PANTOMAX 40/MG TAB 30/TAB

Indications

Approved Uses

GERD-related indications (including reflux symptoms and erosive esophagitis treatment and maintenance) and pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome).

Off-Label Uses

Common off-label uses include stress-ulcer prophylaxis in critically ill patients (often IV/oral depending on setting), laryngopharyngeal reflux, and adjunctive therapy in H. pylori eradication and NSAID-ulcer prevention where not specifically labeled locally.

Dosage & Administration

Dosing by Condition

Erosive esophagitis/GERD: 40 mg PO once daily for up to 8 weeks (may extend to 8 additional weeks if needed); maintenance: 40 mg once daily (some patients may be maintained on lower doses depending on response and local labeling). Pathological hypersecretory conditions (e.g., Zollinger-Ellison): start 40 mg PO twice daily and titrate; doses up to 240 mg/day have been used. H. pylori eradication: pantoprazole 40 mg twice daily as part of combination therapy for 10-14 days (where locally recommended/approved).

Initial Dose

40mg once daily.

Maintenance Dose

20-40mg once daily

Maximum Dose

240mg daily (Zollinger-Ellison syndrome); 80mg daily for standard indications

Children's Dosage

Approved for 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.

Dose Adjustment Notes

Renal impairment: no dose adjustment. Hepatic impairment: mild-moderate-generally no adjustment; severe hepatic impairment-use with caution and consider dose reduction/monitoring (some references limit to 20 mg/day). H. pylori combination regimens are generally avoided/contraindicated in moderate-severe hepatic impairment due to the antibiotic components and labeling cautions.

How to Take

Swallow the 40 mg gastro‑resistant (enteric‑coated) tablet whole with water; do not crush, chew, or split. Take once daily 30-60 minutes before a meal (preferably before breakfast); if prescribed twice daily, take before breakfast and before the evening meal.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (1-10%): headache, diarrhea, nausea/vomiting, abdominal pain, flatulence. Uncommon (0.1-1%): dizziness, rash/urticaria/pruritus, fatigue/asthenia, dry mouth, sleep disturbances. Rare/very rare (<0.1%): severe hypersensitivity reactions, severe cutaneous adverse reactions (e.g., SJS/TEN), acute interstitial nephritis, hypomagnesemia (typically with prolonged use), C. difficile-associated diarrhea, hepatic injury (e.g., hepatitis/jaundice), and increased fracture risk with long-term/high-dose therapy.

Safety & Warnings

Contraindications

Hypersensitivity to pantoprazole, substituted benzimidazoles, or any excipients; concomitant use with rilpivirine-containing products

Warnings & Precautions

May mask gastric malignancy-evaluate alarm symptoms; risk of C. difficile diarrhea; long-term/high-dose use: fractures, hypomagnesemia (consider monitoring), and vitamin B12 deficiency; acute interstitial nephritis; cutaneous/systemic lupus-discontinue if suspected; consider lowest effective dose/duration.

Age Restriction

Generally approved for children ≥5 years for erosive esophagitis (age/indication dependent); not established for <5 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major/avoid: rilpivirine (contraindicated), atazanavir and nelfinavir (avoid due to reduced absorption). Important/monitor: high-dose methotrexate (consider holding PPI), warfarin (monitor INR), drugs needing acidic pH (e.g., ketoconazole/itraconazole, iron salts) may have reduced absorption; consider mycophenolate exposure reduction; clopidogrel interaction is less clinically significant with pantoprazole than omeprazole but use clinical judgment; digoxin levels may increase especially with hypomagnesemia-monitor if risk factors.

Interaction Severity

MAJOR/Contraindicated: rilpivirine (avoid). MAJOR: atazanavir and nelfinavir (avoid due to reduced absorption/levels). MODERATE: warfarin (monitor INR), high-dose methotrexate (consider holding PPI/monitor toxicity), drugs with pH-dependent absorption such as ketoconazole/itraconazole/iron salts (reduced absorption-monitor/avoid). Other clinically relevant: digoxin (possible increased levels-monitor in high-risk), mycophenolate mofetil (possible reduced exposure-monitor). Clopidogrel interaction is less clinically significant with pantoprazole than with omeprazole/esomeprazole.

Food Interaction

May be taken with or without food, but for optimal effect take 30-60 minutes before a meal (preferably breakfast).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Approved for 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 dose adjustment required. Use with caution with long-term therapy due to increased risk of fractures and hypomagnesemia

Kidney Impairment

No adjustment needed.

Liver Impairment

Severe hepatic impairment: reduce dose (commonly max 20 mg once daily) and monitor; mild-moderate: usually no adjustment.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not double the dose.

Stopping the Medicine

Generally safe to stop; after prolonged use, consider tapering to reduce rebound acid hypersecretion.

Overdose

Overdose usually causes non-specific symptoms (e.g., somnolence, confusion, tachycardia, nausea/vomiting, flushing, headache); management is supportive/symptomatic and pantoprazole is not meaningfully removed by hemodialysis-seek urgent medical care/poison center.

Patient Counseling

Swallow whole (do not crush/chew/split) and take 30-60 minutes before a meal; take regularly as prescribed. Seek care for severe/persistent diarrhea, signs of low magnesium (muscle cramps, palpitations, seizures), or rash; discuss long-term risks (fracture risk, low magnesium, possible B12 deficiency) if prolonged therapy. Tell clinicians about warfarin or HIV meds (rilpivirine/atazanavir/nelfinavir). Store below 30°C in the original blister to protect from moisture.

Monitoring Requirements

Short-term: usually no routine labs. Long-term/high-risk: consider magnesium (especially >3 months or with diuretics), vitamin B12 with prolonged therapy, and assess fracture risk/bone health in at-risk patients; monitor INR/prothrombin time if on warfarin; monitor for C. difficile-associated diarrhea if persistent diarrhea occurs.

Pharmacology

Mechanism of Action

Prodrug that irreversibly inhibits the gastric parietal cell H+/K+-ATPase (proton pump) via covalent binding, suppressing basal and stimulated acid secretion.

Onset of Action

Onset of acid suppression occurs within a few hours (about 2-3 hours), with maximal effect after 2-4 days of daily dosing.

Duration of Effect

Acid suppression lasts approximately 24 hours per dose after steady use.

Half-Life

1-2 hours.

Bioavailability

Approximately 77%.

Metabolism

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

Excretion

Excreted mainly as metabolites in urine (~80%) with the remainder in feces/bile (~20%).

Protein Binding

Approximately 98%.

Product Information

Available Dosage Forms

For this SFDA product: oral gastro‑resistant (enteric‑coated) tablet 40 mg (blister pack of 30). Other pantoprazole dosage forms that exist in general include delayed‑release tablets, delayed‑release granules/oral suspension, and IV powder for injection/infusion (product-specific availability varies).

Composition per Dose

Each gastro-resistant coated tablet: 40mg pantoprazole (as pantoprazole sodium sesquihydrate)

Generic Availability

Yes

OTC Alternatives

OTC alternatives for acid symptoms include antacids (e.g., calcium carbonate or aluminum/magnesium hydroxide) and H2-receptor antagonists (e.g., famotidine). In some markets, OTC PPIs (e.g., omeprazole 20 mg) may also be available.

Gi Condition

Acid Reflux/GERD, Ulcer

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