insulin aspart and insulin aspart protamine

What is the most important information I should know about this medicine?

What is insulin aspart and insulin aspart protamine?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin aspart is a fast-acting insulin. Insulin aspart protamine is an intermediate-acting insulin. This combination insulin starts to work within 10 to 20 minutes after injection, peaks in 2 hours, and keeps working for up to 24 hours.

Insulin aspart and insulin aspart protamine is a combination medicine used to improve blood sugar control in adults with diabetes mellitus (type 1 or type 2).

Insulin aspart and insulin aspart protamine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using this medicine?

Tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use this medicine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

This medicine is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself. Do not inject this medicine into a vein or a muscle. This type of insulin must not be given with an insulin pump, or mixed with other insulins.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. This medicine should look white and cloudy. Do not use the medicine if it looks clear or has particles in it. Call your pharmacist for new medicine.

• If you have type 1 diabetes: Use this medicine within 15 minutes before the start of a meal.
• If you have type 2 diabetes: Use this medicine within 15 minutes before or after the start of a meal.

If you use an injection pen, use only the injection pen that comes with this medicine. Attach a new needle before each use.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Storing this medicine unopened (not in use):

• Refrigerate and use until expiration date; or
• Store at room temperature, and use the vial within 28 days or use the injection pen within 14 days.

Storing this medicine opened (in use):

• Store vial in a refrigerator or at room temperature and use within 28 days.
• Store the injection pen at room temperature (do not refrigerate) and use within 14 days. Do not store the injection pen with a needle attached.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Since this medicine is used with meals, you may not be on a timed dosing schedule. Whenever you use this insulin, be sure to eat a meal within 15 minutes. Do not use extra medicine to make up a missed dose.

What happens if I overdose?

What should I avoid while using this medicine?

Avoid medication errors by always checking the medicine label before injecting your insulin.

What are the possible side effects of insulin aspart and insulin aspart protamine?

• fluid retention --weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• low potassium;
• itching, mild skin rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect insulin aspart and insulin aspart protamine?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

Your pharmacist can provide more information about insulin aspart and insulin aspart protamine.