Vonoprazandosage

Recommended Dosage: Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks. Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up to 6 months. Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease: 10 mg once daily for 4 weeks. Treatment of H. pylori Infection: see full prescribing information. See also full prescribing information for the recommended dosage by indication for patients with renal or hepatic impairment.

Administration Instructions: Take with or without food. Swallow whole; do not chew or crush.

2.1 Recommended

Dosage Healing of Erosive Esophagitis The recommended adult oral dosage is VOQUEZNA 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 VOQUEZNA 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 VOQUEZNA 10 mg once daily for 4 weeks. Treatment of H. pylori Infection Triple Therapy: The recommended adult oral dosage is VOQUEZNA 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 VOQUEZNA 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.

2.2 Recommended

Dosage in Patients with Renal Impairment Healing of Erosive Esophagitis The recommended dosage of VOQUEZNA in adult patients with renal impairment is described in Table 1 below.

Table 1: Recommended VOQUEZNA Dosage in Patients with Renal Impairment: Healing of Erosive Esophagitis Estimated glomerular filtration rate (GFR) Recommended Dosage 30 mL/minute or greater 20 mg once daily Less than 30 mL/minute 10 mg once daily Maintenance of Healed Erosive Esophagitis or Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease The recommended dosage of VOQUEZNA in adult patients with renal impairment is the same as for adult patients with normal renal function. Treatment of H. pylori Infection The recommended dosage of VOQUEZNA in adult patients with renal impairment is described in Table 2 below.

Table 2: Recommended VOQUEZNA Dosage in Patients with Renal Impairment: Treatment of H. pylori Infection Also refer to the Dosage and Administration section of the amoxicillin and clarithromycin prescribing information for dosage recommendations in patients with renal impairment. Estimated GFR Recommended Dosage 30 mL/minute or greater 20 mg twice daily Less than 30 mL/minute Use is not recommended

2.3 Recommended

Dosage in Patients with Hepatic Impairment Healing of Erosive Esophagitis The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is described in Table 3 below.

Table 3: Recommended VOQUEZNA Dosage in Patients with Hepatic Impairment: Healing of Erosive Esophagitis Classification Recommended Dosage Child-Pugh Class A 20 mg once daily Child-Pugh Class B 10 mg once daily Child-Pugh Class C 10 mg once daily Maintenance of Healed Erosive Esophagitis or Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is the same as for patients with normal hepatic function. Treatment of H. pylori Infection The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is described in Table 4 below.

Table 4: Recommended VOQUEZNA Dosage in Patients with Hepatic Impairment: Treatment of H. pylori Infection Classification Recommended Dosage Child-Pugh Class A 20 mg twice daily Child-Pugh Class B Use is not recommended Child-Pugh Class C Use is not recommended

2.4 Administration

Instructions Take VOQUEZNA with or without food. Swallow VOQUEZNA 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 VOQUEZNA 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 VOQUEZNA 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.