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Indications and Dosage
Topical/Cutaneous
Aid to haemostasis when bleeding from capillaries and small venules Adult: As recombinant or human-derived: Apply directly to or flood bleeding site surface or use in conjunction with absorbable gelatin sponge. The amount depends upon the area of tissue to be treated. As bovine-derived: Apply 1,000-2,000 units for profuse bleeding or 100 units for bleeding from skin or mucosal surfaces.
Child: Same as adult dose. |
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Reconstitution
Powder for solution: Reconstitute vial labelled as containing 5,000 or 20,000 units with appropriate volume of NaCl 0.9% solution.
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Contraindications
Hypersensitivity to human blood products, snake or hamster protein, material of bovine-origin or known or suspected antibodies to bovine thrombin and/or factor V. Not indicated for treatment of severe or brisk arterial bleeding. Not intended for IV or IA administration.
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Special Precautions
Children. Pregnancy and lactation.
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Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylaxis), risk of infection transmission.
Blood and lymphatic system disorders: Thromboembolism. Immune system disorders: Antibody formation. Potentially Fatal: Severe bleeding or thrombosis (bovine thrombin). |
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Topical: C
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Monitoring Parameters
Monitor for signs of hypersensitivity, bleeding, thrombosis, abnormal coagulation laboratory values.
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Lab Interference
May alter coagulation test (e.g. prothrombin time, partial thromboplastin time) results.
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Action
Description: Thrombin is a protein substance produced from prothrombin. It catalyses the conversion of soluble fibrinogen into insoluble fibrin to producing coagulation and haemostasis.
Synonym: factor IIa, trombin. |
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Storage
Store between 2-25°C. Frozen solution: Store at -18°C. Unopened thawed vials: Store at 2-8°C for up to 30 days. Protect from light. Do not re-freeze thawed solutions. Do not refrigerate once at room temp. Powder for solution: Do not freeze.
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MIMS Class
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ATC Classification
B02BC06 - thrombin ; Belongs to the class of local hemostatics. Used in the treatment of hemorrhage.
B02BD30 - thrombin ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage. |
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References
Anon. Thrombin (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/05/2018. Anon. Thrombin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com/. Accessed 07/05/2018. Buckingham R (ed). Thrombin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/05/2018. Evithrom, Topical (Human) (Omrix Biopharmaceuticals Ltd.). U.S. FDA. https://www.fda.gov/. Accessed 08/05/2018. Recothrom, Topical (Recombinant) (Zymo Genetics, Inc.). U.S. FDA. https://www.fda.gov/. Accessed 08/05/2018. Thrombin-JMI, Topical (Bovine) (GenTrac, Incorporated). U.S. FDA. https://www.fda.gov/. Accessed 08/05/2018.
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