ILETIN® ILETIN® II PORK
Lilly
Insulin
Diabetes Mellitus Therapy
Description: Insulin is a protein hormone secreted by the beta cells of the pancreatic islets of Langerhans.
The administration of suitable doses of insulin to patients with diabetes mellitus, along with controlled diet and exercise, temporarily restores their ability to metabolize carbohydrates, fats and proteins; to store glycogen in the liver; and to convert glucose to fat. When given in suitable doses at regular intervals to a patient with diabetes mellitus, the blood sugar is maintained within a reasonable range, the urine remains relatively free of sugar and ketone bodies, and diabetic acidosis and coma are prevented.
Insulin preparations differ in onset, peak and duration of action (see Table I). The addition of protamine to insulin, in the presence of zinc, produces a stable complex with less intense and more prolonged action, due to its slow solubility. The onset and duration of action is also modified by reprecipitation in the presence of sodium acetate and zinc. This modified action depends on the structure of the resulting precipitate.
Regular insulin is rapid acting while NPH and Lente are intermediate acting. Regular insulin is a clear solution, while the others are cloudy, white suspensions. Unless otherwise specified, Iletin is of mixed beef-pork origin. Iletin II Pork is of monospecies pork origin.
Regular insulin may be mixed with NPH or Lente insulin in any proportion desired.
The rapid action of the Regular Iletin is preserved when mixed with NPH Iletin preparations; independent of the time lag between mixing and administration, and independent of the proportion of Regular insulin incorporated in the mixture.
Mixtures of Lente and Regular Iletin insulins are subject to a binding phenomenon which is detectable within 15 minutes in vitro and continues for up to 24 hours. This binding increases as the ratio of Lente to Regular Iletin increases, and may be reduced by administering the dose immediately after preparation.
All mixtures are stable for at least 1 month if stored at or below room temperature and for 3 months if refrigerated. Because of this improved stability, it is feasible for the physician to prepare the mixtures during office visits for patients requiring a combination but incapable of preparing it themselves.
When the 2 types of insulin are mixed, it is important to recognize that the hypodermic syringes of different manufacturers may vary in the amount of space between the bottom line in the barrel and the needle. This is called dead space. The problem can be reduced if the patient consistently uses injection equipment of the same manufacturer and does not vary the order in which the insulins are added to the syringe.
When employing the simultaneous administration of different insulin preparations in 1 syringe, the physician’s instructions concerning the order in which the materials are taken into the syringe and the degree to which the materials simultaneously measured into the syringe are mixed should be consistently followed. Under some circumstances dosage variation can result from neglect of these instructions.
The simultaneous administration of 2 insulin preparations in 1 syringe should be undertaken only if prescribed. In following the procedure all instructions for sterilizing, shaking the vial, etc. should be adhered to.
Observing aseptic technique, inject a volume of air equal to the dose into the vial of modified insulin. Withdraw the needle without withdrawing the dose. Inject air and withdraw the proper dose of regular insulin from the vial in the usual manner. Invert the vial of modified insulin several times and withdraw the dose into the syringe containing the regular insulin. Holding the syringe with the needle upright, draw an air bubble into the syringe, invert the syringe and roll the bubble through to mix. Expel the air bubble and inject in the usual manner.
Indications And Clinical Uses: Replacement therapy in the treatment of diabetes mellitus which cannot be controlled satisfactorily by dietary regulation alone. Insulin is indicated in the treatment of juvenile onset diabetes or brittle diabetes. The drug may also be indicated in maturity onset diabetes which cannot be controlled by diet alone. In addition, insulin must often be substituted for oral hypoglycemic therapy in patients with maturity onset diabetes complicated by acidosis, ketosis, diabetic coma, major surgery, fever, severe trauma, infections, serious impairment of renal or hepatic functions, thyroid or other endocrine dysfunctions, acute cardiac accidents, gangrene or Raynaud’s disease, and in pregnant women. Combinations of insulin and oral hypoglycemic drugs may be used when a patient is being transferred from insulin to therapy with oral hypoglycemics. Long-term use combining insulin and oral hypoglycemic therapy is seldom warranted.
May be used to improve appetite and increase weight in selected cases of nondiabetic malnutrition e.g., anorexia nervosa.
Insulin has been used as a test for the completeness of vagotomy because of its stimulant effect on gastric secretion.
Precautions And Adverse Reactions: Every diabetic patient taking insulin should carry an identification card containing pertinent medical information.
Any change of insulin should be made cautiously and only under medical supervision. Changes in strength, purity, brand, type and/or source of species may result in the need for a change in dosage. It is not possible to identify which patients will require a change in dose. Adjustment may be needed with the first dose or occur over a period of several weeks. Be aware of the possibility of symptoms of either hypoglycemia or hyperglycemia.
The number and size of daily doses and the time of administration, as well as diet and exercise, are problems that require direct and continuous medical supervision. Usually, the most satisfactory injection time is before breakfast.
Prompt recognition and appropriate management of the complications of insulin therapy are essential for safe and effective control of diabetes mellitus.
Hypoglycemia may occur in any patient receiving insulin and is most commonly manifested by hunger, nervousness, warmth and sweating, and palpitations. Patients also may experience headache, confusion, drowsiness, fatigue, anxiety, blurred vision, diplopia, or numbness of the lips, nose, or fingers. The clinical manifestations of hypoglycemia can be masked by the concomitant administration of propranolol or other beta adrenergic blockers.
Symptoms are likely to appear anytime when the blood sugar concentration falls below 40 mg/100 mL but may occur with a sudden drop in blood glucose even when the value remains above 40 mg/100 mL.
If a patient is unable to take soluble carbohydrate or fruit juice orally, hypoglycemia is treated with 10 to 20 g of dextrose in sterile solution administered i.v. If glucose is unavailable, 1 mg of glucagon may be given s.c. or i.m. every 20 minutes for 2 or 3 doses.
Local and allergic reactions are commonly seen in patients receiving insulin for the first time or when therapy is reinstated. Local inflammatory responses also result from improper cleansing of the skin, contamination of the injection site with alcohol, use of an antiseptic containing impurities or accidental intracutaneous rather than s.c. injection. Local reactions that result from skin sensitivity phenomena usually subside spontaneously. Allergic urticaria, angioedema, and anaphylactic reactions occur infrequently and may sometimes be avoided by changing the species source of insulin. Rarely, an intradermal or s.c. hyposensitization procedure may be required.
It has been observed that areas of fat atrophy (lipodystrophy) resulting from previous administration of older insulin preparations are frequently restored to normal or near normal appearance by repeated injection of current insulin preparations into, or adjacent to, the areas of fat atrophy.
Visual disturbances in uncontrolled diabetes due to refractive changes are reversed during the early phase of effective management. However, since alteration in osmotic equilibirum between the lens and ocular fluids may not stabilize for a few weeks after initiating therapy, it is wise to postpone prescribing new corrective lenses for 3 to 6 weeks.
Hormones that tend to counteract the hypoglycemic effects of insulin include growth hormone, corticotropin, glucocorticoids, thyroid hormone, and glucagon. Epinephrine not only inhibits the secretion of insulin, but also stimulates glycogen breakdown to glucose. Thus, the presence of such diseases as acromegaly, Cushing’s syndrome, hyperthyroidism, and pheochromocytoma complicate the control of diabetes.
The hypoglycemic action of insulin may also be antagonized by phenytoin. Insulin’s hypoglycemic action can be increased in some patients by concomitant administration of anabolic steroids, MAO inhibitors, guanethidine, alcohol, propranolol (masking effect), or other drugs affecting beta adrenergic receptors, or by daily doses of 1.5 to 6 g of salicylates.
Insulin requirements can be increased, decreased, or unchanged in patients receiving diuretics. Concomitant administration of oral contraceptives can cause a decrease in glucose tolerance in diabetic women possibly resulting in increased daily insulin requirements.
In case a meal is unavoidably omitted as a result of fever or nausea and vomiting, the next dose of insulin should not be omitted unless a urine test shows the absence of sugar or only trace amounts and the patient has not urinated for 4 hours or more. If no sugar or trace amounts are present, urine tests should be made at intervals not exceeding 4 hours.
For patients using insulin who have unavoidably omitted a meal, replace the food with similar amounts of carbohydrate in the form of orange juice or some other source of available glucose.
If the patient becomes ill from any cause, he should notify the physician immediately, have his urine tested at once, and take plenty of fluids, at least a cupful of sweetened hot tea, coffee, milk, broth, or orange juice every hour. Coma may be avoided by prompt treatment.
Avoid the use of heavily chlorinated water or chemical solutions for sterilizing the syringe prior to injection. The use of distilled or clean rainwater rather than hard water is to be preferred if the syringe is to be sterilized by boiling.
Syringes which have been used for a time may become coated with a precipitate. The opaque layer may be easily removed by a swab of cotton saturated with vinegar, and the syringe should then be thoroughly rinsed in water and sterilized. Very fine needles may become plugged with the precipitate unless cleaned with a wire after use.
Availability And Storage: Each 10 mL multidose vial of Iletin Regular, NPH or Lente contains: 100 units/mL of the stated insulin preparation, prepared from a mixture of insulin crystals extracted from beef and pork pancreas. Each 10 mL multidose vial of Iletin II Pork Regular, NPH or Lente contains: 100 units/mL of the stated insulin preparation, prepared from insulin crystals extracted from pork pancreas.
Store in a cool place, preferably a refrigerator, and avoid freezing or high temperatures. No vial should be used in which the precipitate has become clumped or granular in appearance or has formed a deposit of solid particles on the wall of the vial. Vials in use should be kept cold and protected from strong light and their contents used as continuously as practical. A partially empty vial should be discarded if it has not been used for several weeks.
ILETIN® ILETIN® II PORK Lilly Insulin Diabetes Mellitus Therapy Description: Insulin is a protein hormone secreted by the beta cells of the pancreatic islets of Langerhans. The administration of suitable doses of insulin to patients with diabetes mellitus, along with controlled diet and exercise, temporarily restores their ability to metabolize carbohydrates, fats and proteins; to store glycogen in the liver; and to convert glucose to fat. When given in suitable doses at regular intervals to a patient with diabetes mellitus, the blood sugar is maintained within a reasonable range, the urine remains relatively free of sugar and ketone bodies, and diabetic acidosis and coma are prevented. Insulin preparations differ in onset, peak and duration of action. The addition of protamine to insulin, in the presence of zinc, produces a stable complex with less intense and more prolonged action, due to its slow solubility. The onset and duration of action is also modified by reprecipitation in the presence of sodium acetate and zinc. This modified action depends on the structure of the resulting precipitate. Regular insulin is rapid acting while NPH and Lente are intermediate acting. Regular insulin is a clear solution, while the others are cloudy, white suspensions. Unless otherwise specified, Iletin is of mixed beef-pork origin. Iletin II Pork is of monospecies pork origin. Regular insulin may be mixed with NPH or Lente insulin in any proportion desired. The rapid action of the Regular Iletin is preserved when mixed with NPH Iletin preparations; independent of the time lag between mixing and administration, and independent of the proportion of Regular insulin incorporated in the mixture. Mixtures of Lente and Regular Iletin insulins are subject to a binding phenomenon which is detectable within 15 minutes in vitro and continues for up to 24 hours. This binding increases as the ratio of Lente to Regular Iletin increases, and may be reduced by administering the dose immediately after preparation. All mixtures are stable for at least 1 month if stored at or below room temperature and for 3 months if refrigerated. Because of this improved stability, it is feasible for the physician to prepare the mixtures during office visits for patients requiring a combination but incapable of preparing it themselves. When the 2 types of insulin are mixed, it is important to recognize that the hypodermic syringes of different manufacturers may vary in the amount of space between the bottom line in the barrel and the needle. This is called dead space. The problem can be reduced if the patient consistently uses injection equipment of the same manufacturer and does not vary the order in which the insulins are added to the syringe. When employing the simultaneous administration of different insulin preparations in 1 syringe, the physician’s instructions concerning the order in which the materials are taken into the syringe and the degree to which the materials simultaneously measured into the syringe are mixed should be consistently followed. Under some circumstances dosage variation can result from neglect of these instructions. The simultaneous administration of 2 insulin preparations in 1 syringe should be undertaken only if prescribed. In following the procedure all instructions for sterilizing, shaking the vial, etc. should be adhered to. Observing aseptic technique, inject a volume of air equal to the dose into the vial of modified insulin. Withdraw the needle without withdrawing the dose. Inject air and withdraw the proper dose of regular insulin from the vial in the usual manner. Invert the vial of modified insulin several times and withdraw the dose into the syringe containing the regular insulin. Holding the syringe with the needle upright, draw an air bubble into the syringe, invert the syringe and roll the bubble through to mix. Expel the air bubble and inject in the usual manner.
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