PANTOLOC 40/MG TAB 15/TAB

Indications

Approved Uses

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

Off-Label Uses

Common off-label uses include H. pylori eradication as part of combination therapy, peptic ulcer disease (non-erosive/ulcer healing depending on local labeling), prevention of NSAID-associated ulcers in high-risk patients, stress-ulcer prophylaxis in critically ill patients, and laryngopharyngeal reflux/functional dyspepsia.

Dosage & Administration

Dosing by Condition

Erosive esophagitis (healing): 40 mg PO once daily for up to 8 weeks (may consider an additional 8 weeks if not healed). Maintenance of healing of erosive esophagitis: 40 mg PO once daily. Zollinger-Ellison/pathological hypersecretion: start 40 mg PO twice daily and titrate to clinical response (doses up to 240 mg/day have been used).

Initial Dose

40mg once daily in the morning

Maintenance Dose

20mg to 40mg once daily.

Maximum Dose

Up to 240mg daily has been administered for pathological hypersecretory conditions.

Children's Dosage

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

Dose Adjustment Notes

No dosage adjustment is required in renal impairment. No adjustment is required in mild-moderate hepatic impairment; in severe hepatic impairment, use with caution and consider a reduced dose (commonly not exceeding 20 mg/day) with monitoring.

How to Take

Swallow the 40 mg delayed‑release (enteric‑coated) tablet whole with water; do not crush, chew, or split. Take preferably 30-60 minutes before a meal (often breakfast).

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): None established. Common (1-10%): Headache, diarrhea, nausea/vomiting, abdominal pain, flatulence. Uncommon (0.1-1%): Dizziness, rash/pruritus, urticaria, arthralgia/myalgia, dry mouth, elevated liver enzymes. Rare/very rare: Interstitial nephritis, severe cutaneous reactions (e.g., SJS/TEN), hepatitis/jaundice, hypomagnesemia (typically with prolonged use).

Safety & Warnings

Contraindications

Hypersensitivity to pantoprazole or other substituted benzimidazoles (e.g., omeprazole, lansoprazole), concomitant use with rilpivirine-containing products.

Warnings & Precautions

May increase risk of C. difficile diarrhea; long-term use may cause hypomagnesemia and increase fracture risk; symptomatic response does not exclude gastric malignancy (evaluate alarm features); consider B12 deficiency risk with prolonged therapy; risk of acute interstitial nephritis; use caution in severe hepatic impairment.

Age Restriction

Not approved for children under 5 years of age.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: contraindicated/avoid with rilpivirine; avoid with atazanavir and nelfinavir (reduced antiviral exposure); caution/monitor with high-dose methotrexate (delayed clearance/toxicity), warfarin (monitor INR), and drugs needing acidic pH for absorption (e.g., ketoconazole/itraconazole, iron salts); possible reduced mycophenolate exposure; clopidogrel interaction is less clinically significant with pantoprazole than with omeprazole but monitor if high thrombotic risk.

Interaction Severity

MAJOR/CONTRAINDICATED or AVOID: rilpivirine; atazanavir and nelfinavir (and other ARVs highly dependent on gastric acidity) due to reduced absorption/exposure. MODERATE: high-dose methotrexate (possible increased levels/toxicity-consider temporary PPI hold/monitor), warfarin (possible INR increase-monitor), drugs with pH-dependent absorption such as ketoconazole/itraconazole and iron salts (reduced absorption-monitor/adjust).

Food Interaction

Administer on an empty stomach, ideally 30-60 minutes before a meal.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Not assigned (previously Category B)

Breastfeeding

Caution

Children

Approved for children 5 years and older for short-term treatment of erosive esophagitis. 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 routine dose adjustment required. Use with caution in elderly patients on long-term therapy due to increased risk of fractures and hypomagnesemia.

Kidney Impairment

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

Liver Impairment

Mild-moderate hepatic impairment: no adjustment; severe hepatic impairment: use with caution and consider 20 mg once daily (or lowest effective dose) with periodic LFT monitoring.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Safe to stop after short-term use; after prolonged/maintenance therapy consider tapering or step-down to reduce rebound acid hypersecretion-consult prescriber for long-term users.

Overdose

Symptoms are usually mild/non-specific (e.g., somnolence, confusion, tachycardia, nausea/vomiting); management is supportive/symptomatic, and pantoprazole is not meaningfully removed by hemodialysis-seek urgent medical care.

Patient Counseling

Take 30-60 minutes before a meal; swallow whole (do not crush/chew/split). Use for the prescribed duration; report persistent/severe diarrhea, rash/allergy, or symptoms of low magnesium (cramps, palpitations). If on long-term therapy, discuss fracture risk and possible magnesium/B12 monitoring; tell your clinician about warfarin or HIV medicines (e.g., rilpivirine/atazanavir/nelfinavir).

Monitoring Requirements

Long-term therapy: consider baseline and periodic magnesium (especially if also on diuretics/digoxin) and consider vitamin B12 with prolonged use; monitor INR if co-administered with warfarin; monitor for C. difficile-associated diarrhea and fracture risk with chronic use.

Pharmacology

Mechanism of Action

Irreversibly inhibits the gastric parietal cell H+/K+-ATPase (proton pump), blocking the final step of acid secretion.

Onset of Action

Initial acid suppression begins within ~2-3 hours after a dose; maximal effect typically occurs after 2-4 days of daily dosing.

Duration of Effect

Approximately 24 hours per dose (acid suppression can persist beyond the short plasma half-life).

Half-Life

Approximately 1 hour (range about 0.9-1.9 hours in healthy adults).

Bioavailability

Approximately 77%.

Metabolism

Extensively hepatic metabolism primarily via CYP2C19 and secondarily via CYP3A4; metabolites are inactive.

Protein Binding

Approximately 98%.

Product Information

Available Dosage Forms

Delayed-release tablet

Composition per Dose

Each tablet: 40mg pantoprazole as pantoprazole sodium sesquihydrate.

Generic Availability

Yes

OTC Alternatives

OTC options (market-dependent) include H2-receptor antagonists (e.g., famotidine), antacids (e.g., aluminum/magnesium hydroxide or calcium carbonate), and in some countries OTC PPIs such as omeprazole 20 mg or esomeprazole 20 mg.

Gi Condition

Acid Reflux/GERD, Ulcer

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