FOAMCOAT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FOAMCOAT (FOAMCOAT).
FOAMCOAT is a proprietary fibrin sealant containing human fibrinogen and thrombin. When applied topically, thrombin converts fibrinogen into fibrin monomers that polymerize into a stable clot. This forms a mechanical barrier and promotes hemostasis through the final step of the coagulation cascade.
| Metabolism | Fibrin sealant components are biodegraded by fibrinolysis via plasmin; fibrin degradation products are cleared by the reticuloendothelial system and excreted renally. |
| Excretion | Primarily renal excretion of intact drug (60-70%) with biliary/fecal elimination accounting for 20-30%. |
| Half-life | Terminal elimination half-life is 3-4 hours in patients with normal renal function; may be prolonged in renal impairment. |
| Protein binding | Approximately 50% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is 0.3-0.5 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Intramuscular: approximately 90%; oral: negligible due to extensive first-pass metabolism (not administered orally). |
| Onset of Action | Intravenous: immediate (within minutes); intramuscular: 15-30 minutes. |
| Duration of Action | Clinical effect lasts 4-6 hours after intravenous administration, with duration influenced by renal function. |
| Molecular Weight | 180.16 |
FOAMCOAT is a topical hemostatic agent; standard adult dose is 1 to 2 mL applied directly to bleeding site, repeated as needed.
| Dosage form | TABLET, CHEWABLE |
| Renal impairment | No dose adjustment required as FOAMCOAT is not systemically absorbed. |
| Liver impairment | No dose adjustment required due to topical application and lack of systemic absorption. |
| Pediatric use | Dose based on body weight: 0.03 mL/kg applied to bleeding site, not to exceed 2 mL total. |
| Geriatric use | Dose same as adults; caution in frail elderly due to potential for bleeding complications. |
| 1st trimester | No adequate human studies; animal studies suggest risk. Use only if clearly needed. |
| 2nd trimester | No adequate human studies; animal studies suggest risk. Use only if clearly needed. |
| 3rd trimester | Avoid near term due to risk of bleeding and premature closure of ductus arteriosus. |
Clinical note
Comprehensive clinical and safety monograph for FOAMCOAT (FOAMCOAT).
| Placental transfer | Crosses placenta; degree of transfer not fully quantified. |
| Breastfeeding | Excretion in milk unknown; potential for serious adverse effects in infant; consider discontinuing nursing or drug. |
| Lactation Rating |
■ FDA Black Box Warning
None
| Serious Effects |
Active peptic ulcer diseaseHistory of peptic ulcer diseaseHypersensitivity to FOAMCOAT or any componentSevere renal impairment (GFR <30 mL/min)Severe hepatic impairment
| Precautions | Risk of thromboembolic events if intravascular injection occurs; hypersensitivity reactions including anaphylaxis; do not use in patients with known allergy to human blood products or aprotinin; avoid application to infected or contaminated wounds; use caution in patients with coagulation disorders. |
| Food/Dietary | Food can delay and reduce the binding of sucralfate to the ulcer site. Take sucralfate on an empty stomach at least 1 hour before or 2 hours after meals. Avoid high-protein meals as they may interfere with drug absorption. No specific food restrictions other than timing. |
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| L4 |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. In animal studies, no evidence of teratogenicity or fetal harm at doses up to 10 times the maximum recommended human dose. Not known to cause fetal abnormalities. Risk cannot be excluded. |
| Fetal Monitoring | Monitor fetal growth and development via ultrasound if used during pregnancy. No specific maternal monitoring required. |
| Fertility Effects | No known effects on fertility in animal studies. Human data lacking; unlikely to impair fertility. |
| Clinical Pearls | FOAMCOAT (sucralfate) is a mucosal protective agent used primarily for stress ulcer prophylaxis and treatment of duodenal ulcers. It forms a protective barrier over ulcerated mucosa by binding to positively charged proteins in the exudate. Administer on an empty stomach (1 hour before meals and at bedtime) for maximal efficacy. Avoid concurrent administration with antacids, H2RAs, or PPIs, as they can interfere with sucralfate's binding. Use with caution in patients with renal impairment due to aluminum accumulation. Not effective for NSAID-induced ulcers or bleeding ulcers. |
| Patient Advice | Take sucralfate on an empty stomach, one hour before meals and at bedtime. · Do not take antacids, H2 blockers, or proton pump inhibitors within 2 hours of sucralfate. · Continue taking the medication for the full prescribed course even if symptoms improve. · Report any signs of aluminum toxicity such as bone pain, muscle weakness, or mental status changes, especially if you have kidney disease. · Sucralfate can cause constipation; ensure adequate fluid intake and dietary fiber. |