-diet cola, to increase gastric acidity and improve absorption if concomitant use with proton pump inhibitors or potassium-competitive acid blockers is necessary. Risk D: Consider Therapy Modification

Khat: May decrease serum concentration of Amoxicillin. Management: Consider administering amoxicillin before, or 2 hours after, khat chewing to avoid reductions in amoxicillin bioavailability. Risk D: Consider Therapy Modification

Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Ledipasvir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Ledipasvir. Management: PPI or PCAB doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Use of ledipasvir with higher doses or with food, or 2 hours after a these agents, may reduce ledipasvir bioavailability. Risk D: Consider Therapy Modification

Lemborexant: CYP3A4 Inhibitors (Weak) may increase serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Levoketoconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease absorption of Levoketoconazole. Levoketoconazole may increase serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Risk X: Avoid

Lomitapide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Risk D: Consider Therapy Modification

Mavacamten: CYP2C19 Inhibitors (Weak) may increase serum concentration of Mavacamten. Management: Start mavacamten at 5 mg/day if stable on a weak CYP2C19 inhibitor, and reduce the mavacamten dose by one dose level if initiating a weak CYP2C19 inhibitor. Avoid initiating weak CYP2C19 inhibitors in patients on mavacamten 2.5 mg/day. Risk D: Consider Therapy Modification

Methotrexate: Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Methotrexate. Management: Consider temporarily interrupting PPI or PCAB therapy in patients receiving high-dose methotrexate. If coadministered, monitor for increased methotrexate toxicity (eg, mucositis, myalgias) and/or delayed methotrexate elimination. Risk D: Consider Therapy Modification

Midazolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of Midazolam. Risk C: Monitor

Multivitamins/Minerals (with ADEK, Folate, Iron): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Risk C: Monitor

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Mycophenolate: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: Monitor

Nelfinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Nelfinavir. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease active metabolite exposure of Nelfinavir. Management: Due to potentially significant reductions in nelfinavir exposure, avoid concurrent use of nelfinavir with a PPI or PCAB when possible. If unavoidable, consider PPI or PCAB use for a short duration (less than 30 days) and closely monitor viral load. Risk D: Consider Therapy Modification

Neratinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Risk X: Avoid

Nilotinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Nilotinib. Management: Avoid this combination. Histamine H2 receptor antagonists (H2RAs) given 10 hours before or 2 hours after nilotinib, or antacids given 2 hours before or 2 hours after nilotinib are acceptable alternatives. Risk X: Avoid

NiMODipine: CYP3A4 Inhibitors (Weak) may increase serum concentration of NiMODipine. Risk C: Monitor

Nirogacestat: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Nirogacestat. Risk X: Avoid

Octreotide: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Octreotide. Risk C: Monitor

Palbociclib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Palbociclib. Specifically, this has been reported with the use of palbociclib capsules. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Palbociclib. Specifically, this may occur with the use of palbociclib capsules, and to the greatest extent when taken without food. Management: Carefully evaluate potential risks and benefits of coadministration of palbociclib capsules and proton pump inhibitors or potassium-competitive acid blockers due to the risk of reduced palbociclib efficacy. Palbociclib capsules should be taken with food. Risk D: Consider Therapy Modification

PAZOPanib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of PAZOPanib. Risk X: Avoid

PEMEtrexed: Inhibitors of the Proton Pump (PPIs and PCABs) may increase adverse/toxic effects of PEMEtrexed. Specifically, the risk of hematological toxicities may be increased. Risk C: Monitor

Pexidartinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Pexidartinib. Management: Avoid this combination. If acid-reduction is needed, consider administering an antacid 2 hours before or after pexidartinib, or administer pexidartinib 2 hours before or 10 hours after an H2 receptor antagonist. Risk X: Avoid

Pimozide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Pimozide. Risk X: Avoid

Posaconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Posaconazole. Management: Avoid coadministration of PPIs or PCABs and posaconazole oral suspension. Posaconazole delayed-release tablets do not appear to be sensitive to this interaction and do not required dose adjustment if coadministered with PPIs or PCABs. Risk D: Consider Therapy Modification

Probenecid: May increase serum concentration of Penicillins. Risk C: Monitor

Rilpivirine: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Rilpivirine. Risk X: Avoid

Riociguat: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Riociguat. Risk C: Monitor

Risedronate: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Risedronate. Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Management: Coadministration of PPIs or PCABs with delayed-release risedronate formulations is not recommended. Limit PPI/PCAB dose and duration during coadministration with risedronate as possible. Patients over age 70 are at higher risk of adverse effects. Risk D: Consider Therapy Modification

Saquinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Saquinavir. Risk C: Monitor

Secretin: Coadministration of Inhibitors of the Proton Pump (PPIs and PCABs) and Secretin may alter diagnostic results. Specifically, use of PPIs may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of PPIs or PCABs and secretin, and discontinue PPI or PCAB several weeks prior to secretin administration, with the duration of separation determined by the specific acid suppressant. See full monograph for details. Risk D: Consider Therapy Modification

Selpercatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Selpercatinib. Management: Coadministration of selpercatinib and PPIs or PCABs should be avoided. If coadministration cannot be avoided, selpercatinib and PPIs or PCABs should be administered simultaneously with food. Risk D: Consider Therapy Modification

Simvastatin: CYP3A4 Inhibitors (Weak) may increase serum concentration of Simvastatin. CYP3A4 Inhibitors (Weak) may increase active metabolite exposure of Simvastatin. Risk C: Monitor

Sirolimus (Conventional): CYP3A4 Inhibitors (Weak) may increase serum concentration of Sirolimus (Conventional). Risk C: Monitor

Sirolimus (Protein Bound): CYP3A4 Inhibitors (Weak) may increase serum concentration of Sirolimus (Protein Bound). Management: Reduce the dose of protein bound sirolimus to 56 mg/m2 when used concomitantly with a weak CYP3A4 inhibitor. Risk D: Consider Therapy Modification

Sodium Benzoate: Penicillins may decrease therapeutic effects of Sodium Benzoate. Risk C: Monitor

Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification

SORAfenib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease absorption of SORAfenib. Risk C: Monitor

Sotorasib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Sotorasib. Risk X: Avoid

Sparsentan: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Sparsentan. Risk X: Avoid

Sulpiride: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Sulpiride. Management: Consider alternatives to this combination due to the possibility of reduced sulpiride absorption and efficacy. If gastric acid suppressing therapy is required, consider use of antacids administered at least 2 hours after sulpiride. Risk D: Consider Therapy Modification

Tacrolimus (Systemic): CYP3A4 Inhibitors (Weak) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor

Tacrolimus (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor

Technetium Tc 99m Sestamibi: Coadministration of Inhibitors of the Proton Pump (PPIs and PCABs) and Technetium Tc 99m Sestamibi may alter diagnostic results. Management: Consider holding/stopping proton pump inhibitor therapy for at least 3 days prior to the use technetium Tc 99m sestamibi in cardiac imaging procedures. Risk D: Consider Therapy Modification

Technetium Tc 99m Tetrofosmin: Coadministration of Inhibitors of the Proton Pump (PPIs and PCABs) and Technetium Tc 99m Tetrofosmin may alter diagnostic results. Risk C: Monitor

Tetracyclines: May decrease therapeutic effects of Penicillins. Risk C: Monitor

Thiazolidinediones: Inhibitors of the Proton Pump (PPIs and PCABs) may increase adverse/toxic effects of Thiazolidinediones. Specifically, the risk of osteoporosis or fracture may be increased. Risk C: Monitor

Tipranavir: May decrease serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor

Triazolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of Triazolam. Risk C: Monitor

Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification

Ubrogepant: CYP3A4 Inhibitors (Weak) may increase serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (given at least 2 hours later if needed) of ubrogepant should be limited to 50 mg. Risk D: Consider Therapy Modification

Velpatasvir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Velpatasvir. Management: Sofosbuvir/velpatasvir should be administered with food and taken 4 hours before omeprazole 20 mg. Sofosbuvir/velpatasvir/voxilaprevir can be administered with omeprazole 20 mg. Use with other PPIs or PCABs has not been studied. Risk D: Consider Therapy Modification

Vitamin K Antagonists: Penicillins may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

Voriconazole: May increase serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Voriconazole. Risk C: Monitor

Pregnancy Considerations

Animal reproductions studies have not been conducted with this combination.

Adverse events were observed in some animal reproduction studies following administration of oral vonoprazan.

Refer to the amoxicillin monograph for additional information.

Data collection to monitor pregnancy and infant outcomes following exposure to this combination is ongoing. Health care providers are encouraged to report pregnancies exposed to vonoprazan and amoxicillin to the Phathom Pharmaceuticals Adverse Event reporting line (1-888-775-7428).

Breastfeeding Considerations

Amoxicillin is present in human milk; the presence of vonoprazan is not known.

Based on liver injury observed in rat pups exposed to vonoprazan during lactation, breastfeeding is not recommended by the manufacturer during treatment. Patients may express and discard breast milk during therapy and for 2 days after the last dose of vonoprazan and amoxicillin.

Refer to the amoxicillin monograph for additional information.

Monitoring Parameters

Renal and hepatic function tests; susceptibility testing is recommended in patients who fail H. pylori–eradication regimen; signs and symptoms of hypersensitivity or dermatological reactions.

Mechanism of Action

Vonoprazan: A potassium-competitive acid blocker, suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H+, K+-ATPase enzyme system in a potassium competitive manner.

Amoxicillin: An antibacterial agent, inhibits bacterial cell wall synthesis.

Pharmacokinetics (Adult Data Unless Noted)

Note: Also refer to individual components.

Onset: Vonoprazan: 2 to 3 hours.

Duration: Vonoprazan: 24 hours after single dose and with repeated dosing steady state reached by day 4.

Distribution: Vonoprazan: Average 1,001 L after single dose; 782.7 L after repeated dosing.

Protein binding: Vonoprazan: 85% to 88%.

Metabolism: Vonoprazan: Via multiple pathways, cytochrome P450 (CYP) isoforms (CYP3A4/5, CYP2B6, CYP2C19, CYP2C9, and CYP2D6) along with sulfo- and glucuronosyl-transferases, to inactive metabolites.

Half-life elimination: Vonoprazan: Average 7.1 hours after single dose; average 6.8 hours after repeated dosing.

Time to peak: Vonoprazan: Average 2.5 hours after single dose; average 3 hours after repeated dosing.

Excretion: Vonoprazan: Urine 67% (8% as unchanged drug); Feces 31% (1.4% as unchanged drug).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Vonoprazan: AUC was 1.7, 1.3, and 2.4 times greater in patients with mild, moderate, and severe renal impairment, respectively, compared to patients with normal renal function. AUC was 1.3-fold greater in patients on dialysis compared to patients with normal renal function.

Hepatic function impairment: Vonoprazan: AUC was 1.2, 2.4, and 2.6 times greater in patients with mild, moderate, and severe hepatic impairment, respectively, compared to patients with normal hepatic function.

  1. Voquezna Triple Pak and Dual Pak (vonoprazan and amoxicillin) [prescribing information]. Buffalo Grove, IL: Phathom Pharmaceuticals Inc; May 2024.
Topic 138609 Version 55.0