In the U.S.—

• Antidiabetic agent

Insulin glargine (IN-su-lin GLARE-jeen) is a type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have diabetes mellitus (sugar diabetes), your body does not produce enough insulin, or the insulin produced is not used properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Insulin glargine is a long-acting insulin that works slowly over about 24 hours. You may have to use insulin glargine in combination with another type of insulin or with a type of oral diabetes medicine to keep your blood sugar under control.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For insulin glargine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to insulin glargine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—The amount of insulin or insulin glargine you need changes during pregnancy. It is especially important for your health and your baby's health that your blood sugar be closely controlled.

Breast-feeding—It is not known whether insulin glargine passes into breast milk. However, your insulin glargine dosage, your meal plan, or both may need adjustment.

Children— This medicine has been tested in a limited number of children 6 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines— Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking insulin glargine, it is especially important that your health care professional know if you are taking any of the following:

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne, Trandate], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Betapace], timolol [e.g., Blocadren]) or
• Clonidine (e.g., Catapres) or
• Guanethidine (e.g., Ismelin) or
• Reserpine (e.g., Serpalan)—These medicines may hide symptoms of low blood sugar (such as fast heartbeat). Because of this, a person with diabetes might not recognize that he or she has low blood sugar and might not take immediate steps to treat it

• Emotional disturbances or
• Infection or
• Stress—These conditions increase blood sugar and may increase the amount of insulin or insulin glargine you need

• Kidney disease or
• Liver disease—Effects of insulin glargine may be increased; this may change the amount of insulin glargine you need

Dosing—

Each package of insulin glargine contains a patient information sheet. Read this sheet carefully and make sure you understand:

• How to prepare the medicine.
• How to inject the medicine.
• How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over 24 hours, it should be taken once daily at bedtime

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

The dose of insulin glargine will be different for different patients. Follow your doctor's orders or the directions on the label.

• For injection dosage form:
  • For diabetes mellitus (sugar diabetes):
    • Adults, teenagers, and children 6 years of age or older—The dose is based on your blood sugar and must be determined by your doctor.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Store in the refrigerator. However, keep the medicine from freezing.
• After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking insulin glargine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin glargine can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin glargine with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have emotional stress or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Convulsions (seizures);  unconsciousness  
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Low blood sugar, including anxious feeling; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue 
  
  

• Less common or rare
  • Allergic reaction, including fast pulse, shortness of breath, skin rash or itching over the entire body, sweating, and wheezing 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• Less common or rare
  • Bloating or swelling of face, hands, lower legs, and/or feet ;  depression of skin at injection site;  injection site pain;  local allergy, including itching, redness, or swelling at injection site;  thickening of skin at injection site 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.