Humulin (Insulin Human)


Indications

 

Humulin R 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 U-100 may be administered intravenously under proper medical supervision in a clinical setting for glycemic control (see DOSAGE AND ADMINISTRATION and Storage).
Contraindications

Humulin R U-100 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-100 or any of its excipients.

adverse reactions

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
  • drowsiness
  • dizziness
  • sleep disturbances
  • palpitation
  • anxiety
  • tremor
  • blurred vision
  • hunger
  • slurred speech
  • restlessness
  • depressed mood
  • tingling in the hands, feet, lips, or tongue
  • irritability
  • lightheadedness
  • abnormal behavior
  • inability to concentrate
  • unsteady movement
  • headache
  • personality changes
Signs of severe hypoglycemia can include:
  • disorientation
  • seizures
  • unconsciousness
  • coma
  • death
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

Precautions

Lipodystrophy


Administration of insulin subcutaneously can result in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue).

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.

– 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.

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 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, inhibitors of 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.

warnings

Needles or syringes must never be reused or shared between patients. Sharing poses a risk for transmission of blood-borne pathogens.

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.

Fluid retention and heart failure with concomitant use of PPAR-gamma agonists: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Humulin R U-100, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

overdosage

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.

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 bacteria. Humulin R U-100 has the empirical formula C257H383N65O77S6 and a molecular weight of 5808.

Humulin R 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. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH. Adequate insulin dosage permits patients with diabetes to effectively utilize carbohydrates, proteins and fats. Regardless of dose strength, insulin enables carbohydrate metabolism to occur and thus to prevent the production of ketone bodies by the liver. Some patients develop severe insulin resistance such that daily doses of several hundred units of insulin or more are required.

Humulin Package Photos

About the Author

Truman Lewis
Truman has been a bureau chief and correspondent in D.C., Los Angeles, Phoenix and elsewhere, reporting for radio, television, print and news services, for more than 30 years. Most recently, he has reported extensively on health and consumer issues for ConsumerAffairs.com and FairfaxNews.com.