Humulin N

Humulin N is an over-the-counter medication used to control blood sugar levels in those with diabetes mellitus.

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Regular Insulin Human Injection Isophane Suspension (NPH)

Glycerin, metacresol, zinc, phenol, protamine sulfate, dibasic sodium phosphate, water, hydrochloric acid, sodium hydroxide

THIS HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY’S PANCREAS AND BECAUSE OF 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 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.

Humulin N may cause serious side effects, including:

• swelling of your hands and feet
• heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Humulin N may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Humulin N. Your healthcare provider should monitor you closely while you are taking TZDs with Humulin N. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath
  • swelling of your ankles or feet
  • sudden weight gain

Treatment with TZDs and Humulin N may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Other:

A. Hypoglycemia

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 Make sure you take this medication as prescribed by your doctor.
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
• palpitations
• tremor
• hunger
• restlessness
• tingling of the hands, feet, lips, or tongue
• lightheadedness
• inability to concentrate
• headache
• drowsiness
• sleep disturbance
• anxiety
• blurred vision
• slurred speech
• depressed mood
• irritability
• abnormal behavior
• unsteady movement
• personality changes

Signs of severe hypoglycemia include disorientation, unconsciousness, seizures, and death. Therefore, it is important that help be obtained immediately.

Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. You 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 by mouth or who are unconscious require an injection of glucagon or should be treated with injection (IV) 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.

B. Hyperglycemia 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.

C. Lipodystrophy (fat redistribution)

Rarely, taking insulin 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 the problem.

D. 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 cases, this condition may be caused by 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. This may cause a rash to form 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.

ADDITIONAL INFORMATION:

Information about diabetes may be obtained from your diabetes educator.

Dosage:

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 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 dose are:

• Illness
• Pregnancy
• Exercise
• Travel
• Medication
• Before you use Humulin N, tell your healthcare provider if you:
  • take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Humulin N.

A. Humulin N VIAL for injection:

DO NOT USE ANY OTHER INSULIN EXCEPT ON YOUR DOCTOR’S ADVICE AND 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 before withdrawing each dose. Before each injection the Humulin N bottle must be carefully shaken or rotated several times to completely mix the insulin. Humulin N suspension should look uniformly cloudy or milky after mixing. If not, repeat the above steps until contents are mixed. Do not use Humulin N:

• 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 suspension in your bottle or notice your insulin requirements changing, talk to your doctor.

Storage:

• Not in-use (unopened): Humulin N bottles not in-use should be stored in a refrigerator, but not in the freezer.
• In-use (opened): The Humulin N bottle you are currently using can be kept unrefrigerated as long as it is kept as cool as possible [below 86°F (30°C)] away from heat and light.
• Do not use Humulin N after the expiration date stamped on the label or if it has been frozen.

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, 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 puncture-resistant container as directed by your healthcare provider.

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 suspension should look uniformly cloudy or milky. Do not use Humulin N if you notice anything unusual in its appearance.
4. If using a new Humulin N 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 and Regular Human Insulin” section below.
6. Draw an amount of air into the syringe that is equal to the Humulin N dose. Put the needle through rubber top of the Humulin N bottle and inject the air into the bottle.
7. Turn the Humulin N 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 suspension, withdraw the correct dose of Humulin N into the syringe.
9. Before removing the needle from the Humulin N 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.
10. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
11. If you do not need to mix your Humulin N with Regular human insulin, go to the “Injection Instructions” section below and follow the directions.

Mixing Humulin N and Regular Human Insulin (Humulin R):

1. Humulin N 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 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 bottle. Turn the Humulin N 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, withdraw the correct dose of Humulin N.
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 healthcare provider.

B. Humulin N PEN for injection:

DO NOT USE ANY OTHER INSULIN EXCEPT ON YOUR DOCTOR’S ADVICE AND DIRECTION.

The Humulin N Pen is available in boxes of 5 prefilled insulin delivery devices (“insulin Pens”). The Humulin N Pen is not designed to allow any other insulin to be mixed in its cartridge, or for the cartridge to be removed.

Always check the carton and the Pen 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 Humulin N suspension in your insulin Pen before using. A cartridge of Humulin N contains a small glass bead to assist in mixing. Roll the Pen back and forth between the palms 10 times (see Figure 1). Gently turn the Pen up and down 10 times until the insulin is evenly mixed.

If not evenly mixed, repeat the above steps until contents are mixed. Pens containing Humulin N suspension should be examined frequently.

Do not use Humulin N:

• if the insulin substance (the white material) remains visibly separated from the liquid after mixing or
• if there are clumps in the insulin after mixing, or
• if solid white particles stick to the walls of the cartridge, giving a frosted appearance.

If you see anything unusual in the appearance of the Humulin N suspension in your Pen or notice your insulin requirements changing, talk to your doctor.

Never attempt to remove the cartridge from the Humulin N Pen. Inspect the cartridge through the clear cartridge holder.

Storage

• Not in-use (unopened): Humulin N Pens not in-use should be stored in a refrigerator, but not in the freezer.
• In-use (opened): Humulin N Pens in-use should NOT be refrigerated but should be kept at room temperature [below 86°F (30°C)] away from direct heat and light. The Humulin N Pen you are currently using must be discarded 2 weeks after the first use, even if it still contains Humulin N.
• Do not use Humulin N after the expiration date stamped on the label or if it has been frozen.

Instructions for Humulin N Pen Use:

It is important to read, understand, and follow the instructions in the Insulin Delivery Device User Manual before using. Failure to follow instructions may result in getting too much or too little insulin. The needle must be changed and the Pen must be primed to a stream of insulin (not just a few drops) before each injection to make sure the Pen is ready to dose. You may need to prime a new Pen up to six times before a stream of insulin appears. Performing these steps before each injection is important to confirm that insulin comes out when you push the injection button, and to remove air that may collect in the insulin cartridge during normal use.

Every time you inject:

• Use a new needle.
• Prime to a stream of insulin (not just a few drops) to make sure the Pen is ready to dose.
• Make sure you got your full dose.

NEVER SHARE INSULIN PENS, CARTRIDGES, OR NEEDLES.

Preparing the Injection:

1. Wash your hands.
2. 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.
3. Follow the instructions in your Insulin Delivery Device User Manual to prepare for injection.
4. After injecting the dose, pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
5. After the injection, remove the needle from the Humulin N Pen. Do not reuse needles.
6. Place the used needle in a puncture-resistant disposable container and properly dispose of the puncture-resistant container as directed by your healthcare provider.

see "Directions" above

Humulin N Vial

A 10 mL vial contains a total 1000 units of Humulin N (with a concentration of 100 units/mL).

Humulin N Pen

A 3mL pen contains a total of 300 units of Humulin N (with a concentration of 100 units/mL).