2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets
*
For adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered.
†
Controlled studies did not extend beyond 12 months
‡
Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 Years and Older)
≥ 15 kg to < 40 kg
20 mg
Once Daily for up to 8 wks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily†
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily‡
2.2 Administration Instructions
Directions for method of administration are presented in Table 2.
Table 2: Administration Instructions
*
Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.
Formulation
Route
Instructions*
Delayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole Sodium Delayed-Release Tablets
Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.