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Insulin Glargine

General Information and Indications:

Insulin glargine is used to treat type 1 (insulin-dependent) diabetes (formerly called 'juvenile-onset'). It is also used to treat people with type 2 (noninsulin-dependent) diabetes (formerly called 'adult-onset') who need long-acting insulin to control their diabetes. Insulin glargine is a long-acting, man-made version of human insulin. Insulin is a hormone made in the pancreas. Insulin helps move sugar from the blood into other body tissues where it is used for energy. It also helps the body break down carbohydrates, fats, and proteins from the diet. In a person with diabetes, the pancreas does not produce enough insulin for the body's needs, so additional insulin is required. People with diabetes may gradually develop serious nerve, blood vessel, kidney, and eye problems if the diabetes is not controlled properly.

Information For Users:

Insulin glargine comes as an injection to inject subcutaneously (beneath the skin, not into a vein). It is injected once a day at bedtime. The medication comes in vials (bottles) and also prefilled containers called cartridges. The amount of insulin glargine you need depends on diet, other diseases, exercise, and other drugs you are taking and may change with time. Your doctor will tell you how much you should take. Follow the directions on your prescription label, ask your doctor or pharmacist If you have any questions. Take insulin glargine exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Insulin glargine controls diabetes but does not cure it. It must be taken regularly. Continue taking insulin glargine even if you feel well. Do not discontinue taking insulin glargine without informing your doctor.

You do not have to shake the vial or cartridge of insulin glargine before use. Do not dilute or mix insulin glargine with any other insulin or solution. The syringe must not have any other medicine or residue in it.

If your insulin glargine comes in cartridges, the medication will already be inside. You must only use the OptiPen One Insulin Delivery Device with the cartridges. Before you use the device for the first time, read the written directions that come with it. Ask your doctor, pharmacist, or nurse to show you the right way to use this device. Practice while your health care provider watches.

If your insulin glargine comes in vials, you will have to withdraw (draw up) the medication into a syringe. Before you do this for the first time, read the written directions that come with it. Ask your doctor or pharmacist to show you the right way to withdraw the insulin glargine and to inject the medication subcutaneously. Practice while your health care provider watches.

If your insulin glargine comes in vials you will need to use syringes. Always use a syringe that is marked for U-100 insulin products. If you use the wrong syringe, you may get the wrong dose, and your blood glucose level may end up being too low or too high.

Plastic syringes are disposable; use a new one for each injection. Used needles will hurt more and may cause an infection. Never share needles and syringes. To withdraw insulin glargine into the syringe, follow these steps:

o Wash your hands.
o Hold the vial in your hands to warm the medicine. Look at the medicine in the vial. Make sure it is clear and colorless. If it is cloudy or has particles (specks) in it, throw the vial away and get a new one.
o If you are using a new vial, remove the protective cap. Do not remove the stopper (the rubber inside the cap).
o Wipe the top of the vial with an alcohol swab or cotton dipped in rubbing alcohol.
o It is easier to withdraw insulin glargine if you first inject air into the vial. To do this, pull the plunger (the cylinder inside the syringe) back to the number of insulin glargine units you will have to take. Now your syringe is filled with the right amount of air. Insert the needle through the rubber cap and push on the plunger to inject the air into the vial.
o Keep the syringe in the vial and turn both upside down. Hold the syringe and vial firmly with one hand.
o Make sure the tip of the needle is in the insulin. With your free hand, pull back on the plunger to withdraw insulin glargine into the syringe, and measure the correct number of units of insulin glargine.
o Before you take the needle out of the vial, be sure that there are no bubbles in the syringe. If there are bubbles in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin glargine back in until you have the correct dose.
o Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.
o If you have trouble seeing the small markings on the syringe, have someone help you. Also, let your doctor and pharmacist know about this problem. They can provide syringes that are easier to read, special tools to help you fill the syringe, or prefilled syringes.

To inject your insulin glargine dose, follow these steps:

o Decide on an injection area, either your abdomen, buttocks, thighs, or arms.
o Clean the skin at the injection site with an alcohol pad or cotton dipped in rubbing alcohol.
o Pinch a fold of skin with your fingers at least 3 inches apart and insert the needle at a 45- to 90-degree angle.
o Then slowly push the plunger of the syringe all the way, making sure you have injected all the insulin glargine. Leave the needle in the skin for several seconds.
o Pull the needle straight out and press lightly on the spot where you injected yourself for several seconds. Do not rub the area.
o Follow the directions given to you for throwing away the needle and syringe.

Use a different site for each injection, about 1 inch away from the previous injection but in the same general area (for example, the thigh). Use all available sites in the same general area before switching to a different area (for example, the upper arm). Do not use the same injection site more often than once every month.

Special precautions:

o Inform your doctor or pharmacist if you have allergy to insulin or any other medications.
o Inform your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetazolamide (Diamox); AIDS antiviral medications; albuterol (Proventil, Ventolin); allergy or cold medications; angiotensin-converting enzyme inhibitors (ACE inhibitors) such as captopril (Capoten), enalapril (Vasotec), or lisinopril (Prinivil, Zestril); antibiotics; antipsychotics such as fluphenazine (Prolixin), mesoridazine (Serentil), or thioridazine (Mellaril); beta-blockers such as propranolol (Inderal); calcitonin (Calcimar); chloroquine (Aralen); chlorpromazine (Thorazine); clofibrate (Atromid-S); clonidine (Catapres); corticosteroids such as dexamethasone (Decadron), methylprednisolone (Medrol), or prednisone (Deltasone, Orasone); danazol (Danocrine); disopyramide (Norpace); diuretics ('water pills'); epinephrine; estrogens; fenofibrate (TriCor); fluoxetine (Prozac, Sarafem); gemfibrozil (Lopid); guanethidine (Ismelin); isoniazid (INH); lithium (Eskalith, Lithobid); mebendazole (Vermox); medications that contain alcohol or sugar; morphine (MS Contin, others); niacin; nicotine; octreotide (Sandostatin); oral contraceptives (birth control pills); oral medications for diabetes; pentamidine (Pentam); phenelzine (Nardil); phenytoin (Dilantin); prochlorperazine (Compazine); promethazine (Phenergan); propoxyphene (Darvon); reserpine (Serpalan, others); salicylates such as aspirin, diflunisal (Dolobid), or salsalate (Disalcid); somatropin (human growth hormone); sulfa drugs; sulfinpyrazone (Anturane); terbutaline (Brethine, Bricanyl); thyroid medications; tranylcypromine (Parnate); trimeprazine (Temaril); and vitamins or herbal products.
o inform your doctor if you are breast-feeding thyroid, liver, or kidney disease.
o Inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking insulin glargine, call your doctor.
o if you are having surgery, including dental surgery, Inform your doctor or dentist that you are taking insulin glargine.
o Inform your doctor if you have fever, infection, injury, or illness with vomiting or diarrhea. These may affect your blood sugar level.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet. Do not start a diet or an exercise program without informing your doctor. Your insulin dose may need to be changed.

To monitor the effectiveness of insulin glargine, measure the amount of sugar (glucose) in your blood or urine (when blood sugar is above a certain high level, you will have sugar in your urine). For measuring the amount of glucose in your blood, you can use a blood glucose meter. For the urine measurements, you will need special paper tapes, tablets, or plastic strips that change color depending on how much sugar is present. Your doctor also may ask you to test your urine for ketones (substances present when diabetes is not under control). Follow your doctor's recommendations for testing your urine and blood and for recording the results. If your blood sugar is high or if sugar or ketones are present in your urine, call your doctor.

Your dose of insulin glargine may need to be changed when you are ill (especially with fever, vomiting, or diarrhea), have emotional changes or stress, gain or lose weight, or change the amount of food you eat or amount of exercise you do. If any of these things happen, call your doctor.

See your dentist twice yearly; see your eye doctor regularly; get your blood pressure checked regularly.

If you travel across time zones, ask your doctor how to time your injections. When you travel, take extra insulin and supplies with you.

Keep yourself and your clothes clean. Wash cuts, scrapes, and other wounds quickly, and do not let them get infected. Wear medical alert identification (a bracelet or tag) that says you have diabetes.


Possible Adverse Effects:

You should know the symptoms of low and high blood sugar and what to do if you have them.

Eat or drink a food or beverage with sugar in it, such as hard candy or fruit juice, and call your doctor without delay if you have any of the symptoms of hypoglycemia (low blood sugar):

o shakiness
o lightheadedness or dizziness
o sweating
o confusion
o nervousness or irritability
o sudden changes in behavior or mood
o headache
o numbness or tingling around the mouth
o weakness
o pale skin
o sudden hunger
o clumsy or jerky movements
o seizures

call your doctor without delay if you have any of the following symptoms of hyperglycemia (high blood sugar):

o extreme thirst
o frequent urination
o extreme hunger
o weakness
o blurred vision (Impaired vision)

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. call your doctor without delay if you have any of the these symptoms:

o dry mouth
o upset stomach and vomiting
o shortness of breath
o breath that smells fruity
o decreased consciousness

Insulin glargine can cause side effects. Inform your doctor if any of the following symptoms are severe or do not go away:

o redness, swelling, pain, and itching at the injection site
o changes in the feel of your skin, skin thickening (fat build-up), or a little depression in the skin (fat breakdown)

If you have any of the following symptoms, call your doctor without delay:

o exaggerated sunburn
o difficulty speaking or moving
o skin rash or hives (Urticaria) all over the body
o itching or redness
o swelling of hands or feet
o difficulty swallowing
o wheezing (problem with breathing)
o fast pulse
o low blood pressure

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