Monday, October 24, 2016

Insulin regular, concentrated U-500


Generic Name: insulin regular, concentrated (U-500) (IN soo lin)

Brand Names: HumuLIN R (Concentrated)


What is concentrated insulin?

Concentrated insulin is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Concentrated insulin (U-500) is a long-acting form of insulin that is different from other forms that are made from animal insulin.


Concentrated insulin is used to treat type 1 (insulin-dependent) diabetes in people with significant daily insulin needs (more than 200 units per day).


Concentrated insulin may also be used for purposes other than those listed in this medication guide.


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


Concentrated insulin works differently from other types of insulin, and its effects may last for up to 24 hours after a single dose. Always check your medicine when it is refilled to make sure you have received the correct brand and type prescribed by your doctor.

While you are using concentrated insulin, do not use any other type of insulin or diabetes medications you take by mouth unless your doctor tells you to.


Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of hypoglycemia may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating.


If your blood sugar gets too high (hyperglycemia), you may have symptoms such as increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting. Call your doctor right away if you have any of these symptoms.


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


Measure each dose of this medication carefully. Concentrated insulin contains 500 units of insulin in each milliliter. This is five times the concentration of other Humulin or Novolin insulins. Using too much concentrated insulin can cause severely low blood sugar (hypoglycemia), which could lead to insulin shock or death.

You should not use concentrated insulin if you are in a state of hypoglycemia.


Tell your doctor if you are pregnant or plan to become pregnant while you are using concentrated insulin. It is not known whether concentrated insulin 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 concentrated insulin?


Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. It is important to use insulin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Concentrated insulin works differently than other types of insulin, and its effects may last for up to 24 hours after a single dose. The length of insulin effect will depend on your dose, your level of physical activity, and many other factors.

Concentrated insulin is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will show you how to inject your medicine at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.


Use only an insulin or tuberculin syringe to inject this medication. Do not mix or dilute concentrated insulin with any other insulin.

Use a different place on your body each time you give yourself an injection. Your care provider will show you the places on your body where you can safely inject the medication.


Use a disposable needle and syringe only one time. Throw away used needles and syringes in a puncture-proof container. If your medicine does not come with such a container, ask your pharmacist where you can get one. Keep this container out of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the container.


Some 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.


Check your blood sugar levels often, especially during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your doctor may adjust your insulin dose if your levels are too high or too low.


Take care to keep your blood sugar from getting too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating.


Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose tablets or gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection. Be sure your family and close friends know how to help you in an emergency.


If your blood sugar gets too high (hyperglycemia), you may have symptoms such as increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting. Call your doctor right away if you have any of these symptoms.


If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type prescribed by 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 a diabetic.

Insulin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, overall proper health care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely.


Store concentrated insulin in the refrigerator, but do not allow it to freeze.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. Concentrated insulin should look as clear as water.


What happens if I miss a dose?


Follow your doctor's directions if you miss a dose of insulin. To prevent missed doses, be sure to keep insulin on hand at all times, especially when you are traveling away from home.


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 concentrated insulin?


Avoid drinking alcohol while using concentrated insulin. Alcohol can lower your blood sugar.

Concentrated insulin side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your doctor if you have any pain, redness, swelling, or skin changes where the insulin was injected.

Low blood sugar is the most common side effect of concentrated insulin. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, seizure (convulsions), or death. Watch for signs of low blood sugar.


This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Insulin regular, concentrated Dosing Information


Usual Adult Dose for Gestational Diabetes:

Regular insulin is a short-acting insulin and is generally injected subcutaneously 2-5 times daily within 30-60 minutes before a meal.

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 1-2 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 30-50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1-2 times daily. Meal boluses are approximately 50-70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2-5 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: 0.5-0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2-0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5-1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7-2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type I:

Regular insulin is a short-acting insulin and is generally injected subcutaneously 2-5 times daily within 30-60 minutes before a meal.

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 1-2 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 30-50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1-2 times daily. Meal boluses are approximately 50-70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2-5 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: 0.5-0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2-0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5-1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7-2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type II:

Regular insulin is a short-acting insulin and should be injected within 30-60 minutes before a meal.

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 daily requirement: 0.1 unit/kg/day subcutaneously. 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 1-2 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 1.5-2.5 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 30-50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1-2 times daily. Meal boluses are approximately 50-70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2-5 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: 0.5-1.5 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 Adult Dose for Diabetic Ketoacidosis:

Begin after intravenous fluid/electrolyte therapy has been initiated:
Initial dose: 10-20 units IV or 20 units IM or 0.1 unit/kg IM or IV.
Maintenance dose: 0.1 unit/kg/hour by continuous IV infusion in normal saline; monitor blood glucose hourly and adjust rate to gradually decrease plasma glucose. Usual range is 0.05-0.2 units/kg/hour. Switch patients to subcutaneous insulin after recovery from the acute episode.
or
5-10 units IM hourly
or
0.5-4 units/hour by continuous IV infusion to achieve a maximal blood glucose decrease of 50 mg/dL/hour.

Usual Adult Dose for Growth Hormone Reserve Test:

0.05-1.5 units/kg one time by rapid IV push. Monitor patient closely.

Usual Adult Dose for Hyperkalemia:

Begin after administration of calcium gluconate and sodium bicarbonate IV:
10-20 units IV once with 25-50 g dextrose.

Usual Adult Dose for Insulin Resistance:

Total daily insulin requirements range from 0.7 to 2.5 units/kg. Concentrated insulin (500 units/mL) may be used for patients taking more than 200 units/day to allow for reasonable subcutaneous dose volumes.

Usual Adult Dose for Nonketotic Hyperosmolar Syndrome:

Begin after intravenous fluid therapy has been initiated:
Initial dose: 5-10 units or 0.1 unit/kg IV once
Maintenance dose: 0.05-0.1 unit/kg/hour by continuous IV infusion. Monitor vital signs, cardiovascular status, I/O, and plasma glucose and potassium levels. Add potassium to the IV to correct hypokalemia. Add dextrose to the IV once glucose levels reach 250 mg/dL to avoid hypoglycemia. Switch patients to subcutaneous insulin therapy after recovery from the acute episode.

Usual Pediatric Dose for Diabetes Mellitus Type I:

Regular insulin is a short-acting insulin and is generally injected subcutaneously 2-5 times daily within 30-60 minutes before a meal.

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 1-2 injections. Twice daily injections are recommended 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. 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.

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. 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 30-50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, glargine), 1-2 times daily. Meal boluses are approximately 50-70% of the total dose, given as rapid/short-acting insulin (regular, lispro) 2-5 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: 0.5-0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2-0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5-1.2 unit/kg/day subcutaneously
Adolescents during growth spurts. 0.8-1.5 units/kg/day subcutaneously

Usual Pediatric Dose for Diabetes Mellitus Type II:

Regular insulin is a short-acting insulin and should be injected within 30-60 minutes before a meal.

Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents (metformin). Insulin may be considered if children 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 daily requirement: 0.1 unit/kg/day subcutaneously. 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 1-2 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 1.5-2.5 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 30-50% of the total dose, given as intermediate or long-acting insulin (NPH,zinc, extended zinc, glargine), 1-2 times daily. Meal boluses are approximately 50-70% of the total dose, given as rapid/short-acting insulin (regular, lispro) 2-5 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: 0.5-1.5 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 Diabetic Ketoacidosis:

Begin after intravenous fluid/electrolyte therapy has been initiated:
Initial dose: 0.1-0.25 unit/kg IM or IV
Maintenance dose: 0.1 unit/kg/hour by continuous IV infusion in normal saline or 0.05-0.1 unit/kg/hour by IM or subcutaneous injection. Monitor blood glucose hourly and adjust rate to gradually decrease plasma glucose. Usual range is 0.05-0.3 units/kg/hour. Switch patients to subcutaneous insulin after recovery from the acute episode.

Usual Pediatric Dose for Growth Hormone Reserve Test:

0.05-1.5 units/kg one time by rapid IV push. Monitor patient closely.

Usual Pediatric Dose for Hyperkalemia:

Begin after administration of calcium gluconate and sodium bicarbonate IV:
0.25-1 g/kg dextrose with 1 unit regular insulin per 3-5 g dextrose infused IV over 2 hours.
or
0.25-1 g/kg dextrose infused IV over 15-30 minutes, then give 0.1 unit/kg regular insulin subcutaneously or IV.
or
0.05-0.1 unit/kg/hour regular insulin infused IV with dextrose. 1 unit insulin per 1.9-3.9 g dextrose ratio has been used in premature infants. Adjust rate to target blood glucose level.

Usual Pediatric Dose for Insulin Resistance:

True insulin resistance is rare in children. Daily requirements may be greater than 2 units/kg. Extreme insulin resistance with insulin requirements greater than 10 units/kg/day has been reported in children with acanthosis nigricans and polycystic ovaries.

Concentrated insulin (500 units/mL) may be used for patients taking more than 200 units/day to allow for reasonable subcutaneous dose volumes.

Usual Pediatric Dose for Nonketotic Hyperosmolar Syndrome:

Begin after intravenous fluid therapy has been initiated:
Initial dose: 0.05-0.1 unit/kg IV once
Maintenance dose: 0.05 unit/kg/hour by continuous IV infusion. Monitor vital signs, cardiovascular status, I/O, and plasma glucose and potassium levels. Add potassium to the IV to correct hypokalemia. Add dextrose to the IV once glucose levels reach 250 mg/dL to avoid hypoglycemia. Switch patients to subcutaneous insulin therapy after recovery from the acute episode.


What other drugs will affect concentrated insulin?


Do not use any other insulins or diabetes medications you take by mouth, unless your doctor tells you to.


Hyperglycemia (high blood sugar) may be more likely to occur if you also use certain other medications such as:



  • diuretics (water pills);




  • steroids (prednisone and others);




  • phenothiazines (Compazine and others);




  • thyroid medicine (Synthroid and others);




  • birth control pills and other hormones;




  • seizure medicines (Dilantin and others);




  • diet pills, or medicines to treat asthma, colds or allergies.



Hypoglycemia (low blood sugar) may be more likely to occur if you also use certain other medications such as:



  • some nonsteroidal anti-inflammatory drugs (NSAIDs);




  • aspirin or other salicylates (including Pepto-Bismol);




  • sulfa drugs (Bactrim and others);




  • a monoamine oxidase inhibitor (MAOI); or




  • beta-blockers (Tenormin and others).



This list is not complete and there may be other drugs that can interact with concentrated insulin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More insulin regular, concentrated resources


  • Insulin regular, concentrated Side Effects (in more detail)
  • Insulin regular, concentrated Use in Pregnancy & Breastfeeding
  • Insulin regular, concentrated Drug Interactions
  • Insulin regular, concentrated Support Group
  • 2 Reviews for Insulin regular, concentrated - Add your own review/rating


Compare insulin regular, concentrated with other medications


  • Diabetes, Type 1
  • Diabetes, Type 2
  • Diabetic Ketoacidosis
  • Gestational Diabetes
  • Growth Hormone Reserve Test
  • Hyperkalemia
  • Insulin Resistance Syndrome
  • Nonketotic Hyperosmolar Syndrome


Where can I get more information?


  • Your pharmacist can provide more information about concentrated insulin (U-500).

See also: insulin regular, concentrated side effects (in more detail)



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