Brand Names:

• Thrombin-JMI
• Thrombinar
• Thrombostat

Dosage Forms:

• Powder for Solution

Warnings:

Warning: Severe Bleeding and Thrombosis ComplicationsBovine thrombin can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies against bovine thrombin. Bleeding may result from the development of antibodies against factor V. These may cross-react with human factor V and lead to its deficiency. Do not re-expose patients to Bovine thrombin if there are known or suspected antibodies to bovine thrombin and/or factor V. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis .

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Thrombin, bovine topical solution is used to help control minor bleeding during surgery.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of thrombin, bovine topical solution in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of thrombin, bovine topical solution in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Active bleeding, severe or
• Bovine thrombin or factor V antibodies, known or suspected—Should not be used in patients with these conditions.

• Bleeding problems or
• Blood clotting problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is applied only to your skin or incision during surgery. This medicine should not be given as an injection.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue. or unusual tiredness or weakness.

Check with your doctor right away if you have tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area. These may be symptoms of blood clotting problems.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Cough or hoarseness

difficulty breathing

fast heartbeat

fever or chills

hives, itching, skin rash

irritation

joint pain, stiffness, or swelling

lower back or side pain

pain in the chest, groin, or legs, especially the calves

painful or difficult urination

redness of the skin

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in arm or leg

swelling of the eyelids, face, lips, hands, or feet

vision changes

Less common

Black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

pale skin

pinpoint red spots on the skin

red, tender, or oozing skin at the incision

sweating

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Bruising

collection of blood under the skin

coughing or vomiting blood

chest tightness

deep, dark purple bruise

difficulty swallowing

itching, pain, redness, or swelling

persistent bleeding or oozing from puncture sites, mouth, or nose

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

muscle spasms

nausea

trouble sleeping

vomiting

Incidence not known

Swelling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.