Thrombin human, recombinant (Topical application)

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

Thrombin is a protein that the body makes naturally. Recothrom® is a man-made version of this protein that is designed to work like the natural thrombin in the body. It helps stop bleeding by promoting blood clotting.

This medicine should only be given by or under the supervision of your doctor.

It is very important that your doctor check you or your child closely while you are receiving this medicine to ensure 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 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 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.

In deciding to use this medicine, you and your doctor need to consider the risks and benefits. Here are important points to think about:

Allergies

Let your doctor know if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. If you are using non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of thrombin topical in children. However, safety and effectiveness have not been established for newborn babies younger than one month old.

Geriatric

Studies have not found any specific problems that limit the use of thrombin topical in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken with food or specific types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how you can use this medicine. Make sure to tell your doctor about any other medical issues you have, 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 worsen this condition.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require 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 happen that usually do not require 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 how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Recothrom

In Canada

• Thrombinar
• Thrombostat

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

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.