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HUMULIN®R
(regular insulin human) Injection, USP
(rDNA Origin) 100 Units per ML (U-100)
Humulin® R U-100 is a polypeptide hormone structurally identical to human insulin synthesized through rDNA technology in a special non-disease-producing laboratory strain of Escherichia coli bacteria. Humulin R (insulin human recombinant) U-100 has the empirical formula C257H383N65O77S6 and a molecular weight of 5808.
Humulin R (insulin human recombinant) U-100 is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerin 16 mg/mL and metacresol 2.5 mg/mL, endogenous zinc (approximately 0.015 mg/100 units) and water for injection. The pH is 7.0 to 7.8. Sodiumhydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.
Adequate insulin dosage permits patients with diabetes to effectively utilize carbohydrates, proteins and fats. Regardless of dose strength, insulin enables carbohydrate metabolism to occur and thus to prevent the production of ketone bodies by the liver. Some patients develop severe insulin resistance such that daily doses of several hundred units of insulin or more are required.
Humulin R (insulin (human recombinant)) U-100 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus.
Humulin R (insulin (human recombinant)) U-100 may be administered intravenously under proper medical supervision in a clinical setting for glycemic control (see DOSAGE AND ADMINISTRATION and Storage).
Humulin R (insulin (human recombinant)) U-100, when used subcutaneously, is usually given three or more times daily before meals. The dosage and timing of Humulin R (insulin (human recombinant)) U-100 should be individualized and determined, based on the physician's advice, in accordance with the needs of the patient. Humulin R (insulin (human recombinant)) U-100 may also be used in combination with oral antihyperglycemic agents or longer-acting insulin products to suit the needs of the individual patients with diabetes. The injection of Humulin R (insulin (human recombinant)) U-100 should be followed by a meal within approximately 30 minutes of administration.
The average range of total daily insulin requirement for maintenance therapy in insulin-treated patients without severe insulin resistance lies between 0.5 and 1 unit/kg/day. However, in prepubertal children it usually varies from 0.7 to 1 unit/kg/day, but can be much lower during the period of partial remission. In situations of insulin resistance, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for patients with diabetes are often lower, e.g., 0.2 to 0.4 units/kg/day.
Humulin R (insulin (human recombinant)) U-100 may be administered by subcutaneous injection in the abdominal wall, the thigh, the gluteal region or in the upper arm. Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites. Injection into a lifted skin fold minimizes the risk of intramuscular injection. Injection sites should be rotated within the sameregion. As with all insulin, the duration of action will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.
Intravenous administration of Humulin R (insulin (human recombinant)) U-100 is possible under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.
For intravenous use, Humulin R (insulin (human recombinant)) U-100 should be used at concentrations from 0.1 unit/mL to 1 unit/mL in infusion systems with the infusion fluids 0.9% sodium chloride using polyvinyl chloride infusion bags.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Never use Humulin R (insulin (human recombinant)) U-100 if it has become viscous (thickened) or cloudy; use it only if it is clear and colorless. Humulin R (insulin (human recombinant)) U-100 should not be used after the printed expiration date.
Not in-use (unopened): Humulin R (insulin (human recombinant)) U-100 vials not in-use should be stored in a refrigerator (2° to 8°C [36° to 46°F]), but not in the freezer.
In-use (opened): The Humulin R (insulin (human recombinant)) U-100 vial currently in-use can be kept unrefrigerated as long as it is kept as cool as possible [below 30°C (86°F)] away from heat and light. In-use vials must be used within 31 days or be discarded, even if they still contain Humulin R (insulin (human recombinant)) U-100.
Admixture: Infusion bags prepared with Humulin R (insulin (human recombinant)) U-100 as indicated under DOSAGE AND ADMINISTRATION are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours.
Do not use Humulin R (insulin (human recombinant)) U-100 after the expiration date stamped on the label or if it has been frozen.
Humulin R (insulin (human recombinant)) U-100, Regular, insulin human injection, USP (rDNA origin), 100 units/mL, is supplied as follows:
10 mL vials NDC 0002-8215-01 (HI-210)
3 mL vials NDC 0002-8215-17 (HI-213)
Literature issued March, 2011. Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Hypoglycemia is one of the most frequent adverse events experienced by insulin users.
Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:
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Signs of severe hypoglycemia can include:
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Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, autonomic diabetic neuropathy, use of medications such as beta-adrenergic blockers, changing insulin preparations, or intensified control (3 or more insulin injections per day) of diabetes.
Without recognition of early warning symptoms, the patient may not be able to take steps to avoid more serious hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should monitor their blood glucose more frequently, especially prior to activities such as driving. Mild to moderate hypoglycemia may be treated by eating foods or taking drinks that contain sugar. Patients should always carry a quick source of sugar, such as hard candy, non-diet carbohydrate-containing drinks or glucose tablets.
See PRECAUTIONS
Administration of insulin subcutaneously can result in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue).
Allergy
Local Allergy – Patients occasionally experience erythema, local edema, and pruritus at the site of injection. This condition usually is self-limiting. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Systemic Allergy – Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy (anaphylaxis) may be life threatening.
Weight gain can occur with some insulin therapies and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.
Drugs that may increase the blood-glucose-lowering effect of Humulin R (insulin (human recombinant)) U-100 and susceptibility to hypoglycemia:
Drugs that may reduce the blood-glucose-lowering effect:
Drugs that may increase or decrease blood-glucose-lowering effect:
Drugs that may mask the signs of hypoglycemia:
Any change in insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., regular, NPH, analog, etc.), species, or method of administration may result in the need for a change in dosage.
Hypoglycemia is the most common adverse reaction of all insulin therapies, including Humulin R (insulin (human recombinant)) U-100. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring the assistance of another person and/or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with Humulin R (insulin (human recombinant)) U-100.
As with all insulin preparations, the time course of Humulin R (insulin (human recombinant)) U-100 action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Insulin requirements may be altered during illness, emotional disturbances, or other stresses. Concomitant antihyperglycemic agents may need to be adjusted.
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations. Other factors such as changes in food intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia (See PRECAUTIONS: DRUG INTERACTIONS).
As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., the pediatric population and patients who fast or have erratic food intake). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Hyperglycemia, diabetic ketoacidosis, or hyperosmolar coma may develop if the patient takes less Humulin R (insulin (human recombinant)) U-100 than needed to control blood glucose levels. This could be due to increases in insulin demand during illness or infection, neglect of diet, omission or improper administration of prescribed insulin doses or use of drugs that affect glucose metabolism or insulin sensitivity. Early signs of diabetic ketoacidosis include glycosuria and ketonuria. Polydipsia, polyuria, loss of appetite, fatigue, dry skin, abdominal pain, nausea and vomiting and compensatory tachypnea come on gradually, usually over a period of some hours or days, in conjunction with hyperglycemia and ketonemia. Severe sustained hyperglycemia may result in hyperosmolar coma or death.
Insulin stimulates potassium movement into the cells, possibly leading to hypokalemia, that left untreated may cause respiratory paralysis, ventricular arrhythmia, and death. Since intravenously administered insulin has a rapid onset of action, increased attention to hypokalemia is necessary. Therefore, potassium levels must be monitored closely when Humulin R (insulin (human recombinant)) U-100 or any other insulin is administered intravenously. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Humulin R U-100 (see ADVERSE REACTIONS).
Localized reactions and generalized myalgias have been reported with the use of metacresol as an injectable excipient.
Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment.
Some medications may alter insulin requirements and the risk for hypoglycemia and hyperglycemia (see DRUG INTERACTIONS).
Pregnancy Category B. All pregnancies have a background risk of birth defects, miscarriage, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and is decreased with good glucose control. It is important for patients to maintain good control of diabetes before conception and during pregnancy. Special attention should be paid to diet, exercise and insulin regimens. Insulin requirements may decrease during the first trimester, usually increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring is essential in these patients. Female patients should be advised to tell their physician if they intend to become, or if they become pregnant.
Studies show that endogenous insulin only crosses the placenta in minimal amounts. While there are no adequate and well-controlled studies in pregnant women, an extensive body of published literature demonstrates the maternal and fetal benefits of insulin treatment in patients with diabetes during pregnancy. Humulin R (insulin (human recombinant)) is a recombinant human insulin that is identical to the endogenous hormone; therefore, reproduction and fertility studies were not performed in animals.
Careful glucose monitoring and management of patients with diabetes during labor and delivery are required.
Endogenous insulin is present in human milk. Insulin orally ingested is degraded in the gastrointestinal tract. No adverse reactions have been associated with infant exposure to insulin through the consumption of human milk. In a study of eight preterm infants between 26 to 30 weeks gestation, enteral administration of Humulin R (insulin (human recombinant)) did not result in hypoglycemia. Good glucose control supports lactation in patients with diabetes. Patients with diabetes who are lactating may require adjustments in insulin dose and/or diet.
Excess insulin may cause hypoglycemia and hypokalemia, particularly after intravenous administration. Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.
Humulin R (insulin (human recombinant)) U-100 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R (insulin (human recombinant)) U-100 or any of its excipients.
No information provided.
HUMULIN® R
Regular Insulin Human Injection, Usp (RDNA Origin) 100 Units Per Ml (U-100)
WARNING
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY'S PANCREAS AND BECAUSE OF ITS UNIQUE MANUFACTURING PROCESS.
ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH, MANUFACTURER, TYPE (E.G., REGULAR, NPH, ANALOG), SPECIES, OR METHOD OF MANUFACTURE MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE.
SOME PATIENTS TAKING HUMULIN® (HUMAN INSULIN, rDNA ORIGIN) MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH OTHER INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS OR MONTHS.
Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This hormone is necessary for the body's correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet your body's needs.
To control your diabetes, your doctor has prescribed injections of insulin products to keep your blood glucose at a near-normal level. You have been instructed to test your blood regularly for glucose. Studies have shown that some chronic complications of diabetes such as eye disease, kidney disease, and nerve disease can be significantly reduced if the blood sugar is maintained as close to normal as possible. Proper control of your diabetes requires close and constant cooperation with your doctor. Despite diabetes, you can lead an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin injections as prescribed by your doctor.
Always keep an extra supply of insulin as well as a spare syringe and needle on hand. Always wear diabetic identification so that appropriate treatment can be given if complications occur away from home.
Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered to produce human insulin. Humulin R [Regular insulin human injection, USP (rDNA origin)] consists of zinc-insulin crystals dissolved in a clear fluid. It takes effect within 30 minutes and has a duration of activity of approximately 4 to 12 hours. 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 (insulin (human recombinant)) is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin R (insulin (human recombinant)) is a sterile solution and is for subcutaneous injection. It should not be used intramuscularly. The concentration of Humulin R (insulin (human recombinant)) is 100 units/mL (U-100).
Human insulin from Eli Lilly and Company has the trademark Humulin. Your doctor has prescribed the type of insulin that he/she believes is best for you.
DO NOT USE ANY OTHER INSULIN EXCEPT ON YOUR DOCTOR'S 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 prescribed by your doctor. There are two Humulin R (insulin (human recombinant)) formulations: Humulin R (insulin (human recombinant)) U-100 and Humulin R (insulin (human recombinant)) U-500. Make sure that you have the formulation prescribed by your doctor.
Always check the appearance of your bottle of Humulin R (insulin (human recombinant)) before withdrawing each dose. Humulin R (insulin (human recombinant)) is a clear and colorless liquid with a water-like appearance and consistency. Do not use Humulin R (insulin (human recombinant)) :
If you see anything unusual in the appearance of Humulin R (insulin (human recombinant)) solution in your bottle or notice your insulin requirements changing, talk to your doctor.
Not in-use (unopened): Humulin R (insulin (human recombinant)) U-100 bottles not in-use should be stored in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer.
In-use (opened): The Humulin R (insulin (human recombinant)) U-100 bottle you are currently using can be kept unrefrigerated as long as it is kept as cool as possible [below 86°F (30°C)] away from heat and light. In-use bottles must be used within 31 days or be thrown out, even if they still contain Humulin R (insulin (human recombinant)) U-100.
Do not use Humulin R (insulin (human recombinant)) after the expiration date stamped on the label or if it has been frozen.
Your doctor has told you which insulin to use, how much, and when and how often to inject it. Because each patient's diabetes is different, this schedule has been individualized for you.
Your usual dose of Humulin R (insulin (human recombinant)) may be affected by changes in your diet, activity, or work schedule. Carefully follow your doctor's instructions to allow for these changes. Other things that may affect your Humulin R (insulin (human recombinant)) dose are:
Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you will still require insulin. You and your doctor should establish a sick day plan for you to use in case of illness. When you are sick, test your blood glucose frequently. If instructed by your doctor, test your ketones and report the results to your doctor.
Good control of diabetes is especially important for you and your unborn baby. Pregnancy may make managing your diabetes more difficult. If you are planning to have a baby, are pregnant, or are nursing a baby, talk to your doctor.
Insulin requirements may be increased if you are taking other drugs with blood-glucose-raising activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin requirements may be reduced in the presence of drugs that lower blood glucose or affect how your body responds to insulin, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, alcohol, certain antidepressants and some kidney and blood pressure medicines. Your Health Care Professional may be aware of other medications that may affect your diabetes control. Therefore, always discuss any medications you are taking with your doctor.
Exercise may lower your body's need for insulin during and for some time after the physical activity. Exercise may also speed up the effect of an insulin dose, especially if the exercise involves the area of injection site (for example, the leg should not be used for injection just prior to running). Discuss with your doctor how you should adjust your insulin regimen to accommodate exercise.
When traveling across more than 2 time zones, you should talk to your doctor concerning adjustments in your insulin schedule.
Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events experienced by insulin users. It can be brought about by:
Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:
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|
Signs of severe hypoglycemia can include:
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|
Therefore, it is important that assistance be obtained immediately.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, changing insulin preparations, or intensified control (3 or more insulin injections per day) of diabetes.
A few patients who have experienced hypoglycemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycemia were less pronounced or different from those experienced with their previous insulin.
Without recognition of early warning symptoms, you may not be able to take steps to avoid more serious hypoglycemia. Be alert for all of the various types of symptoms that may indicate hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should monitor their blood glucose frequently, especially prior to activities such as driving. If the blood glucose is below your normal fasting glucose, you should consider eating or drinking sugar-containing foods to treat your hypoglycemia.
Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. Patients should always carry a quick source of sugar, such as hard candy or glucose tablets. More severe hypoglycemia may require the assistance of another person. Patients who are unable to take sugar orally or who are unconscious require an injection of glucagon or should be treated with intravenous administration of glucose at a medical facility.
You should learn to recognize your own symptoms of hypoglycemia. If you are uncertain about these symptoms, you should monitor your blood glucose frequently to help you learn to recognize the symptoms that you experience with hypoglycemia.
If you have frequent episodes of hypoglycemia or experience difficulty in recognizing the symptoms, you should talk to your doctor to discuss possible changes in therapy, meal plans, and/or exercise programs to help you avoid hypoglycemia.
Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin. Hyperglycemia can be brought about by any of the following:
In patients with type 1 or insulin-dependent diabetes, prolonged hyperglycemia can result in DKA (a life-threatening emergency). The first symptoms of DKA usually come on gradually, over a period of hours or days, and include a drowsy feeling, flushed face, thirst, loss of appetite, and fruity odor on the breath. With DKA, blood and urine tests show large amounts of glucose and ketones. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or DKA can lead to nausea, vomiting, stomach pain, dehydration, loss of consciousness, or death. Therefore, it is important that you obtain medical assistance immediately.
Rarely, administration of insulin subcutaneously can result in lipoatrophy (seen as an apparent depression of the skin) or lipohypertrophy (seen as a raised area of the skin). If you notice either of these conditions, talk to your doctor. A change in your injection technique may help alleviate the problem.
Local Allergy — Patients occasionally experience redness, swelling, and itching at the site of injection. This condition, called local allergy, usually clears up in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. If you have local reactions, talk to your doctor.
Systemic Allergy — Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life threatening. If you think you are having a generalized allergic reaction to insulin, call your doctor immediately.
Information about diabetes may be obtained from your diabetes educator.
Additional information about diabetes and Humulin can be obtained by calling The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or by visiting www.LillyDiabetes.com.
NEVER SHARE NEEDLES AND SYRINGES.
Doses of insulin are measured in units. U-100 insulin contains 100 units/mL (1 mL=1 cc). With Humulin R (insulin (human recombinant)) , it is important to use a syringe that is marked for U-100 insulin preparations. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high.
To help avoid contamination and possible infection, follow these instructions exactly.
Disposable syringes and needles should be used only once and then discarded by placing the used needle in a puncture-resistant disposable container. Properly dispose of the puncture-resistant container as directed by your Health Care Professional.
Follow your doctor's instructions on whether to mix your insulins ahead of time or just before giving your injection. It is important to be consistent in your method.
Syringes from different manufacturers may vary in the amount of space between the bottomline and the needle. Because of this, do not change:
