PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Clinical safety rating: safe
No significant drug interactions Can cause hypernatremia and fluid overload.
Proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of gastric parietal cells.
| Metabolism | Hepatic metabolism via CYP2C19 (major) and CYP3A4 (minor); metabolites include inactive desmethylpantoprazole and sulfone conjugates. |
| Excretion | Renal: approximately 80% as metabolites and unchanged drug; fecal: approximately 20% as metabolites. |
| Half-life | Approximately 1 hour (range 0.5–2 hours) in healthy adults; prolonged in hepatic impairment (up to 3–6 hours) and CYP2C19 poor metabolizers. |
| Protein binding | Approximately 98% bound to albumin. |
| Volume of Distribution | Approximately 0.15–0.26 L/kg, indicating limited extravascular distribution. |
| Bioavailability | Intravenous: 100% (administered as infusion over 15 minutes); oral bioavailability is approximately 77% but this monograph pertains to IV formulation. |
| Onset of Action | Intravenous: inhibition of acid secretion begins within 15–30 minutes; maximal effect is achieved after 1–2 hours. |
| Duration of Action | Duration of acid suppression approximately 24 hours, allowing once-daily dosing; acid inhibition persists for several days after cessation due to irreversible binding to proton pumps. |
40 mg intravenously over 2-15 minutes once daily for up to 10 days.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment, including hemodialysis. |
| Liver impairment | In Child-Pugh Class A: no adjustment. In Child-Pugh Class B and C: maximum daily dose of 20 mg intravenously. |
| Pediatric use | For children ≥5 years: 15 kg to <40 kg: 20 mg once daily; ≥40 kg: 40 mg once daily. For children <5 years: safety and efficacy not established. |
| Geriatric use | No specific dose adjustment, but monitor for potential increased risk of adverse effects such as Clostridioides difficile infection and osteoporosis-related fractures. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
No significant drug interactions Can cause hypernatremia and fluid overload.
| FDA category | Animal |
| Breastfeeding | Unknown if excreted in human milk; M/P ratio not available. Caution advised; consider risk of infant acid suppression. Preferred alternatives may include PPIs with more lactation data. |
| Teratogenic Risk | FDA Pregnancy Category B. No evidence of teratogenicity in animal studies. First trimester: limited human data, no increased risk of major malformations. Second/third trimester: no known fetal risks. Risk of maternal hypomagnesemia with prolonged use may affect fetal bone development. |
■ FDA Black Box Warning
None reported.
| Common Effects | Nausea Diarrhea Vomiting Stomach pain Flatulence Taste change Headache Rash |
| Serious Effects |
["Known hypersensitivity to pantoprazole or other proton pump inhibitors","Coadministration with rilpivirine","Coadministration with atazanavir (due to reduced absorption)"]
| Precautions | ["Prolonged use may increase risk of Clostridium difficile-associated diarrhea","Increased risk of osteoporosis-related fractures with long-term high-dose use","Hypomagnesemia reported with long-term use","Acute interstitial nephritis","May mask symptoms of gastric malignancy","Coadministration with methotrexate may increase methotrexate toxicity","Possible reduced absorption of vitamin B12 with long-term use"] |
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| Fetal Monitoring | Monitor for maternal hypomagnesemia if prolonged therapy (>1 month); consider serum magnesium levels. No specific fetal monitoring required. |
| Fertility Effects | No evidence of impaired fertility in animal studies. Human data lacking; potential indirect effects via acid suppression not established. |