Vonoprazan, amoxicillin, and clarithromycin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rithish Nimmagadda,MBBS.[2]
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Overview
Vonoprazan, amoxicillin, and clarithromycin is a Potassium-competitive acid blocker that is FDA approved for the treatment of - erosive esophagitis (all grades) and relief of heartburn associated with erosive esophagitis in adults. ,Helicobacter pylori Infection. Common adverse reactions include -Common adverse reactions (≥2%) with vonoprazan when used for healing of erosive esophagitis: gastritis, diarrhea, abdominal distension, abdominal pain, nausea -common adverse reactions (≥2%) with vonoprazan when used for treatment of H. pylori infection: diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, nasopharyngitis..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
10 mg (of vonoprazan) 20 mg (of vonoprazan)
orally
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Known hypersensitivity to vonoprazan or any components of the formulation.
Concomitant use with rilpivirine-containing products.
Warnings
Gastric Malignancy
-Symptomatic response to therapy does not preclude the presence of gastric malignancy. -Consider additional follow-up and diagnostic testing in patients who have suboptimal response or early symptomatic relapse after completing treatment with vonoprazan. In older patients, also consider endoscopy.
Acute Tubulointerstitial Nephritis -Acute tubulointerstitial nephritis reported. If suspected, discontinue drug and evaluate patients.
Clostridioides difficile-Associated Diarrhea
-Clostridioides difficile-associated diarrhea (CDAD) reported with use of acid suppressing therapies and nearly all antibacterial agents. -Consider CDAD in all patients with diarrhea that does not improve. [ref] Use shortest duration of therapy appropriate to the condition being treated.
Bone Fracture
-PPI therapy may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine; risk is increased in patients who receive high dosages (multiple daily doses or long-term therapy). -Bone fractures, including osteoporosis-related fracture, also reported with vonoprazan. -Use shortest duration of therapy appropriate to the condition being treated. -Patients with increased risk of osteoporosis-related fracture should be managed according to established guidelines.
Severe Cutaneous Reactions
-Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), reported. -Discontinue vonoprazan at first sign or symptom of a severe cutaneous adverse reaction or other sign of hypersensitivity, and consider further evaluation.
Vitamin B12 (Cobalamin) Deficiency
-Long-term use of acid-suppressing drugs can lead to malabsorption of vitamin B12 caused by hypo- or achlorhydria. ---Vitamin B12 deficiency reported during postmarketing experience with vonoprazan. -If clinical symptoms consistent with vitamin B12 deficiency observed, consider further workup.
Hypomagnesemia and Mineral Metabolism
-Hypomagnesemia reported during postmarketing experience. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. -Consider monitoring magnesium levels prior to and during therapy in patients expected to be on prolonged treatment, in patients taking drugs that may have increased toxicity in the presence of hypomagnesemia (e.g., digoxin), or drugs that may cause hypomagnesemia (e.g., diuretics). Treatment of hypomagnesemia may require magnesium replacement and discontinuation of therapy. -Consider monitoring magnesium and calcium levels prior to and during therapy in patients with preexisting risk of hypocalcemia (e.g., hypoparathyroidism). Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment, consider discontinuing vonoprazan.
Interactions with Diagnostic Investigations for Neuroendocrine Tumors
-Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity; may cause false positive results in diagnostic investigations for neuroendocrine tumors.
Temporarily discontinue treatment at least 14 days before assessing CgA levels and consider repeating test if initial CgA levels are high.If serial tests are performed (e.g., for monitoring), use the same commercial laboratory for testing.
Fundic Gland Polyps
-Fundic gland polyps reported; risk increases with long-term use, especially beyond 1 year. Most patients were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. -Use shortest duration of therapy appropriate to the condition being treated.
Use of Fixed Combinations
-When vonoprazan is used in fixed combination with amoxicillin and clarithromycin, consider the cautions, precautions, and contraindications of amoxicillin and clarithromycin
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Postmarketing Experience in the drug label.
Drug Interactions
-CYP3A4/5, CYP2B6, CYP2C19, CYP2C9, and CYP2D6 substrate; also metabolized by sulfo- and glucoronosyl-transferases. Inhibits CYP2B6, CYP2C19, and CYP3A4/5.
-Inhibits multidrug and toxin extrusion protein 1 (MATE1) and organic cation transporter 1 (OCT1) at concentrations higher than clinically relevant.
CYP3A inhibitors: potential increased exposure of vonoprazan
CYP3A inducers: potential decreased exposure of vonoprazan (by 80% with a strong inducer or 50% with a moderate inducer). Avoid concomitant use.
-Vonoprazan reduces intragastric acidity, which may alter absorption of drugs dependent on gastric pH for absorption.
-co-administration of vonoprazan, amoxicillin, and clarithromycin had no effect on pharmacokinetics of amoxicillin.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
No adequate and well-controlled studies in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vonoprazan, amoxicillin, and clarithromycin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Vonoprazan, amoxicillin, and clarithromycin during labor and delivery.
Nursing Mothers
No data regarding presence of vonoprazan in human milk, effects on the breastfed infant, or effects on milk production. [ref] Vonoprazan and its metabolites are present in rat milk.
Pediatric Use
Safety and effectiveness in pediatric patients not established.
Geriatic Use
No overall differences in safety or effectiveness observed between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Gender
There is no FDA guidance on the use of Vonoprazan, amoxicillin, and clarithromycin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Vonoprazan, amoxicillin, and clarithromycin with respect to specific racial populations.
Renal Impairment
Systemic exposure to vonoprazan was 1.7-, 1.3-, and 2.4- times greater in patients with mild, moderate, and severe renal impairment, respectively. [ref] In subjects requiring dialysis, AUC estimates were 1.3-fold greater
Hepatic Impairment
systemic exposure to vonoprazan was 1.2-, 2.4-, and 2.6-times greater in patients with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment, respectively
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Vonoprazan, amoxicillin, and clarithromycin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Vonoprazan, amoxicillin, and clarithromycin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Administration in the drug label.
Monitoring
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Vonoprazan, amoxicillin, and clarithromycin and IV administrations.
Overdosage
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Mechanism of Action in the drug label.
Structure
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Pharmacodynamics in the drug label.
Pharmacokinetics
Steady state concentrations achieved in 3–4 days 85–88% protein-boundApproximately 67% of oral dose recovered in urine (8% unchanged) and 31% in feces (1.4% unchanged).
Half-life 6.8 hours
Nonclinical Toxicology
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Clinical Studies in the drug label.
How Supplied
Oral Tablets, film-coated 10 mg (of vonoprazan) Voquezna®
20 mg (of vonoprazan)
Voquezna®
Storage
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Storage in the drug label.
Images
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Package and Label Display Panel
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Patient Counseling Information
Advise patients to call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis.
Advise patients to immediately call their healthcare provider if they experience diarrhea that does not improve.
Advise patients to report any fractures, especially of the hip, wrist, or spine to their healthcare provider.
Advise patients to discontinue vonoprazan and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity.
Advise patients to report any clinical symptoms that may be associated with vitamin B12 deficiency to their healthcare provider, if they have been receiving vonoprazan long-term.
Advise patients to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to their healthcare provider.
Advise patients to report to their healthcare provider if they start treatment with rilpivirine-containing products.
Advise patients to contact Phathom Pharmaceuticals if exposed to vonoprazan during pregnancy.
Advise patients to not breastfeed during treatment with vonoprazan.
Advise patients of important administration instructions, including how to take the tablets and what to do in the event of missed doses.
Advise patients to inform clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Inform patients of other important precautionary information.
Precautions with Alcohol
Alcohol-Vonoprazan, amoxicillin, and clarithromycin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Vonoprazan, amoxicillin, and clarithromycin Brand Names in the drug label.
Look-Alike Drug Names
Voquezna®
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.