Topical (Bovine)
Topical (Bovine) Uses, Dosage, Side Effects, Food Interaction and all others data.
Also known as coagulation factor II, thrombin is a serine protease that plays a physiological role in regulating hemostasis and maintaining blood coagulation. Once converted from prothrombin, thrombin converts fibrinogen to fibrin, which, in combination with platelets from the blood, forms a clot.
Medical thrombin is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin in the presence of calcium chloride. Topical (Bovine) requires no intermediate physiological agent for its action. It clots the fibrinogen of the blood directly. Failure to clot blood occurs in the rare case where the primary clotting defect is the absence of fibrinogen itself.
Bovine thrombin however, is capable of causing fatal severe bleeding or thrombosis . This thrombosis may result from the development of antibodies against bovine thrombin . Bleeding may result from the development of antibodies against bovine factor V . These antibodies may subsequently cross-react with endogenous human factor V and lead to its deficiency . Patients who are know or suspected to have antibodies to bovine thrombin and/or bovine factor V should not be re-exposed to the product . Patients who are administered bovine thrombin should be monitored for abnormal coagulation laboratory values, bleeding, or indeed, thrombosis .
| Trade Name | Topical (Bovine) |
| Generic | Thrombin |
| Thrombin Other Names | coagulation factor II, Thrombin, Thrombin bovine, Thrombin, Topical (Bovine) |
| Type | |
| Protein binding | Little has been reported about the systemic pharmacokinetics of bovine thrombin preparations . Protein binding data is subsequently not readily available, although thrombin functions naturally to interact with a very specific set of clotting factors . |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Topical (Bovine) is a coagulation factor used to stop bleeding during surgery.
Bovine thrombin is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (like suture, ligature, or cautery) is ineffective or impractical . Additionally, topical bovine thrombin can also be used in combination with an absorbable gelatin sponge, USP .
Topical (Bovine) is also used to associated treatment for these conditions: Refractory to surgical techniques Bleeding, Tissue Adhesions
How Topical (Bovine) works
Bovine thrombin requires no intermediate physiological agent for its action . It activates platelets and catalyzes the conversion of fibrinogen to fibrin, which are essential steps for clot formation . Failure to clot blood occurs in the case where the primary clotting defect is the absence of fibrinogen itself . The speed with which the bovine thrombin clots blood is dependent upon the concentration of both the bovine thrombin and the fibrinogen present .
Toxicity
With regards to bovine thrombin, no cases of overdose have been reported so far . Bovine thrombin however, is capable of causing fatal severe bleeding or thrombosis . This thrombosis may result from the development of antibodies against bovine thrombin . Bleeding may result from the development of antibodies against bovine factor V . These antibodies may subsequently cross-react with endogenous human factor V and lead to its deficiency . Patients who are know or suspected to have antibodies to bovine thrombin and/or bovine factor V should not be re-exposed to the product . Patients who are administered bovine thrombin should be monitored for abnormal coagulation laboratory values, bleeding, or indeed, thrombosis .
LD50 values are available for rat and mouse models where rat subcutaneous LD50 > 40mg/kg, rat IP LD50 > 40mg/kg, and mouse subcutaneous LD50 > 50 mg/kg (in which the greater than symbol indicates that the toxicity endpoint being tested was not achievable at the highest dose used in the test) .
Regardless, the most common adverse reactions following administration of bovine thrombin include hypersensitivity, bleeding, anemia, post-operative wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, and/or thrombocytopenia .
Food Interaction
No interactions found.Volume of Distribution
Little has been reported about the systemic pharmacokinetics of bovine thrombin preparations , but owing to its topical mode of application, systemic exposure or distribution to other organs and tissues is not expected.
Elimination Route
Little has been reported about the systemic pharmacokinetics of bovine thrombin preparations , but owing to its topical mode of administration, it is expected that any kind of systemic absorption would be minimal.
Half Life
Unfortunately, little has been reported about the systemic pharmacokinetics of bovine thrombin preparations .
Clearance
Although little has been reported about the systemic pharmacokinetics of bovine thrombin preparations , it is expected that they are generally rapidly neutralized by naturally circulating plasma inhibitors limiting its duration of action and preventing the active form from diffusing into the general circulation .
Elimination Route
Although little has been reported about the systemic pharmacokinetics of bovine thrombin preparations , they are expected to act in much the same way as endogenous thrombin does. Natural bodily thrombin is cleared by two primary separate pathways: (1) through rapid formation of thrombin inhibitor complexes, which are recognized by hepatic receptors and degraded, and (2) via direct binding to thrombomodulin on the endothelium, followed by internalization and degradation . Specific thrombin inhibitors include ATIII, alpha-2M and heparin cofactor II .
Innovators Monograph
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