The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Generic Name: insulin detemir (IN-su-lin DET-e-mir)
Brand Name: Levemir
Levemir vials are used for:
Treating diabetes mellitus.
Levemir vials are a long-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.
Do NOT use Levemir vials if:
- you are allergic to any ingredient in Levemir vials
- you are having an episode of low blood sugar
Contact your doctor or health care provider right away if any of these apply to you.
Before using Levemir vials:
Some medical conditions may interact with Levemir vials. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you drink alcoholic beverages or smoke
- if you have heart problems (eg, heart failure); kidney or liver problems; nerve problems; adrenal, pituitary, or thyroid problems; or diabetic ketoacidosis
- if you use 3 or more insulin injections per day
- if you are fasting, have high blood sodium levels, or are on a low-salt (sodium) diet
Some MEDICINES MAY INTERACT with Levemir vials. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs
- 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, pentoxifylline, pramlintide, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
- Thiazolidinediones (eg, pioglitazone, rosiglitazone) because the risk of heart failure may be increased
- Atypical antipsychotics (eg, olanzapine, clozapine), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), protease inhibitors (eg, saquinavir), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Levemir vials's effectiveness, resulting in high blood sugar
This may not be a complete list of all interactions that may occur. Ask your health care provider if Levemir vials may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Levemir vials:
Use Levemir vials as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Levemir vials. Talk to your pharmacist if you have questions about this information.
- Use Levemir vials at the same time each day, as directed by your doctor.
- If you will be using Levemir vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Levemir vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Levemir vials should be clear and colorless. Do not use Levemir vials if it contains particles, is cloudy, discolored, or thickened, or if the vial is cracked or damaged.
- Do NOT dilute Levemir vials 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 muscle or a vein.
- 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.
- Do not draw into a syringe and store for future use.
- 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 Levemir vials may last for up to 24 hours.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse or share needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.
Ask your health care provider any questions you may have about how to use Levemir vials.
Important safety information:
- Drowsiness, dizziness, light-headedness, or blurred vision may occur while you use Levemir vials. These effects may be worse if you take it with alcohol or certain medicines. Use Levemir vials 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.
- Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), or species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.
- Illness (especially with nausea and vomiting), emotional problems, stress, or changes in diet or activity level may cause your insulin requirements to change. 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. When you are sick, test your blood/urine frequently and call your doctor as instructed.
- Tell your doctor or dentist that you use Levemir vials 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.
- Carry an ID card at all times that says you have diabetes.
- Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Levemir vials. Follow your doctor's instructions carefully. If your blood sugar level is often higher than it should be and you are taking Levemir vials according to the directions, check with your doctor.
- Tell your doctor if you have had a recent change in diet or physical activity.
- 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 make you more hungry. 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 nondiet 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.
- 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.
- Lab tests, including fasting blood glucose levels or hemoglobin A1c, may be performed while you use Levemir vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Levemir vials with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.
- Caution is advised when using Levemir vials in CHILDREN; they may be more sensitive to its effects, especially low blood sugar.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Levemir vials 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 Levemir vials, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Levemir vials:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Redness, swelling, itching, or mild pain at the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; unusual hoarseness); blurred vision; burning, numbness, or tingling sensation; change in skin to thick or thin where the injection was given; 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; shortness of breath; slurred speech; swelling of the hands, ankles, or feet; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; unusual weight gain; weakness.
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Levemir 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 in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). If refrigeration is not possible, store at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. Throw away unrefrigerated or opened vials after 42 days, even if they still contain medicine.
Do not use Levemir vials if it has been frozen or overheated. Throw it away. Do not leave Levemir vials in a car on a warm or sunny day. Do not use Levemir vials after the expiration date stamped on the label. Keep Levemir vials, as well as syringes and needles, out of the reach of children and away from pets.
- If you have any questions about Levemir vials, please talk with your doctor, pharmacist, or other health care provider.
- Levemir vials are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Levemir vials or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Levemir vials. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Levemir vials. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Levemir vials.