"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
(NO-voe-lin) (Regular, Human Insulin Injection [recombinant DNA origin] DSP) solution for subcutaneous injection
Read the Patient Information leaflet that comes with Novolin R before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or your treatment. Make sure you know how to manage your diabetes. Ask your healthcare provider if you have any questions about managing your diabetes.
What is Novolin R?
Who should not use Novolin R?
Do not take Novolin R if:
- Your blood sugar is too low (hypoglycemia). After treating your low blood sugar, follow your healthcare provider's instructions on the use of Novolin R.
- You are allergic to any of the ingredients in Novolin R. See the end of this leaflet for a complete list of ingredients in Novolin R. Check with your healthcare provider if you are not sure.
What should I tell my healthcare provider before taking Novolin R?
Before you take Novolin R, tell your healthcare providers if you:
- have liver or kidney problems.
- have any other medical conditions. Medical conditions can affect your insulin needs and your dose of Novolin R.
- are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant.
- are breast-feeding or plan to breast-feed. It is not known if Novolin R passes into breast milk. You and your healthcare provider should decide if you will take Novolin R while you breast-feed.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Novolin R may affect the way other medicines work, and other medicines may affect how Novolin R works.
Know the medicines you take. Keep a list of your medicines with you to show all your healthcare providers and pharmacist when you get a new medicine.
How should I take Novolin R?
- Novolin R comes in 10 mL vials for use with a syringe.
- Take Novolin R exactly as prescribed.
- Your healthcare provider will tell you how much Novolin R to take and when to take it.
- Do not make any changes to your dose or type of insulin unless you are told to do so by your healthcare provider.
- The effects of Novolin R usually start working within about 30 minutes after your injection and usually lasts for up to 8 hours.
- While using Novolin R your healthcare provider may change your total dose of insulin, your dose of Novolin R, your dose of longer-acting insulin, or the number of injections of insulin you use.
- Do not mix Novolin R with any insulins other than NPH in the same syringe.
- Inject Novolin R under your skin (subcutaneously) of your abdomen (stomach area), upper arms, buttocks or upper legs. Novolin R may affect your blood sugar levels faster if you inject it into the skin of your abdomen (stomach area). Never inject Novolin R into a vein or into a muscle.
- Do not use Novolin R in an insulin pump.
- Change (rotate) your injection site within the chosen area (for example, stomach or upper arm) with each dose. Do not inject into the same spot for each injection.
- Read the instructions for use that comes with your Novolin R. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject Novolin R before you start taking it.
- If you take too much Novolin R, your blood sugar may fall too low (hypoglycemia). You can treat mild low blood sugar (hypoglycemia) by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar (hypoglycemia) right away because it could get worse and could lead to passing out (loss of consciousness), seizures and death.
- If you forget to take your dose of Novolin R, your blood sugar may go too high (hyperglycemia). If high blood sugar (hyperglycemia) is not treated it can lead to serious problems, like loss of consciousness (passing out), coma or even death. Follow your healthcare provider's instructions for treating high blood sugar. Know your symptoms of high blood sugar which may include:
- Do not share needles or syringes with others. You may give an infection to them or get an infection from them.
- Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and how often you should check your blood sugar levels for hypoglycemia (too low blood sugar) and hyperglycemia (too high blood sugar).
Your insulin dosage may need to change because of:
See the end of this patient information for instructions about preparing and giving the injection.
What should I avoid while taking Novolin R?
- Drinking alcohol. Alcohol may affect your blood sugar when you take Novolin R. This could lead to blood sugar that is too low (hypoglycemia).
- Driving and operating machinery. You may have trouble paying attention
or reacting if you have low blood sugar (hypoglycemia). Be careful when you
drive a car or operate machinery. Ask your healthcare provider if it is alright
for you to drive if you often have:
- low blood sugar
- decreased or no warning signs of low blood sugar
What are the possible side effects of Novolin R?
Novolin R may cause serious side effects, including:
- Low blood sugar (hypoglycemia).
The general symptoms of low blood sugar (hypoglycemia) may be one or more of the following:
Very low blood sugar (hypoglycemia) can cause loss of consciousness (passing out), seizures, temporary or permanent brain problems or death.
Talk to your healthcare provider about how to tell if you have low blood sugar and what to do if this happens while taking Novolin R. Know your symptoms of low blood sugar. Follow your healthcare provider's instructions for treating low blood sugar.
Talk to your healthcare provider if low blood sugar is a problem for you. Your dose of Novolin R may need to be changed.
- Low blood potassium (hypokalemia). A decrease of potassium in your blood can cause breathing problems, a change in your heartbeat and death.
- Serious allergic reaction (whole body reaction). You can have a serious
allergic reaction that may be life-threatening. Get medical help right away
if you have any of these symptoms of an allergic reaction:
- a rash over your body
- have trouble breathing
- a fast heartbeat
- feel faint
Other side effects of Novolin R may include:
- Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions, or they are serious, talk to your healthcare provider. You may need to stop using Novolin R and use a different insulin. Do not inject insulin into skin that is red, swollen, or itchy.
- Changes at the injection site (lipodystrophy). The fatty tissue under the skin may shrink (lipoatrophy) or thicken (lipohypertrophy) at the injection site. Change (rotate) the site where you inject your insulin to help reduce the chance of developing these skin changes. Do not inject insulin into this type of skin.
- Weight gain.
- Swelling of your arms and legs.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects from Novolin R. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Novolin R? Unopened Novolin R:
- Unopened Novolin R should be kept in the refrigerator between 36°F to 46°F (2° to 8°C). Unopened vials can be used until the expiration date on the Novolin R label, if the medicine has been stored in a refrigerator.
- If refrigeration is not possible or if you want to carry a spare Novolin R vial you can keep the unopened vial at room temperature for up to 42 days, as long as it is kept at or below 77°F (25°C). Throw away the vial 42 days after it is first kept out of the refrigerator, even if the vial is unopened.
- Do not freeze. Do not use Novolin R if it has been frozen.
- Keep unopened Novolin R in the carton to protect it from light.
Novolin R in use:
- Keep at room temperature below 77°F (25°C).
- Keep vials away from heat or light.
- Do not refrigerate an opened vial.
- Throw away the vial 42 days after it is first kept out of the refrigerator, even if there is insulin left in the vial.
Never use insulin after the expiration date which is printed on the label and carton.
General information about Novolin R
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Novolin R for a condition for which it was not prescribed. Do not give Novolin R to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Novolin R. If you would like more information about Novolin R or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Novolin R that is written for healthcare professionals.
For more information about Novolin R, call 1-800-727-6500 or go to www.novonordisk-us.com.
What are the ingredients in Novolin R?
Active ingredient: Regular Human Insulin Injection (recombinant DNA origin) USP.
Inactive ingredients: glycerol, metacresol, zinc chloride, water for injection, hydrochloric acid and sodium hydroxide may be added.
All Novolin R vials are latex-free.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Patient Instructions for Use
Novolin® R 10 mL vial (100 Units/mL, U-100)
Please read the following Instructions for Use carefully before using your Novolin® R 10 mL vial and each time you get a refill. You should read the instructions in this manual even if you have used an insulin 10 mL vial before. There may be new information.
Before starting, gather all of the supplies that you will need to use for preparing and giving your insulin injection.
Never re-use syringes and needles.
How should I use the Novolin R vial?
1. Check to make sure that you have the correct type of insulin. This is especially important if you use different types of insulin.
2. Look at the vial and the insulin. The insulin should be clear and colorless. The tamper-resistant cap should be in place before the first use. If the cap had been removed before your first use of the vial, or if the insulin is cloudy, colored, or contains any particles, do not use it and call Novo Nordisk at 1-800-727-6500.
3. Wash your hands with soap and water. Clean your injection site with an alcohol swab and let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.
4. If you are using a new vial, pull off the tamper-resistant
Wipe the rubber stopper with an alcohol swab.
5. Do not roll or shake the vial. Shaking right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin.
6. Pull back the plunger on the syringe until the black tip reaches the marking for the number of units you will inject.
7. Push the needle through the rubber stopper of the vial.
8. Push the plunger all the way in to force air into the vial.
9. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose.
10. If there are any air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles present in the syringe back into the vial.
11. Check to make sure you have the right dose of Novolin R in the syringe.
12. Pull the syringe out of the vial's rubber stopper.
13. Your healthcare provider should tell you if you need to pinch the skin before and while inserting the needle. This can vary from patient to patient so it is important to ask your healthcare provider if you did not receive instructions on pinching the skin. Insert the needle into the skin. Press the plunger of the syringe to inject the insulin. When you are finished injecting the insulin, pull the needle out of your skin. You may see a drop of Novolin R at the needle tip. This is normal and has no effect on the dose you just received. 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 wipe. Do not rub the area.
14. After your injection, do not recap the needle. Place used syringes, needles and used insulin vials in a disposable puncture-resistant sharps container, or some type of hard plastic or metal container with a screw on cap such as a detergent bottle or coffee can.
15. Ask your healthcare provider about the right way to throw away used syringes and needles. There may be state or local laws about the right way to throw away used syringes and needles. Do not throw away used needles and syringes in household trash or recycle.
How should I mix Novolin R with NPH insulin?
Different insulins should be mixed only under instruction from a healthcare provider. Do not mix Novolin R with any other type of insulin except NPH insulin. Novolin R should be mixed with NPH insulin right before use. When you are mixing Novolin R insulin with NPH insulin, always draw the Novolin R (clear) insulin into the syringe first.
1. Add together the total number of units of NPH and Novolin R that you need to inject. Your total dose of medicine to inject will be the amount of NPH and Novolin R in the syringe after drawing up both insulins. For example, if you need 5 units of NPH and 2 units of Novolin R, the total dose of insulin in the syringe would be 7 units.
Preparing your NPH and Novolin R insulins for injection:
2. Roll the NPH vial between your hands until all of the liquid in the vial is cloudy.
3. Pull the plunger of the syringe down so that the dark end is lined up to the number of units needed for your NPH insulin. This will draw into the syringe the same amount of air as the NPH dose needed.
4. Put the needle through the rubber stopper of the cloudy NPH insulin bottle. After you inject the air into the NPH vial, remove the needle from the vial but do not withdraw any of the NPH insulin. Putting air in the bottle makes it easier to draw the insulin out of the bottle.
5. Pull the plunger of the syringe down to the number of units needed for your Novolin R insulin. After you draw the air into the syringe, inject the air into the Novolin R vial.
Drawing up and mixing your NPH and Novolin R insulins for injection:
6. With the needle in place, turn the clear insulin vial of Novolin R upside down and slowly pull the plunger back to a few units beyond the right dose of Novolin R. The tip of the needle must be in the Novolin R liquid to get the full dose and not an air dose.
7. Check the syringe for air bubbles. If you see air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles in the syringe back into the vial.
8. After withdrawing the needle from the Novolin R vial, insert the needle into the NPH vial.
9. Turn the NPH vial upside down with the syringe and needle still in the vial. Slowly pull the plunger back to withdraw your NPH dose.
Remember the total dose of medicine in the syringe should be your total dose of NPH and Novolin R insulins. (See Step 1 under "How should I mix Novolin R with NPH insulin?")
10. Inject your insulin right away otherwise it might not work properly.
This Patient Instructions for Use has been approved by the Food and Drug Administration.
Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Novolin R Information
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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