PANTOPRAZOLE SODIUM
Clinical safety rating: safe
Animal studies have demonstrated safety
Proton pump inhibitor. Suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of gastric parietal cells.
| Metabolism | Primarily metabolized by CYP2C19 and CYP3A4. |
| Excretion | Renal: ~71% as metabolites; fecal: ~18% via bile; unchanged renal excretion: <1% |
| Half-life | Terminal elimination half-life: ~1 hour (range 0.5–2 h); clinically, acid suppression lasts longer due to covalent binding to proton pumps |
| Protein binding | ~98% bound, primarily to albumin |
| Volume of Distribution | 0.15 L/kg; low Vd indicates limited extravascular distribution |
| Bioavailability | Oral: 77% (tablet); IV: 100% |
| Onset of Action | Oral: peak effect on gastric acid secretion in 2–4 hours; IV: within 15–30 minutes |
| Duration of Action | Acid suppression lasts up to 24 hours; maximal effect after 2–4 days of repeated dosing |
40 mg orally once daily for 8 weeks for erosive esophagitis; 40 mg intravenously once daily for 7-10 days for GERD with esophagitis.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to severe renal impairment. For patients on hemodialysis, maximum dose is 40 mg/day. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B or C: maximum dose 20 mg/day (oral or intravenous). |
| Pediatric use | Children 5 years and older: weight <40 kg: 20 mg orally once daily for 8 weeks; weight ≥40 kg: 40 mg orally once daily for 8 weeks. For intravenous use in children ≥5 years: 0.5-1 mg/kg once daily, max 40 mg/day. |
| Geriatric use | No dose adjustment generally required; consider reduced hepatic function: maximum 40 mg/day for short-term use (8 weeks) for erosive esophagitis; monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Can reduce absorption of drugs requiring gastric pH for absorption (eg ketoconazole) May increase risk of Clostridium difficile-associated diarrhea and bone fractures with long-term use.
| Breastfeeding | Excreted in human milk; M/P ratio approximately 0.1. Low relative infant dose (<1% maternal weight-adjusted dose). Considered compatible with breastfeeding; monitor infant for diarrhea or irritability. |
| Teratogenic Risk | Pregnancy Category B. No evidence of teratogenicity in animal studies. Limited human data; increased risk of congenital malformations not observed. Avoid use in first trimester unless essential. |
■ FDA Black Box Warning
None.
| Common Effects | Diarrhea Flatulence Headache Nausea Stomach pain Vomiting Dizziness Upper respiratory tract infection |
| Serious Effects |
["Known hypersensitivity to pantoprazole or any component of the formulation","Concomitant use with rilpivirine"]
| Precautions | ["Acute interstitial nephritis","Clostridium difficile-associated diarrhea","Bone fracture risk with long-term use","Hypomagnesemia","Vitamin B12 deficiency with prolonged use","Cutaneous lupus erythematosus","Possible interaction with methotrexate"] |
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| Fetal Monitoring |
| Monitor maternal symptoms for acid-related disorders; assess for hypomagnesemia with prolonged use; monitor infant growth and development if exposed in utero. |
| Fertility Effects | No known adverse effects on fertility in animal studies or human data. |