Insulin Lispro(insulin lispro)

Insulin Lispro is a man-made fast-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.

Do not take Insulin Lispro if you:• are having an episode of low blood sugar (hypoglycemia).• have an allergy to Insulin Lispro or any of the ingredients in Insulin Lispro. See the end of this Patient Information leaflet for a complete list of ingredients in Insulin Lispro.

Before taking Insulin Lispro, tell your healthcare provider about all of your medical conditions, including if you:• have kidney or liver problems.• take any other medicines, especially ones called TZDs (thiazolidinediones).• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Insulin Lispro.• are pregnant or plan to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.• are breastfeeding or plan to breastfeed. Talk with your healthcare provider about the best way to feed your baby while taking Insulin Lispro. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start taking Insulin Lispro, talk to your healthcare provider about low blood sugar and how to manage it.

Read the Instructions for Use that comes with your Insulin Lispro.• Take Insulin Lispro exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Insulin Lispro to take and when to take it.• Insulin Lispro starts acting fast. Inject Insulin Lispro within 15 minutes before or right after you eat a meal.• Know the type, strength and amount of insulin you take. Do not change the type or amount of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.• Check your insulin label each time you give your injection to make sure you are taking the correct insulin.• Inject Insulin Lispro under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms, or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the exact same spot for each injection. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.• Always use a new needle for each injection to help prevent infections and blocked needles. Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.• Keep Insulin Lispro and all medicines out of the reach of children. Your dose of Insulin Lispro may need to change because of a change in physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

While taking Insulin Lispro do not:• drive or operate heavy machinery, until you know how Insulin Lispro affects you.• drink alcohol or take prescription or over-the-counter medicines that contain alcohol.

Insulin Lispro may cause serious side effects that can lead to death, including:• low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include: dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger. Your healthcare provider may prescribe a glucagon product for emergency use so that someone else can give you glucagon if your blood sugar becomes too low (severe hypoglycemia) and you are unable to take sugar by mouth.• serious allergic reactions (whole body allergic reaction). Get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat, sweating, feel faint.• low potassium in your blood (hypokalemia).• heart failure. Taking certain diabetes pills called thiazolidinediones or "TZDs" with Insulin Lispro may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Insulin Lispro. Your healthcare provider should monitor you closely while you are taking TZDs with Insulin Lispro. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: shortness of breath, swelling of your ankles or feet, sudden weight gain. Treatment with TZDs and Insulin Lispro may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

The most common side effects of Insulin Lispro include: low blood sugar (hypoglycemia), reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling in your hands or feet, itching, rash.

These are not all the possible side effects of Insulin Lispro. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take Insulin Lispro for a condition for which it was not prescribed. Do not give Insulin Lispro to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about Insulin Lispro. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Insulin Lispro that is written for health professionals.

Active ingredient: insulin lispro Inactive ingredients: dibasic sodium phosphate, glycerin, hydrochloric acid, metacresol, trace amounts of phenol, sodium hydroxide, zinc oxide (zinc ion), and Water for Injection, USP.