Thursday, October 20, 2016

insulin glulisine


Generic Name: insulin glulisine (IN su lin GLOO lis een)

Brand Names: Apidra, Apidra OptiClik Cartridge, Apidra SoloStar Pen


What is insulin glulisine?

Insulin glulisine is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin glulisine is a faster-acting form of insulin than regular human insulin.


Insulin glulisine is used to treat diabetes in adults and children who are at least 4 years old. It is usually given together with a long-acting insulin.


Insulin glulisine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about insulin glulisine?


Insulin glulisine is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.


Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.


Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.


Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin glulisine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.


What should I discuss with my healthcare provider before using insulin glulisine?


Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin glulisine, tell your doctor if you have liver or kidney disease.


Tell your doctor about all other medications you use, including any oral (taken by mouth) diabetes medications.


Insulin glulisine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.


Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.


FDA pregnancy category C. It is not known whether insulin glulisine is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin glulisine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use insulin glulisine?


Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.


Insulin glulisine is given as an injection (shot) under your skin using a needle and syringe, an injection pen, or an insulin pump. It may also be given through a needle placed into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Insulin glulisine is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.


Insulin glulisine should be thin, clear, and colorless. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.


Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.


If you use this medication with an insulin pump, do not mix or dilute insulin glulisine with any other insulin. Call your doctor at once if you think your infusion pump is not working properly.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.


Infusion pump tubing, catheters, and the needle location on your skin should be changed every 48 hours.


Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.


Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.


Ask your doctor how to adjust your insulin glulisine dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials, cartridges, or injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Unopened vials, cartridges, or injection pens may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days.

Storing after your first use: You may keep "in-use" vials in the refrigerator or at room temperature, protected from light. Use within 28 days.


In-use cartridges or injection pens must be stored at room temperature, away from heat and bright light. Do not refrigerate an in-use cartridge or injection pen. Keep it at room temperature and use within 28 days. An infusion set should be stored at room temperature and used within 48 hours.

Do not freeze insulin glulisine, and throw away the medication if it has become frozen.


What happens if I miss a dose?


Since insulin glulisine is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin glulisine, be sure to eat a meal within 15 minutes. Do not use extra insulin glulisine to make up a missed dose.


It is important to keep insulin glulisine on hand at all times. Get your prescription refilled before you run out of medicine completely.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.


What should I avoid while using insulin glulisine?


Do not change the brand of insulin glulisine or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin glulisine. Do not expose insulin glulisine to high heat. Throw the medication away if it becomes hotter than 98 degrees F.

Insulin glulisine side effects


Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glulisine. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.


Insulin glulisine can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin glulisine.


This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Insulin glulisine Dosing Information


Usual Adult Dose for Diabetes Mellitus Type I:

Insulin glulisine is a rapid-acting insulin and is given 1 to 4 times daily within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump. Intravenous administration of insulin glulisine is possible under strict medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal.

Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro, glulisine) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.

Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type II:

Insulin glulisine is a rapid-acting insulin and is given 1 to 4 times daily within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump. Intravenous administration of insulin glulisine is possible under strict medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.

Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents. Insulin may be considered if patients are very hyperglycemic or symptomatic and/or not controlled with oral agents. Insulin may exacerbate obesity, further increase insulin resistance, and increase the frequency of hypoglycemia.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen:
Initial dose, monotherapy: Total insulin requirement: 0.1 unit/kg/day. When insulin is used alone, twice daily injections are recommended for better glycemic control. The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 1.5 to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Intensive regimen:
The necessity for and efficacy of intensive insulin therapy in type II diabetes has been controversial. The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro, glulisine) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Initial dose, monotherapy: 0.5 to 1.5 unit/kg/day subcutaneously.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Usual Pediatric Dose for Diabetes Mellitus Type I:

4 years and older:
Insulin glulisine is a rapid-acting insulin and is given 1 to 4 times daily within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump. Intravenous administration of insulin glulisine is possible under strict medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose. Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro, glulisine) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels. Total daily insulin requirements: Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously


What other drugs will affect insulin glulisine?


Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:



  • albuterol (Proventil, Ventolin);




  • clonidine (Catapres);




  • guanethidine (Ismelin);




  • lanreotide (Somatuline Depot);




  • niacin (Niaspan, Niacor, Advicor);




  • octreotide (Sandostatin);




  • pramlintide (Symlin);




  • reserpine;




  • beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.




There are many other medicines that can increase or decrease the effects of insulin glulisine on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More insulin glulisine resources


  • Insulin glulisine Side Effects (in more detail)
  • Insulin glulisine Use in Pregnancy & Breastfeeding
  • Insulin glulisine Drug Interactions
  • Insulin glulisine Support Group
  • 1 Review for Insulin glulisine - Add your own review/rating


  • insulin glulisine Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Insulin Glulisine Monograph (AHFS DI)

  • Insulin Glulisine Cartridges MedFacts Consumer Leaflet (Wolters Kluwer)

  • Apidra Prescribing Information (FDA)

  • Apidra Consumer Overview



Compare insulin glulisine with other medications


  • Diabetes, Type 1
  • Diabetes, Type 2


Where can I get more information?


  • Your pharmacist can provide more information about insulin glulisine.

See also: insulin glulisine side effects (in more detail)


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