Thrombin (Topical)

RECOTHROM®, Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, 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.

All products:

• If you have an allergy to thrombin or any other part of thrombin (topical).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have very bad bleeding.

Thrombin-JMI, Thrombogen:

• If you are allergic to beef products, talk with the doctor.

Recothrom:

• If you are allergic to hamsters, talk with the doctor.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take thrombin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will put on the skin.
• This medicine must not be given as a shot. It can be deadly if given as a shot. Talk with the doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

There are no dosage adjustments provided in the manufacturer's labeling.

Evithrom: Reconstitute with 2 mL of SWFI using device provided by the manufacturer. Shake gently to dissolve until clear.

Recothrom: Reconstitute using diluent provided in prefilled syringe. Gently swirl to dissolve powder; avoid excessive agitation; powder should dissolve within 1 minute at room temperature. For some vial sizes, do not use diluent syringe to withdraw solution from vial.

Thrombi-Gel: Must wet with NS or SWFI before use; may cut or roll to desired shape prior to wetting. Refer to manufacturer’s labeling for fluid volume used for wetting a specific product. Once wetted and prior to applying, knead thoroughly to saturate the pad and remove trapped air bubbles.

Thrombin-JMI: Used as drug powder or wetted. If wetted, reconstitute with sodium chloride 0.9% or provided diluent to a concentration of 1,000 to 2,000 units/mL using a syringe or transfer device. In cases in which approximately 1,000 units/mL is desired, reconstitute with entire vial of provided diluent.

Thrombi-Pad: Used dry or wetted with up to 10 mL of NS.

There are no known significant interactions.

Frequency not always defined.

Cardiovascular: Thromboembolism (1% to 9%)

Dermatologic: Pruritus

Gastrointestinal: Nausea, vomiting

Hematologic and oncologic: Increased INR, increased neutrophils, lymphocytopenia, prolonged partial thromboplastin time, prolonged prothrombin time

Hypersensitivity: Hypersensitivity reaction

Immunologic: Antibody development (≤2%)

Local: Postoperative wound complication

Signs of hypersensitivity, bleeding, thrombosis, abnormal coagulation laboratory values.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.