A-Z Drug Facts > Insulin

Insulin

Pronouncation: (IN-suh-lin)
Class: Antidiabetic agent Regular, Insulin Injection or Inhalation

Trade Names:
Exubera
- Powder for inhalation 1 mg
- Powder for inhalation 3 mg

Trade Names:
Humulin R
- Injection 100 units/mL human insulin (rDNA)

Trade Names:
Novolin R
- Injection 100 units/mL human insulin (rDNA)

Novolin ge Toronto (Canada)
NPH, Isophane Insulin Suspension

Trade Names:
Humulin N
- Injection 100 units/mL human insulin (rDNA)

Trade Names:
Novolin N
- Injection 100 units/mL human insulin (rDNA)

Novolin ge 30/70 (Canada)
Novolin ge 40/60 (Canada)
Novolin ge 50/50 (Canada)
Novolin ge NPH (Canada)
Insulin Zinc Suspension

Trade Names:
Lente Iletin II
- Injection 100 units/mL purified pork

Novolin ge Lente (Canada)
Novolin ge Ultralente (Canada)
50% NPH, Human Insulin Isophane Suspension and 50% Regular, Human Insulin Injection (rDNA Origin)

Trade Names:
Humulin 50/50
- Injection 100 units/mL human insulin (rDNA)

70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection (rDNA Origin)

Trade Names:
Humulin 70/30
- Injection 100 units/mL human insulin (rDNA)

Trade Names:
Novolin 70/30
- Injection 100 units/mL human insulin (rDNA)

Pharmacology

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Insulin and its analogs lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis, proteolysis, and enhances protein synthesis.

Pharmacokinetics

Absorption

Inhalation insulin is absorbed as quickly as subcutaneously administered rapid-acting insulin analogs and more quickly than subcutaneous regular human insulin.

Onset

0.5 to 1 h (regular). 1 to 1.6 h (NPH). 1 to 2.5 h (lente). 4 to 8 h (ultralente). 10 to 20 min (inhalation).

Peak

4 to 12 h (NPH). 7 to 15 h (lente). 10 to 30 h (ultralente). Max effect approximately 2 h after inhalation.

Duration

8 to 12 h (regular). 24 h (NPH, lente). 20 to 36 h (ultralente). Approximately 6 h (inhalation).

Special Populations

Passive cigarette smoking

Insulin C _max and AUC may be reduced approximately 30% to 20%, respectively.

Indications and Usage

Management of type 1 diabetes mellitus (insulin-dependent) and type 2 diabetes mellitus (non–insulin-dependent) not properly controlled by diet, exercise, and weight reduction. In hyperkalemia, infusions of glucose and insulin lower serum potassium levels. IV or IM regular insulin may be given for rapid effect in severe ketoacidosis or diabetic coma. Highly purified (single component) and human insulins are used for treatment of local insulin allergy, immunologic insulin resistance, lipodystrophy at injection site, temporary insulin administration, and in newly diagnosed diabetic patients.

Inhalation

For the treatment of adult patients with type 1 diabetes, use in regimens that include longer-acting insulins. For the treatment of adults with type 2 diabetes, use as monotherapy or in combination with oral agents or longer-acting insulins.

Contraindications

Hypersensitivity to any ingredient of the product; during episodes of hypoglycemia.

Inhalation

Patients who smoke, start smoking, or who have discontinued smoking less than 6 mo prior to starting inhalational insulin therapy; patients with unstable or poorly controlled lung disease; hypersensitivity to the drug or any of its excipients.

Dosage and Administration

Parenteral Insulins

Insulin preparations are classified into 3 groups based on promptness, duration, and intensity of action following subcutaneous administration. These classifications are rapid- (regular or semilente), intermediate- (lente or NPH ), or long-acting (ultralente). Maintenance doses are given subcutaneous and must be individualized by monitoring patients closely. Consider following dosage guidelines.

Children and Adults

Subcutaneous 0.5 to 1 units/kg/day. Adjust doses to achieve premeal and bedtime blood glucose levels of 80 to 140 mg/dL (children younger than 5 yr of age, 100 to 200 mg/dL).

Severe Ketoacidosis or Diabetic Coma

Subcutaneous 0.8 to 1.2 units/kg/day. Regular insulin is given IV or IM.

Inhaled Insulin
Adults

Oral Inhalation Initial dose: Body Weight (kg) × 0.05 mg/kg = premeal dose (mg) rounded down to nearest whole mg number (eg, 3.7 mg rounded down to 3 mg).

Conversion from subcutaneously injected regular insulin

1 mg blister of inhaled insulin is approximately equivalent to 3 units of subcutaneous regular insulin; 3 mg blister of inhaled insulin is approximately equivalent to 8 units subcutaneous regular insulin. Combine 1 and 3 mg blisters so that the least number of blisters per dose are taken.

Dose Adjustments

Titrate all insulin products (parenteral and inhaled) to optimal dosage based on blood glucose monitoring results.

General Advice

• Parenteral insulins
• Regular insulin is for subcutaneous, IM, or IV administration only. Not for intradermal, intra-arterial, or oral administration.
• Long-acting insulins are for subcutaneous administration only. Not for intradermal, IM, IV, intra-arterial, or oral administration.
• Administer direct subcutaneous injections into abdominal wall, thigh, or deltoid. Rotate injection sites within same region.
• Do not use regular insulin if cloudy, thickened, discolored, or contains particulate matter.
• Do not use long-acting insulin if white material (insulin) remains at bottom of bottle after mixing or if there are clumps.
• If mixing regular insulin with long-acting insulin, draw regular insulin into syringe first.
• If using insulin pen, mix contents by rolling between the palms 10 times then inverting 180° 10 times, then prime the pen before each dose. Do not administer if white material (insulin) remains visibly separated from the liquid after mixing, if clumps are noted, or if solid white particles stick to walls of cartridge.

• Inhaled insulin
• For oral inhalation only using insulin inhaler. Not for oral administration or inhalation without insulin inhaler.
• Use in combination with longer-acting insulins when treating patients with type 1 diabetes.
• Use as monotherapy or in combination with oral hypoglycemic agents or longer-acting insulins when treating patients with type 2 diabetes.
• The 3 mg blister is not interchangeable with three 1 mg blisters; if necessary, substitute two 1 mg blisters for one 3 mg blister of inhaled insulin.
• Follow the Medication Guide instructions for preparing and administering dose using insulin inhaler.
• Administer prescribed dose within 10 min before a meal.

Storage/Stability

Parenteral insulins

Store in refrigerator (36° to 46°F). Protect from freezing. Discard insulin that has been frozen. If refrigeration is not possible, store unrefrigerated at temperature below 86°F, away from heat and light for 1 mo. Store unopened pens in refrigerator. Store in-use pens at room temperature away from heat and light Do not refrigerate. Discard in-use pen after 10 days, even if pen still contains insulin.

Inhaled insulin

Store foil packs at controlled room temperature (59° to 86°F). Do not freeze or refrigerate. Discard blister if frozen. Protect opened unit-dose blisters from moisture and humid conditions; return unused unit dose blisters to foil overwrap to protect from moisture. Use unit dose blisters within 3 mo after opening foil overwrap. Store insulin inhaler at controlled room temperature. Inhaler can be used for up to 1 yr from date of first use. Change release unit in inhaler every 2 wk.

Drug Interactions

ACE inhibitors, anabolic steroids, clofibrate, disopyramide, fibrates, fluoxetine, guanethidine, MAOIs, oral antidiabetics, propoxyphene, salicylates, sulfinpyrazone, sulfonamide antibiotics, tetracyclines

May increase hypoglycemic effects of insulin.

Alcohol, beta-blockers, clonidine, lithium salts

May increase or decrease the blood glucose-lowering effect of insulin.

Atypical antipsychotics, corticosteroids, danazol, diazoxide, diltiazem, glucagon, isoniazid, oral contraceptives, phenothiazines, protease inhibitors, somatropin, sympathomimetics, thyroid hormone

May decrease hypoglycemic effects of insulin.

Beta-blockers, clonidine, guanethidine, reserpine

Signs and symptoms of hypoglycemia may be reduced or absent.

Bronchodilators, other inhaled products

May alter the absorption of inhaled human insulin.

Pentamidine

May cause hypoglycemia, which may be followed by hyperglycemia.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Lipodystrophy.

EENT

Inhalation

Pharyngitis (18%); otitis media (6%); ear pain (4%); ear disorder (1%).

GI

Inhalation

Dry mouth (2%).

Lab Tests

Hypokalemia.

Metabolic

Hypoglycemia.

Respiratory

Inhalation

Respiratory tract infection (43%); increased cough (30%); rhinitis (145%); sinusitis (10%); respiratory disorder (7%); bronchitis (5%); dyspnea, increased sputum (4%); asthma (2%); epistaxis, laryngitis, voice alteration, pneumonia (1%).

Miscellaneous

Hypersensitivity reaction (eg, anaphylaxis, angioedema, fast pulse, hypotension, rash, shortness of breath, sweating); local reactions (eg, itching at injection site, redness, swelling).

Inhalation

Chest pain (5%).

Precautions

Monitor Check blood sugar frequently and observe for signs of hypoglycemia and hyperglycemia. Periodically measure glycosylated hemoglobin (A 1c ) to monitor long-term glycemic control. Check urine for ketones in patient at risk for ketoacidosis and observe for signs and symptoms of ketoacidosis (eg, drowsiness, frequent urination, fruit-like breath, thirst). Assess pulmonary function (eg, spirometry) in all patients prior to starting inhaled insulin. Repeat pulmonary function 6 mo after starting therapy and then annually thereafter.

Pregnancy

Category B (parenteral); Category C (inhalation).

Lactation

Parenteral insulin

Not excreted in breast milk.

Inhalation insulin

Excreted in breast milk.

Children

Safety and efficacy not established (inhalation).

Renal Function

Dose requirements may be reduced; careful glucose monitoring and dose adjustments of insulin may be necessary.

Hepatic Function

Dose requirements may be reduced; careful glucose monitoring and dose adjustments of insulin may be necessary.

Antibody production

Increases in insulin binding antibodies are greater in patients receiving inhaled insulin as compared with patients receiving subcutaneous insulin only.

Bronchospasm

Has been rarely reported in patients using inhaled insulin. Discontinue inhaled insulin and evaluate patient.

Changing insulin

Changes in purity, strength, brand, type, or species source of insulin may necessitate dosage adjustment.

Diabetic ketoacidosis

May result from stress, illness, or insulin omission and may develop slowly after long period of poor insulin control. Condition is potentially life-threatening and requires prompt diagnosis and treatment.

Hypoglycemia

May result from excessive insulin dose, increased work or exercise without eating, or from illness with vomiting, fever, or diarrhea. May also occur when insulin requirements decline.

Insulin resistance

Occurs rarely. Requirements of more than 200 units/day of insulin for more than 2 days in absence of ketoacidosis or acute infection may occur, especially in obese patients, patients with acanthosis nigricans, patients with insulin receptor defects, or during infection.

Lung disease

Use of inhaled insulin not recommended in patients with underlying lung disease (eg, asthma, COPD) because safety and efficacy not established.

Respiratory infections

Close monitoring and dose adjustments of inhaled insulin may be required during intercurrent respiratory infections.

Thyroid

Hyperthyroidism may cause an increase in the renal Cl of insulin; hyperthyroidism may delay insulin turnover.

Overdosage

Symptoms

Hypoglycemia.

Patient Information

• Caution patient or caregiver not to discontinue therapy or change the dose unless advised by health care provider.
• Educate patient or caregiver regarding diabetes and its management, including target ranges for blood sugar control. Instruct patient that insulin is not a substitute for diet and exercise and that they should continue to follow prescribed regimens.
• Educate patient or caregiver regarding potential long-term complications of diabetes and need for regular general physical and eye examinations.
• Ensure that patient or caregiver understands how to use home glucose monitor and has a plan for monitoring and recording blood sugar measurements (eg, log). Advise patient to take log to each visit with health care provider.
• Educate patient regarding value of periodic A _1c testing to confirm level of glucose control.
• Advise patient that insulin dosage will usually be adjusted based on the results of home glucose A _1c monitoring.
• Ensure that patient with type 1 diabetes understands how to monitor for ketones and has a plan of action if ketones are detected.
• Review symptoms of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) as well as action plans to undertake in the event either event occurs.
• Advise patient to discuss with health care provider a plan for managing each of the following situations: insulin dosing during intercurrent conditions (eg, infection, stress, sick days, trauma, vomiting); accidental administration of too little or too much insulin; missed insulin dose; inadequate food intake or a skipped meal; travel across time zones; change in physical activity.
• Advise patient with diabetes to carry medical identification (eg, card, bracelet) indicating condition.
• Instruct patient to notify health care provider if experiencing severe, continuous, or frequent hypoglycemic episodes, hypoglycemic episodes with few or no warning symptoms, continuous or severe hyperglycemia, or injection-site reactions that do no go away after a few days or continue to occur.

• Parenteral insulin
• Advise patient or caregiver to read the patient information leaflet(s) for their particular insulin product(s) before using the first time and to read and check for new information each time medication is refilled.
• Instruct patient or caregiver using more than 1 injectable insulin to always check bottle label for name and letter designation of insulin before withdrawing and administering dose.
• Ensure that patient or caregiver understands how to store, prepare, administer the insulin dose(s), and dispose of used equipment and supplies.
• Advise patient to continuously rotate injection sites (abdomen, thigh, upper arm) to prevent or reduce severity of injection-site reactions (eg, lipodystrophy, pain, inflammation).
• Caution patient not to inject into skin sites that are reddened, itching, or show signs of lipodystrophy.

• Inhaled insulin
• Advise patient or caregiver to read the Medication Guide before using the first time and to read and check for new information each time the medication is refilled.
• Caution patient not to use any injectable short- or rapid-acting forms of insulin while using inhaled insulin.
• Caution patient to never swallow contents of blister nor attempt to breathe in insulin powder without using the supplied inhaler.
• Ensure that patient or caregiver understands how to store, prepare insulin-containing blisters for administration, administer prescribed dose, discard used blisters, clean and store the inhaler, and replace the release unit.
• Advise patient to inhale prescribed dose within 10 min before a meal.
• Ensure that patient has plan of action if discontinuation of inhaled insulin becomes necessary, if any problems with the insulin inhaler occur, or if inhaler breaks and a replacement is needed.
• Advise patient to continue to use any oral diabetes medicines prescribed by health care provider.
• Instruct patient to immediately discontinue inhaled insulin and notify health care provider in the case of a change in breathing or if resuming or starting smoking.
• Advise patient that inhaled insulin may cause a cough, dry mouth, or chest discomfort, and to notify health care provider if these or any other adverse reactions occur and are bothersome.

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