Indication
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Medicine Overview
Adult Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: Helicobacter pylori infection Age: Adult |
Dose: Oral – Vonoprazan 20 mg plus Amoxicillin 1000 mg plus Clarithromycin 500 mg Frequency: twice daily Duration: 14 days Note: Administered as 1 strip |
|
Indication: Helicobacter pylori infection Age: Adult Condition: Mild hepatic impairment (Child-Pugh A) |
Dose: Oral – Vonoprazan 20 mg plus Amoxicillin 1000 mg plus Clarithromycin 500 mg Frequency: twice daily Duration: 14 days Note: No dosage adjustment required |
Child Dose
| Clinical Information | Administration Information |
|---|---|
|
Age: Pediatric |
Dose: No approved pediatric dosage available Note: No approved pediatric dosage available |
Renal Dose
| Clinical Information | Administration Information |
|---|---|
|
Condition: Mild-to-moderate renal impairment (estimated glomerular filtration rate 30-89 mL/minute) |
Dose: Not specified Note: No dosage adjustment required |
|
Condition: Severe renal impairment (estimated glomerular filtration rate less than 30 mL/minute) |
Dose: Not specified Note: Avoid |
Administration
Administer the copackaged vonoprazan tablets, amoxicillin capsules, and clarithromycin tablets orally twice daily, in the morning and evening, approximately 12 hours apart for 14 days. The medication can be taken with or without food. Each dose consists of one 20 mg vonoprazan tablet, two 500 mg amoxicillin capsules, and one 500 mg clarithromycin tablet; components should not be crushed or chewed. This triple therapy is not recommended for patients with severe renal impairment or moderate-to-severe hepatic impairment. Use with caution in patients with known hypersensitivity to penicillin or macrolides, and monitor for QT prolongation or severe diarrhea. Safety and effectiveness in pediatric patients have not been established.
Side Effect
- Dysgeusia (4.6%)
- Diarrhea (4%)
- Vulvovaginal candidiasis (3.2%)
- Headache (2.6%)
- Abdominal pain (2.3%)
- Hypertension (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 (URTI), Urinary Tract Infection (UTI), 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
- Nasopharyngitis (0.3%)
Drug Interaction
Drug Interaction
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Disease Interaction
Disease Interaction
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Pregnancy
Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
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Data Sources
Clinical & regulatory information on this page is compiled from the following government sources:
DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.