Novolin N PenFill Actions

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Actions of Novolin N PenFill in details

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Pharmacology: The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin is dependent on dose, site of injection, blood supply, temperature and physical activity.

Vial: Novolin N PenFill (NPH) contains isophane human insulin of recombinant DNA origin. It is an intermediate-acting preparation; onset of action is approximately 1 hr, with a duration of about 14 hrs and peak activity at 2-8 hrs.

Cartridge: Novolin N PenFill (NPH) is a sterile, crystalline suspension of human insulin with protamine and zinc, providing an intermediate-acting insulin with a slower onset of action and a longer duration of activity (up to 24 hrs) than that of regular insulin.

How should I take Novolin N PenFill?

This section provides information on the proper use of a number of products that contain insulin human isophane (nph). It may not be specific to Novolin N PenFill. Please read with care.

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin.

Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.

Each package of Humulin® N contains a patient information sheet. Read this sheet carefully before beginning your treatment and each time you refill for any new information, and make sure you understand:

The insulin solution should look cloudy all the way through after mixing. Do not use Humulin® N if it has any small particles in it.

Use a new needle for the prefilled pen each time you give yourself an injection. Always remove and throw the needle after each injection from the pen. Store it without a needle attached.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or ketones in your urine as directed.

Do not change the brand, type, or dose of your insulin unless your doctor tells you to. When you receive a new supply of insulin, check the label to be sure if it is the correct type of insulin.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store insulin containers that have not been opened in the refrigerator in the original carton until the expiration date. Do not freeze. Do not use the insulin if it has been frozen. You may also store the unopened prefilled pen at room temperature for 14 days, or the unopened vials at room temperature for up to 31 days.

Store the opened vial of insulin in the refrigerator for 31 days. Do not freeze. If you cannot keep your vial of insulin in the refrigerator, you may store it at room temperature in a cool place, away from direct heat and light, for only 31 days.

The prefilled pen you are currently using should not be refrigerated. You should store the pen at room temperature in a cool place away from direct heat and light, for only 14 days.

Novolin N PenFill administration

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Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Novolin N PenFill is given as an injection (shot) under your skin. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your Novolin N PenFill dose if needed. Do not change your dose without first talking to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic.

Storing unopened vials, cartridges, injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label.

Unopened vials may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days.

Storing after your first use: Keep the "in-use" vials, cartridges, or prefilled syringes at room temperature and use prior to the expiration date. Keep the in-use injection pen at room temperature and use it within 14 days. Do not refrigerate.

Do not freeze Novolin N PenFill, and throw away the medication if it has become frozen.

Novolin N PenFill pharmacology

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Mechanism Of Action

Novolin N PenFill lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

Pharmacodynamics

Novolin N PenFill is an intermediate-acting insulin with a slower onset of action and a longer duration of activity than that of regular human insulin. In a study in which healthy subjects (n=16) received subcutaneous injections of Novolin N PenFill (0.4 unit/kg) on 4 occasions, the median maximum effect occurred at 6.5 hours (range: 2.8 to 13 hours). In this study, insulin activity was measured by the rate of glucose infusions.

The time course of action of insulin, such as Novolin N PenFill may vary in different individuals or within the same individual. The parameters of Novolin N PenFill activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, physical activity level, and other variables.

Figure 1: Mean Insulin Activity Versus Time Profile After Subcutaneous Injection of Novolin N PenFill (0.4 unit/kg) in Healthy Subjects.

Pharmacokinetics

Absorption

In healthy subjects given subcutaneous doses of Novolin N PenFill (0.4 unit/kg), median peak serum concentration of insulin occurred at approximately 4 hours (range: 1 to 12 hours) after dosing.

Metabolism

The uptake and degradation of insulin occurs predominantly in liver, kidney, muscle, and adipocytes, with the liver being the major organ involved in the clearance of insulin.

Elimination

Because of the absorption-rate limited kinetics of insulin mixtures, a true half-life cannot be accurately estimated from the terminal slope of the concentration versus time curve. In healthy subjects given subcutaneous doses of Novolin N PenFill (0.4 unit/kg), the mean apparent half-life was approximately 4.4 hours (range: 1-84 hours).

Specific Populations

The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of Novolin N PenFill have not been studied. Careful glucose monitoring and dose adjustments of insulin, including Novolin N PenFill, may be necessary in patients with renal or hepatic dysfunction.



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Information checked by Dr. Sachin Kumar, MD Pharmacology

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