INSULIN GLARGINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Lantus

Category

• Antidiabetic agent

Description

Insulin glargine(IN-su-linGLARE-jeen) is a type of insulin. Insulin is one of many hormonesthat help the body turn the food we eat into energy. This is done by usingthe glucose (sugar) in the blood as quick energy. Also, insulin helps us storeenergy that we can use later. When you have type 2 diabetes mellitus, yourbody does not produce enough insulin, or the insulin produced is not usedproperly. This causes you to have too much sugar in your blood. Like othertypes of insulin, insulin glargine is used to keep your blood sugar levelclose to normal. Insulin glargine is a long-acting insulin that works slowlyover about 24 hours. You may have to use insulin glargine in combination withanother type of insulin or with a type of oral diabetes medicine to keep yourblood sugar under control.

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

Parenteral
• Injection (U.S.)

Before Using This Medicine

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

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

Pregnancy?The amount of insulin or insulin glargine you needchanges during pregnancy. It is especially important for your health and yourbaby's health that your blood sugar be closely controlled.

Breast-feeding?It is not known whether insulin glargine passesinto breast milk. However, your insulin glargine dosage, your meal plan, orboth may need adjustment.

Children? This medicine has been tested in a limited numberof children 6 years of age or older. In effective doses, the medicine hasnot been shown to cause different side effects or problems than it does inadults.

Older adults?This medicine has been tested in a limited numberof patients 65 years of age or older and has not been shown to cause differentside 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 casestwo different medicines may be used together even if an interaction mightoccur. In these cases, your doctor may want to change the dose, or other precautionsmay be necessary. When you are taking insulin glargine, it is especially importantthat 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 symptomsof low blood sugar (such as fast heartbeat). Because of this, a person withdiabetes might not recognize that he or she has low blood sugar and mightnot take immediate steps to treat it

Other medical problems?The presence of other medical problems may affect the use of insulin glargine.Make sure you tell your doctor if you have any other medical problems, especially:

• Emotional disturbances or
• Infection or
• Stress?These conditions increase blood sugar and may increasethe 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

Proper Use of This Medicine

Dosing?Each package of insulin glargine contains a patient information sheet. Readthis 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 foreach injection (e.g., abdomen, thigh, or upper arm). If you have questionsabout this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over24 hours, it should be taken once daily at bedtime

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

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

• For injection dosage form:
  • For type 2 diabetes mellitus:
    • Adults, teenagers, and children 6 years of age or older?Thedose 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 determinedby 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 cartridgeand pen at room temperature, not in the refrigerator.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor will want to checkyour progress at regular visits, especially during the first few weeksyou take this medicine.

It is very important to follow carefully any instructionsfrom 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 timeyou are taking insulin glargine unless they have been discussed with yourdoctor. This especially includes nonprescription medicines such as aspirin,and medicines for appetite control, asthma, colds, cough, hay fever, or sinusproblems.
• Counseling?Other family members need to learn how to preventside effects or help with side effects if they occur. Also, patients withdiabetes may need special counseling about diabetes medicine dosing changesthat might occur because of lifestyle changes, such as changes in exerciseand diet. Furthermore, counseling on contraception and pregnancy is neededbecause of the problems that can occur in patients with diabetes during pregnancy.
• Travel?Keep a recent prescription and your medical historywith you. Be prepared for an emergency as you would normally. Make allowancesfor changing time zones and keep your meal times as close as possible to yourusual meal times.

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

• Wear a medical identification (ID) bracelet or neck chain at alltimes. Also, carry an ID card in your wallet or purse that says that you havediabetes and a list of all of your medicines.
• Keep an extra supply of insulin glargine and syringes with needlesor 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 severelow blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin glargine can cause hypoglycemia (low blood sugar). Lowblood sugar also can occur if you use insulin glargine with another antidiabeticmedicine, delay or miss a meal or snack, exercise more than usual, or drinkalcohol. Symptoms of low blood sugar must be treatedbefore they lead to unconsciousness (passing out). Different peoplemay feel different symptoms of low blood sugar. It isimportant that you learn which symptoms of low blood sugar you usually haveso 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; excessivehunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness;nightmares; restless sleep; shakiness; slurred speech; and tingling in thehands, feet, lips, or tongue.

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

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

Symptoms of high blood sugar include blurredvision; 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 yourblood sugar level and then call your doctor for instructions.

Side Effects of This Medicine

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

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

More common

Convulsions (seizures); unconsciousness

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

More common

Low blood sugar, including anxious feeling; behavior change similarto being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficultyin thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fastheartbeat; 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

Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor 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 insome patients. If you notice any other effects, check with your doctor.