thrombin
Thrombin-JMI, Thrombogen, Thrombostat

Pharmacologic classification: enzyme
Therapeutic classification: topical hemostatic
Pregnancy risk category C


Available forms
Available by prescription only
Kit: 5,000, 10,000, 20,000 units with sprayer assembly
Powder: 1,000-, 5,000-, 10,000-, 20,000-, 50,000-unit vials

Indications and dosages
 Bleeding from parenchyma, cancellous bone, dental sockets, during nasal and laryngeal surgery, and in plastic surgery and skin-grafting procedures. Adults: Apply 100 units/ml of sterile isotonic saline solution or sterile distilled water to area where clotting is needed (or apply dry powder in bone surgery); in major bleeding, apply 1,000 to 2,000 units/ml sterile isotonic saline solution. Sponge blood from area before application, but avoid sponging area after application.

Pharmacodynamics
Hemostatic action: Catalyzes the conversion of fibrinogen to fibrin, one of the last stages of clot formation.

Pharmacokinetics
Absorption: Onset, peak, and duration aren’t applicable.

Contraindications and precautions
Contraindicated in patients hypersensitive to thrombin or bovine products. Don’t inject thrombin into or allow it to enter large blood vessels; death may result from severe intravascular clotting.

Interactions
None reported.

Adverse reactions
CNS: fever.
CV: intravascular clotting (could cause death if thrombin enters large vessels).
Other: hypersensitivity.

Effects on lab test results
• May increase or decrease PT and PTT.

Overdose and treatment
No information available.

Special considerations
• Obtain patient history of reactions to thrombin or bovine products.
• Contents of a 5,000-unit vial dissolved in 5 ml saline solution are capable of clotting an equal volume of blood in less than 1 second, or 1,000 ml in less than 1 minute.
• It may be beneficial to sprinkle the dry powder form directly on oozing surfaces.
• Observe patient for hypersensitivity reaction after administering.
• Thrombostat can be stored at a controlled room temperature of 59° to 86° F (15° to 30° C). Thrombin-JMI must be refrigerated at 36° to 46° F (2° to 8° C). Thrombogen must be used immediately upon reconstitution. If necessary, it can be refrigerated at 36° to 46° F for up to 3 hours. Thrombin may be used with absorbable gelatin sponge but not oxidized cellulose; check label before using.
Pediatric patients
• Safety in children hasn’t been established.

Patient education
• Advise patient to report signs and symptoms of hypersensitivity reaction or anaphylaxis.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use