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|Insulin Glargine Cartridge Systems

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Insulin Glargine Cartridge Systems

Generic Name: Insulin Glargine Cartridge Systems and Vials (IN-su-lin GLAR-gene)
Brand Name: Lantus

Insulin Glargine Cartridge Systems is used for:

Treating diabetes mellitus.

Insulin Glargine Cartridge Systems is a hormone that is produced by the pancreas and is necessary for the body"s correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet the body"s needs. Insulin helps to keep blood glucose at a nearly normal level.

Do NOT use Insulin Glargine Cartridge Systems if:

you are allergic to any ingredient in Insulin Glargine Cartridge Systems
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 Insulin Glargine Cartridge Systems:

Some medical conditions may interact with Insulin Glargine Cartridge Systems. 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
if you have liver or kidney problems, diabetic ketoacidosis, or nerve problems
if you have high blood sodium levels or you are on a low salt diet

Some MEDICINES MAY INTERACT with Insulin Glargine Cartridge Systems. 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 (MAO) inhibitors (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
Corticosteroids (eg, propranolol), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Glargine Cartridge Systems"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 Insulin Glargine Cartridge Systems 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 Insulin Glargine Cartridge Systems:

Use Insulin Glargine Cartridge Systems as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Insulin Glargine Cartridge Systems. Talk to your pharmacist if you have questions about this information.
If you will be using Insulin Glargine Cartridge Systems at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulin Glargine Cartridge Systems. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Insulin Glargine Cartridge Systems is a clear, colorless solution. If the medicine contains particles or is discolored, or if the vial/container is cracked or damaged in any way, do not use it.
Use Insulin Glargine Cartridge Systems once a day at the same time every day.
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, or 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.
Insulin Glargine Cartridge Systems begins lowering blood sugar about 1 to 2 hours after an injection. There is no peak effect. The effect lasts for up to 24 hours.
Do not mix this insulin together with any other type of insulin or any other medicine in the same syringe.
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 Insulin Glargine Cartridge Systems.

Important safety information:

Insulin Glargine Cartridge Systems may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Insulin Glargine Cartridge Systems 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 exceed the recommended dose, use Insulin Glargine Cartridge Systems more often than prescribed, or change the type or dose of insulin you are taking without checking with your doctor.
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.
If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.
Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Glargine Cartridge Systems. Follow your doctor"s instructions carefully. If your blood sugar level is often higher or lower than it should be and you are taking Insulin Glargine Cartridge Systems according to directions, check with 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 usual, 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. If not treated, loss of consciousness, coma, or death may occur.
Carry an ID card at all times that says you have diabetes.
Use Insulin Glargine Cartridge Systems with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar.
Lab tests, including fasting blood glucose levels or glycosylated hemoglobin levels, may be performed while you use Insulin Glargine Cartridge Systems. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Insulin Glargine Cartridge Systems should be used with extreme caution in CHILDREN younger than 6 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 Insulin Glargine Cartridge Systems while you are pregnant. Insulin Glargine Cartridge Systems is found in breast milk. If you are or will be breast-feeding while you use Insulin Glargine Cartridge Systems, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Insulin Glargine Cartridge Systems:

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:

Depression in the skin; enlargement or thickening of the skin; 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; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath odor; swelling of the arms or legs; tremor; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm) or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; headache; increased heartbeat; increased hunger; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Glargine Cartridge Systems:

VIALS: Store new (unopened) vials in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Insulin Glargine Cartridge Systems. Store used (open) vials either in the refrigerator, between 36 and 46 degrees (2 and 8 degrees C), or at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. If Insulin Glargine Cartridge Systems has been frozen or overheated, throw it away.

CARTRIDGE SYSTEMS: Store new (unopened) cartridge systems in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Insulin Glargine Cartridge Systems. Store used (open) cartridge systems at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) cartridges in the refrigerator. Store away from heat and light. If Insulin Glargine Cartridge Systems has been frozen or overheated, throw it away.

Do not leave Insulin Glargine Cartridge Systems in a car on a warm or sunny day. Do not use Insulin Glargine Cartridge Systems after the expiration date stamped on the label. Throw away opened vials or used cartridge systems 28 days after the first use, even if they still contain medicine. Keep Insulin Glargine Cartridge Systems, as well as syringes and needles, out of the reach of children and away from pets.

General information:

If you have any questions about Insulin Glargine Cartridge Systems, please talk with your doctor, pharmacist, or other health care provider.
Insulin Glargine Cartridge Systems is 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 Insulin Glargine Cartridge Systems. 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.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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