Vonoprazan fumarate is a Potassium-Competitive Acid Blocker (P-CAB). It 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. 

Description

Vonoprazan fumarate is a Potassium-Competitive Acid Blocker (P-CAB). It 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. It does not require activation by acid. Vonoprazan may selectively concentrate in the parietal cells in both the resting and stimulated states. It binds to the active proton pumps in a non-covalent and reversible
manner.

Presentation

    Vonofix 10 Tablet: Each film-coated tablet contains Vonoprazan Fumarate INN 13.36 mg equivalent to Vonoprazan 10 mg.

    Vonofix 20 Tablet: Each film-coated tablet contains Vonoprazan Fumarate INN 26.72 mg equivalent to Vonoprazan 20 mg.

Indications

    Vonoprazan is usually used to treat gastric/duodenal ulcers, reflux esophagitis, and for suppression of recurrence of gastric ulcer & duodenal ulcers associated with low-dose aspirin or nonsteroidal anti-inflammatory drug, medication in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori.

Dosage & Administration

    Vonoprazan tablet is administered orally before or after food. The recommended doses of Vonoprazan for general adults are as follows:

    Indication  Recommended
    Dose 
    Dose Frequency
    Gastric ulcer 20 mg Once daily for up to 8 weeks
    Duodenal ulcer 20 mg Once daily for up to 6 weeks
    Reflux esophagitis 20 mg Once daily for up to 4 weeks. If
    the effect is insufficient, the
    treatment may be continued for
    up to 8 weeks
    Maintenance therapy for repeatedly
    relapsing reflux esophagitis
    10 mg Once daily.
    If the effect is insufficient, the
    dosage may be increased to 20
    mg once daily
    Suppression of recurrence of
    gastric/duodenal ulcers associated
    with low-dose aspirin or
    non-steroidal anti-inflammatory
    drug therapy
    10 mg Once daily
    In combination with clarithromycin
    and amoxicillin for the eradication of
    Helicobacter pylori
    20 mg Twice daily for 7 day

     

Contrainidications

    Vonoprazan is contraindicated in patients with hypersensitivity to Vonoprazan or to any excipient of the product. Also, it is contraindicated in patients receiving atazanavir sulphate, nelfinavir, or rilpivirine hydrochloride.

Warning & Precautions

    Vonoprazan should be administered with care in patients with hepatic and renal disorders as a delay in the metabolism and excretion of Vonoprazan may occur, which may result in an increase in the concentration of Vonoprazan in the blood.

Side effects

    Most commonly reported adverse reactions include constipation, diarrhea, enlarged feeling of abdomen, nausea, rash, and edema.

Drug interaction

    Vonoprazan may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g. Atazanavir, nelfinavir).

Use in special groups

    Use in Pregnancy & Lactation: There are no adequate and well-controlled studies with Vonoprazan in pregnant women. Vonoprazan should be used during pregnancy only if clearly needed. It is not known whether Vonoprazan is excreted in human milk. During treatment with Vonoprazan, nursing should be avoided if the administration of this drug is necessary for the mother.
    Use in Children: Vonoprazan has not been studied in patients under 18 years of age.
    Use in Geriatric Patients: Since physiological functions such as hepatic or renal function are decreased in elderly patients in general, Vonoprazan should be carefully administered.

Packing

    Vonofix 10 Tablet: Each box contains 60 tablets in alu-alu blister pack.
    Vonofix 20 Tablet: Each box contains 30 tablets in alu-alu blister pack.