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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FOAMCOAT (FOAMCOAT).
| Breastfeeding | Not known if excreted in human breast milk. M/P ratio not available. Caution advised; consider developmental and health benefits of breastfeeding along with mother's clinical need. |
| 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 |
■ FDA Black Box Warning
None
| Serious Effects |
Absolute: Known hypersensitivity to any component (human fibrinogen, thrombin, or aprotinin); arterial bleeding or hemorrhagic diathesis. Relative: Pregnancy (insufficient data); patients with history of anaphylactoid reactions to blood products.
| 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. |
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| 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. |