NovoLIN R

Name: NovoLIN R

Manufacturer

  • Novo Nordisk, Inc.

NovoLIN R Dosage

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your level of physical activity
  • your meal times and eating habits

What is regular insulin?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Regular insulin is a short-acting insulin that starts to work within 30 minutes after injection, peaks in 2 to 3 hours, and keeps working for up to 8 hours.

Regular insulin is used to improve blood sugar control in adults and children with diabetes mellitus. This medicine may be used for type 1 or type 2 diabetes.

Regular insulin may also be used for purposes not listed in this medication guide.

What should I avoid while using regular insulin?

Do not change the brand of insulin or syringe you are using without first talking to your doctor or pharmacist. Some brands of insulin and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

What other drugs will affect regular insulin?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

How is this medicine (Novolin R) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a muscle, vein, or into the fatty part of the skin.
  • Some brands of Novolin R must not be used in an insulin pump unless your doctor tells you to. If you will be using an insulin pump, check with your doctor or pharmacist to see if your brand may be used in a pump.
  • If you are using this medicine in a pump, be sure you know how to use it. Follow what your doctor has told you or read the package insert. Change the drug and parts of the pump when you have been told.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Take within 30 minutes of a meal.
  • Move the site where you give the shot with each shot.
  • Do not give into red or irritated skin.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • Do not use out dated insulin.
  • Do not draw into a syringe and store for future use.
  • Keep using Novolin R (insulin regular (U-100) vials) as you have been told by your doctor or other health care provider, even if you feel well.
  • Follow the diet and workout plan that your doctor told you about.
  • Be sure you know what to do if you do not eat as much as normal or if you skip a meal.

What do I do if I miss a dose?

  • Be sure you know what to do if you forget to take a dose
  • If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Anxiety.
  • Change in eyesight.
  • Chills.
  • Very bad dizziness or passing out.
  • Mood changes.
  • Seizures.
  • Slurred speech.
  • Very bad irritation where the shot was given.
  • A burning, numbness, or tingling feeling that is not normal.
  • Swelling in the arms or legs.
  • Change in skin to thick or thin where the shot was given.
  • Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.

Adverse Reactions

Adverse events commonly associated with human insulin therapy include the following:

Body as Whole - Allergic reactions (see PRECAUTIONS, Allergy).

Skin and Appendages - Injection site reaction, lipodystrophy, pruritus, rash (see PRECAUTIONS, Allergy).

Other - Hypoglycemia, Hyperglycemia and ketosis (see PRECAUTIONS).

Patient package insert

R Human

 Patient Information for Novolin® R

NOVOLIN® R (NO-voe-lin)

Regular,

Human Insulin Injection

(recombinant DNA origin) USP 100 units/mL

Important:

Know your insulin. Do not change the type of insulin you use unless told to do so by your healthcare provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.

Make sure that you know the type and strength of insulin that is prescribed for you.

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 structurally identical to the insulin produced by the human pancreas that is used to control high blood sugar in patients with diabetes mellitus.

Who should not use Novolin R?

Do not take Novolin R if:

  • Your blood sugar is too low (hypoglycemia).
  • You are allergic to anything 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.

Tell your healthcare provider:

  • about all of your medical conditions. Medical conditions can affect your insulin needs and your dose of Novolin  R.
  • if you are pregnant or breastfeeding. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant or breastfeeding. Novolin R has not been studied in pregnant or nursing women.
  • about all of the medicines you take, including prescription and   non-prescription medicines, vitamins and herbal supplements. Many medicines can affect your blood sugar levels and your insulin needs. Your Novolin R dose may need to change if you take other medicines.

 

 Know the medicines you take. Keep a list of your medicines with you to show all your healthcare providers when you get a new medicine.

How should I take Novolin R?

Only use Novolin R if it appears clear and colorless. There may be air bubbles. This is normal. If it looks cloudy, thickened, or colored, or if it contains solid particles do not use it, and call Novo Nordisk at 1-800-727-6500.

Novolin R comes in:

  • 10 mL vials (small bottles) for use with syringe

Read the instructions for use that come with your Novolin R product. 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. Follow your healthcare provider’s instructions to make changes to your insulin dose.

  • Take Novolin R exactly as prescribed.
  • Novolin R is a fast-acting insulin. The effects of Novolin R start working ½ hour after injection.
  • The greatest blood sugar lowering effect is between 2½ and 5 hours after the injection. This blood sugar lowering lasts for 8 hours.
  • While using Novolin R you may have to change your total dose of insulin, your dose of longer-acting  insulin, or the number of injections of longer-acting insulin you use.
  • Do not mix Novolin  R with any insulins other than NPH in the same syringe.
  • Inject Novolin R into the skin of your stomach area, upper arms, buttocks or upper legs. Novolin R may affect your blood sugar levels sooner if you inject it into the skin of your stomach area. Never inject Novolin R into a vein or into a muscle.
  • Due to risk of precipitation in some pump catheters, Novolin R is not recommended for use in insulin pumps.
  • 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.
  • If you take too much Novolin  R, your blood sugar may fall 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 you could pass out (become unconscious). If you pass out, you will need help from another person or emergency medical services right away, and will need treatment with a glucagon injection or treatment at a hospital. See “What are the possible side effects of Novolin  R?” for more information on low blood sugar (hypoglycemia).
  • 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 diabetic ketoacidosis, which 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 (hyperglycemia), and talk to your healthcare provider if high blood sugar is a problem for you. Severe or continuing high blood sugar (hyperglycemia) requires prompt evaluation and treatment by your healthcare provider. Know your symptoms of high blood sugar (hyperglycemia) and diabetic ketoacidosis which may include:
  • increased thirst
  • fruity smell on breath
  • frequent urination and dehydration
  • high amounts of sugar and ketones in your urine
  • confusion or drowsiness
  • nausea, vomiting (throwing up) or stomach pain
  • loss of appetite
  • a hard time breathing
  • Check your blood sugar levels. Ask your healthcare provider 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:

  • illness
  • change in diet
  • stress
  • change in physical activity or exercise
  • other medicines you take
  • surgery

See the end of this patient information for instructions about preparing and giving the injection.

What should I avoid while using Novolin R?

  • Alcohol. Alcohol, including beer and wine, may affect your blood sugar when you take Novolin R. 
  • Driving and operating machinery. You may have difficulty concentrating 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 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?

  • Low blood sugar (hypoglycemia). Symptoms of hypoglycemia (low blood sugar) may include:
  • sweating
  • trouble concentrating or confusion
  • dizziness or lightheadedness
  • blurred vision
  • shakiness
  • slurred speech
  • hunger
  • anxiety, irritability or mood changes
  • fast heart beat
  • headache
  • tingling of lips and tongue

Severe low blood sugar (hypoglycemia) can cause unconsciousness (passing out), seizures, and death. 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.

  • Serious allergic reaction (whole body reaction). Get medical help right away if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
  • 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.
  • Skin thickens or pits at the injection site (lipodystrophy). Change (rotate) where you inject your insulin to help prevent these skin changes from happening. Do not inject insulin into this type of skin.
  • Swelling of your hands and feet
  • Vision changes
  • Low potassium in your blood (hypokalemia)

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?

All Unopened Novolin R:

  • Keep all unopened Novolin R in the refrigerator between 36° to 46°F (2° to 8°C).
  • Do not freeze. Do not use Novolin R if it has been frozen.
  • If refrigeration is not possible, the unopened vial may be kept at room temperature for up to 6 weeks (42 days), as long as it is kept at or below 77°F (25°C).
  • Keep unopened Novolin R in the carton to protect from light.

Novolin R in use:

Vials

  • Keep at room temperature below 77°F (25°C) for up to 6 weeks (42 days).
  • Keep vials away from direct heat or light.
  • Throw away an opened vial after 6 weeks (42 days) of use, even if there is insulin left in the vial.
  • Unopened vials can be used until the expiration date on the Novolin R label, if the medicine has been stored in a refrigerator.

General advice about Novolin R

Novolin R is used for the treatment of diabetes only. 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. For more information, call 1-800-727-6500 or visit www.novonordisk-us.com.

Helpful information for people with diabetes is published by the American Diabetes Association, 1701 N Beauregard Street, Alexandria, VA 22311 and on www.diabetes.org.

Novolin R ingredients include:

  • Regular Human Insulin Injection (recombinant DNA origin) USP
  • Metacresol
  • Zinc chloride
  • Glycerol
  • Sodium hydroxide
  • Hydrochloric acid
  • Water for injections

All Novolin R vials are latex-free.

Date of issue: May 14, 2010

Version: 5

Novolin® and Novo Nordisk® are trademarks of Novo Nordisk A/S.

© 2005-2010 Novo Nordisk A/S

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

For information about Novolin R contact:

Novo Nordisk Inc.

100 College Road West

Princeton, New Jersey 08540

_______________________

Patient Instructions for Use

Novolin® R 10 mL vial (100 Units/mL, U-100)

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. If you clean your injection site with an alcohol swab, 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 cap. 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 froth. 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, and push the plunger all the way in to force air into the vial.
  8. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose.
  9. 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.
  10. Check to make sure you have the right dose of Novolin R in the syringe.
  11. Pull the syringe with needle out of the vial’s rubber stopper.
  12. Your doctor should tell you if you need to pinch the skin before inserting the needle.  This can vary from patient to patient so it is important to ask your doctor 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.
  13. 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.
  14. 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 besides NPH insulin. Novolin R should be mixed only when injections with syringes are used.  Insulin syringes may vary in the amount of space between the bottom line and the needle (“dead space”), so if you are mixing two types of insulin be sure to discuss any change in the model and brand of syringe you are using with your healthcare provider. Novolin R can 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 doses (total number of units) of NPH and Novolin R that you need to inject. The total dose will determine the final amount (volume) in the syringe after drawing up both insulins into the syringe. 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.
  2. Roll the NPH vial between your hands until the liquid is equally cloudy throughout.
  3. Draw into the syringe the same amount of air as the NPH dose. Inject this air into the NPH vial and then remove the needle from the vial but do not withdraw any of the NPH insulin. (Transferring NPH to the Novolin R vial will contaminate the Novolin R vial and may change how quickly it works.)
  4. Draw into the syringe the same amount of air as the Novolin R dose. Inject this air into the Novolin R vial. With  the needle in place, turn the vial upside down and withdraw the correct dose of Novolin R. The tip of the needle  must be in the Novolin R to get the full dose and not an air dose.
  5. After withdrawing the needle from the Novolin R vial, insert the needle into the NPH vial.   Turn the NPH vial upside down with the syringe and needle still in it. Withdraw the correct dose of NPH.
  6. Inject right away to avoid changes in how quickly the insulin works.

Novolin® and Novo Nordisk® are trademarks of Novo Nordisk A/S.

© 2005-2010 Novo Nordisk A/S

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

For information about Novolin R contact:

Novo Nordisk Inc.

100 College Road West

Princeton, New Jersey 08540

________________

For Healthcare Professionals

Applies to insulin regular: injectable solution, subcutaneous solution

Ocular

Frequency not reported: Transitory, reversible ophthalmologic refraction disorder, worsening diabetic neuropathy[Ref]

Transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy has been reported with insulin initiation and glucose control intensification. Over the long-term, improved glycemic control decreases the risk for diabetic neuropathy.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Lipodystrophy[Ref]

Long-term use of insulin can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissues).[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Local reactions such as redness, swelling, or itching at the injection site
Very rare (less than 0.01%): Anaphylactic reactions[Ref]

Hypersensitivity reactions have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks. In some instances these reactions have been caused by other factors such as irritants in a skin cleansing agent or poor injection technique. Localized reactions have been reported with metacresol, which is an excipient in many insulin products.

Generalized allergy to insulin may present as a whole body rash, dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.[Ref]

Immunologic

Increases in titers of anti-insulin antibodies that react with human insulin have been observed; some data indicates the increase is transient. The clinical significance of these antibodies is unknown; it does not appear to cause deterioration in glycemic control.[Ref]

Frequency not reported: Formation of anti-insulin antibodies[Ref]

Cardiovascular

Frequency not reported: Sodium retention and edema[Ref]

Insulin may cause sodium retention and edema, especially with intensified insulin therapy. Combination use with thiazolidinediones has resulted in fluid retention which has led to or exacerbated heart failure.[Ref]

General

Adverse reactions reported with this insulin include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, and edema[Ref]

Metabolic

Very common (10% or more): Hypoglycemia
Rare (less than 0.1%): Insulin resistance
Frequency not reported: Hypokalemia, hyperglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic non-ketotic syndrome, hypomagnesemia, hypophosphatemia[Ref]

Hypoglycemia is the most common adverse reaction of all insulin therapies. The timing of hypoglycemia generally reflects the time-action profile of the administered insulin, however, the time action profile of any insulin may vary considerably in different individuals or at different times in the same individual depending on dose, site of injection, blood supply, temperature, and physical activity. Other factors such as changes in food intake (timing of meals, amount or type of food) and concomitant medications will also affect the risk of hypoglycemia.

Hypokalemia, which is due to a shift in potassium from the extracellular to the intracellular space, occurs with all insulins. Hypokalemia and hypomagnesemia has been reported, particularly in patients treated for diabetic ketoacidosis (DKA). Insulin increases the intracellular transport of phosphate, which often results in hypophosphatemia during treatment of DKA. In situations in which not enough insulin is available to control blood glucose, hyperglycemia, diabetic ketoacidosis, and hyperosmolar hyperglycemic non-ketotic syndrome may occur.[Ref]

Local

Injection site reactions including pain, redness, hives, inflammation, bruising, swelling, and itching have occurred. These usually resolve in a few days to a few weeks; rotation of the injection site reduces the risk of these reactions developing.[Ref]

Common (1% to 10%): Injection site hypertrophy
Frequency not reported: Injection site reactions[Ref]

Nervous system

Frequency not reported: Acute painful peripheral neuropathy[Ref]

Acute painful peripheral neuropathy has been reported with insulin initiation and glucose control intensification. Over the long-term, improved glycemic control decreases the risk for neuropathy.[Ref]

Other

Weight gain can occur with insulin use; it is believed to be due to the anabolic effects of insulin and the decrease in glucosuria.[Ref]

Frequency not reported: Weight gain[Ref]

Some side effects of Novolin R may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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