Dosing & Uses
Dosage Forms & Strengths
powder for topical solution
- 5000 units (with 5mL diluent)
- 20,000 units (with 20mL diluent)
spray kit
- 5000 units (with 5mL diluent)
- 20,000 units (with 20mL diluent)
pad
- 3 x 3 ≥200 units
topical solution
- 800-1200 units/mL
Hemorrhage Control
Indicated for hemostasis whenever oozing blood and minor bleeding from microvessels is accessible
Recothrom dose depends on area to be treated
Apply on surface of bleeding tissue (solution or spray)
Severe bleeding: Concentrations of 1000-2000 units/mL (Thrombin-JMI) for profuse bleeding
Mild/moderate bleeding: Concentrations of 100 units/mL (Thrombin-JMI) for general use (plastic surgery, dental, skin grafts etc)
Apply pad (Thrombi-Pad) dry or wetted with up to 10 mL of 0.9% sodium chloride directly over source of bleeding; may leave product in place for up to 24 hr; do not leave in the body
Apply powder (Thrombin-JMI) directly to the bleeding area or on oozing surfaces
May soak in up to 10 mL of absorbable gelatin sponge (Evithrom) applied on bleeding surface
Wet product with up to 3 mL, 10 mL, or 20 mL of Thrombi-Gel 10, 40, 100, respectively, of 0.9% sodium chloride or SWFI; apply directly over source of the bleeding with manual pressure
Do not inject systemically, can lead to intravascular clotting and death
Dosing Considerations
Recothrom: Recombinant product from a genetically modified CHO cell line using a protein derived from snakes
Thrombin JMI: Bovine origin
Evithrom: Human thrombin
Administration
Sponge (not wipe) blood off surface before applying
Reconstituted solution should be used immediately, but may be refrigerated at 2-8 C for up to 3 hr
Dosage Forms & Strengths
powder for reconstitution
- 5000 IU (with 5mL diluent)
- 20,000 IU (with 20mL diluent)
topical solution
- 800-1200 IU/mL
Hemorrhage Control
Recothrom is approved in children for hemostasis whenever oozing blood and minor bleeding from microvessels is accessible
<1 month: Safety and efficacy not established
>1 month: Dose depends on area to be treated (Recothrom)
Children and adolescents: May soak in up to 10 mL of absorbable gelatin sponge (Evithrom) applied on bleeding surface
Severe bleeding: Concentrations of 1000-2000 units/mL (Thrombin-JMI) for profuse bleeding
Mild/moderate bleeding: Concentrations of 100 units/mL (Thrombin-JMI) for general use (plastic surgery, dental, skin grafts etc)
May soak in up to 10 mL of absorbable gelatin sponge (Evithrom) applied on bleeding surface
Wet product with up to 3 mL, 10 mL, or 20 mL of Thrombi-Gel 10, 40, 100, respectively, of 0.9% sodium chloride or SWFI; apply directly over source of the bleeding with manual pressure
Do not inject systemically, can lead to intravascular clotting and death
Administration
For topical use only
Sponge (not wipe) blood off surface before applying
Reconstituted solution should be used immediately, but may be refrigerated at 2-8 C for up to 3 hr
Adverse Effects
>10%
Skin incision finding (63% )
Nausea and vomiting (33% )
Pain, procedural (29% )
Nausea without vomiting (28%)
Immune hypersensitivity reaction (15% )
1-10%
Thromboembolic disorder (6% )
Frequency not defined
General allergic reactions
Antibody formation
Warnings
Black Box Warnings
The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis, which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and/or factor V, which in some cases may cross-react with human factor V, potentially resulting in factor V deficiency.
Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and/or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin.
Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.
Contraindications
Hypersensitivity to product or any component
Evithrom: Treatment of severe or brisk arterial bleeding; patients with known anaphylactic or severe systemic reactions to blood products
Recothrom: Hypersensitivity to hamster proteins; treatment of severe or brisk arterial bleeding
Thrombi-Gel: Closure of skin incisions, due to possible interference with healing or skin edges
Thrombin-JMI and Thrombi-Pad: Hypersensitivty to material of bovine origin
Injection into large blood vessels
Cautions
Human plasma products may potentially contain infectious agents that could transmit disease
Hypersensitivity to snake proteins can potentially (theoretically) may increase risk of allergic reaction to recothrom
Thrombi-Gel or Thrombi-Pad not for use in the presence of infection; exercise caution in areas of contamination
Thrombi-Pad not absorbable; do not leave in the body
For tropical use only; not for intravenous injection
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not applicable
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Human serine protease that promotes hemostasis and acts locally when applied topically to a site of bleeding; activates platelets and catalyzes the conversion of fibrinogen to fibrin, which are steps that are essential for blood clot formation
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Thrombin-JMI topical - | 20,000 unit syringe |  | |
| Thrombin-JMI topical - | 5,000 unit vial |  | |
| Thrombin-JMI topical - | 5,000 unit syringe |  | |
| Thrombin-JMI topical - | 20,000 unit vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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