Novolin Insulin Reg. U-100 Human

Manufacturer NOVO NORDISK Active Ingredient Insulin Regular (U-100) Vials(IN soo lin REG yoo ler) Pronunciation NO-vo-lin IN-soo-lin REG-yoo-ler
It is used to lower blood sugar in patients with high blood sugar (diabetes).
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Drug Class
Antidiabetic agent
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Pharmacologic Class
Insulin, short-acting
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Pregnancy Category
Not available
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FDA Approved
Oct 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Novolin R is a type of insulin that helps your body use sugar for energy. It starts working fairly quickly (about 30 minutes) and lasts for several hours. You usually take it about 30 minutes before your meals to help control your blood sugar after eating. It's important to check your blood sugar regularly and follow your doctor's instructions carefully.
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How to Use This Medicine

Proper Use of This Medication

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.
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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).

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on patient's metabolic needs, blood glucose monitoring, and glycemic goals. Typically administered subcutaneously 30 minutes before meals. Can also be given intravenously in emergency settings (e.g., DKA).

Condition-Specific Dosing:

Type 1 Diabetes: Initial total daily dose often 0.5-1.0 units/kg/day, with 50-70% as basal and 30-50% as prandial (divided before meals). Regular insulin is typically used for prandial coverage.
Type 2 Diabetes: Initial dose often 0.1-0.2 units/kg/day or 10 units/day, adjusted based on glucose levels. Regular insulin may be used for mealtime coverage or in combination with basal insulin.
Diabetic Ketoacidosis (DKA): IV infusion: Initial bolus of 0.1 units/kg, followed by continuous infusion of 0.1 units/kg/hour. Adjust rate to decrease blood glucose by 50-75 mg/dL/hour.
Hyperkalemia: IV infusion: 10 units regular insulin with 25-50g dextrose (e.g., 50mL of D50W) over 15-30 minutes.
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Pediatric Dosing

Neonatal: Dosing individualized, often 0.05-0.1 units/kg/hour IV infusion for hyperglycemia, or 0.1 units/kg/dose SC for diabetes management.
Infant: Dosing individualized, often 0.1-0.2 units/kg/day total daily dose, adjusted based on glucose levels.
Child: Initial total daily dose often 0.5-1.0 units/kg/day, with 50-70% as basal and 30-50% as prandial. Regular insulin is typically used for prandial coverage.
Adolescent: Initial total daily dose often 0.5-1.0 units/kg/day, with 50-70% as basal and 30-50% as prandial. During puberty, insulin requirements may increase to 1.0-1.5 units/kg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment typically required, but monitor glucose closely.
Moderate: Dose reduction may be necessary due to decreased insulin clearance and increased risk of hypoglycemia. Monitor glucose frequently.
Severe: Significant dose reduction (e.g., 25-50% or more) is often required. Close glucose monitoring is essential due to high risk of hypoglycemia.
Dialysis: Insulin is not significantly removed by dialysis. Dose adjustments are based on residual renal function and glucose monitoring. Patients on dialysis are at increased risk of hypoglycemia.

Hepatic Impairment:

Mild: No specific dose adjustment typically required, but monitor glucose closely.
Moderate: Dose reduction may be necessary due to impaired hepatic glucose production and reduced insulin degradation. Monitor glucose frequently.
Severe: Significant dose reduction may be required. Close glucose monitoring is essential due to increased risk of hypoglycemia.

Pharmacology

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Mechanism of Action

Insulin regular is a short-acting insulin that lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. It binds to insulin receptors on target cells, facilitating glucose transport across cell membranes. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable (subcutaneous), approaching 100% (intravenous)
Tmax: Subcutaneous: 2-3 hours
FoodEffect: Administered 30 minutes before meals to coincide with postprandial glucose rise.

Distribution:

Vd: Approximately 0.1 L/kg
ProteinBinding: Minimal (less than 10%)
CnssPenetration: Limited

Elimination:

HalfLife: Subcutaneous: 1.5-4.5 hours (functional half-life, reflecting absorption and elimination); IV: 5-10 minutes (circulating half-life)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (approximately 80% of filtered insulin is reabsorbed and degraded by the kidney)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Subcutaneous: 30 minutes
PeakEffect: Subcutaneous: 2-3 hours
DurationOfAction: Subcutaneous: 6-8 hours (can extend up to 10 hours depending on dose and individual variability)
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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.
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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.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

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.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Ensure you have the correct insulin product, as it comes in various containers such as vials, cartridges, and pens. Understand how to accurately measure and prepare your dose. If you have any questions or concerns, consult your doctor or pharmacist.

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.
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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

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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.
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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.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and set treatment goals.

Timing: Prior to initiation of insulin therapy.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glucose levels.

Timing: Prior to initiation of insulin therapy.

Renal function (SCr, eGFR)

Rationale: To assess kidney function, as insulin clearance is reduced in renal impairment, increasing hypoglycemia risk.

Timing: Prior to initiation and periodically thereafter.

Hepatic function (ALT, AST)

Rationale: To assess liver function, as hepatic impairment can affect glucose production and insulin degradation.

Timing: Prior to initiation and periodically thereafter.

Potassium levels

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.

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Routine Monitoring

Blood Glucose (Self-Monitoring Blood Glucose - SMBG)

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.

HbA1c

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.

Weight

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.

Injection sites

Frequency: At each injection.

Target: Not applicable

Action Threshold: Presence of lipodystrophy (lipoatrophy or lipohypertrophy) requires rotation of injection sites.

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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

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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:

First Trimester: Insulin requirements may decrease. Risk of hypoglycemia.
Second Trimester: Insulin requirements typically increase.
Third Trimester: Insulin requirements continue to increase. Close monitoring to prevent hyperglycemia and associated fetal risks.
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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.

Infant Risk: L1 (Safest - compatible with breastfeeding, no known adverse effects on the infant).
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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.

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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

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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.
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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.
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Cost & Coverage

Average Cost: Varies widely, typically $100-$300 per 10 mL vial (U-100)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often preferred due to lower cost compared to insulin analogs)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.