Thrombostat

In the U.S.

• Recothrom

In Canada

• Thrombinar
• Thrombostat

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

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.

Pediatric

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.

Geriatric

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

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

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.

Applies to thrombin topical: nasal powder for reconstitution, topical kit, topical pad, topical powder for reconstitution, topical solution

Hematologic

Hematologic side effects including increased activated partial thromboplastin time, increased international normalized ratio, decreased lymphocyte count, prolonged prothrombin time, and increased neutrophil count have been reported.[Ref]

Dermatologic

Dermatologic side effects including pruritus have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting have been reported.

Local

Local side effects including incision site complications have been reported.[Ref]

Immunologic

Immunologic side effects including antibody development have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects including hypersensitivity reactions have been reported.[Ref]

Some side effects of Thrombostat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.