SUCRALFATE
Clinical safety rating: safe
Animal studies have demonstrated safety
Sucralfate forms a barrier over the ulcer site by binding to positively charged proteins in the exudate, creating a protective layer against acid, pepsin, and bile salts.
| Metabolism | Sucralfate is not significantly metabolized; it is minimally absorbed and primarily excreted unchanged in the feces. |
| Excretion | Primarily fecal (90% unabsorbed); absorbed fraction eliminated renally as intact drug and metabolites. |
| Half-life | Terminal half-life not clinically meaningful due to minimal systemic absorption; local GI residence time ~6 hours. |
| Protein binding | Low protein binding (approx. 5–10%); minimal binding due to limited absorption. |
| Volume of Distribution | Vd is very small (not applicable for systemic distribution) due to negligible absorption; acts locally in GI tract. |
| Bioavailability | Oral bioavailability <5% (mostly unabsorbed, acts topically); not administered parenterally. |
| Onset of Action | Oral: Binding to ulcer site occurs within 1–2 hours; clinical effect (pain relief) may begin within hours to days. |
| Duration of Action | Duration of mucosal protection is approximately 6 hours after a dose; requires qid dosing for continuous effect. |
1 g orally four times daily (one hour before meals and at bedtime) for active duodenal ulcer; 2 g orally twice daily (after breakfast and at bedtime) for maintenance therapy.
| Dosage form | SUSPENSION |
| Renal impairment | No specific GFR-based dose adjustments are recommended; use with caution in patients with chronic renal failure due to aluminum absorption risk. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Children: 40-80 mg/kg/day orally in divided doses every 6 hours, up to a maximum of 1 g per dose. |
| Geriatric use | No specific dose adjustment; consider potential for reduced renal function and monitor for aluminum accumulation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Can decrease the absorption of many other drugs administer other drugs 2 hours before or after Can cause constipation.
| Breastfeeding | Not known if excreted in human milk; minimal oral absorption suggests low levels in breast milk. Caution advised, but considered compatible with breastfeeding. M/P ratio not available. |
| Teratogenic Risk | Pregnancy Category B. In animal studies, no evidence of fetal harm. No adequate, well-controlled studies in pregnant women; however, systemic absorption is minimal (<5%), suggesting low risk. Use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Common Effects | No common side effects seen |
| Serious Effects |
["Hypersensitivity to sucralfate or any component of the formulation"]
| Precautions | ["Aluminum accumulation in patients with renal impairment","Constipation","Bezoar formation in critically ill or debilitated patients","Reduced absorption of other medications (e.g., ciprofloxacin, digoxin, phenytoin, tetracyclines, theophylline, warfarin) when taken concomitantly; separate administration by at least 2 hours"] |
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| No specific monitoring required beyond standard prenatal care. Observe for constipation and potential interference with iron or folate absorption; monitor hemoglobin/hematocrit if prolonged use. |
| Fertility Effects | No data on human fertility effects. Animal studies have not shown impaired fertility. |