VOQUEZNA Tablet Ref.[107221] Active ingredients: Vonoprazan

2.1 Recommended Dosage

Healing of Erosive Esophagitis and Relief of Heartburn:

• The recommended adult oral dosage is VOQUEZNA 20 mg once daily for 8 weeks.

Maintenance of Healed Erosive Esophagitis and Relief of Heartburn:

• The recommended adult oral dosage is VOQUEZNA 10 mg once daily for up to 6 months.

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 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Table 1. Recommended VOQUEZNA Dosage in Patients with Renal Impairment: Healing of Erosive Esophagitis:

Maintenance of Healed Erosive Esophagitis

The recommended dosage of VOQUEZNA in adult patients with renal impairment is the same as for adult patients with normal renal function [see Dosage and Administration (2.1)].

Treatment of H. pylori Infection

The recommended dosage of VOQUEZNA in adult patients with renal impairment is described in Table 2 below [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Table 2. Recommended VOQUEZNA Dosage in Patients with Renal Impairment: Treatment of H. pylori Infection*:

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 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Table 3. Recommended VOQUEZNA Dosage in Patients with Hepatic Impairment: Healing of Erosive Esophagitis:

Maintenance of Healed Erosive Esophagitis

The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is the same as for patients with normal hepatic function [see Dosage and Administration (2.1)].

Treatment of H. pylori Infection

The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is described in Table 4 below [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Table 4. Recommended VOQUEZNA Dosage in Patients with Hepatic Impairment: Treatment of H. pylori Infection:

2.4 Administration Instructions

• Take VOQUEZNA with or without food [see Clinical Pharmacology (12.3)].
• Swallow VOQUEZNA tablets whole; do not chew or crush the tablet.
• Missed doses:
  • For the healing or maintenance of healed erosive esophagitis: 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.

Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].