Vonaspire 20 mg 14 tablets

Vonaspire 20 mg 14 Tablets

Composition

Active Ingredient:

Each tablet contains 20 mg of Vonoprazan.

Indications:

• Treatment of gastric ulcer, duodenal ulcer, or reflux esophagitis;

• Prevention of recurrent gastric or duodenal ulcer associated with low-dose aspirin administration;

• Prevention of recurrent gastric or duodenal ulcer associated with nonsteroidal anti-inflammatory drug

administration;

• Adjunct therapy to Helicobacter pylori eradication in the following:

• Gastric or duodenal ulcer, Gastric mucosa-associated lymphatic tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early stage gastric cancer, or Helicobacter pylori gastritis.

Dosage:

-Treatment of gastric ulcer and duodenal ulcer

Usually, for adults, a daily oral dose of 20 mg of Vonaspireis administered once a day. 

-Treatment of reflux esophagitis

Usually, for adults, a daily oral dose of 20 mg of Vonaspire Is administered once a day. 

-For the maintenance therapy of healing of reflux esophagitis in patients who repeat recurrence or/ and relapse of the condition, a daily oral dose of 10 mg is administered once a day, however, when the efficacy is Inadequate, a daily oral dose of 20 mg may be administered once a day.

-Prevention of recurrent gastric or duodenal ulcer associated with low dose aspirin administration:

Usually, for adults, a daily oral dose of 10 mg of Vonaspire is administered orally once a day.

-Prevention of recurrent gastric or duodenal ulcer associated with non-steroidal anti-inflammatory drug administration:

Usually, for adults, a daily oral dose of 10 mg of Vonaspire is administered orally once a day.

Contraindications:

Vonaspire is contraindicated in:

• Patients with a history of hypersensitivity to vonoprazan or to any of the excipients.

• Patients receiving atazanavir sulfate or rilpivirine hydrochloride (see leaflet).

Precautions:

• Patients receiving atazanavir sulfate or rilpivirine hydrochloride.

-History of gastric ulcer or duodenal ulcer should be confirmed before starting administration.

-The efficacy of Helicobacter pylori eradication therapy for the suppression of gastric cancer has not been established except for stomach after endoscopic resection of early stage cancer.

-When using for Helicobacter pylori-infected gastritis, confirm that Helicobacter pylori is positive and the Helicobacter pylori-infected gastritis is confirmed by endoscopy.

-For long-term administration of Vonaspire, sufficient observations should be made, such as regular endoscopy.

-In maintenance therapy for reflux esophagitis, the drug should be administered to patients who have repeated recurrences and relapses, and care should be taken not to administer Vonaspire to patients who do not need maintenance therapy. In cases where remission continues for a long period of time and there is no risk of recurrence, consider reducing the dose from 20 mg to 10 mg at a time or withdrawing the drug.

-Since administration of vonoprazan may mask symptoms caused by gastric cancer, it should be administered after confirming that it is not malignant.

Side Effects:

Serious adverse reaction common indications:

Pancytopenia, agranulocytosis, leukopenia, thrombocytopenia, Toxic epidermal necrolysis (TEN), mucocutaneous ocular syndrome (Stevens-Johnson syndrome), erythema multiforme (frequency not known).

Adjunct therapy to Helicobacter pylori eradication:

Serious colitis with bloody stool such as pseudomembranous colitis.

other effects: Constipation, diarrhea, flatulence, nausea, rash, Edema, eosinophilia, stomatitis, abdominal discomfort.

Storage Method:

Store at a temperature not exceeding 30 C in a dry place.

Package:

A carton box contains 2 blisters and each contains 7 tablets.