Pronunciation:

THROM-bin HUE-man, ree-KOM-bi-nant

Brand Names:

• Recothrom
• Thrombinar
• Thrombostat

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Thrombin topical is used to help control minor bleeding and oozing during surgery.

Thrombin is a protein that is produced naturally in the body. Recothrom® is a man-made protein produced to replicate the naturally occurring thrombin in the body. It is used to stop bleeding by helping the blood to clot.

This medicine is to be given only by or under the 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of thrombin topical in children. However, safety and efficacy have not been established in newborn babies younger than one month of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of thrombin topical in the elderly.

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 (massive or brisk arterial bleeding), severe or
• Allergy to hamster proteins, history of—Should not be used in patients with these conditions.

• Allergy to snake proteins, history of—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. This medicine is applied only to your skin or incision during surgery. It may be used with a sponge or a spray applicator.

This medicine should not be given as an injection.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly.

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, trouble breathing or swallowing, swelling or tenderness in your leg, or numbness or weakness while you are receiving this medicine.

This medicine may cause serious type of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have a cough, difficulty with swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, wheezing, shortness of breath, trouble breathing, chest tightness, swelling in your face, hands, tongue, or throat, a fever, chills, a runny nose or sneezing, itching or hives, or lightheadedness or faintness after you receive the medicine.

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

Difficulty breathing

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

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sudden, unexplained shortness of breath

vision changes

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:

Rare

Burning feeling, redness, swelling, itching, or skin rash at the place of application

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.