Humulin R U-100 3ml

Manufacturer LILLY Active Ingredient Insulin Regular (U-100) Vials(IN soo lin REG yoo ler) Pronunciation 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
Pancreatic hormone; short-acting insulin
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Pregnancy Category
Category B
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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?

Insulin Regular is a type of insulin that works quickly to lower your blood sugar. It's often used before meals to help your body use the sugar from the food you eat. It helps manage diabetes by allowing sugar to enter your cells for energy.
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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

Before use, wash your hands thoroughly. Take the medication 30 minutes before meals. Rotate the injection site with each dose to avoid tissue damage. Do not shake the medication. Avoid injecting into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.

Important Safety Precautions

Do not use the medication if the solution is cloudy, leaking, or contains particles. Check the solution for any changes in color before use. Dispose of used needles and syringes in a sharps disposal container. Do not reuse needles or other equipment. When the container is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.

Special Instructions

Do not draw the medication into a syringe and store it for future use. This medication may be administered intravenously by a healthcare professional. If you are mixing this medication with insulin NPH, ensure you follow your doctor's instructions and understand the proper mixing technique. Do not mix this medication with other types of insulin.

Insulin Pump Use

Some brands of this medication may not be suitable for use in an insulin pump, unless specified by your doctor. If you plan to use an insulin pump, consult your doctor or pharmacist to confirm whether your brand is compatible. If using an insulin pump, follow your doctor's instructions and the manufacturer's guidelines for use, maintenance, and replacement of the medication and pump parts.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor. Be aware of the steps to take if you miss a meal or do not eat as much as usual.

Storage and Disposal

Store unopened containers in the refrigerator. Do not freeze the medication. If the medication has been frozen, do not use it.

Missed Dose

If you forget to take a dose, follow your doctor's instructions or call your doctor for guidance.
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Lifestyle & Tips

  • Administer insulin 30 minutes before a meal.
  • Follow a consistent meal plan and exercise routine as advised by your healthcare provider.
  • Learn proper injection technique and rotate injection sites to prevent skin problems.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, fruit juice) to treat low blood sugar.
  • Monitor your blood sugar levels regularly as instructed by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on metabolic needs, blood glucose monitoring, and HbA1c. Typically administered subcutaneously 30 minutes before meals.

Condition-Specific Dosing:

Type 1 Diabetes: Initial total daily dose typically 0.5 to 1 unit/kg/day, divided into basal and bolus doses. Regular insulin is used for bolus (mealtime) doses.
Type 2 Diabetes: Initial dose often 0.1 to 0.2 units/kg/day, or 4 to 6 units once or twice daily, adjusted based on blood glucose levels.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, highly individualized)
Infant: Highly individualized based on weight, age, and glycemic control. Typically 0.25 to 0.5 units/kg/day, adjusted.
Child: Highly individualized based on weight, age, and glycemic control. Typically 0.5 to 1 unit/kg/day, adjusted.
Adolescent: Highly individualized based on weight, age, and glycemic control. May require higher doses during puberty (up to 1.5 units/kg/day).
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Dose Adjustments

Renal Impairment:

Mild: Dose reduction may be required; monitor blood glucose closely.
Moderate: Dose reduction typically required (e.g., 25-50% reduction); monitor blood glucose closely.
Severe: Significant dose reduction required (e.g., 50-75% reduction); monitor blood glucose closely.
Dialysis: Dose adjustments necessary; insulin clearance may be reduced. Administer after dialysis if possible, or adjust based on pre-dialysis glucose.

Hepatic Impairment:

Mild: Dose reduction may be required; monitor blood glucose closely.
Moderate: Dose reduction typically required; monitor blood glucose closely.
Severe: Significant dose reduction required; monitor blood glucose closely.

Pharmacology

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Mechanism of Action

Insulin regular binds to specific insulin receptors on target cells (e.g., muscle, adipose tissue, liver), facilitating the cellular uptake of glucose, inhibiting hepatic glucose production, and promoting glycogen synthesis. It also promotes protein synthesis and inhibits lipolysis and proteolysis.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100% (subcutaneous, but absorption rate varies)
Tmax: 1.5 to 3.5 hours (subcutaneous)
FoodEffect: Administered 30 minutes before meals to coincide with postprandial glucose rise.

Distribution:

Vd: Approximately 0.2 L/kg
ProteinBinding: Low (<10%)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 5-10 minutes (intravenous); effective half-life after subcutaneous injection is longer due to absorption kinetics (variable, 1-2 hours).
Clearance: Variable, dependent on renal and hepatic function.
ExcretionRoute: Renal (primarily metabolites, small amount of unchanged insulin)
Unchanged: Less than 2% (renal)
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Pharmacodynamics

OnsetOfAction: 30 to 60 minutes (subcutaneous)
PeakEffect: 2 to 4 hours (subcutaneous)
DurationOfAction: 6 to 8 hours (subcutaneous)
Confidence: Medium

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 have mild 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, shaking, dizziness, confusion, hunger, irritability. Treat immediately.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision. Contact your doctor if persistent.
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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.

Additionally, this medication may interact with other health conditions or medications. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm 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 and symptoms of low blood sugar 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 alertness. 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 illness, infection, injury, or surgery, your blood sugar levels may be more challenging to control. Changes in physical activity, exercise, or diet can also impact your blood sugar levels.

For your safety, wear a medical alert identification (ID) that indicates you have diabetes. Do not drive if you have experienced low blood sugar, as this can increase your risk of being involved in an accident.

Monitor your blood sugar levels as directed by your doctor. Regular blood tests will also be necessary to assess your condition; follow your doctor's instructions and discuss any concerns 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 years 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 (blood glucose <50 mg/dL)
  • Confusion, disorientation
  • Seizures
  • Loss of consciousness
  • Coma

What to Do:

If conscious, administer oral glucose (e.g., glucose tablets, fruit juice, sugary soda). If unconscious, administer glucagon injection (if available and trained) and/or seek immediate medical attention. Call 911 or your local emergency number. In a medical setting, intravenous dextrose may be administered.

Drug Interactions

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Major Interactions

  • Thiazolidinediones (TZDs): Increased risk of fluid retention and heart failure when co-administered with insulin, especially in patients with pre-existing heart failure.
  • Beta-blockers: May mask symptoms of hypoglycemia (e.g., tremor, palpitations) and delay recovery from hypoglycemia.
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Moderate Interactions

  • Corticosteroids, diuretics (thiazide, loop), sympathomimetics (e.g., epinephrine, albuterol), atypical antipsychotics, danazol, diazoxide, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, somatropin, thyroid hormones: May decrease the hypoglycemic effect of insulin (increase blood glucose).
  • ACE inhibitors, angiotensin receptor blockers (ARBs), disopyramide, fibrates, fluoxetine, MAO inhibitors, propoxyphene, salicylates (e.g., aspirin), somatostatin analogs (e.g., octreotide), sulfonamide antibiotics: May increase the hypoglycemic effect of insulin (decrease blood glucose).
  • Alcohol: May potentiate the hypoglycemic effect of insulin.

Monitoring

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Baseline Monitoring

HbA1c (Glycated Hemoglobin)

Rationale: To assess long-term glycemic control and establish a baseline for treatment goals.

Timing: Prior to initiation of therapy.

Fasting Plasma Glucose (FPG)

Rationale: To assess baseline glucose levels.

Timing: Prior to initiation of therapy.

Renal Function (Serum Creatinine, eGFR)

Rationale: To assess kidney function, as insulin clearance can be affected by renal impairment.

Timing: Prior to initiation of therapy.

Hepatic Function (ALT, AST)

Rationale: To assess liver function, as insulin metabolism occurs in the liver.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Self-Monitoring Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., pre-meal, 2 hours post-meal, bedtime, overnight) depending on treatment regimen and patient needs.

Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL post-meal.

Action Threshold: Adjust insulin dose based on patterns of hyperglycemia or hypoglycemia; seek medical attention for persistent out-of-range values.

HbA1c (Glycated Hemoglobin)

Frequency: Every 3-6 months.

Target: Individualized, typically <7% for most adults.

Action Threshold: Adjust therapy if target not met; investigate causes of poor control.

Signs and Symptoms of Hypoglycemia

Frequency: Daily, ongoing patient education.

Target: Not applicable

Action Threshold: Immediate treatment with fast-acting carbohydrates if blood glucose <70 mg/dL or symptomatic.

Injection Sites

Frequency: With each injection.

Target: Not applicable

Action Threshold: Rotate sites to prevent lipodystrophy (lumps or depressions in the skin).

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Symptom Monitoring

  • Symptoms of Hypoglycemia: Sweating, tremor, palpitations, anxiety, hunger, dizziness, lightheadedness, confusion, irritability, headache, blurred vision, slurred speech, weakness, seizures, unconsciousness.
  • Symptoms of Hyperglycemia: Polyuria (frequent urination), polydipsia (increased thirst), polyphagia (increased hunger), fatigue, blurred vision, weight loss, nausea, vomiting, abdominal pain (especially in DKA).

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for managing diabetes (pre-existing or gestational) during pregnancy. It does not cross the placenta in significant amounts. Close monitoring of blood glucose is essential, and insulin requirements may change throughout pregnancy.

Trimester-Specific Risks:

First Trimester: Insulin requirements may decrease due to nausea/vomiting. Risk of congenital anomalies is related to glycemic control, not insulin itself.
Second Trimester: Insulin requirements typically increase due to increasing insulin resistance.
Third Trimester: Insulin requirements continue to increase, often peaking in the late third trimester.
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Lactation

Insulin is compatible with breastfeeding. It is a large protein molecule and is not excreted into breast milk in clinically significant amounts. It is considered safe for the nursing infant.

Infant Risk: L1 (Safest - no increase in risk to the infant).
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Pediatric Use

Insulin regular is safe and effective for use in pediatric patients with diabetes. Dosing is highly individualized based on age, weight, pubertal status, and glycemic control. Close monitoring is crucial to prevent hypoglycemia.

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Geriatric Use

Geriatric patients may be at increased risk of hypoglycemia due to impaired renal/hepatic function, comorbidities, polypharmacy, and reduced counter-regulatory responses. Dosing should be initiated cautiously and titrated slowly with careful monitoring of blood glucose. Education on hypoglycemia recognition is vital.

Clinical Information

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Clinical Pearls

  • Humulin R U-100 is a short-acting insulin. It should be administered 30 minutes before a meal.
  • Always check the insulin label carefully to ensure the correct type and concentration of insulin is being used.
  • Rotate injection sites (abdomen, thigh, upper arm, buttocks) to prevent lipodystrophy (fat accumulation or atrophy at injection sites).
  • Do not mix Humulin R U-100 with long-acting insulins (e.g., insulin glargine, insulin detemir). It can be mixed with NPH insulin (Humulin N) in the same syringe, drawing regular insulin first.
  • Store unopened vials/pens in the refrigerator (2°C to 8°C). Once opened, store at room temperature (below 25°C) and use within 28 days.
  • Educate patients and caregivers on the signs and symptoms of hypoglycemia and how to treat it promptly.
  • Patients should always carry identification indicating they have diabetes and use insulin.
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Alternative Therapies

  • Rapid-acting insulins (e.g., insulin lispro, insulin aspart, insulin glulisine)
  • Intermediate-acting insulins (e.g., NPH insulin)
  • Long-acting insulins (e.g., insulin glargine, insulin detemir, insulin degludec)
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists - for Type 2 Diabetes)
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Cost & Coverage

Average Cost: Highly variable; check current drug pricing databases (e.g., GoodRx, Red Book) per 10mL vial or 3mL pen
Generic Available: Yes
Insurance Coverage: Often Tier 2 or Tier 3 on most commercial and Medicare Part D plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.