Humulin R (Insulin (Human Recombinant))
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Humulin R (Insulin (Human Recombinant))

HUMULIN®R
(
regular insulin human) Injection, USP
(rDNA Origin) 100 Units per ML (U-100)

DRUG DESCRIPTION

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.

What are the possible side effects of insulin regular (Humulin R, Novolin R, Novolin R Innolet, Novolin R PenFill, ReliOn/Novolin R)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose...

Read All Potential Side Effects and See Pictures of Humulin R »

What are the precautions when taking insulin (human recombinant) (Humulin R)?

Before using insulin, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, thyroid problems.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities...

Read All Potential Precautions of Humulin R »

Last reviewed on RxList: 4/10/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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).

DOSAGE AND ADMINISTRATION

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.

Mixing of Insulins

  • Humulin R (insulin (human recombinant)) U-100 should only be mixed as directed by the physician
  • Humulin R (insulin (human recombinant)) U-100 is short-acting and is often used in combination with intermediate- or long-acting insulins.
  • The order of mixing and brand or model of syringe should be specified by the physician. A U-100 insulin syringe should always be used. Failure to use the correct syringe can lead to dosage errors.
  • In general, when an intermediate-acting insulin (e.g., NPH insulin isophane suspension) is mixed with short-acting soluble insulin (e.g., regular), the short-acting insulin should be drawn into the syringe first.

Storage

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.

HOW SUPPLIED

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

Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Hypoglycemia

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:

  • sweating
  • dizziness
  • palpitation
  • tremor
  • hunger
  • restlessness
  • tingling in the hands, feet, lips, or tongue
  • lightheadedness
  • inability to concentrate
  • headache
  • drowsiness
  • sleep disturbances
  • anxiety
  • blurred vision
  • slurred speech
  • depressed mood
  • irritability
  • abnormal behavior
  • unsteady movement
  • personality changes

Signs of severe hypoglycemia can include:

  • disorientation
  • unconsciousness
  • death
  • seizures
  • coma

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.

Hypokalemia

See PRECAUTIONS

Lipodystrophy

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

Weight gain can occur with some insulin therapies and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Peripheral Edema

Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Read the Humulin R (insulin (human recombinant)) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

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:

  • Oral antihyperglycemic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors [SSRIs]), pramlintide, disopyramide, fibrates, fluoxetine, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitorsof pancreatic function (e.g., octreotide), and alcohol.

Drugs that may reduce the blood-glucose-lowering effect:

  • Corticosteroids, isoniazid, certain lipid-lowering drugs (e.g., niacin), estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents, somatropin, atypical antipsychotics, glucagon, protease inhibitors and thyroid replacement therapy.

Drugs that may increase or decrease blood-glucose-lowering effect:

  • Beta-adrenergic blockers, clonidine, lithium salts, and alcohol.
  • Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Drugs that may mask the signs of hypoglycemia:

  • Beta-adrenergic blockers, clonidine, guanethidine, and reserpine.

Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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.

PRECAUTIONS

Hypoglycemia

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, and Hyperosmolar Non-Ketotic Syndrome

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.

Hypokalemia

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).

Hypersensitivity and Allergic Reactions

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.

Renal or Hepatic Impairment

Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment.

Drug Interactions

Some medications may alter insulin requirements and the risk for hypoglycemia and hyperglycemia (see DRUG INTERACTIONS).

Use in Pregnancy

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.

Labor and Delivery

Careful glucose monitoring and management of patients with diabetes during labor and delivery are required.

Nursing Mothers

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.

Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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.

CONTRAINDICATIONS

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.

Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

No information provided.

Last reviewed on RxList: 7/6/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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.

Diabetes

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.

Regular Human Insulin

Description

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).

Identification

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 it appears cloudy, thickened, or slightly colored, or
  • if solid particles are visible.

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.

Storage

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.

Dosage

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

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.

Pregnancy

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.

Medication

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

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.

Travel

When traveling across more than 2 time zones, you should talk to your doctor concerning adjustments in your insulin schedule.

Common Problems Of Diabetes

Hypoglycemia (Low Blood Sugar)

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:

  1. Missing or delaying meals.
  2. Taking too much insulin.
  3. Exercising or working more than usual.
  4. An infection or illness associated with diarrhea or vomiting.
  5. A change in the body's need for insulin.
  6. Diseases of the adrenal, pituitary, or thyroid gland, or progression of kidney or liver disease.
  7. Interactions with certain drugs, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, certain antidepressants and some kidney and blood pressure medicines.
  8. Consumption of alcoholic beverages.

Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:

  • sweating
  • dizziness
  • palpitation
  • tremor
  • hunger
  • restlessness
  • tingling in the hands, feet, lips, or tongue
  • lightheadedness
  • inability to concentrate
  • headache
  • drowsiness
  • sleep disturbances
  • anxiety
  • blurred vision
  • slurred speech
  • depressed mood
  • irritability
  • abnormal behavior
  • unsteady movement
  • personality changes

Signs of severe hypoglycemia can include:

  • disorientation
  • unconsciousness
  • seizures
  • death

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 (High Blood Sugar) and Diabetic Ketoacidosis (DKA)

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:

  1. Omitting your insulin or taking less than your doctor has prescribed.
  2. Eating significantly more than your meal plan suggests.
  3. Developing a fever, infection, or other significant stressful situation.

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.

Lipodystrophy

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.

Allergy

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.

Additional Information

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.

Instructions For Insulin Vial Use

NEVER SHARE NEEDLES AND SYRINGES.

Correct Syringe Type

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.

Syringe Use

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.

Preparing the Dose

  1. Wash your hands.
  2. Inspect the insulin. Humulin R (insulin (human recombinant)) solution should look clear and colorless. Do not use Humulin R (insulin (human recombinant)) if it appears cloudy, thickened, or slightly colored, or if you see particles in the solution. Do not use Humulin R (insulin (human recombinant)) if you notice anything unusual in its appearance.
  3. If using a new Humulin R (insulin (human recombinant)) bottle, flip off the plastic protective cap, but do not remove the stopper. Wipe the top of the bottle with an alcohol swab.
  4. If you are mixing insulins, refer to the “Mixing Humulin R (insulin (human recombinant)) with Longer-Acting Human Insulins” section below.
  5. Draw an amount of air into the syringe that is equal to the Humulin R (insulin (human recombinant)) dose. Put the needle through rubber top of the Humulin R (insulin (human recombinant)) bottle and inject the air into the bottle.
  6. Turn the Humulin R (insulin (human recombinant)) bottle and syringe upside down. Hold the bottle and syringe firmly in one hand.
  7. Making sure the tip of the needle is in the Humulin R (insulin (human recombinant)) solution, withdraw the correct dose of Humulin R (insulin (human recombinant)) into the syringe.
  8. Before removing the needle from the Humulin R (insulin (human recombinant)) bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
  9. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
  10. If you do not need to mix your Humulin R (insulin (human recombinant)) with a longer-acting insulin, go to the “Injection Instructions” section below and follow the directions.

Mixing Humulin R (insulin (human recombinant)) with Longer-Acting Human Insulins

  1. Humulin R (insulin (human recombinant)) should be mixed with longer-acting human insulins only on the advice of your doctor.
  2. Draw an amount of air into the syringe that is equal to the amount of longer-acting insulin you are taking. Insert the needle into the longer-acting insulin bottle and inject the air. Withdraw the needle.
  3. Draw an amount of air into the syringe that is equal to the amount of Humulin R you are taking. Insert the needle into the Humulin R (insulin (human recombinant)) bottle and inject the air, but do not withdraw the needle.
  4. Turn the Humulin R (insulin (human recombinant)) bottle and syringe upside down.
  5. Making sure the tip of the needle is in the Humulin R (insulin (human recombinant)) solution, withdraw the correct dose of Humulin R (insulin (human recombinant)) into the syringe.
  6. Before removing the needle from the Humulin R (insulin (human recombinant)) bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
  7. Remove the syringe with the needle from the Humulin R (insulin (human recombinant)) bottle and insert it into the longer-acting insulin bottle. Turn the longer-acting insulin bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the longer-acting insulin, withdraw the correct dose of longer-acting insulin.
  8. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
  9. Follow the directions under “Injection Instructions” section below

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:

  • the sequence of mixing, or
  • the model and brand of syringe or needle that your doctor has prescribed.

Injection Instructions

  1. To avoid tissue damage, choose a site for each injection that is at least ½ inch from the previous injection site. The usual sites of injection are abdomen, thighs, and arms.
  2. Cleanse the skin with alcohol where the injection is to be made.
  3. With one hand, stabilize the skin by spreading it or pinching up a large area.
  4. Insert the needle as instructed by your doctor.
  5. Push the plunger in as far as it will go.
  6. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
  7. Place the used needle in a puncture-resistant disposable container and properly dispose of the puncture-resistant container as directed by your Health Care Professional.

Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

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.

Diabetes

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.

Regular Human Insulin

Description

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).

Identification

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 it appears cloudy, thickened, or slightly colored, or
  • if solid particles are visible.

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.

Storage

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.

Dosage

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

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.

Pregnancy

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.

Medication

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

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.

Travel

When traveling across more than 2 time zones, you should talk to your doctor concerning adjustments in your insulin schedule.

Common Problems Of Diabetes

Hypoglycemia (Low Blood Sugar)

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:

  1. Missing or delaying meals.
  2. Taking too much insulin.
  3. Exercising or working more than usual.
  4. An infection or illness associated with diarrhea or vomiting.
  5. A change in the body's need for insulin.
  6. Diseases of the adrenal, pituitary, or thyroid gland, or progression of kidney or liver disease.
  7. Interactions with certain drugs, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, certain antidepressants and some kidney and blood pressure medicines.
  8. Consumption of alcoholic beverages.

Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:

  • sweating
  • dizziness
  • palpitation
  • tremor
  • hunger
  • restlessness
  • tingling in the hands, feet, lips, or tongue
  • lightheadedness
  • inability to concentrate
  • headache
  • drowsiness
  • sleep disturbances
  • anxiety
  • blurred vision
  • slurred speech
  • depressed mood
  • irritability
  • abnormal behavior
  • unsteady movement
  • personality changes

Signs of severe hypoglycemia can include:

  • disorientation
  • unconsciousness
  • seizures
  • death

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 (High Blood Sugar) and Diabetic Ketoacidosis (DKA)

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:

  1. Omitting your insulin or taking less than your doctor has prescribed.
  2. Eating significantly more than your meal plan suggests.
  3. Developing a fever, infection, or other significant stressful situation.

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.

Lipodystrophy

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.

Allergy

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.

Additional Information

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.

Instructions For Insulin Vial Use

NEVER SHARE NEEDLES AND SYRINGES.

Correct Syringe Type

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.

Syringe Use

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.

Preparing the Dose

  1. Wash your hands.
  2. Inspect the insulin. Humulin R (insulin (human recombinant)) solution should look clear and colorless. Do not use Humulin R (insulin (human recombinant)) if it appears cloudy, thickened, or slightly colored, or if you see particles in the solution. Do not use Humulin R (insulin (human recombinant)) if you notice anything unusual in its appearance.
  3. If using a new Humulin R (insulin (human recombinant)) bottle, flip off the plastic protective cap, but do not remove the stopper. Wipe the top of the bottle with an alcohol swab.
  4. If you are mixing insulins, refer to the “Mixing Humulin R (insulin (human recombinant)) with Longer-Acting Human Insulins” section below.
  5. Draw an amount of air into the syringe that is equal to the Humulin R (insulin (human recombinant)) dose. Put the needle through rubber top of the Humulin R (insulin (human recombinant)) bottle and inject the air into the bottle.
  6. Turn the Humulin R (insulin (human recombinant)) bottle and syringe upside down. Hold the bottle and syringe firmly in one hand.
  7. Making sure the tip of the needle is in the Humulin R (insulin (human recombinant)) solution, withdraw the correct dose of Humulin R (insulin (human recombinant)) into the syringe.
  8. Before removing the needle from the Humulin R (insulin (human recombinant)) bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
  9. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
  10. If you do not need to mix your Humulin R (insulin (human recombinant)) with a longer-acting insulin, go to the “Injection Instructions” section below and follow the directions.

Mixing Humulin R (insulin (human recombinant)) with Longer-Acting Human Insulins

  1. Humulin R (insulin (human recombinant)) should be mixed with longer-acting human insulins only on the advice of your doctor.
  2. Draw an amount of air into the syringe that is equal to the amount of longer-acting insulin you are taking. Insert the needle into the longer-acting insulin bottle and inject the air. Withdraw the needle.
  3. Draw an amount of air into the syringe that is equal to the amount of Humulin R you are taking. Insert the needle into the Humulin R (insulin (human recombinant)) bottle and inject the air, but do not withdraw the needle.
  4. Turn the Humulin R (insulin (human recombinant)) bottle and syringe upside down.
  5. Making sure the tip of the needle is in the Humulin R (insulin (human recombinant)) solution, withdraw the correct dose of Humulin R (insulin (human recombinant)) into the syringe.
  6. Before removing the needle from the Humulin R (insulin (human recombinant)) bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
  7. Remove the syringe with the needle from the Humulin R (insulin (human recombinant)) bottle and insert it into the longer-acting insulin bottle. Turn the longer-acting insulin bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the longer-acting insulin, withdraw the correct dose of longer-acting insulin.
  8. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
  9. Follow the directions under “Injection Instructions” section below

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:

  • the sequence of mixing, or
  • the model and brand of syringe or needle that your doctor has prescribed.

Injection Instructions

  1. To avoid tissue damage, choose a site for each injection that is at least ½ inch from the previous injection site. The usual sites of injection are abdomen, thighs, and arms.
  2. Cleanse the skin with alcohol where the injection is to be made.
  3. With one hand, stabilize the skin by spreading it or pinching up a large area.
  4. Insert the needle as instructed by your doctor.
  5. Push the plunger in as far as it will go.
  6. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
  7. Place the used needle in a puncture-resistant disposable container and properly dispose of the puncture-resistant container as directed by your Health Care Professional.

Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Humulin R Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

INSULIN REGULAR HUMAN - INJECTION

(IN-sue-lin)

COMMON BRAND NAME(S): Humulin R, Novolin R

USES: This man-made insulin product is identical to human insulin. It is used to treat diabetes mellitus. Like other insulin products, it works by helping sugar (glucose) get into cells. It is a short-acting insulin.

This insulin is usually used in combination with a medium- or long-acting insulin product injected under the skin to control high blood sugar. In some people with diabetes, insulin may be used alone or with oral diabetes drugs (e.g., sulfonylureas like glyburide or glipizide).

Even with diabetes, you can lead an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin as directed. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

HOW TO USE: The cartridge form of this insulin comes with a Patient Information Leaflet. Read it before you start using this insulin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This insulin must be injected. Learn all preparation and usage instructions, including how to inject this medication properly and how to self-manage your diabetes (e.g., monitoring blood glucose, recognizing and treating high/low blood sugar). Your health care professional will teach you how to use this medication. If you have any questions, consult your doctor, diabetes educator, or pharmacist.

Before using, inspect this product visually for particles or discoloration. If either is present, do not use the insulin.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid developing problem areas under the skin (lipodystrophy). To reduce discomfort at the injection site, do not inject cold insulin. The insulin container you are currently using can be kept at room temperature. Insulin may be injected in the abdominal wall, the thigh, or the back of the upper arm.

Inject this medication under the skin within 30-60 minutes before eating a meal or immediately after the meal as directed by your doctor. Because this insulin is fast-acting, not eating immediately after a dose of this insulin may lead to low blood sugar (hypoglycemia). After pulling out the needle, apply gentle pressure on the injection site. Do not rub the area.

The dosage is based on your medical condition and response to therapy. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar levels.

Check your urine/blood sugar as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

If you are directed to inject this insulin with an infusion pump, read the instruction manual and directions that come with the infusion pump. If you have any questions, consult your doctor, diabetes educator, or pharmacist. Avoid exposing the pump or its tubing to direct sunlight or other heat sources.

This product may be mixed only with certain other insulin products such as NPH insulin. Always draw this insulin into the syringe first, then follow with the longer-acting insulin. Consult your pharmacist about which products may be mixed and the proper method for mixing insulin. Never inject a mixture of different insulins into a vein. Do not mix insulins if you are using an insulin pump.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Disclaimer

Humulin R Consumer (continued)

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, irritation) may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.) or if you have taken too much insulin. The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, quickly raise your blood sugar level by eating a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist about what you should do if you miss a meal.

Too little insulin can cause symptoms of high blood sugar (hyperglycemia). Symptoms include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, fast heartbeat, sweating, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Humulin R (insulin (human recombinant)) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using insulin, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, thyroid problems.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while using this medication because it can increase the risk of developing hypoglycemia.

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medication or how often you test your blood sugar may be required.

Check your blood sugar readings before and after exercise. You may need a snack beforehand.

If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you.

The elderly may be more sensitive to the effects of this drug, especially hypoglycemia.

Children may be more sensitive to the effects of this drug, especially hypoglycemia. When used in children, diluting insulin before injecting is recommended. Ask your pharmacist about the correct way to dilute insulin.

Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details.

This medication does not pass into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Disclaimer

Humulin R Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: rosiglitazone.

Beta-blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about the safe use of those products.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include headache, sweating, shakiness, increased hunger, vision changes, nervousness, tiredness, seizures, loss of consciousness.

NOTES: Do not share this medication, needles, or syringes with others.

It is recommended you attend a diabetes education program to understand diabetes and all the important aspects of its treatment, including meals/diet, exercise, personal hygiene, medications, and getting regular eye, foot and medical exams.

Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to monitor for side effects and response to therapy.

Wear or carry identification stating that you have diabetes and are using this drug. See Medical Alert section.

MISSED DOSE: It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Discuss specific instructions with your doctor now in case you miss a dose of insulin in the future.

STORAGE: It is best to refrigerate the unopened vial/cartridge between 36-46 degrees F (2-8 degrees C). Once opened, this medication may be stored in the refrigerator or at room temperature below 86 degrees F (30 degrees C). Store in the carton to protect from light. Depending on your brand, discard the vial either 31 days or 42 days after opening. Check with your pharmacist regarding your specific brand. Do not freeze. Discard the insulin if it has been frozen.

If using this drug in an insulin pump, do not store this drug in the pump for more than 48 hours. Doing so may lead to ineffective therapy and high blood sugars. Do not expose the insulin in your pump to direct sunlight or temperatures above 98.6 degrees F (37 degrees C).

Protect insulin from direct sunlight, heat, and moisture. Keep all medicines away from children and pets.

Keep extra supplies of insulin, syringes, and needles on hand.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Humulin R Patient Information Including Side Effects

Brand Names: Humulin R, Novolin R, Novolin R Innolet, Novolin R PenFill, ReliOn/Novolin R

Generic Name: insulin regular (Pronunciation: IN soo lin REG yoo lar)

What is insulin regular (Humulin R)?

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin regular is a short-acting form of insulin.

Insulin regular is used to treat diabetes.

Insulin regular may also be used for other purposes not listed in this medication guide.

What are the possible side effects of insulin regular (Humulin R)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Humulin R (insulin (human recombinant)) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about insulin regular (Humulin R)?

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your insulin dose.

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.

Insulin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

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

Side Effects Centers

Humulin R Patient Information including How Should I Take

What should I discuss with my healthcare provider before using insulin regular (Humulin R)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

To make sure you can safely use insulin, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

FDA pregnancy category B. Insulin is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether insulin regular passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use insulin regular (Humulin R)?

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

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Insulin regular is injected under the skin. You may be shown how to use injections at home. 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.

Insulin regular should look as clear as water. Do not use the medication if has changed colors, looks cloudy, or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. 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 types of insulin needles can be used more than once. But reusing needles increases your risk of infection. Used needles must be properly cleaned and inspected for bending or breakage. Ask your doctor or pharmacist whether you can 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.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

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

Your doctor may want you to stop taking insulin for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your insulin dose if needed. Do not change your medication dose or schedule without your doctor's advice.

If your doctor changes your brand, strength, or type of insulin, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of insulin you receive at the pharmacy.

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.

Insulin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Unopened vials may also be stored at room temperature, away from heat and bright light.

Storing after your first use: Keep the "in-use" vials or cartridges at room temperature.

Do not freeze insulin regular, and throw away the medication if it has become frozen.

Throw away any insulin not used before the expiration date on the medicine label.

Side Effects Centers

Humulin R Patient Information including If I Miss a Dose

What happens if I miss a dose (Humulin R)?

Since insulin regular is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin regular, be sure to eat a meal or snack within 15 to 30 minutes. Do not use extra insulin to make up a missed dose.

It is important to keep insulin regular on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose (Humulin R)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while using insulin regular (Humulin R)?

Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin regular.

What other drugs will affect insulin regular (Humulin R)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

  • albuterol (Proventil, Ventolin);
  • clonidine (Catapres);
  • reserpine; or
  • beta-blockers such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

Where can I get more information?

Your pharmacist can provide more information about insulin regular.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision date: 2/14/2011.

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Side Effects Centers

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