Novolin R

What is Novolin R?

Novolin R is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Description

NOVOLIN R (insulin human injection) is a short-acting human insulin. It is a polypeptide hormone structurally identical to regular human insulin and is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. NOVOLIN R has the empirical formula C257H383N65O77S6 and a molecular weight of 5808.

Figure 1: Structural formula of NOVOLIN R

NOVOLIN R for subcutaneous or intravenous use is a sterile, clear, aqueous, and colorless solution that contains insulin human 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc approximately 21 mcg/mL and water for injection. The pH is adjusted to 7.0 – 7.8. Hydrochloric acid 2N and sodium hydroxide 2N are added to adjust pH.

Mechanism of Action

The primary activity of insulin, including NOVOLIN R is the regulation of glucose metabolism. Insulins lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

What is the most important information I should know about Novolin R?

Do not share your Novolin R FlexPen or syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Who should not use Novolin R?

Do not use Novolin R if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to human insulin or any of the ingredients in Novolin R. See the end of this Patient Information guide for a complete list of ingredients in Novolin R.

What should I tell my healthcare provider before using Novolin R?

Before using Novolin R, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems.
• take other medicines, especially ones 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.
• are pregnant or plan to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breastfeeding or plan to breastfeed. Novolin R may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using Novolin R.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

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

How should I use Novolin R?

• Read the detailed Instructions for Use that comes with your Novolin R.
• Use Novolin R exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Novolin R to use and when to use it.
• Use Novolin R about 30 minutes before eating a meal.
• Know the type, strength, and amount of insulin you use. Do not change the type or amount 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 insulin label each time you give your injection to make sure you are using the correct insulin.
• Inject Novolin R under the skin (subcutaneously) of your stomach area, buttocks, upper legs (thighs), or upper arms. Do not inject Novolin R into your vein (intravenously) or muscle (intramuscularly) or use in an insulin infusion pump. Novolin R may be given into your vein only by your healthcare provider.
  • Do not mix Novolin R with any other insulin except isophane insulin human suspension. If Novolin R is mixed with isophane insulin human suspension, Novolin R should be drawn into the syringe first. Inject immediately after mixing.
• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Keep Novolin R and all medicines out of the reach of children.

Your dose of Novolin R may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What should I avoid while using Novolin R?

While using Novolin R do not:

• drive or operate heavy machinery until you know how Novolin R affects you.
• drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Novolin R?

Novolin R may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include:
  • dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger.
  • Your healthcare provider may prescribe a glucagon emergency kit so that others can give you an injection if your blood sugar becomes too low (hypoglycemia) and you are unable to take sugar by mouth.
• severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
  • a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
• low potassium in your blood (hypokalemia).
• 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.

Get emergency medical help if you have:

• severe hypoglycemia needing hospitalization or emergency room care, and be sure to tell the hospital staff the units of Novolin R your healthcare provider has prescribed for you.
• 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 Novolin R include:

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

These are not all of the possible side effects of Novolin R. 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 Novolin R

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information 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 Patient Information leaflet summarizes the most important information about Novolin R. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Novolin R that is written for healthcare providers.

For more information about Novolin R, call 1-800-727-6500 or go to www.novonordisk-us.com.

How should I store Novolin R?

Novolin R vials:

• Do not freeze Novolin R. Do not use Novolin R if it has been frozen.
• Keep Novolin R away from heat or light.
• All unopened vials:
  • Store unopened Novolin R vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
  • Unopened vials should be thrown away after 42 days, if they are stored at room temperature below 77°F (25°C).
• After vials have been opened:
  • Opened Novolin R vials can be stored at room temperature below 77°F (25°C). Do not refrigerate.
  • Throw away all opened Novolin R vials after 42 days, even if they still have insulin left in them

Novolin R FlexRen:

• Do not freeze Novolin R. Do not use Novolin R if it has been frozen.
• Keep Novolin R away from heat and light.
• Until first use:
  • Store unused Novolin R FlexPen in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unused Novolin R FlexPen may be used until the expiration date printed on the label, if kept in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unused Novolin R FlexPen stored at room temperature should be thrown away after 28 days.
• In-use:
  • Store the Novolin R FlexPen you are currently using out of the refrigerator at room temperature below 86°F (30°C) for up to 28 days.
  • The Novolin R FlexPen you are using should be thrown away after 28 days, even if it still has insulin left in it.
  • Store the Novolin R FlexPen without the needle attached.

What are the ingredients in Novolin R?

Active ingredient: insulin human

Inactive ingredients: glycerol, metacresol, zinc, water for injection, hydrochloric acid and sodium hydroxide.

Label

PRINCIPAL DISPLAY PANEL – 10 ML VIAL RELION

PRINCIPAL DISPLAY PANEL – 3 ML FLEXPEN

• NDC 0169-3003-15 List 300315
• Novolin®R
• FlexPen®
• (insulin human injection)
• 100 units/mL (U-100)
• For Single Patient Use Only
• 5 x 3 mL Prefilled Pens
• For subcutaneous use only
• Recommended for use with NovoFine®, NovoFine®
• Plus or NovoTwist® disposable needles.
• Until first use: Keep in a cold place.
• Store at 2°C to 8°C (36°F to 46°F).
• Do not freeze.
• In-use: Keep at room temperature below
• 30°C (86°F) and discard after 28 days.
• Protect from light.
• Dispense in this sealed carton.

Rnovo nordisk®

SRC: NLM .