insulin lispro and insulin lispro protamine

Generic Name: insulin lispro and insulin lispro protamine (IN soo lin LISS pro and IN soo lin LISS pro PRO ta meen)
Brand Name: HumaLOG Mix 50/50, HumaLOG Mix 50/50 KwikPen, HumaLOG Mix 75/25, HumaLOG Mix 75/25 KwikPen, HumaLOG Mix 75/25 Pen, HumaLOG Mix 50/50 Pen

What is insulin lispro and insulin lispro protamine?

Insulin lispro is a fast-acting form of insulin that works by lowering levels of glucose (sugar) in the blood.

Insulin lispro and insulin lispro protamine is a combination medicine used to treat type 1 (insulin-dependent) diabetes in adults. It is usually given together with another long-acting insulin.

Insulin lispro and insulin lispro protamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

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

Slideshow: Flashback: FDA Drug Approvals 2013

What should I discuss with my healthcare provider before using this medicine?

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

To make sure insulin lispro and insulin lispro protamine is safe for you, tell your doctor if you have:

  • liver or kidney disease; or

  • if you take any oral (taken by mouth) diabetes medicine.

FDA pregnancy category B. This medicine is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old without medical advice.

How should I use this medicine?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin lispro and insulin lispro protamine is given as an injection (shot) under your skin. You will be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes. Do not mix this medicine with any other insulin.

Use this medication within 15 minutes before eating a meal.

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

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

Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Insulin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Storing unopened vials 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. Do not freeze insulin, and throw away the medicine if it has become frozen.

Unopened vials may also be stored at room temperature, away from heat and bright light. Throw away any vial not used within 28 days.

Unopened injection pens may also be stored at room temperature, away from heat and bright light. Throw away any injection pen not used within 10 days.

After your first use: You may keep "in-use" vials in the refrigerator, protected from light. Use within 28 days.

Do not refrigerate an in-use injection pen. Keep it at room temperature and use within 10 days.

What happens if I miss a dose?

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

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 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 this medicine?

Do not change the brand of insulin lispro and insulin lispro protamine or syringe you are using without first talking to your doctor or pharmacist.

Avoid drinking alcohol. It can affect your blood sugar levels.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

This medicine 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.

Call your doctor at once if you have:

  • itching, swelling, redness, or thickening of the skin where you inject the medicine; or

  • low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Common side effects may include:

  • low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery.

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.

See also: Side effects (in more detail)

Insulin lispro and insulin lispro protamine dosing information

Usual Adult Dose for Diabetes Type 1:

Insulin lispro-lispro protamine is a mixture of rapid and intermediate-acting insulins and is given subcutaneously 1 to 3 times daily. It should be given within 15 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 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) 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 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 Type 2:

Insulin lispro-lispro protamine is a mixture of rapid and intermediate-acting insulins and is given subcutaneously 1 to 3 times daily. It should be given within 15 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 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: An average of 0.65 units/kg/day in 2 divided doses of lispro-lispro protamine insulin has been used in studies. 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) 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.

What other drugs will affect insulin lispro and insulin lispro protamine?

Many other medicines can increase or decrease the effects of insulin on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about insulin lispro and insulin lispro protamine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.01. Revision Date: 2014-04-08, 2:48:24 PM.

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