Vini

• Gastroesophageal Reflux Disease (GERD):
  Treatment of erosive esophagitis and symptomatic GERD.
• Helicobacter pylori Infection Eradication:
  Used as part of triple therapy in combination with antibiotics (e.g., amoxicillin, clarithromycin) to eradicate H. pylori infection.
• Peptic Ulcer Disease:
  Treatment and prevention of gastric and duodenal ulcers, including those induced by NSAIDs.
• Prevention of NSAID-associated Gastric Ulcers:
  In patients requiring long-term NSAID therapy.
• Off-label Uses:
  Management of Zollinger-Ellison syndrome and other acid-related disorders.

• Adults:
• GERD (erosive esophagitis): 20 mg orally once daily, typically for 8 weeks; may extend to 24 weeks if needed.
• H. pylori Eradication:
  Vonoprazan 20 mg orally twice daily for 7 days, combined with antibiotics such as amoxicillin and clarithromycin.
• Peptic Ulcer Disease: 20 mg orally once daily for 4 to 8 weeks.
• NSAID-induced Ulcer Prevention: 10–20 mg once daily, depending on ulcer risk.
• Elderly:
  Same dosing as adults; no adjustment required but monitor for adverse effects.
• Pediatrics:
  Safety and efficacy not established; not recommended.
• Renal/Hepatic Impairment:
  No dose adjustment necessary in mild to moderate impairment. Use caution in severe impairment; limited data.
• Administration:
  Oral tablets taken with or without food.
• Duration:
  Varies per indication, generally weeks to months depending on clinical response.

Vonoprazan is a potassium-competitive acid blocker (P-CAB) that reversibly inhibits the gastric H+,K+-ATPase enzyme (proton pump) in parietal cells. Unlike proton pump inhibitors (PPIs), vonoprazan does not require acid activation and provides rapid, potent, and sustained suppression of gastric acid secretion by competitively blocking potassium binding on the proton pump. This results in effective and prolonged inhibition of gastric acid secretion, leading to increased gastric pH and promoting healing of acid-related mucosal damage.

• Absorption: Rapid and nearly complete oral absorption with peak plasma concentration (Cmax) reached within 1 to 2 hours.
• Bioavailability: High oral bioavailability; unaffected by food.
• Distribution: Moderate plasma protein binding (~80%).
• Metabolism: Primarily metabolized by CYP3A4; minor contribution from CYP2B6, CYP2C19, and CYP2D6.
• Elimination: Primarily excreted in urine (~65%) and feces (~30%) as metabolites.
• Half-life: Effective plasma half-life approximately 7 hours, allowing twice-daily or once-daily dosing depending on indication.

• Pregnancy:
  No adequate, well-controlled studies in pregnant women. Animal studies have not shown direct teratogenic effects. Use only if clearly needed.
• Lactation:
  Unknown if excreted in human milk. Caution advised; breastfeeding not recommended during treatment unless benefits outweigh risks.
• Note: Data are limited; use with caution.

• Primary Class: Acid Suppressant
• Subclass: Potassium-competitive acid blocker (P-CAB)

• Known hypersensitivity to vonoprazan or any formulation components.
• Concurrent use with rilpivirine-containing products (due to potential decreased rilpivirine plasma concentrations).
• Severe hepatic impairment (caution advised).

• Monitor patients for potential development of gastric mucosal changes with long-term acid suppression.
• Use caution in patients with severe hepatic impairment.
• Rare risk of hypomagnesemia with prolonged use; monitor serum magnesium if symptomatic.
• Monitor for signs of Clostridium difficile infection in patients with diarrhea.
• Not recommended for use in children due to lack of safety data.

Common:

• Diarrhea
• Constipation
• Nausea
• Abdominal discomfort
• Headache

Less Common / Rare:

• Elevated liver enzymes
• Hypersensitivity reactions (rash, pruritus)
• Hypomagnesemia (with long-term use)

Side effects are generally mild to moderate and tend to resolve with continued treatment or discontinuation.

• CYP3A4 substrates: Vonoprazan may increase plasma concentrations of drugs metabolized by CYP3A4.
• Rilpivirine: Vonoprazan reduces plasma levels; concurrent use contraindicated.
• Atazanavir and other pH-dependent drugs: Gastric pH increase may reduce absorption and efficacy.
• No significant interaction with clopidogrel noted.

• Approved in multiple countries for treatment of acid-related disorders, including Japan, South Korea, and others.
• Recognized in clinical guidelines as effective alternative to PPIs with faster onset of acid suppression.
• Growing clinical use in H. pylori eradication regimens due to superior acid suppression enhancing antibiotic efficacy.
• No recent major safety warnings added by regulatory agencies.

• Store at controlled room temperature between 20°C and 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep tablets in original container until use.
• Do not freeze.
• Keep out of reach of children.