Insulin Glargine (rDNA origin) Injection

Name: Insulin Glargine (rDNA origin) Injection

What special precautions should I follow?

Before using insulin glargine,

  • tell your doctor and pharmacist if you are allergic to insulin (Humulin, Novolin, others), any of the ingredients of insulin glargine, or any other medications. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: albuterol (Accuneb, Proair, Proventil, others); angiotensin-converting enzyme inhibitors (ACE inhibitors) such as benazepril (Lotensin, in Lotrel), captopril (Capoten), enalapril (Enalaprilat, Vasotec, in Vaseretic), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten, in Teveten HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), telmisartan (Micardis, in Micardis HCT, in Twynsta), valsartan (Diovan, in Diovan HCT, in Exforge); atypical antipsychotics such as clozapine (Clozaril, Fazaclo, Versacloz) and olanzapine (Zyprexa, in Symbyax); beta-blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate, in Corzide), metoprolol (Lopressor, Toprol XL), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal LA, Innopran XL); certain cholesterol-lowering medications such as fenofibrate (Antara, Lipofen, TriCor, Triglide), gemfibrozil (Lopid), and niacin (Niacor, Niaspan, in Advicor); clonidine (Catapres, Catapres-TTS, Kapvay, in Clorpres, others); danazol; disopyramide (Norpace); diuretics ('water pills'); estrogens; fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax); glucagon; guanethidine (not available in the U.S.); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak), and saquinavir (Invirase); hormone replacement therapy (birth control pills, patches, rings, injections, or implants); isoniazid (Laniazid, in Rifamate, in Rifater); lithium (Lithobid); medications for asthma and colds; medications for mental illness and nausea; monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); octreotide (Sandostatin); oral contraceptives (birth control pills); oral medications for diabetes such as pioglitazone (Actos, in Actoplus Met) and rosiglitazone (Avandia, in Avandamet, in Avandaryl); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); pentamidine (NebuPent, Pentam); pentoxifylline (Pentoxil); pramlintide (Symlin); propoxyphene (not available in the U.S.); reserpine; salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate, diflunisal, magnesium salicylate (Doan's, others), and salsalate; somatropin (Genotropin, Humatrope, Nutropin, Serostim, others); sulfa antibiotics; terbutaline; and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had nerve damage caused by your diabetes, heart failure, or any other medical conditions, including heart, liver or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using insulin glargine, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using insulin glargine.
  • alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin glargine.
  • ask your doctor what to do if you get sick, experience unusual stress, or change your diet, exercise, or activity schedule. These changes can affect your blood sugar and the amount of insulin you will need.
  • ask your doctor how often you should check your blood sugar. Be aware that hypoglycemia may affect your ability to perform tasks such as driving and ask your doctor if you need to check your blood sugar before driving or operating machinery.

What special dietary instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet and to eat about the same amounts of the same kinds of food at about the same times each day. Skipping or delaying meals or changing the amount or kind of food you eat can cause problems with your blood sugar control.

What should I do if I forget a dose?

Before you start using insulin glargine, ask your doctor what to do if you forget to use a dose or if you accidentally use an extra dose. Write these directions down so you can refer to them later.

What side effects can this medication cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Insulin glargine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  1. redness, swelling, pain, or itching at the injection site
  2. changes in the feel of your skin, skin thickening (fat build-up), or a little depression in the skin (fat breakdown)
  3. swelling of the hands or feet
  4. weight gain
  5. cough

Some side effects can be serious. If you experience these symptoms, call your doctor immediately or get emergency treatment:

  1. rash, hives, or itching all over the body
  2. wheezing
  3. difficulty breathing or swallowing
  4. shortness of breath
  5. fast pulse
  6. sweating
  7. swelling of the eyes, face, lips, tongue, or throat
  8. hoarseness
  9. weakness
  10. muscle cramps
  11. abnormal heartbeat

Insulin glargine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in and out of reach of children. Store unopened insulin glargine vials and pens in the refrigerator. Never allow insulin glargine to freeze; do not use insulin glargine that has been frozen and thawed. Unopened refrigerated insulin glargine can be stored until the date shown on the company's label.

If a refrigerator is unavailable (for example, when on vacation), store the vials or pens at room temperature and away from direct sunlight and extreme heat. Unrefrigerated vials or pens can be used within 28 days or after that time they must be thrown away. Opened vials can be stored for 28 days at room temperature or in the refrigerator. Opened pens must be stored at room temperature and may be used for up to 28 days after the first use. Dispose of any insulin that has been exposed to extreme heat or cold.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Insulin glargine overdose can occur if you use too much insulin glargine or if you use the right amount of insulin glargine but eat less than usual or exercise more than usual. Insulin glargine overdose can cause hypoglycemia. If you have symptoms of hypoglycemia, follow your doctor's instructions for what you should do if you develop hypoglycemia. Other symptoms of overdose:

  1. loss of consciousness
  2. seizures
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