Pantoprazole
PROTONIX
Pronunciation: pan-TOE-pra-zoel (proe-TAH-nix)
“Proton Pants”
What it isProton pump inhibitor; GERD, ulcer disease and stress ulcer prophylaxis.
Why this oneIt has little clinically relevant CYP2C19 inhibition, so it is preferred with clopidogrel; an IV form is available.
What limits itSame long-term costs as the class: B12, magnesium, fracture and enteric infection. Deprescribe when the indication lapses.
FDA-approved for
- GERD (2000)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Erosive esophagitis (GERD), short-term | Adults | 40 mg QD | 40 mg QD | 40 mg QD for up to 8 wks |
| Erosive esophagitis (GERD), short-term | Children ≥5 yr | 20 mg QD (15–<40 kg); 40 mg QD (≥40 kg) | for up to 8 wks | |
| Maintenance of healing of erosive esophagitis | Adults | 40 mg QD | 40 mg QD | |
| Pathological hypersecretory conditions (Zollinger-Ellison) | Adults | 40 mg BID | 40 mg BID | up to 240 mg/day |
Renal Undefined
Hepatic Undefined
Instructions
- Swallow tablet whole; do not split, chew, or crush
- Take with or without food
- For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be taken
- Concomitant antacids do not affect absorption
Available strengths
- DR tab 20, 40 mg
- susp 40 mg
- tab 20, 40 mg
- granules 40 mg
- inj 40 mg
Contraindications
- Concomitant use of rilpivirine-containing products
Cautions
- Symptomatic response does not preclude gastric malignancy
- Acute tubulointerstitial nephritis
- Clostridioides difficile-associated diarrhea
- Bone fracture (long-term, high-dose)
- Severe cutaneous adverse reactions (SJS/TEN, DRESS, AGEP, erythema multiforme)
- Cutaneous and systemic lupus erythematosus
- Cyanocobalamin (B-12) deficiency with long-term use
- Hypomagnesemia (may cause hypocalcemia/hypokalemia)
- Fundic gland polyps
- Interference with chromogranin A and urine THC assays
- May raise methotrexate levels (high-dose)
Adverse reactions
- Adults: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, arthralgia
- Pediatric: URI, headache, fever, diarrhea, vomiting, rash, abdominal pain
Pregnancy Observational data did not show an association with major malformations or adverse pregnancy outcomes.
Lactation Present in breast milk at low levels; no effects on breastfed infant reported.
Cost
Generic entry2007
NO BOXED WARNINGS
Principal riskLong-term use: B12 deficiency, hypomagnesemia, fracture
Classes and tags
Clinical profile
Legacy pregnancy categoryB
Defining liabilityLong-term infection, magnesium/B12 and bone risks; selected agents have clinically important CYP interactions.
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