Novolin Insulin Reg. U-100 Human
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin in the upper arm, thigh, buttocks, or stomach area. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Preparation and Administration
1. Wash your hands before use.
2. Take the medication 30 minutes before meals.
3. Rotate the injection site with each dose to avoid tissue damage.
4. Do not shake the medication.
5. Avoid injecting into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
6. Check the solution for cloudiness, leakage, or particles before use. If the solution is cloudy, leaking, or has particles, or if the color has changed, do not use it.
Disposal and Safety
1. Dispose of used needles and syringes in a puncture-proof container.
2. Do not reuse needles or other equipment.
3. When the disposal container is full, follow local regulations for proper disposal.
4. If you have any questions or concerns, consult your doctor or pharmacist.
Additional Administration Information
This medication may be administered intravenously by a healthcare provider. If you are mixing this medication with insulin NPH, ensure you understand the proper mixing technique. Do not mix this medication with other types of insulin. Some brands of this medication may not be suitable for use in an insulin pump, so consult your doctor or pharmacist before using it in a pump. If you are using an insulin pump, follow the manufacturer's instructions and your doctor's guidance for use, maintenance, and replacement of the medication and pump parts.
Storage and Handling
Store unopened containers in the refrigerator. Do not freeze the medication, and do not use it if it has been frozen.
Missed Dose
If you miss a dose, follow your doctor's instructions for what to do. If you are unsure, contact your doctor for guidance. It is also important to follow your doctor's recommended diet and exercise plan, and to know what to do if you skip a meal or do not eat as much as usual.
Lifestyle & Tips
- Always check your blood sugar levels as instructed by your doctor.
- Follow a consistent meal plan and carbohydrate intake as advised by your healthcare provider or dietitian.
- Engage in regular physical activity, but be aware that exercise can lower blood sugar, so adjust insulin or food intake as advised.
- Rotate injection sites to prevent skin problems (lipodystrophy).
- Never share insulin pens, syringes, or needles with others, even if the needle is changed, as this carries a risk of transmitting blood-borne pathogens.
- Always carry a source of fast-acting sugar (e.g., glucose tablets, juice, candy) to treat low blood sugar (hypoglycemia).
- Inform all healthcare providers that you are taking insulin.
- Store insulin as directed (unopened vials in refrigerator, opened vials at room temperature for a limited time).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Some allergic reactions can be life-threatening, so prompt medical attention is crucial.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Swelling in the arms or legs
Thick skin, pits, or lumps at the injection site
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures
If you experience any of these symptoms, call your doctor right away. If you have low blood sugar, follow the instructions you have been given, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Weight gain
Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Symptoms of low blood sugar (hypoglycemia): sweating, shakiness, dizziness, confusion, hunger, irritability, blurred vision, rapid heartbeat, headache. If these occur, treat immediately with fast-acting sugar.
- Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, increased hunger, fatigue, blurred vision. Report persistent high blood sugar to your doctor.
- Symptoms of allergic reaction: rash, itching, swelling of face/lips/tongue, difficulty breathing. Seek immediate medical attention.
- Symptoms of fluid retention/heart failure: unusual swelling in your hands or feet, sudden weight gain, shortness of breath. Report these to your doctor.
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have low blood sugar (hypoglycemia), as this may affect your treatment plan.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent any potential interactions or adverse effects.
Precautions & Cautions
Be aware that this medication can cause low blood sugar (hypoglycemia), which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not treated promptly. Discuss the risks with your doctor.
Additionally, this medication can cause low blood potassium (hypokalemia), which, if left untreated, may result in abnormal heart rhythms, severe breathing difficulties, and potentially death. Consult your doctor if you experience any symptoms.
Until you understand how this medication affects you, avoid driving and other activities that require your full attention. Certain diabetes medications, such as pioglitazone or rosiglitazone, may increase the risk of heart failure when used with insulin. If you are taking one of these medications, discuss the potential risks with your doctor.
During times of stress, such as fever, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar. Monitor your condition closely and consult your doctor as needed.
Wear a medical alert identification to ensure prompt care in case of an emergency. Do not drive if you have experienced low blood sugar, as it can increase your risk of being involved in an accident.
Regularly check your blood sugar levels as instructed by your doctor. Also, have your blood work checked as recommended by your doctor and discuss the results with them.
Before consuming alcohol or using products containing alcohol, consult your doctor. Never share your insulin product, including pens, cartridge devices, needles, or syringes, with another person, even if the needle has been changed, as this can transmit infections.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (extremely low blood sugar)
- Confusion
- Seizures
- Loss of consciousness
- Hypokalemia (low potassium levels)
What to Do:
Immediately consume fast-acting carbohydrates (e.g., glucose tablets, juice, sugary drinks). For severe hypoglycemia with unconsciousness, administer glucagon injection (if available and trained) and seek emergency medical attention. Call 911 or 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Beta-blockers (non-selective): Can mask symptoms of hypoglycemia (e.g., tremor, tachycardia) and prolong hypoglycemic episodes. May also impair glucose counter-regulation.
- Thiazolidinediones (TZDs) e.g., pioglitazone, rosiglitazone: Increased risk of dose-related fluid retention and heart failure when used with insulin, especially in patients with pre-existing heart failure or renal impairment.
- Alcohol: Can potentiate the hypoglycemic effect of insulin, especially on an empty stomach, by inhibiting hepatic gluconeogenesis.
Moderate Interactions
- Corticosteroids: Can increase blood glucose levels, requiring higher insulin doses.
- Diuretics (thiazide and loop): Can cause hyperglycemia, requiring increased insulin doses.
- Sympathomimetics (e.g., epinephrine, albuterol): Can increase blood glucose levels.
- Growth hormone: Can increase blood glucose levels.
- Danazol: Can increase blood glucose levels.
- Oral Contraceptives: May cause insulin resistance, requiring increased insulin doses.
- Thyroid hormones: May alter glucose metabolism, requiring insulin dose adjustments.
- Salicylates (high dose): Can enhance the glucose-lowering effect of insulin.
- Sulfonamide antibiotics: Can enhance the glucose-lowering effect of insulin.
- Monoamine Oxidase Inhibitors (MAOIs): Can enhance the glucose-lowering effect of insulin.
- Angiotensin-converting enzyme (ACE) inhibitors: May enhance the glucose-lowering effect of insulin.
- Somatostatin analogs (e.g., octreotide): Can either decrease or increase insulin requirements.
- Pentamidine: Can cause hypoglycemia followed by hyperglycemia.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline glycemic control and set treatment goals.
Timing: Prior to initiation of insulin therapy.
Rationale: To establish baseline glucose levels.
Timing: Prior to initiation of insulin therapy.
Rationale: To assess kidney function, as insulin clearance is reduced in renal impairment, increasing hypoglycemia risk.
Timing: Prior to initiation and periodically thereafter.
Rationale: To assess liver function, as hepatic impairment can affect glucose production and insulin degradation.
Timing: Prior to initiation and periodically thereafter.
Rationale: To establish baseline and monitor for hypokalemia, especially in patients at risk or receiving IV insulin.
Timing: Prior to initiation and periodically thereafter, particularly with IV use.
Routine Monitoring
Frequency: Multiple times daily (e.g., pre-meal, 2-hour post-meal, bedtime, overnight) depending on regimen and glycemic control.
Target: Individualized (e.g., pre-meal 80-130 mg/dL, post-meal <180 mg/dL for most non-pregnant adults).
Action Threshold: Hypoglycemia (<70 mg/dL) requires immediate action; persistent hyperglycemia requires dose adjustment.
Frequency: Every 3-6 months (or more frequently if glycemic goals are not met or therapy is changed).
Target: Individualized (e.g., <7% for most non-pregnant adults).
Action Threshold: Above target range indicates need for therapy adjustment.
Frequency: Periodically (e.g., every 3-6 months).
Target: Maintain healthy weight or manage weight gain.
Action Threshold: Significant or rapid weight gain may indicate fluid retention or excessive caloric intake.
Frequency: At each injection.
Target: Not applicable
Action Threshold: Presence of lipodystrophy (lipoatrophy or lipohypertrophy) requires rotation of injection sites.
Symptom Monitoring
- Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, palpitations, headache, slurred speech, seizures, unconsciousness)
- Symptoms of hyperglycemia (e.g., polyuria, polydipsia, polyphagia, fatigue, blurred vision, weight loss)
- Symptoms of allergic reactions (e.g., rash, itching, swelling, difficulty breathing)
- Symptoms of fluid retention/heart failure (e.g., swelling in ankles/feet, shortness of breath, rapid weight gain)
Special Patient Groups
Pregnancy
Insulin is the preferred treatment for diabetes in pregnancy. Insulin requirements typically decrease in the first trimester, increase in the second and third trimesters, and rapidly decrease postpartum. Close monitoring of blood glucose is essential.
Trimester-Specific Risks:
Lactation
Insulin is compatible with breastfeeding. Insulin is a large protein molecule and is not excreted into breast milk in clinically significant amounts. Insulin requirements may be lower during lactation, especially in the immediate postpartum period.
Pediatric Use
Insulin is essential for the management of Type 1 Diabetes in children and adolescents. Dosing is highly individualized based on age, weight, pubertal status, activity level, and glycemic control. Close monitoring is crucial due to varying insulin sensitivity and risk of hypoglycemia.
Geriatric Use
Older adults may be more susceptible to the hypoglycemic effects of insulin due to impaired renal function, reduced counter-regulatory responses, and polypharmacy. Lower starting doses and careful titration are often recommended. Glycemic targets may be less stringent to avoid severe hypoglycemia.
Clinical Information
Clinical Pearls
- Regular insulin is the only insulin formulation that can be administered intravenously, making it crucial for emergency situations like DKA or severe hyperkalemia.
- It is a short-acting insulin, meaning it has a relatively rapid onset and shorter duration compared to intermediate or long-acting insulins. This makes it suitable for mealtime coverage or correction doses.
- Patients must eat a meal within 30 minutes of injecting regular insulin to prevent hypoglycemia.
- Always verify the insulin type (e.g., Regular, NPH, Glargine) and concentration (U-100, U-500) carefully before administration to avoid medication errors.
- Proper injection technique and rotation of injection sites are vital to prevent lipodystrophy and ensure consistent absorption.
- Educate patients on the signs and symptoms of hypoglycemia and how to treat it effectively.
- Insulin requirements can change due to illness, stress, changes in diet or exercise, and other medications. Patients should be advised to monitor blood glucose more frequently during these times.
Alternative Therapies
- Rapid-acting insulin analogs (e.g., insulin lispro, insulin aspart, insulin glulisine) for mealtime coverage, offering faster onset and shorter duration.
- Intermediate-acting insulin (e.g., NPH insulin) for basal or prandial coverage.
- Long-acting insulin analogs (e.g., insulin glargine, insulin detemir, insulin degludec) for basal insulin needs.
- Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) for Type 2 Diabetes, often used in combination with insulin or as monotherapy.