API

Pantoprazole sodium

Drug classification

Dosage form

Tablet

API strength per dosage

40 mg

Dose

Adults: 40 mg once daily, usually for 4–8 weeks. Pediatrics (≥5 years, ≥15 kg): 20–40 mg once daily. Dose adjustment may be required in severe hepatic impairment; use with caution. Not routinely recommended in children <5 years.

Mechanism of action

Indications

Gastroesophageal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome, peptic ulcer disease, Helicobacter pylori eradication (as part of combination therapy), pathological hypersecretory conditions.

Side effects

Headache, diarrhea, abdominal pain, nausea, vomiting, flatulence, dizziness, rash, pruritus, hypomagnesemia, vitamin B12 deficiency, Clostridioides difficile infection, bone fracture, interstitial nephritis.

Pregnancy category

Precautions

Hypersensitivity to pantoprazole, severe hepatic impairment, risk of Clostridioides difficile infection, osteoporosis-related fractures, hypomagnesemia, long-term use, concomitant use with atazanavir or rilpivirine, gastric malignancy exclusion, pregnancy and breastfeeding caution, potential drug interactions, monitoring in elderly, dose adjustment in renal impairment.

Contraindications