Levemir Solution

GENERIC NAME: INSULIN (IN-su-lin) DETEMIR (DE-te-mir)

COMMON USES: This medicine is a long-acting form of the hormone insulin used for treating diabetes mellitus.

HOW TO USE THIS MEDICINE: Follow the directions for taking this medicine provided by your doctor. AN EXTRA PATIENT LEAFLET is available with this medicine. Talk to your pharmacist if you have questions about this information. IF YOU WILL BE USING THIS MEDICINE AT HOME, a health care provider will teach you how to use it. Be sure you understand how to use this medicine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. THIS MEDICINE SHOULD BE CLEAR AND COLORLESS. Do not use this medicine if it contains particles; is cloudy, discolored, or thickened; or if the vial or container is cracked or damaged. DO NOT DILUTE THIS MEDICINE OR MIX it with other insulin. Do NOT use it in an insulin pump. USE THE PROPER TECHNIQUE taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle. INJECTION SITES within an injection area (eg, abdomen, thigh, upper arm) must be rotated from one injection to the next. Do not inject insulin into skin that is red, swollen, or itchy. BE SURE YOU HAVE PURCHASED THE CORRECT INSULIN. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. IF YOU HAVE ANY QUESTIONS ABOUT MEASURING AND PREPARING YOUR DOSE, contact your doctor or pharmacist for information. The effect of this medicine may last for up to 24 hours. VIALS: STORE NEW (UNOPENED) VIALS in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. STORE USED (OPEN) VIALS either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C) or, if refrigeration is not possible, store at room temperature, below 86 degrees F (30 degrees C) away from heat and light. THROW AWAY unrefrigerated or opened vials after 42 days, even if they still contain medicine. CARTRIDGE SYSTEMS AND PREFILLED SYRINGES: STORE NEW (UNOPENED) CARTRIDGE SYSTEMS AND PREFILLED SYRINGES in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. STORE USED (OPEN) CARTRIDGE SYSTEMS OR PREFILLED SYRINGES at room temperature, below 86 degrees F (30 degrees C), away from heat and light. Do NOT store used (open) cartridges or prefilled syringes in the refrigerator. Do NOT store used (open) cartridges or prefilled syringes with the needle in place. If this medicine has been frozen or overheated, throw it away. Throw away unrefrigerated or used cartridge systems or prefilled syringes after 42 days, even if they still contain medicine. DO NOT LEAVE THIS MEDICINE in a car on a warm or sunny day. DO NOT use this medicine after the expiration date stamped on the label. IT IS VERY IMPORTANT TO FOLLOW YOUR INSULIN REGIMEN EXACTLY. Use this medicine at the same time each day, as directed by your doctor. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

CAUTIONS: DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. LAB TESTS, including fasting blood glucose levels or hemoglobin A1c, may be performed to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. THIS MEDICINE MAY CAUSE DROWSINESS, DIZZINESS, LIGHTHEADEDNESS, OR BLURRED VISION. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. DO NOT DRIVE OR PERFORM OTHER POSSIBLY UNSAFE TASKS until you know how you react to it. DO NOT DRINK ALCOHOL without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar. DO NOT USE MORE THAN THE RECOMMENDED DOSE, use more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor. ILLNESS, ESPECIALLY WITH NAUSEA AND VOMITING, MAY CAUSE YOUR INSULIN REQUIREMENTS TO CHANGE. When you are sick, test your blood/urine frequently and call your doctor as instructed. TELL YOUR DOCTOR OR DENTIST that you take this medicine before you receive any medical or dental care, emergency care, or surgery. IF YOU WILL BE TRAVELING ACROSS TIME ZONES, ask your doctor about adjustments to your insulin schedule. AN INSULIN REACTION RESULTING FROM LOW BLOOD SUGAR LEVELS (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or increased hunger. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. TO PREVENT LOW BLOOD SUGAR, eat meals at the same time each day and do not skip meals. Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). HIGH BLOOD SUGAR may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. Use this medicine with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients. FOR WOMEN: IF YOU BECOME PREGNANT, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you use this medicine, check with your doctor. Discuss any possible risks to your baby.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include redness, swelling, itching, or mild pain at the injection site. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mental or mood changes; muscle pain, weakness, or cramping; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; or weakness. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or wheezing. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking beta-blockers (eg, propranolol); clonidine; guanethidine; lithium; reserpine; angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril); disopyramide; fenfluramine; fibrates (eg, clofibrate, gemfibrozil); fluoxetine; monoamine oxidase inhibitors (MAOIs) (eg, phenelzine); oral medicines for diabetes (eg, glipizide, metformin, nateglinide); pentamidine; propoxyphene; salicylates (eg, aspirin); somatostatin analogs (eg, octreotide); sulfonamide antibiotics (eg, sulfamethoxazole); corticosteroids (eg, prednisone); danazol; diuretics (eg, furosemide, hydrochlorothiazide); estrogen; hormonal contraceptives (eg, birth control pills); isoniazid; niacin; phenothiazines (eg, chlorpromazine); progesterones (eg, medroxyprogesterone); somatropin; sympathomimetics (eg, albuterol, epinephrine, terbutaline); or thyroid hormones (eg, levothyroxine). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including if you have kidney or liver problems; nerve problems; adrenal, pituitary, or thyroid problems; diabetic ketoacidosis; allergies; pregnancy; or breast-feeding. Tell your doctor if you drink alcoholic beverages or smoke; if you use 3 or more insulin injections per day; or if you are fasting, have high blood sodium levels, or are on a low-salt diet. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are having an episode of low blood sugar. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

OVERDOSE: IF OVERDOSE IS SUSPECTED, contact. Symptoms may include chills; dizziness; drowsiness; fainting; headache; increased heartbeat; increased hunger; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; or weakness.

ADDITIONAL INFORMATION: ANY CHANGE OF INSULIN should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose. PROPER DIET, regular exercise, and regular testing of blood sugar are important for best results when using this medicine. Tell your doctor if you have had a recent change in diet or physical activity. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. CHECK WITH YOUR DOCTOR if you notice a depression in the skin or skin thickening at the injection site. You may need to change your injection technique. CARRY AN ID CARD at all times that says you have diabetes. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.