Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. HumuLIN N KwikPen is an intermediate-acting insulin that starts to work within 2 to 4 hours after injection, peaks in 4 to 12 hours, and keeps working for 12 to 18 hours.

HumuLIN N KwikPen is used to improve blood sugar control in adults and children with diabetes mellitus.

HumuLIN N KwikPen may also be used for purposes not listed in this medication guide.

You should not use HumuLIN N KwikPen if you are having an episode of low blood sugar.

Never share an injection pen or syringe with another person, even if the needle has been changed.

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

HumuLIN N KwikPen is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

HumuLIN N KwikPen must not be given with an insulin pump, or mixed with other insulins. Do not inject into a vein or a muscle.

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

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

HumuLIN N KwikPen should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject HumuLIN N KwikPen. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

If you use an injection pen, use only the injection pen that comes with HumuLIN N KwikPen. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

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.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

HumuLIN N KwikPen is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) HumuLIN N KwikPen:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within the number of days specified in the Instructions for Use provided with your medicine.

Storing opened (in use) HumuLIN N KwikPen:

• Store in a refrigerator or at room temperature as directed in the Instructions for Use provided with your medicine. Do not refrigerate an in-use injection pen.

• In-use HumuLIN N KwikPen is stable for only a certain number of days. Throw away any medicine not used within that time. Follow all storage directions provided with your medicine.

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.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

You should not use HumuLIN N KwikPen if you are allergic to it, or if you are having an episode of hypoglycemia (low blood sugar).

Do not give HumuLIN N KwikPen to a child without a doctor's advice.

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.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how HumuLIN N KwikPen will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin. Some brands of insulin isophane and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, chest tightness, feeling like you might pass out, or swelling in your tongue or throat.

HumuLIN N KwikPen may cause serious side effects. Call your doctor at once if you have:

• 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 of HumuLIN N KwikPen may include:

• low blood sugar;

• weight gain, swelling in your hands or feet;

• 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.

HumuLIN N KwikPen may not work as well when you use other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.