PROTON 40/MG EC TAB 28/TAB

Indications

Approved Uses

Erosive esophagitis associated with GERD (healing) and maintenance of healing of erosive esophagitis; pathological hypersecretory conditions including Zollinger-Ellison syndrome.

Dosage & Administration

Children's Dosage

Approved for short-term treatment of erosive esophagitis in children 5 years and older. 15kg to <40kg: 20mg once daily for up to 8 weeks. ≥40kg: 40mg once daily for up to 8 weeks.

Side Effects

Common Side Effects

Headache, diarrhea, nausea, abdominal pain, flatulence, constipation, vomiting, dizziness

Safety & Warnings

Age Restriction

Pediatric use: generally approved for children ≥5 years for specific indications (e.g., erosive esophagitis/GERD); not established/typically not recommended <5 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: contraindicated/avoid with rilpivirine; avoid with atazanavir/nelfinavir (reduced antiretroviral exposure); caution/monitor with high-dose methotrexate (delayed clearance/toxicity risk), warfarin (monitor INR), and drugs with pH-dependent absorption (e.g., ketoconazole/itraconazole, iron salts); consider reduced exposure of mycophenolate; digoxin toxicity risk may increase indirectly via hypomagnesemia (monitor).

Food Interaction

Swallow whole, with or without food.

Special Populations

Breastfeeding

Caution

Children

Approved for short-term treatment of erosive esophagitis in children 5 years and older. 15kg to <40kg: 20mg once daily for up to 8 weeks. ≥40kg: 40mg once daily for up to 8 weeks.

Elderly

Standard adult dosing. No dosage adjustment is recommended based on age.

Kidney Impairment

No renal dose adjustment needed (including severe renal impairment).

Liver Impairment

Mild-moderate hepatic impairment: no adjustment; severe hepatic impairment: do not exceed 20 mg once daily and monitor liver enzymes with prolonged therapy.

Storage & Patient Advice

Overdose

Overdose: limited experience; manage with supportive/symptomatic care; pantoprazole is not significantly removed by hemodialysis; seek urgent medical/poison center advice.

Pharmacology

Half-Life

1-2 hours.

Bioavailability

Approximately 77%.

Metabolism

Extensively hepatically metabolized primarily by CYP2C19 and to a lesser extent by CYP3A4; metabolites are inactive.

Product Information

Available Dosage Forms

For pantoprazole (active ingredient): delayed‑release/enteric‑coated oral tablets; oral granules/suspension formulations in some markets; and IV powder for solution (injection). For this PRODUCT specifically: enteric‑coated tablet (oral).

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD, Ulcer

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