Humulin R

Humulin R is an over-the-counter medication used to control blood sugar levels in those with diabetes mellitus.

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Regular Insulin Human Injection

Glycerin, metacresol, water, hydrochloric acid, sodium hydroxide

THIS 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 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.

Humulin R may cause serious side effects, including:

• swelling of your hands and feet
• heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Humulin R may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Humulin R. Your healthcare provider should monitor you closely while you are taking TZDs with Humulin R. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath
  • swelling of your ankles or feet
  • sudden weight gain

Treatment with TZDs and Humulin R may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Other:

A. Hypoglycemia

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 Make sure you take this medication as prescribed by your doctor.
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
• palpitations
• tremor
• hunger
• restlessness
• tingling of the hands, feet, lips, or tongue
• lightheadedness
• inability to concentrate
• headache
• drowsiness
• sleep disturbance
• anxiety
• blurred vision
• slurred speech
• depressed mood
• irritability
• abnormal behavior
• unsteady movement
• personality changes

Signs of severe hypoglycemia include disorientation, unconsciousness, seizures, and death. Therefore, it is important that help be obtained immediately.

Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. You 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 by mouth or who are unconscious require an injection of glucagon or should be treated with injection (IV) 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.

B. Hyperglycemia 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.

C. Lipodystrophy (fat redistribution)

Rarely, taking insulin 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 the problem.

D. 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 cases, this condition may be caused by 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. This may cause a rash to form 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.

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 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 dose are:

• Illness
• Exercise
• Travel
• Pregnancy
• Medication
  • Before you use Humulin R, tell your healthcare provider if you:
    • take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
    • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Humulin R.

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 forms: Humulin R U-100 and Humulin R U-500. Make sure that you have the form prescribed by your doctor.

Always check the appearance of your bottle of Humulin R before withdrawing each dose. Humulin R is a clear and colorless liquid with a water-like appearance and consistency. Do not use Humulin R:

• 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 solution in your bottle or notice your insulin requirements changing, talk to your doctor.

Storage

• Not in-use (unopened): Humulin R 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 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.

Do not use Humulin R after the expiration date stamped on the label or if it has been frozen.

See "Directions" above

Each Humulin R 10 mL-vial contains 1000 units (with a concentration of 100 units/mL).

Each Humulin R 3 mL-vial contains 300 units (with a concentration of 100 units/mL).