Aprotinin (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- TRASYLOL
Indications and Usage
Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.
Contraindications
TISSEEL is contraindicated for the following. • Intravascular Application: Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue, such as nasal mucosa. Intravascular application of TISSEEL can lead to intravascular coagulation, can result in life-threatening thromboembolic events (see Warnings and Precautions (5.3) and Adverse Reactions (6.2) ). TISSEEL must be applied with caution to minimize any risk of intravascular application, for example in coronary bypass surgery. • Aprotinin Hypersensitivity: Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin (see Warnings and Precautions (5.1) and Adverse Reactions (6)). • Severe or Brisk Bleeding: Do not use TISSEEL for treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained. • Application below minimum recommended distance from target site: Do not spray TISSEEL where the minimum recommended distance from the applicator tip to the target site cannot be assured.
Drug Interactions
Oxidized cellulose-containing preparations can reduce the efficacy of TISSEEL and should not be used as carrier materials. No interaction studies have been performed.
Mechanism of Action
Upon mixing Sealer Protein (Human) and Thrombin (Human), soluble fibrinogen is transformed into fibrin, forming a rubber-like mass that adheres to the wound surface and achieves hemostasis and sealing or gluing of tissues. TISSEEL mimics the final coagulation cascade step as it has all relevant components to form a clot. TISSEEL is effective in heparinized patients and in patients medicated with anti-platelet drugs.