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Humulin N

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Humulin N

Humulin N

PATIENT INFORMATION

HUMULIN®
(HU-mu-lin) N (human insulin [rDNA origin] isophane) Suspension

What is HUMULIN N?

Who should not use HUMULIN N?

Do not use HUMULIN N if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • have an allergy to HUMULIN N or any of the ingredients in HUMULIN N.

Before using HUMULIN N, tell your healthcare provider about all your medical conditions including, if you:

  • have liver or kidney problems.
  • 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.
  • are pregnant, planning to become pregnant, or are breastfeeding.
  • are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start using HUMULIN N, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use HUMULIN N?

  • Read the Instructions for Use that come with your HUMULIN N.
  • Use HUMULIN N exactly as your healthcare provider tells you to.
  • Know the type and strength of insulin you use. Do not change the type of insulin you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you use different types of insulin.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Your HUMULIN N dose may need to change because of:

  • change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet.

What should I avoid while using HUMULIN N?

While using HUMULIN N do not:

  • Drive or operate heavy machinery, until you know how HUMULIN N affects you.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of HUMULIN N?

HUMULIN N may cause serious side effects that can lead to death, including:

  • low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
    • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger.
  • serious allergic reaction (whole body reaction). Get medical help right away, if you have any of these symptoms of an allergic reaction:
    • a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
  • low potassium in your blood (hypokalemia).
  • 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.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of HUMULIN N include:

  • low blood sugar (hypoglycemia), allergic reactions including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, weight gain, and swelling of your hands and feet.

These are not all the possible side effects of HUMULIN N. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of HUMULIN N:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about HUMULIN N that is written for health professionals. Do not use HUMULIN N for a condition for which it was not prescribed. Do not give HUMULIN N to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in HUMULIN N?

Active Ingredient: insulin human (rDNA origin)

Inactive Ingredients: protamine sulfate, glycerin, dibasic sodium phosphate, metacresol, phenol, zinc oxide, water for injection, hydrochloric acid or sodium hydroxide For more information, call 1-800-545-5979 or go to www.humulin.com.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: Month DD, YYYY

Instructions for Use

HUMULIN®
(HU-mu-lin) N (human insulin [rDNA origin] isophane suspension) vial (100 Units/mL, U-100)

Read the Instructions for Use before you start taking HUMULIN N and each time you get a new HUMULIN N vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your syringes or needles with anyone else. You may give an infection to them or get an infection from them.

Supplies needed to give your injection:

  • a HUMULIN N vial
  • a U-100 insulin syringe and needle
  • 2 alcohol swabs
  • 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

Supplies needed -  Illustration

Preparing your HUMULIN N dose:

  • Wash your hands with soap and water.
  • Check the HUMULIN N label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
  • Do not use HUMULIN N past the expiration date printed on the label or 31 days after you first use it.
  • Always use a new needle for each injection to help ensure sterility and prevent blocked needles.

Step 1: Gently roll the vial between the palms of your hands at least 10 times.

Gently roll the vial - Illustration

Step 2: Invert the vial at least 10 times.

Do not shake.

Mixing is important to make sure you get the right dose. Humulin N should look white and cloudy after mixing. Do not use it if it looks clear or contains any lumps or particles.

Invert the vial - Illustration

Step 3: If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper.

Pull off the plastic Protective Cap - Illustration

Step 4: Wipe the Rubber Stopper with an alcohol swab.

Wipe the Rubber Stopper - Illustration

Step 5: Hold the syringe with the needle pointing up. Pull down on the Plunger until the tip of the Plunger reaches the line for the number of units for your prescribed dose. (Example Dose: 20 units shown)

Hold the syringe with the needle pointing up - Illustration

Step 6: Push the needle through the Rubber Stopper of the vial.

Push the needle through the Rubber Stopper - Illustration

Step 7: Push the plunger all the way in. This puts air into the vial.

Push the plunger - Illustration

Step 8: Turn the vial and syringe upside down and slowly pull the Plunger down until the tip is a few units past the line for your prescribed dose. (Example Dose: 20 units Plunger is shown at 24 units)

Turn the vial and syringe upside down - Illustration

If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top.

tap the syringe gently - Illustration

Step 9: Slowly push the Plunger up until the tip reaches the line for your prescribed dose.

Check the syringe to make sure that you have the right dose. (Example Dose: 20 units shown)

Slowly push the Plunger up - Illustration

Step 10: Pull the syringe out of the vial's Rubber Stopper.

Pull the syringe out - Illustration

Giving your HUMULIN N injection:

  • Inject your insulin exactly as your healthcare provider has shown you.
  • Change (rotate) your injection site for each injection.

Step 11: Choose your injection site.

HUMULIN N is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms.

Wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose.

Choose your injection site - Illustration

Step 12: Insert the needle into your skin.

Insert the needle into your skin - Illustration

Step 13: Push down on the Plunger to inject your dose.

The needle should stay in your skin for at least 5 seconds to make sure you have injected all of your insulin dose.

Push down on the Plunger - Illustration

Step 14: Pull the needle out of your skin.

  • If you see blood after you take the needle out of your skin, press the injection site with a piece of gauze or an alcohol swab. Do not rub the area.
  • Do not recap the needle. Recapping the needle can lead to a needle stick injury.

Pull the needle out - Illustration

Disposing of used needles and syringes:

  • Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
  • Do not recycle the container.

How should I store HUMULIN N?

All unopened HUMULIN N vials:

  • Store all unopened vials in the refrigerator.
  • Do not freeze. Do not use if it has been frozen.
  • Keep away from heat and out of direct light.
  • Unopened vials can be used until the expiration date on the carton and label, if they have been stored in the refrigerator.
  • Unopened vials should be thrown away after 31 days, if they are stored at room temperature.

After HUMULIN N vials have been opened:

  • Store opened vials in the refrigerator or at room temperature below 86°F (30°C) for up to 31 days.
  • Keep away from heat and out of direct light.
  • Throw away all opened vials after 31 days of use, even if there is still insulin left in the vial.

General information about the safe and effective use of HUMULIN N.

Keep HUMULIN N vials, syringes, needles, and all medicines out of the reach of children.

If you have any questions or problems with your HUMULIN, contact Lilly at 1-800Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULIN and insulin, go to www.humulin.com.

Scan this code to launch the humulin.com website

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Instructions for Use

HUMULIN® N KwikPen
(human insulin [rDNA origin] isophane suspension)

HUMULIN® N KwikPen - Illustration

Read the Instructions for Use before you start taking HUMULIN N and each time you get another HUMULIN® N KwikPen™. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

HUMULIN N KwikPen (“Pen”) is a disposable pen containing 3 mL (300 units) of U100 HUMULIN® N (human insulin isophane suspension [rDNA origin]) insulin. You can inject from 1 to 60 units in a single injection.

HUMULIN N KwikPen has a blue and light green Label with a matching light green Dose Knob (See the KwikPen Parts diagram below).

Do not share your HUMULIN N KwikPen or needles with another person. You may give an infection to them or get an infection from them.

This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

KwikPen Parts

KwikPen Parts - Illustration

Supplies you will need to give your HUMULIN N injection:

  • HUMULIN N KwikPen
  • KwikPen compatible Needle (Becton, Dickinson and Company Pen Needles recommended)
  • alcohol swab

Preparing HUMULIN N KwikPen:

  • Wash your hands with soap and water.
  • Check the HUMULIN N KwikPen Label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
  • Do not use HUMULIN N past the expiration date printed on the Label or 14 days after you start using the Pen.
  • Always use a new needle for each injection to help ensure sterility and prevent blocked needles.

Step 1:

  • Pull the Pen Cap straight off.
  • Wipe the Rubber Seal with an alcohol swab.
    • Do not twist the cap.
    • Do not remove the HUMULIN N KwikPen Label.
    • Do not attach the Needle before mixing.

Pull the Pen Cap straight off - Illustration

Step 2:

  • Gently roll the Pen between your hands 10 times.

Gently roll the Pen between your hands 10 times - Illustration

Step 3:

  • Move the Pen up and down (invert) the Pen 10 times.

Mixing by rolling and inverting the Pen is important to make sure you get the right dose.

Move the Pen up and down - Illustration

Step 4:

  • Check the liquid in the Pen. HUMULIN N should look white and cloudy after mixing. Do not use if it looks clear or has any lumps or particles in it.

Step 5:

  • Select a new Needle.
  • Pull off the Paper Tab from the Outer Needle Shield.

Pull off the Paper Tab - Illustration

Step 6:

  • Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.

Twist the Needle on -  Illustration

Step 7:

  • Pull off the Outer Needle Shield. Do not throw it away.
  • Pull off the Inner Needle Shield and throw it away.

Pull off the Outer Needle Shield - Illustration

Priming the HUMULIN N KwikPen:

Prime the HUMULIN N KwikPen before each injection. Priming ensures the Pen is ready to dose and removes air that may collect in the cartridge during normal use. If you do not prime before each injection, you may get too much or too little insulin.

Step 8:

  • Turn the Dose Knob to select 2 units.

Turn the Dose Knob - Illustration

Step 9:

  • Hold the Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.

Hold the Pen with the Needle pointing up - Illustration

Step 10:

  • Hold the Pen with Needle pointing up. Push the Dose Knob in until it stops, and “0” is seen in the Dose Window.
  • Hold the Dose Knob in and count to 5 slowly.
    A stream of insulin should be seen from the needle.
    • If you do not see a stream of insulin, repeat steps 8 to 10, no more than 4 times.
    • If you still do not see a stream of insulin, change the needle and repeat steps 8 to 10.

Hold the Dose Knob in and count to 5 slowly - Illustration

Selecting your dose:

Step 11:

  • Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.
    The dose can be corrected by turning the Dose Knob in either direction until the correct dose lines up with the Dose Indicator.
    • The even numbers are printed on the dial. (Example: 10 units shown)

Selecting your dose - Illustration

    • The odd numbers, after the number 1, are shown as full lines. (Example: 15 units shown)

Dose window - Illustration

  • The HUMULIN N KwikPen will not let you dial more than the number of units left in the Pen.
  • If your dose is more than the number of units left in the Pen, you may either:
    • inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or
    • get a new Pen and inject the full dose.
  • The Pen is designed to deliver a total of 300 units of insulin. The cartridge contains an additional small amount of insulin that cannot be delivered.

Giving your HUMULIN N injection:

  • Inject your HUMULIN N exactly as your healthcare provider has shown you.
  • Change (rotate) your injection site for each injection.
  • Do not try to change your dose while injecting HUMULIN N.

Step 12:

  • Choose your injection site.
    HUMULIN N is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.
  • Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose.

Choose your injection site - Illustration

Step 13:

  • Insert the Needle into your skin.

Insert the Needle into your skin - Illustration

Step 14:

  • Put your thumb on the Dose Knob and push the Dose Knob in until it stops.

Push the Dose Knob in - Illustration

  • Hold the Dose Knob in and slowly count to 5.

Slowly count to 5 - Illustration

Step 15:

  • Pull the Needle out of your skin.
    You should see “0” in the Dose Window. If you do not see “0” in the Dose Window, you did not receive your full dose.
    • If you see blood after you take the Needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
    • A drop of insulin at the needle tip is normal. It will not affect your dose.
    • If you do not think you received your full dose, do not take another dose. Call Lilly at 1-800-LillyRx (1-800-545-5979) or your healthcare provider for help.

Dose window - Illustration

Step 16:

  • Carefully replace the Outer Needle Shield.

Carefully replace the Outer Needle Shield - Illustration

Step 17:

  • Unscrew the capped Needle and throw it away.
  • Do not store the Pen with the Needle attached to prevent leaking, blocking of the Needle, and air from entering the Pen.

Unscrew the capped Needle - Illustration

Step 18:

  • Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

Replace the Pen Cap - Illustration

After your injection:

  • Put your used needles and pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and pens in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

How should I store my HUMULIN N KwikPen?

  • Store unused HUMULIN N KwikPens in the refrigerator at 36°F to 46°F (2°C to 8°C). The Pen you are currently using should be stored at room temperature, below 86°F (30°C).
  • Do not freeze HUMULIN N. Do not use HUMULIN N if it has been frozen.
  • Unused Pens may be used until the expiration date printed on the Label, if kept in the refrigerator.
  • The HUMULIN N Pen you are using should be thrown away after 14 days, even if it still has insulin left in it.
  • Keep HUMULIN N away from heat and out of the light.

General information about the safe and effective use of HUMULIN N KwikPen.

  • Keep HUMULIN N KwikPen and needles out of the reach of children.
  • Do not use the Pen if any part looks broken or damaged.
  • Always carry an extra Pen in case yours is lost or damaged.
  • If you cannot remove the Pen Cap, gently twist the Pen Cap back and forth, and then pull the Pen Cap straight off.
  • If it is hard to push the Dose Knob or the Pen is not working the right way:
    • Your Needle may be blocked. Put on a new Needle and prime the Pen.
    • You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new one.
    • It may help to push the Dose Knob more slowly during your injection.
  • Use the space below to keep track of how long you should use each HUMULIN N KwikPen.
    • Write down the date you start using your HUMULIN N KwikPen. Count forward 14 days.
    • Write down the date you should throw it away.

Example:

First used on _______ + 14 days = Throw out on ______

__________________Date_____________________ Date

Pen 1 -First used on _______ Throw out on _______

__________________Date_____________________ Date

Pen 2 -First used on _______ Throw out on _______

__________________Date_____________________ Date

Pen 3 -First used on _______ Throw out on _______

__________________Date_____________________ Date

Pen 4 -First used on _______ Throw out on _______

__________________Date_____________________ Date

Pen 5 -First used on _______ Throw out on _______

__________________Date_____________________ Date

If you have any questions or problems with your HUMULIN N KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULIN N KwikPen and insulin, go to www.lilly.com.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 1/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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Humulin N - User Reviews

Humulin N User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Humulin N sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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