THROMBIN TOPICAL RECOMBINANT

Topical Agent

Brand names: RECOTHROM, TachoSil

Oral

Mechanism of Action

12.1 Mechanism of Action RECOTHROM Thrombin topical (Recombinant), is a specific human serine protease that promotes hemostasis and acts locally when applied topically to a site of bleeding. RECOTHROM activates platelets and catalyzes the conversion of fibrinogen to fibrin, which are steps that are essential for blood clot formation.

Indications

1 INDICATIONS AND USAGE RECOTHROM Thrombin topical (Recombinant)

ligature

or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge

USP. RECOTHROM Thrombin topical (Recombinant)

ligature

or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. (1) RECOTHROM may be used in conjunction with an absorbable gelatin sponge

Contraindications

• any components of RECOTHROM or hamster proteins. (4)

FDA Warnings

5 WARNINGS AND PRECAUTIONS • RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system

Known Side Effects

3 documented side effects by frequency

Drug Not Working

>10%

Fever

1-10%

Abdominal Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral