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Humulin (Insulin Human Recombinant) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for human insulin production. Humulin R (U-500) consists of zinc-insulin crystals dissolved in a clear fluid. Humulin R (U-500) is a sterile solution and is for subcutaneous injection. It should not be used intravenously or intramuscularly. The concentration of Humulin R (U-500) is 500 units/mL.

Each milliliter contains 500 units of biosynthetic human insulin, 16 mg glycerin, 2.5 mg m -cresol as a preservative, and zinc-oxide calculated to supplement endogenous zinc to obtain a total zinc content of 0.017 mg/100 units. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.

DESCRIPTION

Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for human insulin production. Humulin R (U-500) consists of zinc-insulin crystals dissolved in a clear fluid. Humulin R (U-500) has had nothing added to change the speed or length of its action. It takes effect rapidly but has a relatively long duration of activity (up to 24 hours) as compared with other Regular insulins. 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 R (U-500) is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin R (U- 500), is a sterile solution and should only be administered subcutaneously. It should not be used intravenously or intramuscularly. The concentration of Humulin R (U-500) is 500 units/mL.

IDENTIFICATION

Human insulin manufactured by Eli Lilly and Company has the trademark Humulin and is available in 6 formulations--Regular (R), NPH (N), Lente (L), Ultralente® (U), 50% Human Insulin Isophane Suspension [NPH]/50% Human Insulin Injection [buffered regular] (50/50), and 70% Human Insulin Isophane Suspension [NPH]/30% Human Insulin Injection [buffered regular] (70/30). Humulin R (U-500) is the only human insulin manufactured by Eli Lilly and Company that has a concentration of 500 units/mL. Your doctor has prescribed this type of insulin because he/she believes it is best for you. DO NOT USE ANY OTHER INSULIN EXCEPT ON HIS/HER ADVICE AND DIRECTION.

Always check the carton and the bottle label for the name and letter designation of the insulin you receive from your pharmacy to make sure it is the same as that your doctor has prescribed.

Always examine the appearance of your bottle of insulin before withdrawing each dose. Humulin R (U-500) is a clear and colorless liquid with a water-like appearance and consistency. Do not use if it appears cloudy, thickened, or slightly colored or if solid particles are visible. Always check the appearance of your bottle of insulin before using, and if you note anything unusual in the appearance of your insulin or notice your insulin requirements changing markedly, consult your doctor.

STORAGE

Insulin should be stored in a refrigerator but not in the freezer. If refrigeration is not possible, the bottle of insulin that you are currently using can be kept unrefrigerated as long as it is kept as cool as possible (below 86°F [30°C]) and away from heat and light. Do not use insulin if it has been frozen. Do not use a bottle of insulin after the expiration date stamped on the label.

INJECTION PROCEDURES

CORRECT SYRINGE

Doses of insulin are measured in units. U-500 insulin contains 500 units/mL (1 mL = 1 cc). With Humulin R (U-500), it is important to use a tuberculin (or similar) syringe as instructed by your doctor. Failure to use the syringe properly can lead to a mistake in dosage, potentially causing serious problems for you, such as a blood glucose level that is too low or too high.

SYRINGE USE

To help avoid contamination and possible spread of infection, follow these instructions exactly.

Disposable syringes and needles should be used only once and then discarded. NEEDLES AND SYRINGES MUST NOT BE SHARED.

Reusable syringes and needles must be sterilized before each injection. Follow the package directions supplied with your syringe. Described below are 2 methods of sterilizing.

BOILING

  1. Put syringe, plunger, and needle in strainer, place in saucepan, and cover with water. Boil for 5 minutes.
  2. Remove articles from water. When they have cooled, insert plunger into barrel, and fasten needle to syringe with a slight twist.
  3. Push plunger in and out several times until water is completely removed.

ISOPROPYL ALCOHOL

If the syringe, plunger, and needle cannot be boiled, as when you are traveling, they may be sterilized by immersion for at least 5 minutes in Isopropyl Alcohol, 91%. Do not use bathing, rubbing, or medicated alcohol for this sterilization. If the syringe is sterilized with alcohol, it must be absolutely dry before use.

PREPARING THE DOSE

  1. Wash your hands.
  2. Inspect the insulin. Humulin R (U-500) should look clear and colorless. Do not use Humulin R (U-500) if it appears cloudy, thickened, or slightly colored or if solid particles are visible.
  3. If using a new bottle, flip off the plastic protective cap, but do not remove the stopper. When using a new bottle, wipe the top of the bottle with an alcohol swab.
  4. Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the insulin bottle and inject the air into the bottle.
  5. Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in 1 hand.
  6. Making sure the tip of the needle is in the insulin, withdraw the correct dose of insulin into the syringe.
  7. Before removing the needle from the bottle, check your syringe for air bubbles which reduce the amount of insulin in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
  8. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.

INJECTION

Cleanse the skin with alcohol where the injection is to be made. Stabilize the skin by spreading it or pinching up a large area. Insert the needle as instructed by your doctor. Push the plunger in as far as it will go. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area. To avoid tissue damage, give the next injection at a site at least 1/2" from the previous site.

CLINICAL PHARMACOLOGY

Adequate insulin dosage permits the diabetic patient to utilize carbohydrates and fats in a comparatively satisfactory manner. Regardless of concentration, the action of insulin is basically the same: to enable carbohydrate metabolism to occur and thus to prevent the production of ketone bodies by the liver. Although, under usual circumstances, diabetes can be controlled with doses in the vicinity of 40 to 60 units or less, an occasional patient develops such resistance or becomes so unresponsive to the effect of insulin that daily doses of several hundred, or even several thousand, units are required. Patients who require doses in excess of 300 to 500 units daily usually have impaired insulin receptor function.

Occasionally, a cause of the insulin resistance can be found (such as hemochromatosis, cirrhosis of the liver, some complicating disease of the endocrine glands other than the pancreas, allergy, or infection), but in other cases, no cause of the high insulin requirement can be determined.

Humulin R (U-500) is unmodified by any agent that might prolong its action; however, clinical experience has shown that it frequently has a time action similar to a repository insulin preparation. It takes effect rapidly but has a relatively long duration of activity following a single dose (up to 24 hours) as compared with other Regular insulins. This effect has been credited to the high concentration of the preparation. 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 R (U-500) is dependent on dose, site of injection, blood supply, temperature, and physical activity.

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