Uses

Insulin aspart protamine/insulin aspart is used along with a proper diet and exercise program to control high blood sugar in people with diabetes. This product is a combination of two man-made insulins: intermediate-acting insulin aspart protamine and rapid-acting insulin aspart. This combination starts working faster and lasts for a longer time than regular insulin.

Insulin is a natural substance that allows the body to properly use sugar from the diet. It replaces the insulin that your body no longer produces, thereby lowering your blood sugar. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

How To Use

Read the patient information leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Follow all package directions for proper use/injection/storage of the particular type of device/insulin you are using. Your health care professional will teach you how to properly inject this medication. If any of the information is unclear, consult your doctor or pharmacist.

Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature. Wash your hands before measuring and injecting insulin. Check the product visually for particles, thickening, or clumps before rolling and turning the container. If any are present, discard that container.

To avoid damaging the insulin, do not shake the container. Gently roll and turn it between your palms at least 10 times. If using a cartridge or pen, turn it upside down so that the glass ball moves from one end to the other. Gently mix the insulin until it appears evenly white and cloudy. If it does not appear this way, discard it.

The dosage is based on your medical condition and response to treatment. Measure each dose carefully, and use exactly as prescribed by your doctor. Even small changes in the amount of insulin may have a large effect on your blood sugar.

Before injecting each dose, make sure the injection site is clean and dry. Inject this medication under the skin of the abdomen, upper arms, or thighs, usually twice daily, 15 minutes or less before the morning and evening meal or as directed by your doctor. Do not inject into a vein or muscle. Eat promptly after taking this insulin to avoid low blood sugar (see also Side Effects section). Change where you inject each time to lessen the risk of problems or damage under the skin (for example, pits/lumps or thickened skin). Do not inject into skin that is red, swollen, itchy, or damaged.

Do not mix this product with other insulins or use it in an insulin pump.

Use this medication regularly as directed by your doctor in order to get the most benefit from it. Carefully follow the insulin treatment plan, meal plan, and exercise program your doctor has recommended. Monitor your blood sugar on a regular basis. Keep track of the results, and share them with your doctor. This is very important in order to determine the correct insulin dose.

If you are measuring doses from vials, do not reuse needles and syringes. If you are using the cartridges or pens, use a new needle each time. Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.

Tell your doctor if your condition does not improve or if it worsens (your blood sugar is too high or too low).

Side Effects

Injection site reactions (such as pain, redness, irritation) or weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat)

Too much insulin can cause low blood sugar (hypoglycemia). This effect may also occur if you do not consume enough calories. The symptoms include chills, cold sweats, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, or hunger. It is a good habit to carry glucose (sugar) tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, raise your blood sugar quickly by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Tell your doctor right away about the reaction. To help prevent low blood sugar, eat meals on a regular schedule and do not skip meals.

Too little insulin can cause high blood sugar (hyperglycemia). Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor right away. Your treatment plan may need to be changed.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease

Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell your doctor right away if you experience symptoms of high or low blood sugar.

Do not use this medication when you have low blood sugar.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your treatment plan may be required.

Changes in your lifestyle or activity level may affect the amount of insulin your body needs to control blood sugar. If you notice an unusual change in your insulin needs, tell your doctor.

Check your blood sugar before and after exercise. You may need a snack before exercising.

If traveling across more than two time zones, ask your doctor about how to adjust your insulin schedule.

Tell your doctor right away if you are pregnant. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on all your medicines (such as cough-and-cold products) carefully. Some products may contain sugar or alcohol and may affect your blood sugar. Ask your doctor or pharmacist about using these products safely.

Other medications can affect the results of urine tests for sugar or ketones. Consult your doctor or pharmacist for more information.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast heartbeat, vision changes, unexplained heavy sweating, agitation, fainting, seizures.

Notes

Do not share this medication, needles, or syringes with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar.

Check your blood sugar regularly as directed and share the results with your doctor. Lab and/or medical tests (such as fasting blood glucose, hemoglobin A1c) should be done while you are taking this medication. Keep all medical and lab appointments.

Wear or carry identification stating that you have diabetes and are using this drug.

Missed Dose

It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Keep extra supplies of insulin and an extra syringe and needle on hand. Discuss specific instructions with your doctor now in case you miss a dose of insulin or a meal in the future.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Protect insulin from light and heat. Do not store in the bathroom. Do not freeze, and do not use insulin that has been frozen. Throw away all insulin products after the expiration date on the package, or after the specified number of days after it has been opened or kept at room temperature, whichever date is earlier. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).