"One in five elderly and "clinically complex" patients with type 2 diabetes may be receiving unnecessarily intensive glucose-lowering treatment, leading to a dramatically increased risk for severe hypoglycemia, a new study finds.
(Regular, Human Insulin Injection [recombinant DNA origin] USP) 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?
Novolin® R is a man-made insulin (recombinant DNA origin) that is used to control high blood sugar in adults and children with diabetes mellitus.
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.
- 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 Novolin® R.
- 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:
- increased thirst
- high amounts of sugar and ketones in your urine
- frequent urination and dehydration
- confusion or drowsiness
- nausea, vomiting (throwing up) or stomach pain
- loss of appetite
- a hard time breathing
- fruity smell on breath
- 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:
- change in diet
- change in physical activity or exercise
- other medicines you take
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:
- dizziness or lightheadedness
- fast heart beat
- blurred vision
- tingling in your hands, feet, lips or tongue
- slurred speech
- anxiety, irritability or mood changes
- trouble concentrating or confusion
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
- Swelling of your hands and feet.
- Heart Failure. Taking certain diabetes pills
called thiazolidinediones or “TZDs” with Novolin® R 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 Novolin® R. Your healthcare provider should monitor you closely
while you are taking TZDs with Novolin® R. 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 Novolin® R may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
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.
Last reviewed on RxList: 2/23/2016
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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