Thrombin

Thrombin is used to prevent and stop bleeding whenever oozing blood and minor bleeding from microvessels is accessible.

Thrombin is available under the following different brand names: Recothrom, Thrombogen, and Thrombin JMI.

Powder for Topical Solution (adult and pediatric)

• 5000 units (with 5mL diluent)
• 20,000 units (with 20mL diluent)

Spray Kit (adult)

• 5000 units (with 5mL diluent)
• 20,000 units (with 20mL diluent)

Pad (adult)

• 3 x 3 ≥200 units

Topical Solution (adult and pediatric)

• 800-1200 units/mL

Dosage Considerations - Should Be Given as Follows

Hemorrhage Control

• Recothrom is approved in children for hemostasis whenever oozing blood and minor bleeding from microvessels is accessible
• Children under 1 month of age: Safety and efficacy not established
• Children over 1 month of age: 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 hours

Common side effects of thrombin include:

• Skin incision finding
• Nausea
• Vomiting
• Pain, procedural
• Immune hypersensitivity reaction
• Blood clotting disorder

Other side effects of thrombin include:

• General allergic reactions
• Antibody formation

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Thrombin has no listed interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains thrombin. Do not take Recothrom, Thrombogen, or Thrombin JMI if you are allergic to thrombin or any ingredients contained in this drug.

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

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

Effects of Drug Abuse

No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Thrombin?"

Long-Term Effects

• Prolonged use not indicated
• Discontinue when tolerance develops - DO NOT EXCEED recommended dose

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 and Lactation

Use thrombin with caution if the benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done. There are no data on the excretion of thrombin topical into breast milk. Consult your doctor before breastfeeding.