Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3148
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Humulin R U-500 (Injection, Suspension)
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| dailymed-instance:dosage |
Humulin R (U���500) should only be administered subcutaneously. It is inadvisable
to inject Humulin R (U���500) intravenously because of possible inadvertent overdosage. It is recommended that an insulin syringe
or tuberculin���type syringe be used for the measurement of dosage. Variations
in dosage are frequently possible in the insulin���resistant
patient, since the individual is unresponsive to the pharmacologic effect
of the insulin.
Nevertheless, accuracy of measurement is to be encouraged because of the potential
danger of the preparation.<br/>STORAGE: Insulin should
be kept in a cold place, preferably in a refrigerator, but must not be frozen. Do not inject insulin that
is not water���clear. Discoloration, turbidity, or unusual viscosity indicates
deterioration or contamination. Use of a package of insulin should not be started after the expiration date stamped on it.
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| dailymed-instance:descripti... |
Humulin is
synthesized in a special non���disease���producing laboratory strain
of Escherichia coli bacteria
that has been genetically altered by the addition of the gene for human insulin production. Humulin R (U���500)
consists of zinc���insulin crystals dissolved in a clear fluid. Humulin R (U���500) is a sterile solution
and is for subcutaneous injection. It should not be used intravenously or
intramuscularly. The concentration of Humulin R (U���500) is 500 units/mL. Each milliliter contains 500 units
of biosynthetic human insulin,
16 mg glycerin, 2.5 mg Metacresol as a
preservative, and zinc���oxide calculated to supplement endogenous zinc
to obtain a total zinc content of 0.017 mg/100 units.
Sodium hydroxide and/or hydrochloric acid may be added during manufacture
to adjust the pH.
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| dailymed-instance:clinicalP... |
Adequate insulin dosage
permits the diabetic patient to utilize carbohydrates and fats in a comparatively
satisfactory manner. Regardless of concentration, the action of insulin is
basically the same: to enable carbohydrate metabolism to occur and thus to
prevent the production of ketone bodies by the liver. Although, under usual
circumstances, diabetes can be controlled with doses in the vicinityof 40 to
60 units or less, an occasional patient develops such resistance
or becomes so unresponsive to the effect of insulin that
daily doses of several hundred, or even several thousand, units are required.
Patients who require doses in excess of 300 to 500 units
daily usually have impaired insulin receptor function. Occasionally, a cause of the insulin resistance
can be found (such as hemochromatosis, cirrhosis of the liver, some complicating
disease of the endocrine glands other than the pancreas, allergy, or infection),
but in other cases, no cause of the high insulin requirement
can be determined. Humulin R (U���500)
is unmodified by any agent that might prolong its action; however, clinical
experience has shown that it frequently has a time action similar to a repository insulin preparation.
It takes effect rapidly but has a relatively long duration of activity following
a single dose (up to 24 hours) as compared with other Regular insulins.
This effect has been credited to the high concentration of the preparation.
The time course of action of any insulin may vary considerably in different individuals or at different times in
the same individual. As with all insulin preparations,the duration of action of Humulin R (U���500)
is dependent on dose, site of injection, blood supply, temperature, and physical
activity.
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Humulin R (U���500) is contraindicated in hypoglycemia.
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| dailymed-instance:supply |
Vials, 500 units/mL, 20 mL (HI���500)
(1s), NDC 0002���8501���01
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| dailymed-instance:precautio... |
General: Every patient exhibiting insulin resistance who requires Humulin R (U���500) for control of diabetes should be under
close observation until appropriate dosage is established. The response will
vary among patients. Some patients can be controlled with a single dose daily;
others may require 2 or 3 injections per
day. Most patients will show a���tolerance���to insulin,
so that minor variations in dosage can occur without the development of untoward
symptoms of insulin shock. Insulin resistance
is frequently self���limited; after several weeks or months during which
high dosage is required, responsiveness to the pharmacologic effect of insulin may
be regained and dosage can be reduced.<br/>Information for Patients: Patients should be instructed regarding their dosage and should be reminded
that this formulation requires the administration of a smaller volume of solution
than is the case with less concentrated formulations.<br/>Laboratory Tests: Blood and urine glucose, glycohemoglobin, and urine ketones should be
monitored frequently.<br/>Drug Interactions: The concurrent use of oral hypoglycemic agents with Humulin R (U���500)
is not recommended since there are no data to support such use. Insulin requirements may be increased by medications with hyperglycemic
activity such as corticosteroids, isoniazid, certain lipid-lowering drugs
(e.g., niacin), estrogens, oral contraceptives, phenothiazines, and thyroid
replacement therapy (see CLINICAL PHARMACOLOGY). Insulin requirements may be decreased in the presence of drugs that
increase insulin sensitivity or have hypoglycemic activity, such as oral antidiabetic
agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine
oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin
II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic
function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask
the symptoms of hypoglycemia in some patients.<br/>Pregnancy: Teratogenic
Effects���No reproduction studies have been conducted in
animals, and there are no adequate and well���controlled studies in pregnant
women. It would be anticipated that the benefits of this insulin preparation
would outweigh any risk to the developing fetus. Nonteratogenic
Effects���Insulin does not cross the placenta as does glucose.<br/>Labor and Delivery: Careful monitoring of the patient is required, since the insulin requirement
may decrease following delivery.<br/>Nursing Mothers: It is not known whether insulin is excreted in significant amounts in human milk. Because many drugs are
excreted in human milk, caution should be exercised when Humulin R (U���500) insulin injection
is administered to a nursing woman.<br/>Pediatric Use: There are no special precautions relating to the use of this insulin formulation
in the pediatric age group.
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| dailymed-instance:genericMe... |
Insulin human
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| dailymed-instance:fullName |
Humulin R U-500 (Injection, Suspension)
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| dailymed-instance:adverseRe... |
As with other human insulin preparations,
hypoglycemic reactions may be associated with the administration of Humulin R (U���500).
However, deep secondary hypoglycemic reactions may develop 18 to
24 hours after the original injection of Humulin R (U���500).
Consequently, patients should be carefully observed, and prompt treatment
of such reactions should be initiated with glucagon injections and/or with
glucose by intravenous injection or gavage. 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: Signs of severe hypoglycemia can include: Early warning symptoms of hypoglycemia may
be different or less pronounced under certain conditions, such as long duration
of diabetes, diabetic nerve disease, medications such as beta���blockers,
change in 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,
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 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 candy mints or glucose tablets. Hypoglycemia when using Humulin R (U���500)
can be prolonged and severe. Lipodystrophy Rarely, administration of insulin subcutaneously
can result in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement
or thickening of tissue). Allergy to Insulin Local
Allergy���Patients occasionally experience erythema, local
edema, and pruritus at the site of injection of insulin.
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.
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| dailymed-instance: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 PURITY, STRENGTH, BRAND (MANUFACTURER), TYPE (REGULAR, NPH, LENTE, ETC),
SPECIES (BEEF, PORK, BEEF���PORK, HUMAN), AND/OR METHOD OF MANUFACTURE
(rDNA VERSUS ANIMAL���SOURCE INSULIN) MAY RESULT IN THE
NEED FOR A CHANGE IN DOSAGE. SOME PATIENTS
TAKING HUMULIN (HUMAN INSULIN, rDNA ORIGIN, LILLY) MAY REQUIRE A CHANGE
IN DOSAGE FROM THAT USED WITH ANIMAL���SOURCE INSULINS. IF AN ADJUSTMENT
IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS
OR MONTHS. This insulin preparation
contains 500 units of insulin in
each milliliter. Extreme caution must be observed in the measurement of dosage
because inadvertent overdose may result in irreversible insulin shock.
Serious consequences may result if it is used other than under constant medical
supervision.
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| dailymed-instance:indicatio... |
Humulin R (U���500) is especially useful for the treatment
of diabetic patients with marked insulin resistance (daily requirements more than 200 units), since
a large dose may be administered subcutaneously in a reasonable volume.
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| dailymed-instance:name |
Humulin R U-500
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