Humulin N (Insulin (Human Recombinant))
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Humulin N (Insulin (Human Recombinant))

HUMULIN® N (insulin human recombinant)
(NPH human insulin (rDNA origin) isophane) Suspension 100 Units per ML (U-100)

10 mL Vial (1000 Units per vial)

DRUG DESCRIPTION

Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered to produce human insulin. Humulin N (insulin human recombinant) [Human insulin (rDNA origin) isophane suspension] is a crystalline suspension of human insulin with protamine and zinc providing an intermediate-acting insulin with a slower onset of action and a longer duration of activity (up to 24 hours) than that of Regular human insulin. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin N (insulin human recombinant) is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin N (insulin human recombinant) is a sterile suspension and is for subcutaneous injection only. It should not be used intravenously or intramuscularly. The concentration of Humulin N (insulin human recombinant) is 100 units/mL (U-100).

What are the possible side effects of insulin isophane?

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 isophane. 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...

Read All Potential Side Effects and See Pictures of Humulin N »

What are the precautions when taking insulin (human recombinant) (Humulin N)?

Before using insulin, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal/pituitary gland problems, infection (especially with diarrhea or vomiting), kidney disease, liver disease, nerve problems (e.g., diabetic neuropathy), thyroid problems.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery,...

Read All Potential Precautions of Humulin N »

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

No information provided.

DOSAGE AND ADMINISTRATION

Your doctor has told you which insulin to use, how much, and when and how often to inject it. Because each patient's diabetes is different, this schedule has been individualized for you.

Your usual dose of Humulin N (insulin (human recombinant)) may be affected by changes in your diet, activity, or work schedule. Carefully follow your doctor's instructions to allow for these changes. Other things that may affect your Humulin N (insulin (human recombinant)) dose are:

Illness

Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you will still require insulin. You and your doctor should establish a sick day plan for you to use in case of illness. When you are sick, test your blood glucose frequently. If instructed by your doctor, test your ketones and report the results to your doctor.

Pregnancy

Good control of diabetes is especially important for you and your unborn baby. Pregnancy may make managing your diabetes more difficult. If you are planning to have a baby, are pregnant, or are nursing a baby, talk to your doctor.

Medication

Insulin requirements may be increased if you are taking other drugs with blood-glucose-raising activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin requirements may be reduced in the presence of drugs that lower blood glucose or affect how your body responds to insulin, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, alcohol, certain antidepressants and some kidney and blood pressure medicines. Your Health Care Professional may be aware of other medications that may affect your diabetes control. Therefore, always discuss any medications you are taking with your doctor.

Exercise

Exercise may lower your body's need for insulin during and for some time after the physical activity. Exercise may also speed up the effect of an insulin dose, especially if the exercise involves the area of injection site (for example, the leg should not be used for injection just prior to running). Discuss with your doctor how you should adjust your insulin regimen to accommodate exercise.

Travel

When traveling across more than 2 time zones, you should talk to your doctor concerning adjustments in your insulin schedule.

HOW SUPPLIED

Identification

Human insulin from Eli Lilly and Company has the trademark Humulin. Your doctor has prescribed the type of insulin that he/she believes is best for you.

DO NOT USE ANY OTHER INSULIN EXCEPT ON YOUR DIRECTION.

Always check the carton and the bottle label for the name and letter designation of the insulin you receive from your pharmacy to make sure it is the same as prescribed by your doctor.

Always check the appearance of your bottle of Humulin N (insulin (human recombinant)) before withdrawing each dose. Before each injection the Humulin N (insulin (human recombinant)) bottle must be carefully shaken or rotated several times to completely mix the insulin. Humulin N (insulin (human recombinant)) suspension should look uniformly cloudy or milky after mixing. If not, repeat the above steps until contents are mixed.

Do not use Humulin N (insulin (human recombinant)) :

  • if the insulin substance (the white material) remains at the bottom of the bottle after mixing or
  • if there are clumps in the insulin after mixing, or
  • if solid white particles stick to the bottom or wall of the bottle, giving a frosted appearance.

If you see anything unusual in the appearance of Humulin N (insulin (human recombinant)) suspension in your bottle or notice your insulin requirements changing, talk to your doctor.

Storage

Not in-use (unopened): Humulin N (insulin (human recombinant)) bottles not in-use should be stored in a refrigerator, but not in the freezer.

In-use (opened): The Humulin N (insulin (human recombinant)) bottle you are currently using can be kept unrefrigerated as long as it is kept as cool as possible [below 86°F

Do not use Humulin N (insulin (human recombinant)) after the expiration date stamped on the label or if it has been frozen.

Additional Information

Information about diabetes may be obtained from your diabetes educator.

Additional information about diabetes and Humulin can be obtained by calling The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or by visiting www.LillyDiabetes.com. Patient Information revised Month dd, yyyy

Vials manufactured by: Eli Lilly and Company, Indianapolis , IN 46285, USA for Wal-Mart Stores, Inc.

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Common Problems Of Diabetes

Hypoglycemia (Low Blood Sugar)

Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events experienced by insulin users. It can be brought about by:

  1. Missing or delaying meals.
  2. Taking too much insulin.
  3. Exercising or working more than usual.
  4. An infection or illness associated with diarrhea or vomiting.
  5. A change in the body's need for insulin.
  6. Diseases of the adrenal, pituitary, or thyroid gland, or progression of kidney or liver disease.
  7. Interactions with certain drugs, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, certain antidepressants and some kidney and blood pressure medicines.
  8. Consumption of alcoholic beverages.

Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:
  • sweating
  • dizziness
  • palpitation
  • tremor
  • hunger
  • restlessness
  • tingling in the hands, feet, lips, or tongue
  • lightheadedness
  • inability to concentrate
  • headache
  • drowsiness
  • sleep disturbances
  • anxiety
  • blurred vision
  • slurred speech
  • depressed mood
  • irritability
  • abnormal behavior
  • unsteady movement
  • personality changes
Signs of severe hypoglycemia can include:
  • disorientation
  • unconsciousness
  • seizures
  • death

Therefore, it is important that assistance be obtained immediately.

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, changing insulin preparations, or intensified control (3 or more insulin injections per day) of diabetes.

A few patients who have experienced hypoglycemic reactions after transfer from animal source insulin to human insulin have reported that the early warning symptoms of hypoglycemia were less pronounced or different from those experienced with their previous insulin.

Without recognition of early warning symptoms, you may not be able to take steps to avoid more serious hypoglycemia. Be alert for all of the various types of symptoms that may indicate hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should monitor their blood glucose frequently, especially prior to activities such as driving. If the blood glucose is below your normal fasting glucose, you should consider eating or drinking sugar containing foods to treat your hypoglycemia.

Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. Patients should always carry a quick source of sugar, such as hard candy or glucose tablets. More severe hypoglycemia may require the assistance of another person. Patients who are unable to take sugar orally or who are unconscious require an injection of glucagon or should be treated with intravenous administration of glucose at a medical facility.

You should learn to recognize your own symptoms of hypoglycemia. If you are uncertain about these symptoms, you should monitor your blood glucose frequently to help you learn to recognize the symptoms that you experience with hypoglycemia.

If you have frequent episodes of hypoglycemia or experience difficulty in recognizing the symptoms, you should talk to your doctor to discuss possible changes in therapy, meal plans, and/or exercise programs to help you avoid hypoglycemia.

Hyperglycemia (High Blood Sugar) and Diabetic Ketoacidosis (DKA)

Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin. Hyperglycemia can be brought about by any of the following:

  1. Omitting your insulin or taking less than your doctor has prescribed.
  2. Eating significantly more than your meal plan suggests.
  3. Developing a fever, infection, or other significant stressful situation.

In patients with type 1 or insulin-dependent diabetes, prolonged hyperglycemia can result in DKA (a life-threatening emergency). The first symptoms of DKA usually come on gradually, over a period of hours or days, and include a drowsy feeling, flushed face, thirst, loss of appetite, and fruity odor on the breath. With DKA, blood and urine tests show large amounts of glucose and ketones. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or DKA can lead to nausea, vomiting, stomach pain, dehydration, loss of consciousness, or death. Therefore, it is important that you obtain medical assistance immediately.

Lipodystrophy

Rarely, administration of insulin subcutaneously can result in lipoatrophy (seen as an apparent depression of the skin) or lipohypertrophy (seen as a raised area of the skin). If you notice either of these conditions, talk to your doctor. A change in your injection technique may help alleviate the problem.

Allergy

Local Allergy

Patients occasionally experience redness, swelling, and itching at the site of injection. This condition, called local allergy, usually clears up in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. If you have local reactions, talk to your doctor.

Systemic Allergy

Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life threatening. If you think you are having a generalized allergic reaction to insulin, call your doctor immediately.

Read the Humulin N (insulin (human recombinant)) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL­SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE

INSULIN PRODUCED BY YOUR BODY'S ITS UNIQUE MANUFACTURING PROCESS.

ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH, MANUFACTURER, TYPE (E.G., REGULAR, NPH, ANALOG), SPECIES, OR METHOD OF MANUFACTURE MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE.

SOME PATIENTS TAKING HUMULIN® (HUMAN INSULIN, rDNA ORIGIN) MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH OTHER INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS OR MONTHS.

PRECAUTIONS

Diabetes

Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This hormone is necessary for the body's correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet your body's need

To control your diabetes, your doctor has prescribed injections of insulin products to keep your blood glucose at a near-normal level. You have been instructed to test your blood and/or your urine regularly for glucose. Studies have shown that some chronic complications of diabetes such as eye disease, kidney disease, and nerve disease can be significantly reduced if the blood sugar is maintained as close to normal as possible. The American Diabetes Association recommends that if your pre-meal glucose levels are consistently above 130 mg/dL or your hemoglobin A1c (HbA1c) is more than 7%, you should talk to your doctor. A change in your diabetes therapy may be needed. If your blood tests consistently show below-normal glucose levels, you should also let your doctor know. Proper control of your diabetes requires close and constant cooperation with your doctor. Despite diabetes, you can lead an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin injections as prescribed by your doctor.

Always keep an extra supply of insulin as well as a spare syringe and needle on hand. Always wear diabetic identification so that appropriate treatment can be given if complications occur away from home.

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

No information provided.

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

No information provided.

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Instructions For Insulin Vial Use

NEVER SHARE NEEDLES AND SYRINGES.

Correct Syringe Type

Doses of insulin are measured in units. U-100 insulin contains 100 units/mL (1 mL=1 cc). With Humulin N (insulin (human recombinant)) , it is important to use a syringe that is marked for U-100 insulin preparations. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high.

Syringe Use

To help avoid contamination and possible infection, follow these instructions exactly. Disposable syringes and needles should be used only once and then discarded by placing the used needle in a puncture-resistant disposable container. Properly dispose of the puncture­resistant container as directed by your Health Care Professional.

Preparing the Dose

  1. Wash your hands.
  2. Carefully shake or rotate the bottle of insulin several times to completely mix the insulin.
  3. Inspect the insulin. Humulin N (insulin (human recombinant)) suspension should look uniformly cloudy or milky. Do not use Humulin N (insulin (human recombinant)) if you notice anything unusual in its appearance.
  4. If using a new Humulin N (insulin (human recombinant)) bottle, flip off the plastic protective cap, but do not remove the stopper. Wipe the top of the bottle with an alcohol swab.
  5. If you are mixing insulins, refer to the “Mixing Humulin N (insulin (human recombinant)) and Regular Human Insulin” section below.
  6. Draw an amount of air into the syringe that is equal to the Humulin N (insulin (human recombinant)) dose. Put the needle through rubber top of the Humulin N (insulin (human recombinant)) bottle and inject the air into the bottle.
  7. Turn the Humulin N (insulin (human recombinant)) bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently.
  8. Making sure the tip of the needle is in the Humulin N (insulin (human recombinant)) suspension, withdraw the correct dose of Humulin N (insulin (human recombinant)) into the syringe.
  9. Before removing the needle from the Humulin N (insulin (human recombinant)) bottle, check the syringe for air bubbles.
  10. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
  11. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
  12. If you do not need to mix your Humulin N (insulin (human recombinant)) with Regular human insulin, go to the “Injection Instructions” section below and follow the directions.

Mixing Humulin N (insulin (human recombinant)) and Regular Human Insulin (Humulin R)

  1. Humulin N (insulin (human recombinant)) should be mixed with Humulin R only on the advice of your doctor.
  2. Draw an amount of air into the syringe that is equal to the amount of Humulin N you are taking. Insert the needle into the Humulin N (insulin (human recombinant)) bottle and inject the air. Withdraw the needle.
  3. Draw an amount of air into the syringe that is equal to the amount of Humulin R you are taking. Insert the needle into the Humulin R bottle and inject the air, but do not withdraw the needle.
  4. Turn the Humulin R bottle and syringe upside down.
  5. Making sure the tip of the needle is in the Humulin R solution, withdraw the correct dose of Humulin R into the syringe.
  6. Before removing the needle from the Humulin R bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
  7. Remove the syringe with the needle from the Humulin R bottle and insert it into the Humulin N (insulin (human recombinant)) bottle. Turn the Humulin N (insulin (human recombinant)) bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the Humulin N (insulin (human recombinant)) , withdraw the correct dose of Humulin N (insulin (human recombinant)) .
  8. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
  9. Follow the directions under “Injection Instructions” section below.

Follow your doctor's instructions on whether to mix your insulins ahead of time or just before giving your injection. It is important to be consistent in your method.

Syringes from different manufacturers may vary in the amount of space between the bottom line and the needle. Because of this, do not change:

  • the sequence of mixing, or
  • the model and brand of syringe or needle that your doctor has prescribed.

Injection Instructions

  1. To avoid tissue damage, choose a site for each injection that is at least 1/2 inch from the previous injection site. The usual sites of injection are abdomen, thighs, and arms.
  2. Cleanse the skin with alcohol where the injection is to be made.
  3. With one hand, stabilize the skin by spreading it or pinching up a large area.
  4. Insert the needle as instructed by your doctor.
  5. Push the plunger in as far as it will go.
  6. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
  7. Place the used needle in a puncture-resistant disposable container and properly dispose of the puncture-resistant container as directed by your Health Care Professional.

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Instructions For Insulin Vial Use

NEVER SHARE NEEDLES AND SYRINGES.

Correct Syringe Type

Doses of insulin are measured in units. U-100 insulin contains 100 units/mL (1 mL=1 cc). With Humulin N (insulin (human recombinant)) , it is important to use a syringe that is marked for U-100 insulin preparations. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high.

Syringe Use

To help avoid contamination and possible infection, follow these instructions exactly. Disposable syringes and needles should be used only once and then discarded by placing the used needle in a puncture-resistant disposable container. Properly dispose of the puncture­resistant container as directed by your Health Care Professional.

Preparing the Dose

  1. Wash your hands.
  2. Carefully shake or rotate the bottle of insulin several times to completely mix the insulin.
  3. Inspect the insulin. Humulin N (insulin (human recombinant)) suspension should look uniformly cloudy or milky. Do not use Humulin N (insulin (human recombinant)) if you notice anything unusual in its appearance.
  4. If using a new Humulin N (insulin (human recombinant)) bottle, flip off the plastic protective cap, but do not remove the stopper. Wipe the top of the bottle with an alcohol swab.
  5. If you are mixing insulins, refer to the “Mixing Humulin N (insulin (human recombinant)) and Regular Human Insulin” section below.
  6. Draw an amount of air into the syringe that is equal to the Humulin N (insulin (human recombinant)) dose. Put the needle through rubber top of the Humulin N (insulin (human recombinant)) bottle and inject the air into the bottle.
  7. Turn the Humulin N (insulin (human recombinant)) bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently.
  8. Making sure the tip of the needle is in the Humulin N (insulin (human recombinant)) suspension, withdraw the correct dose of Humulin N (insulin (human recombinant)) into the syringe.
  9. Before removing the needle from the Humulin N (insulin (human recombinant)) bottle, check the syringe for air bubbles.
  10. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
  11. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
  12. If you do not need to mix your Humulin N (insulin (human recombinant)) with Regular human insulin, go to the “Injection Instructions” section below and follow the directions.

Mixing Humulin N (insulin (human recombinant)) and Regular Human Insulin (Humulin R)

  1. Humulin N (insulin (human recombinant)) should be mixed with Humulin R only on the advice of your doctor.
  2. Draw an amount of air into the syringe that is equal to the amount of Humulin N you are taking. Insert the needle into the Humulin N (insulin (human recombinant)) bottle and inject the air. Withdraw the needle.
  3. Draw an amount of air into the syringe that is equal to the amount of Humulin R you are taking. Insert the needle into the Humulin R bottle and inject the air, but do not withdraw the needle.
  4. Turn the Humulin R bottle and syringe upside down.
  5. Making sure the tip of the needle is in the Humulin R solution, withdraw the correct dose of Humulin R into the syringe.
  6. Before removing the needle from the Humulin R bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
  7. Remove the syringe with the needle from the Humulin R bottle and insert it into the Humulin N (insulin (human recombinant)) bottle. Turn the Humulin N (insulin (human recombinant)) bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the Humulin N (insulin (human recombinant)) , withdraw the correct dose of Humulin N (insulin (human recombinant)) .
  8. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
  9. Follow the directions under “Injection Instructions” section below.

Follow your doctor's instructions on whether to mix your insulins ahead of time or just before giving your injection. It is important to be consistent in your method.

Syringes from different manufacturers may vary in the amount of space between the bottom line and the needle. Because of this, do not change:

  • the sequence of mixing, or
  • the model and brand of syringe or needle that your doctor has prescribed.

Injection Instructions

  1. To avoid tissue damage, choose a site for each injection that is at least 1/2 inch from the previous injection site. The usual sites of injection are abdomen, thighs, and arms.
  2. Cleanse the skin with alcohol where the injection is to be made.
  3. With one hand, stabilize the skin by spreading it or pinching up a large area.
  4. Insert the needle as instructed by your doctor.
  5. Push the plunger in as far as it will go.
  6. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
  7. Place the used needle in a puncture-resistant disposable container and properly dispose of the puncture-resistant container as directed by your Health Care Professional.

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Humulin N Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

INSULIN HUMAN ISOPHANE SUSPENSION - INJECTION

(IN-sue-lin HYOO-muhn EYE-sew-fane)

USES: This man-made insulin product is the same as human insulin. It is used along with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, circulation problems, blindness, and sexual function problems.

Human isophane insulin is an intermediate-acting insulin. It starts to work more slowly but lasts longer than regular insulin. Isophane insulin is often used in combination with a shorter-acting insulin. In some people with diabetes, insulin may be used alone or with other diabetes drugs (e.g., sulfonylureas like glyburide).

People with diabetes do not make enough insulin for their body to properly use the sugar in food. Eating a balanced diet, exercising regularly, and using your insulin as directed can help you live an active and healthy life.

HOW TO USE: Read the Patient Information Leaflet before you start using this insulin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This insulin must be injected. Learn all preparation and usage instructions, including how to measure the correct dose, how to inject this medication properly, and how to self-manage your diabetes (e.g., monitoring blood sugar, recognizing and treating high/low blood sugar). Your health care professional will teach you how to use this medication. If you have any questions, consult your doctor, diabetes educator, or pharmacist.

Wash your hands before measuring and injecting insulin. Before using, warm this drug to room temperature if it has been refrigerated. Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature. The length of time you can store it at room temperature depends on the product. Consult your pharmacist. (See also Storage section.)

Gently roll the vial or cartridge, turning it upside down and back to mix the medication. Do not shake the container. Check the product visually for clumps or discoloration. If either is present, do not use the insulin. Isophane insulin should look evenly cloudy/milky after mixing. Do not use if you see clumps of white material, a "frosty" appearance, or particles stuck to the sides of the vial or cartridge.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to prevent problem areas under the skin (lipodystrophy). Do not reuse the site for 2 weeks. Inject the medication quickly over 2-4 seconds under the skin of the thigh, abdomen, buttock, or back of the upper arm. If you inject too slowly (more than 5 seconds), the tip of the needle may become clogged and you may not get the correct dose. Do not inject into a vein. After pulling out the needle, apply gentle pressure on the injection site. Do not rub the area.

The dosage is based on your medical condition and response to therapy. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar levels.

Use this medication regularly as directed by your doctor to get the most benefit from it. Carefully follow the insulin treatment plan, meal plan, and exercise program your doctor has recommended. Check your urine/blood sugar as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.

This product may be mixed with regular insulin only. Always draw the regular insulin into the syringe first, then follow with the isophane insulin. Consult your pharmacist about which products may be mixed and about the proper method for mixing insulin. Never inject a mixture of different insulins into a vein.

Do not change brands/types of insulin, syringes, or needles without directions on how to do so from your doctor. Do not reuse disposable needles and syringes. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Disclaimer

Humulin N Consumer (continued)

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, irritation) may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories or if you have taken too much insulin. The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, quickly raise your blood sugar level by eating a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist about what you should do if you miss a meal.

Too little insulin can cause symptoms of high blood sugar (hyperglycemia). Symptoms include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Humulin N (insulin (human recombinant)) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using insulin, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal/pituitary gland problems, infection (especially with diarrhea or vomiting), kidney disease, liver disease, nerve problems (e.g., diabetic neuropathy), thyroid problems.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medication or how often you test your blood sugar may be required.

Changes in your activity level may affect the amount of insulin you need. Tell your doctor if your insulin needs are changing. Check your blood sugar readings before and after exercise. You may need a snack beforehand.

If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you.

The elderly may be more sensitive to the effects of this drug, especially low blood sugar.

Children may be more sensitive to the effects of this drug, especially low blood sugar.

Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details.

This medication does not pass into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Disclaimer

Humulin N Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: repaglinide, rosiglitazone.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.

Beta-blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about the safe use of those products.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include headache, sweating, shakiness, increased hunger, vision changes, nervousness, tiredness, seizures, loss of consciousness.

NOTES: Do not share this medication, needles, or syringes with others.

It is recommended you attend a diabetes education program to understand diabetes and all the important aspects of its treatment, including meals/diet, exercise, personal hygiene, medications, and getting regular eye, foot, and medical exams.

Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to monitor for side effects and response to therapy.

Wear or carry identification stating that you have diabetes and are using this drug. (See Medical Alert section.)

MISSED DOSE: It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Discuss specific instructions with your doctor now in case you miss a dose of insulin in the future.

STORAGE: Insulin is usually stored in the refrigerator, but because different types of insulin have different storage requirements, it is important to learn and follow storage directions for your particular product. In general, store the unopened vial/cartridge/pen in the refrigerator between 36-46 degrees F (2-8 degrees C). Some devices for giving insulin should not be refrigerated. Consult your pharmacist about how to store your brand of insulin.

Once opened, the vial may be stored in the refrigerator or at room temperature below 86 degrees F (30 degrees C). Store in the carton to protect from light. Depending on your brand, discard the vial either 31 days or 42 days after opening. Check with your pharmacist regarding your specific brand. Check the labeling on the cartridge or pen for storage after opening and while in use. Most of these products are stored at room temperature for different lengths of time (e.g., 7-14 days). Do not freeze. Discard the insulin if it has been frozen or if it is past the expiration date.

Protect insulin from light, heat, and moisture. Keep all medicines away from children and pets.

Keep extra supplies of insulin, syringes, and needles on hand.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Humulin N Patient Information Including Side Effects

Brand Names: Humulin N, Humulin N Pen, Novolin N, Novolin N Innolet, Novolin N PenFill, Relion Novolin N

Generic Name: insulin isophane (Pronunciation: IN soo lin EYE soe fane)

What is insulin isophane (Humulin N)?

Insulin isophane 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. Insulin isophane is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin isophane is used to treat diabetes.

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

What are the possible side effects of insulin isophane?

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 isophane. 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.

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

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.

Read the Humulin N (insulin (human recombinant)) Side Effects Center for a complete guide to possible side effects »

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

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 isophane 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.

Side Effects Centers

Humulin N Patient Information including How Should I Take

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

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 isophane, tell your doctor if you have liver or kidney disease.

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

Insulin isophane 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 B. This medication 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 insulin isophane 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 isophane?

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 isophane is given as an injection (shot) under your skin. 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.

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.

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.

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 isophane 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.

Unopened vials 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.

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

Side Effects Centers

Humulin N Patient Information including If I Miss a Dose

What happens if I miss a dose?

Since insulin isophane is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane to make up a missed dose.

It is important to keep insulin isophane 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 isophane?

Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin isophane.

What other drugs will affect insulin isophane?

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

Where can I get more information?

Your pharmacist can provide more information about insulin isophane.


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.

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: 6.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com