insulin aspart and insulin aspart protamine

Generic Name: insulin aspart and insulin aspart protamine (IN su lin AS part, IN su lin AS part PRO ta meen)
Brand Name: NovoLOG Mix 70/30, NovoLOG Mix 70/30 FlexPen, NovoLOG Mix 70/30 PenFill

What is insulin aspart and insulin aspart protamine?

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

Insulin aspart and insulin aspart protamine is used to treat type 1 (insulin-dependent) diabetes in adults.

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

What is the most important information I should know about insulin aspart and insulin aspart protamine?

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Slideshow: Flashback: FDA Drug Approvals 2013

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, loss of appetite, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your insulin aspart and insulin aspart protamine dose.

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.

What should I discuss with my healthcare provider before using insulin aspart and insulin aspart protamine?

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

To make sure you can safely use insulin aspart and insulin aspart protamine, tell your doctor if you have liver or kidney disease.

This medication 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.

FDA pregnancy category B. Insulin aspart and insulin aspart protamine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether insulin aspart and insulin aspart protamine 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 aspart and insulin aspart protamine?

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

Insulin aspart and insulin aspart protamine is injected under the skin. You will be shown how to use injections at home. 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 aspart and insulin aspart protamine must not be given with an insulin pump, or mixed with other insulins.

After using insulin aspart and insulin aspart protamine, you should eat a meal within 15 minutes. This medication is usually given with 2 meals per day.

Just before using this medication, roll the vial (medicine bottle) 10 times between the palms of your hands, until the medicine looks white and cloudy. Then give the injection right away.

If you use the injection pen, turn it upside down so the glass ball inside it moves from one end to the other. Do this at least 10 times, until the medicine looks white and cloudy, then give the injection right away. Repeat this procedure each time you use the injection pen.

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.

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.

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.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, 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 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.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, loss of appetite, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully 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 dose needs may also change.

Your doctor may want you to stop taking insulin aspart and insulin aspart protamine for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your insulin aspart and insulin aspart protamine dose if needed. Do not change your medication dose or schedule without your doctor's advice.

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.

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

You may also keep in-use" vials at room temperature. Use within 28 days. Protect from light.

Storing injection pens after your first use: Keep the "in-use" injection pen at room temperature and use within 28 days. Do not refrigerate. Protect from light.

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose can cause life-threatening hypoglycemia.

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

What should I avoid while using insulin aspart and insulin aspart protamine?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Insulin aspart and insulin aspart protamine 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. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Call your doctor at once if you have a serious side effect such as:

  • vision changes;

  • swelling in your hands or feet; or

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

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

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 aspart and insulin aspart protamine Dosing Information

Usual Adult Dose for Diabetes Type 1:

Insulin aspart is a short acting insulin with a rapid onset and should be given immediately before meals. 50 to 70% of the daily insulin requirement may be provided by aspart and the remainder by an intermediate or long-acting insulin.

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 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 Type 2:

Insulin aspart is a short acting insulin with a rapid onset and should be given immediately before meals. 50 to 70% of the daily insulin requirement may be provided by aspart and the remainder by an intermediate or long-acting insulin.

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) 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 aspart and insulin aspart protamine?

Tell your doctor about all other medications you use, especially:

  • albuterol (Proventil, Ventolin);

  • clonidine (Catapres);

  • disopyramide (Norpace);

  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and otheres);

  • pramlintide (Symlin);

  • fenofibrate (Antara, Lipofen, Triglide), fenofibric acid (Trilipix), or gemfibrozil (Lopid);

  • enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others;

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

  • birth control pills and other hormones;

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

  • diuretics (water pills);

  • a monoamine oxidase inhibitor (MAOI);

  • phenothiazines (Phenergan and others);

  • thyroid medicine (Synthroid and others);

  • a beta-blocker (Tenormin, Normodyne, Toprol, Coreg, Inderal, and others);

  • medicines to treat psychiatric disorders (Abilify, Clozaril, Zyprexa, Compazine, Risperdal, and others);

  • steroids (prednisone and others); or

  • sulfa drugs (Bactrim, Septra, and others).

This list is not complete and there are many other medicines that can increase or decrease the effects of insulin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about insulin aspart and insulin aspart 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: 7.03. Revision Date: 2012-06-16, 4:34:22 AM.

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