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thrombin (Rx)Brand and Other Names:Recothrom, Thrombogen, more...Thrombin JMI

 
 
 

Dosing & Uses

AdultPediatric

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
more...

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
more...

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

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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

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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

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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.

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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

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Images

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Formulary

FormularyPatient Discounts

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Tier Description
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6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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Code Definition
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