Hep Flush-10

• It is used to thin the blood so that clots will not form.
• It is used to treat blood clots.
• It is used to keep blood from clotting in catheters.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Very bad and sometimes deadly bleeding problems have happened with Hep Flush-10. Talk with the doctor.
• This medicine has caused a health problem called heparin-induced thrombocytopenia (HIT). HIT can lead to blood clots forming, which is called heparin-induced thrombocytopenia and thrombosis (HITT). These can be deadly or cause other bad effects. HIT and HITT can happen up to several weeks after this medicine is stopped. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Hep Flush-10.
• If you fall or hurt yourself, or if you hit your head, call your doctor right away. Talk with your doctor even if you feel fine.
• Be sure you have the right product. This medicine comes in many containers and strengths. If you have any questions, call your doctor or pharmacist.
• If you are over the age of 60, use this medicine with care. You could have more side effects.
• Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn. Talk with the doctor to see if this product has benzyl alcohol in it.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Hep Flush-10 while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad dizziness or passing out.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Change in skin color where the shot was given.
• Feeling confused.
• Very bad headache.
• Chills.
• Fever.
• Chest pain.
• Back pain.
• Shortness of breath.
• Redness or swelling where the shot is given.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Data not available

Benzyl alcohol, a preservative in the multiple-dose vial preparations of Heparin Lock Flush Solution, USP has been associated with toxicity in neonates. Benzyl alcohol has been reported to be associated with a fetal "Gasping Syndrome" in premature infants. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Heparin Lock Flush Solution, USP should be used for maintaining patency of intravenous injection devices in neonates.

Many concentrations of heparin are available and range from 1 unit/mL to 20,000 units/mL. Carefully examine each prefilled syringe or vial prior to use to ensure that the correct concentration is chosen. Heparin lock flush solution is intended only to maintain patency of IV devices and is not to be used for anticoagulant therapy.

Heparin has been assigned to pregnancy category C by the FDA. Animal studies have not been conducted and there are no controlled data in human pregnancy. It does not cross the placenta due to its large molecular weight (3,000 to 30,000 daltons). Heparin is considered the anticoagulant of choice during pregnancy, although anticoagulation and maternal disease state may pose a risk to both the mother and fetus. Heparin is only recommended for use during pregnancy when benefit outweighs risk.

Heparin is not excreted into human milk due to its large molecular weight (3,000 to 30,000 daltons). Heparin is considered compatible with breast-feeding.