Pantoprazole (pantoprazole sodium)

Pantoprazole is a proton pump inhibitor (PPI). The US label for the delayed-release tablets lists three uses.

First, short-term treatment (up to 8 weeks) of erosive esophagitis linked to gastroesophageal reflux disease (GERD) in adults and children aged 5 years and older. This is damage to the food pipe from acid reflux.

Second, maintaining healing of erosive esophagitis. Third, conditions with too much stomach acid, including Zollinger-Ellison syndrome.

• Short-term healing of erosive esophagitis with GERD
• Keeping erosive esophagitis healed
• Conditions with excess acid, including Zollinger-Ellison syndrome

Pantoprazole blocks the proton pump (the H+/K+-ATPase enzyme) on the acid-making cells of the stomach lining. This is the final step in making stomach acid.

The label says this lowers acid production whatever the trigger, and the effect lasts longer than 24 hours.

The US label says delayed-release tablets are swallowed whole, with or without food. They should not be split, chewed or crushed.

For erosive esophagitis with GERD in adults, the label gives 40 mg once daily for up to 8 weeks. A further 8-week course may be considered if healing has not occurred. For maintaining healing the label gives 40 mg once daily.

For Zollinger-Ellison syndrome and other conditions with excess acid, the label gives 40 mg twice daily, adjusted to individual need.

For children aged 5 years and older, the label gives 20 mg once daily for 15 kg to under 40 kg, and 40 mg once daily from 40 kg, for up to 8 weeks.

For a missed dose, the label says to use it as soon as possible, unless the next dose is almost due. Two doses should not be used at the same time.

Indian pack labels may differ from the US label. The prescriber's instruction always wins. This is not a personal dose recommendation.

Contraindications in the label: allergy to pantoprazole or other substituted benzimidazoles, and use with rilpivirine-containing HIV medicines.

Stomach cancer: relief of symptoms does not rule out stomach cancer. Poor response or early return of symptoms needs more tests, and an endoscopy in older people.

Long-term use: the label links PPIs to bone fractures, low vitamin B12 (after more than 3 years of daily use), low magnesium and stomach polyps. It says to use the shortest duration needed.

Kidney, lupus and diarrhea: acute interstitial nephritis, cutaneous and systemic lupus erythematosus, and C. difficile diarrhea have been reported with PPIs.

Pregnancy: there are no adequate studies in pregnant women. In animals, some tests showed no fetal harm, but bone changes were seen in rat offspring exposed during pregnancy and nursing. The label says to use it only if the benefit justifies the risk. Ask your doctor.

Breastfeeding: the label says pantoprazole has been detected in human milk, and that a decision should be made about nursing or the drug. Ask your doctor.

Children: studied from 1 to 16 years for erosive esophagitis. Elderly: healing rates and side effects were similar to younger people.

Alcohol and driving: the source label we reviewed does not describe these.

• Rilpivirine (contraindicated), nelfinavir, atazanavir, saquinavir
• Warfarin
• Methotrexate
• Iron salts, ketoconazole, itraconazole and other acid-dependent drugs
• Rilpivirine: use together is contraindicated.
• Nelfinavir should be avoided.
• Atazanavir and saquinavir need separate guidance.
• Warfarin: INR and prothrombin time may rise, which can cause abnormal bleeding.
• Monitoring is advised.
• Methotrexate: PPIs may raise and prolong methotrexate levels, mainly at high doses.
• A temporary pause of pantoprazole may be considered.
• Drugs that need stomach acid to be absorbed, such as iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole and itraconazole, may be absorbed less.
• Clopidogrel: no clinically important effect was seen on its platelet action.
• Antacids do not affect the absorption of pantoprazole.

No match in this label text. Ask your pharmacist about any medicine you take.

Experience with very high doses is limited, and reports are generally within the known safety profile.

Pantoprazole is not removed by hemodialysis. Treatment is symptomatic and supportive.

The tablet label says to store at 20 to 25 C.

Follow the storage line on your Indian pack.

We did not find pantoprazole in the Schedule H, H1 or X rows of the Drugs Rules lists we checked. This does not by itself say how a particular pack is sold, so check the pack.

In the National List of Essential Medicines 2022, we found pantoprazole as an injection of 40 mg (page 94, secondary and tertiary care). We did not find the oral tablet in the list.

NPPA has a ceiling price for the 40 mg injection, shown below from the 30 September 2020 list.

Banned combinations: the banned-combination list we checked has 4 mentions of pantoprazole. Use the checker for your exact combination.

The NPPA ceiling price we found is for the injection, per pack. We did not find an NPPA ceiling row for the oral tablet. Check the pack and the seller.

Jan Aushadhi (PMBJP) lists pantoprazole tablets of 20 mg and 40 mg, an injection and several combinations. We have not shown a brand price here.

• Pantoprazole Gastro Resistant Tablets IP 40 mg (pack 10's)
• Pantoprazole Injection 40mg (pack Vial)
• Pantoprazole Gastro-Resistance Tablets IP 20mg (pack 10's)