Vonostom (Film coated tablet)

Composition:

Vonostom 10: Each film coated tablet contains 10 mg of vonoprazan (equivalent to 13.36 mg of vonoprazan fumarate).

Vonostom 20: Each film coated tablet contains 20 mg of vonoprazan (equivalent to 26.72 mg of vonoprazan fumarate).

Indications:

• For healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.
• To maintain healing of all grades of erosive esophagitis and relief of heartburn

associated with erosive esophagitis in adults.

• For the relief of heartburn associated with non-erosive gastroesophageal reflux

disease in adults.

• In combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection in adults.

In combination with amoxicillin for the treatment of H. pylori infection in adults.

Pregnancy and lactation:

There are no adequate and well-controlled studies of vonoprazan in pregnant women. Available data from pharmacovigilance reports with vonoprazan-containing products used in pregnant women are not sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Because of the potential risk of adverse liver effects shown in animal studies with vonoprazan, advise patients not to breastfeed during treatment with VONOPRAZAN.

Dosage and administration:

Recommended Dosage:

Healing of Erosive Esophagitis:

The recommended adult oral dosage is vonoprazan 20 mg once daily for 8 weeks for the treatment of healing of erosive esophagitis and relief of associated heartburn.

Maintenance of Healed Erosive Esophagitis:

The recommended adult oral dosage is vonoprazan 10 mg once daily for up to 6

months for the maintenance of healed erosive esophagitis and relief of associated

heartburn.

Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease:

The recommended adult oral dosage is vonoprazan 10 mg once daily for 4 weeks.

Treatment of H. pylori Infection:

Triple Therapy: The recommended adult oral dosage is vonoprazan 20 mg plus

amoxicillin 1,000 mg plus clarithromycin 500 mg, each given twice daily (in the

morning and evening, 12 hours apart) for 14 days.

Dual Therapy: The recommended adult oral dose is vonoprazan 20 mg given twice

daily (in the morning and evening) plus amoxicillin 1,000 mg three times daily (in the

morning, mid-day, and evening) for 14 days.

Also refer to the amoxicillin and clarithromycin full prescribing information.

Administration Instructions:

Take vonoprazan with or without food.

Swallow vonoprazan tablets whole; do not chew or crush the tablet.

Missed doses:

-For the healing or maintenance of healed erosive esophagitis, or the relief of

heartburn associated with non-erosive gastroesophageal reflux disease: If a dose is missed, administer vonoprazan as soon as possible within 12 hours after the missed dose. If more than 12 hours have passed, skip the missed dose and administer the next dose at the regularly scheduled time.

-For the treatment of H. pylori infection: If a dose is missed, administer as soon as possible within 4 hours after the missed dose. If more than 4 hours have passed, skip the missed dose and administer the next dose at the regularly scheduled time. Continue the normal dosing schedule until the treatment is completed.

Storage conditions:

Store at temperature between 15 – 30 ^o C. Protect from light and moisture, Keep out of the reach of children.

Packaging:

 Vonostom 10: A pack contains of 30 F.C.T inside AL/AL blister.

Vonostom 20: A pack contains of 30 F.C.T inside AL/AL blister.