Humulin R

Humulin R

Manufacturer:

Eli Lilly

Distributor:

Zuellig
Full Prescribing Info
Contents
Human insulin (recombinant DNA origin).
Description
Humulin R contains regular human insulin.
Action
Pharmacology: 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 is dependent on dose, site of injection, blood supply, temperature and physical activity.
Humulin R is a neutral human insulin of recombinant DNA origin. It is a short-acting preparation; onset of action occurs at approximately 30 min, with a duration of about 5 hrs and peak activity at 1-3 hrs.
Indications/Uses
Treatment of patients with diabetes mellitus, for the control of hyperglycemia.
Dosage/Direction for Use
The dosage should be determined according to the individual requirements of the patient.
New Patients: New patients can be started on Humulin in the same manner as they would be on animal-source insulin. Patients should be monitored closely during the adjustment period.
Transfer Patients: When transferring patients, most patients should be initiated at the same dose and dosage schedule. However, when a patient on high doses of animal insulin is initiated to Humulin R, it is appropriate to reduce the starting dosage and monitor the patient carefully.
Administration: Given by SC or IV injection.
Overdosage
Symptoms: Overdosage causes hypoglycemia with accompanying symptoms that include listlessness, confusion, palpitations, sweating and vomiting.
Treatment: Mild hypoglycemic episodes will respond to oral administration of glucose or sugar and rest. Correction of moderately severe hypoglycemia can be accomplished by the IM or SC administration of glucagon. If the patient is comatose, IV administration of dextrose injection is required.
Contraindications
Protamine zinc and isophane insulin, and insulin zinc suspensions should never be given IV and are not indicated for hyperglycemic coma.
Hypoglycemia.
Warnings
Humulin, a human insulin product, differs from animal-source insulins because it is structurally identical to the insulin produced by the 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 refinement, purity, strength, brand (manufacturer), type (regular, NPH, Lente, etc), species (beef, pork, beef-pork, human), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.
Some patients taking Humulin products 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.
Special Precautions
Dosage schedule has been individualized for each patient, because each case of diabetes is different. Consult a physician on the type of insulin, dosage strength and when to inject the insulin.
The usual insulin dose may be affected by changes in food intake, activity or work schedule. The patient should carefully follow the physician's instructions to allow for these changes. Other things that may affect the insulin dose are: Illness: Illness, especially with nausea and vomiting, may cause insulin requirements to change. Even if the patient is not eating, insulin will still be required. The patient and the physician should establish a sick-day plan to use in case of illness. When sick, test blood/urine frequently and the patient should consult physician as instructed.
Exercise: Exercise may lower the body's need for insulin during and for some time after the activity. Exercise may also speed up the effect of an insulin dose, especially if the exercise involves the area of injection site (eg, the leg should not be used for injection just prior to running). Discuss with the physician how to adjust dosage regimen to accommodate exercise.
Travel: Persons traveling across >2 time zones should consult their physician concerning adjustments in their insulin schedule.
Hyperglycemia and Diabetic Acidosis: Hyperglycemia (too much glucose in the blood) may develop if the body has too little insulin. Hyperglycemia can be brought about by: Omitting insulin intake or taking less than the physician has prescribed; eating significantly more than the suggested meal plan and developing fever, infection or other significant stressful situation.
In patients with insulin-dependent diabetes, prolonged hyperglycemia can result in diabetic acidosis. The first symptoms of diabetic acidosis 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 of the breath. With acidosis, urine tests show large amounts of glucose and acetone. Heavy breathing and rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or diabetic acidosis can lead to nausea, vomiting, dehydration, loss of consciousness or death. Therefore, it is important that the patient obtain medical assistance immediately.
Lipodystrophy: Rarely, administration of insulin SC can result in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue). If either of these conditions is noticed, consult a physician. A change in the injection technique may help alleviate the problem.
Allergy to Insulin: Local Allergy: Patients occasionally experience redness, swelling and itching at the site of injection of insulin. 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 eg, irritants in the skin cleansing agent or poor injection technique. If local reactions occur, consult a physician.
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 generalized allergic reaction to insulin occur, notify a physician immediately.
Use in pregnancy: Good control of diabetes is especially important for the patient and the unborn baby. Pregnancy may make managing diabetes more difficult. If planning to be pregnant, already pregnant, or nursing a baby, consult a physician.
Use In Pregnancy & Lactation
Use in pregnancy: Good control of diabetes is especially important for the patient and the unborn baby. Pregnancy may make managing diabetes more difficult. If planning to be pregnant, already pregnant, or nursing a baby, consult a physician.
Adverse Reactions
Lipodystrophy, insulin resistance and hypersensitivity reactions have been associated with insulin therapy, but the incidence and severity of these unwanted effects is minimal with monocomponent insulin.
Common Problems of Diabetes: Hypoglycemia (Insulin Reaction): 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: Taking too much insulin; missing or delaying meals; exercising or working more than usual; an infection or illness (especially with diarrhea or vomiting); a change in the body's need for insulin; diseases of the adrenal, pituitary or thyroid gland, or progression of kidney or liver disease; interactions with other drugs that lower blood glucose eg, oral hypoglycemics, salicylates (eg, aspirin), sulfa antibiotics and certain antidepressants; 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, depressive mood, irritability, lightheadedness, inability to concentrate, headache, abnormal behavior, unsteady movement and personality changes.
Signs of severe hypoglycemia can include: Disorientation, unconsciousness, seizures and death.
Therefore, it is important that assistance be obtained immediately.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions eg, long duration of diabetes, diabetic nerve disease, medications eg, β-blockers, change in insulin preparations, intensified control (≥3 insulin injections/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. Be alert for all 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 eg, driving. If the blood glucose is below the normal fasting glucose, consider eating or drinking sugar-containing foods to treat 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 eg, candy mints 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 IV administration of glucose at a medical facility.
The patient should learn to recognize the symptoms of hypoglycemia. If uncertain about these symptoms, the patient should monitor his/her blood glucose frequently to help him/her learn to recognize the symptoms that the patient experiences with hypoglycemia.
If the patient has frequent episodes of hypoglycemia or experience difficulty in recognizing the symptoms, he/she should consult the physician to discuss possible changes in therapy, meal plans and/or exercise programs to help avoid hypoglycemia.
Drug Interactions
The addition of corticosteroids, diuretics of thiazide, furosemide or ethacrynic acid type, oral contraceptives or thyroid replacement therapy to the patient's treatment may lead to an increase in insulin requirements. The addition of MAOI may necessitate an adjustment of insulin dosage.
Insulin requirements may be reduced in the presence of drugs with hypoglycemic activity, eg oral hypoglycemics, salicylates (eg, aspirin), sulfa antibiotics and certain antidepressants. Always discuss any medications the patient is taking with the physician.
The concomitant use of a β-adrenergic-blocking agent (particularly a noncardioselective agent) may mask the symptoms of and delay recovery from, hypoglycemia. Hypoglycemia in the presence of concomitant use of a β-adrenergic-blocking agent may precipitate a hypertensive crisis.
Caution For Usage
Humulin R consists of zinc insulin crystals dissolved in a clear fluid. It is clear and colorless. Humulin R should not be used if it is cloudy, unusually viscous, precipitated or even slightly colored.
Instructions for Use: Vial: Injection Procedures: Correct Syringe: Doses of insulin are measured in units. Use only U-100 insulin syringe. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems eg, a blood glucose level that is too low or too high.
Syringe Use: To help avoid contamination and possible infection, disposable syringes and needles should be used only once and then discarded. Needles and syringes must not be shared.
Preparing the Dose: Wash hands. Carefully shake or rotate the insulin bottle several times to completely mix the insulin. Inspect the insulin. Do not use it if anything unusual in the appearance is noticed.
If using a new bottle, flip off the plastic protective cap, but do not remove the stopper. When using a new bottle, wipe the top of the bottle with an alcohol swab. Draw air into the syringe equal to the insulin dose. Put the needle through the rubber top of the insulin bottle and inject the air into the bottle. Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in 1 hand and shake gently. Making sure the tip of the needle is in the insulin, withdraw the correct dose of insulin into the syringe.
Before removing the needle from the bottle, check the syringe for air bubbles which reduces the amount of insulin in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
Cleanse the skin with alcohol where the injection is to be made. Stabilize the skin by spreading it or pinching up a large area. Insert the needle as instructed by the physician. Push the plunger in as far as it will go. Pull the needle out and apply gentle pressure over the injection site for several seconds.
Do not rub the area. To avoid tissue damage, give the next injection at a site at least ½ inch from the previous site.
Storage
Humulin should be stored between 2°C and 8°C. It should not be exposed to excessive heat or sunlight and should never be frozen.
Vial: If refrigeration is not possible, the bottle of insulin currently used can be kept unrefrigerated as long as it is kept as cool as possible [below 86°F (30°C)] and away from heat and light.
The vial in use may be kept at room temperature (maximum 25°C) for 1 month.
ATC Classification
A10AB01 - insulin (human) ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.
Presentation/Packing
Inj (cartridge) 100 u/mL x 3 mL x 5's. (vial) 100 u/mL x 10 mL x 1's. KwikPen soln for inj (pre-filled pen) 100 IU/mL x 3 mL x 5's.
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