Apidra VialsGeneric Name: Insulin Glulisine
(IN-su-lin GLOO-lis-een)Brand Name:
Apidra Vials are used for:
Treating diabetes mellitus. Apidra Vials are usually used with a longer-acting insulin or insulin pump therapy.
Apidra Vials are a fast-acting form of the hormone insulin. It works by helping your body use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.
Do NOT use Apidra Vials if:
- you are allergic to any ingredient in Apidra 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 Apidra Vials:
Some medical conditions may interact with Apidra 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 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 diet
- if you have had or will be having heart surgery
Some MEDICINES MAY INTERACT with Apidra 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, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
- Atypical antipsychotics (eg, olanzapine), corticosteroids (eg, prednisone), danazol, diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, HIV protease inhibitors (eg, ritonavir), 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) because they may decrease Apidra 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 Apidra 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 Apidra Vials:
Use Apidra Vials as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Apidra Vials. Talk to your pharmacist if you have questions about this information.
- Use Apidra Vials within 15 minutes before a meal or within 20 minutes after starting a meal, unless directed otherwise by your doctor.
- If you will be using Apidra Vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Apidra Vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- You may use Apidra Vials in an insulin pump if you are directed to do so by your doctor. If you are using an insulin pump, do NOT dilute Apidra Vials or mix it together with any other type of insulin.
- Apidra Vials should be clear and colorless. Do not use Apidra Vials if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- If you are mixing Apidra Vials with NPH insulin, draw Apidra Vials into the syringe first. Inject the dose immediately after mixing, as directed by your doctor. Do not mix Apidra Vials with any other type of insulin except NPH.
- 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 (abdomen, thigh, upper arm) must be rotated from one injection to the next.
- 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.
- Apidra Vials begins lowering blood sugar within minutes after an injection. The peak effect occurs between 30 and 90 minutes after a dose. The effect usually lasts from 1 to 2Â½ hours.
- Keep this product, 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.
- 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 Apidra Vials.
Important safety information:
- Drowsiness, dizziness, lightheadedness, or blurred vision may occur while you are using Apidra Vials. These effects may be worse if you take it with alcohol or certain medicines. Use Apidra 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 the risk of developing high or low blood sugar.
- Do NOT take more than the recommended dose, use Apidra Vials 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), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.
- Illness, especially with nausea and vomiting, 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 take Apidra Vials before you receive any medical or dental care, emergency care, or surgery.
- If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Apidra Vials exactly as prescribed, tell your doctor.
- 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 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.
- 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.
- Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Apidra Vials.
- Lab tests, including fasting blood glucose levels and hemoglobin A1c, may be performed while you use Apidra 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 Apidra Vials with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.
- Apidra Vials should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Apidra Vials while you are pregnant. It is not known if Apidra Vials are found in breast milk. If you are or will be breast-feeding while you use Apidra Vials, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Apidra 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:
Redness, swelling, itching, or mild pain at the injection site.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org) or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.Proper storage of Apidra Vials:
Store new (unopened) vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store used (opened) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 77 degrees F (25 degrees C). Store away from heat and light. If Apidra Vials has been frozen or overheated, throw it away. Throw away unrefrigerated or opened vials after 28 days, even if they still contain medicine.
Avoid temperatures above 98.6 degrees F (37 degrees C). Do not leave Apidra Vials in a car on a warm or sunny day. Do not use Apidra Vials after the expiration date stamped on the label. Keep Apidra Vials, as well as syringes and needles, out of the reach of children and away from pets. If you are using Apidra Vials in an insulin pump, you may need to store it differently. Ask your doctor, pharmacist, or other health care provider how to store Apidra Vials.
- If you have any questions about Apidra Vials, please talk with your doctor, pharmacist, or other health care provider.
- Apidra 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.
This information is a summary only. It does not contain all information about Apidra Vials. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.