Humulin N Insulin (hi-310)

Manufacturer LILLY Active Ingredient Insulin NPH (Vials)(IN soo lin N P H) Pronunciation HYOO-myoo-lin EN IN-soo-lin
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, intermediate-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?

Humulin N is a type of insulin that helps your body use sugar for energy. It's an intermediate-acting insulin, meaning it starts working a few hours after you inject it and lasts for about half a day. It helps control your blood sugar between meals and overnight.
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How to Use This Medicine

Proper Administration of This Medication

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically in the upper arm, thigh, buttocks, or stomach area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.

Preparation and Inspection

Before use, this medication must be mixed according to the instructions provided by your doctor. Once mixed, the solution should appear cloudy and milky. Do not use the medication if the solution is clear, contains lumps, or has powder stuck to the sides of the container. Additionally, do not use the medication if the solution is leaking, contains particles, or has changed color.

Injection Site Selection and Rotation

When administering the injection, avoid areas of thickened skin, or skin with pits, lumps, irritation, tenderness, bruising, redness, scaliness, hardness, scarring, or stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.

Safe Disposal and Handling

Dispose of used needles and syringes in a designated sharps disposal container. Do not reuse needles or other equipment. When the container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.

Diet and Exercise

Adhere to the diet and exercise plan recommended by your doctor to ensure optimal effectiveness and safety of this medication.

Important Usage Considerations

This medication is not intended for use in an insulin pump. If you have questions or concerns, consult your doctor. Additionally, do not draw the medication into a syringe and store it for future use.

Storage and Disposal

Store unopened containers of this medication in the refrigerator, avoiding freezing temperatures. Do not use the medication if it has been frozen. If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine the maximum storage duration and proper disposal procedures.

Missed Dose Instructions

If you miss a dose, administer it as soon as possible. However, if the missed dose is near the time of your next scheduled injection, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or administer extra doses.
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Lifestyle & Tips

  • Administer insulin exactly as prescribed by your doctor. Do not change your dose without consulting your doctor.
  • Inject insulin subcutaneously (under the skin) in areas like the abdomen, thigh, upper arm, or buttocks. Rotate injection sites to prevent skin problems (lipodystrophy).
  • Do not inject into a vein or muscle.
  • Always check the insulin label before each injection to ensure you are using the correct type of insulin.
  • Do not mix Humulin N with other insulins unless instructed by your doctor.
  • Do not share needles or insulin pens with others.
  • Follow a consistent meal plan and exercise routine as advised by your healthcare provider.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, juice, candy) to treat low blood sugar.
  • Monitor your blood sugar levels regularly as instructed by your doctor.
  • Store unopened vials/pens in the refrigerator. Once opened, store at room temperature (below 86°F/30°C) and use within 14-28 days (check specific product instructions). Do not freeze insulin.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized, typically 0.5-1 unit/kg/day in divided doses, often 2/3 of total daily dose in the morning and 1/3 in the evening.
Dose Range: 0.3 - 1 mg

Condition-Specific Dosing:

Type 1 Diabetes: Initial total daily dose (TDD) of 0.5-0.8 units/kg/day, with NPH often comprising 50-70% of TDD, split into 2 doses.
Type 2 Diabetes: Initial dose of 0.1-0.2 units/kg/day or 10 units once or twice daily, adjusted based on blood glucose levels.
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Pediatric Dosing

Neonatal: Not established (use rapid/short-acting insulin with continuous infusion for neonates)
Infant: Highly individualized, typically 0.2-0.5 units/kg/day, adjusted based on blood glucose. NPH may be used as part of a basal-bolus regimen.
Child: Highly individualized, typically 0.5-1 unit/kg/day, adjusted based on blood glucose. NPH often used as basal component.
Adolescent: Highly individualized, typically 0.8-1.2 units/kg/day during puberty, adjusted based on blood glucose. NPH often used as basal component.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor glucose closely.
Moderate: Dose reduction may be required (e.g., 25-50% reduction), monitor glucose closely.
Severe: Significant dose reduction likely required (e.g., 50-75% reduction), monitor glucose closely, increased risk of hypoglycemia.
Dialysis: Dose reduction required, monitor glucose closely, increased risk of hypoglycemia.

Hepatic Impairment:

Mild: No specific dose adjustment, but monitor glucose closely.
Moderate: Dose reduction may be required, monitor glucose closely, increased risk of hypoglycemia.
Severe: Significant dose reduction likely required, monitor glucose closely, increased risk of hypoglycemia.

Pharmacology

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Mechanism of Action

Insulin NPH (Isophane Insulin Suspension) is an intermediate-acting insulin. It lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (subcutaneous administration)
Tmax: 4-12 hours (peak effect)
FoodEffect: Food intake should be coordinated with insulin action to prevent hypoglycemia.

Distribution:

Vd: Not available (insulin distributes widely)
ProteinBinding: Minimal
CnssPenetration: Limited

Elimination:

HalfLife: Not directly measurable due to complex absorption kinetics from subcutaneous tissue; functional half-life related to duration of action.
Clearance: Not available
ExcretionRoute: Renal (metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: 1.5-4 hours
PeakEffect: 4-12 hours
DurationOfAction: 12-18 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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:

Irritation at the injection site
Weight gain

These are not all the possible side effects that may occur. 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 severe hypoglycemia: severe confusion, seizures, loss of consciousness.
  • Symptoms of hyperglycemia/diabetic ketoacidosis: excessive thirst, frequent urination, nausea, vomiting, abdominal pain, fruity breath odor, rapid breathing.
  • Symptoms of allergic reaction: rash over the whole body, shortness of breath, wheezing, fast heartbeat, sweating, low blood pressure.
  • Signs of injection site problems: persistent redness, swelling, itching, or changes in skin texture (lumps or pits).
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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 symptoms you experienced.
If you have low blood sugar (hypoglycemia).

This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems

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 potential interactions and ensure the safe use of this medication.
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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.

This drug may cause low blood sugar, which can lead to seizures, loss of consciousness, permanent brain damage, and even death if not properly managed. It is crucial to discuss this risk with your doctor. Additionally, this medication may cause low blood potassium levels, which can result in abnormal heart rhythms, severe breathing problems, and potentially death if left untreated. If you experience any symptoms, consult your doctor promptly.

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 or worsen existing heart failure, especially when combined with insulin. If you are taking one of these medications, consult your doctor to discuss the potential risks.

Ensure you have the correct insulin product and are familiar with its administration. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns about measuring or preparing your dose, contact your doctor or pharmacist.

During periods 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 levels.

Wear a medical alert identification to ensure prompt care in case of an emergency. Avoid driving if you have experienced low blood sugar, as it increases the risk of accidents. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as recommended.

Before consuming alcohol or using products containing alcohol, consult your doctor to discuss potential risks. 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 benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (low blood sugar)
  • Confusion
  • Dizziness
  • Sweating
  • Tremor
  • Blurred vision
  • Slurred speech
  • Seizures
  • Loss of consciousness
  • Coma

What to Do:

For mild to moderate hypoglycemia, consume 15-20 grams of fast-acting carbohydrates (e.g., 4 oz juice, 3-4 glucose tablets). Recheck blood glucose in 15 minutes. Repeat if necessary. For severe hypoglycemia (unconsciousness, seizures), administer glucagon injection if available and call 911 or emergency medical services immediately. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask hypoglycemia symptoms)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure when used with insulin)
  • Alcohol (can potentiate hypoglycemic effect)
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Moderate Interactions

  • Oral antidiabetic agents (additive hypoglycemic effect)
  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Diuretics (thiazide and loop diuretics may increase blood glucose)
  • Sympathomimetics (e.g., decongestants, asthma medications; may increase blood glucose)
  • Atypical antipsychotics (may cause hyperglycemia)
  • Protease inhibitors (may cause hyperglycemia)
  • Somatostatin analogs (e.g., octreotide, lanreotide; may decrease insulin requirements)
  • Salicylates (e.g., aspirin; high doses may enhance insulin effect)
  • Sulfonamide antibiotics (may enhance insulin effect)

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and guide initial dosing.

Timing: Prior to initiation

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glucose levels.

Timing: Prior to initiation

Renal function (SCr, eGFR)

Rationale: To assess kidney function as insulin clearance can be affected.

Timing: Prior to initiation

Hepatic function (ALT, AST)

Rationale: To assess liver function as insulin metabolism can be affected.

Timing: Prior to initiation

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Routine Monitoring

Self-monitoring Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., pre-meal, bedtime, post-meal, overnight as needed)

Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL 1-2 hours post-meal

Action Threshold: Hypoglycemia (<70 mg/dL) or persistent hyperglycemia (>180-250 mg/dL)

HbA1c

Frequency: Every 3-6 months

Target: <7% for most adults (individualized)

Action Threshold: >7% (or individualized target) indicating need for therapy adjustment

Weight

Frequency: Regularly (e.g., monthly or at each visit)

Target: Stable or within healthy range

Action Threshold: Significant unexplained weight gain or loss

Injection sites

Frequency: At each visit

Target: No signs of lipodystrophy or irritation

Action Threshold: Presence of lipohypertrophy or lipoatrophy

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, confusion, hunger, dizziness, blurred vision, irritability)
  • Symptoms of hyperglycemia (e.g., polyuria, polydipsia, polyphagia, fatigue, blurred vision)
  • Signs of allergic reaction (e.g., rash, itching, swelling, difficulty breathing)
  • Injection site reactions (e.g., redness, swelling, itching, pain)

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy. Insulin NPH has been widely used and is considered safe and effective for controlling blood glucose during pregnancy. Close monitoring of blood glucose is essential.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations directly attributed to insulin use. Good glycemic control is crucial to prevent adverse outcomes.
Second Trimester: Insulin requirements may increase due to hormonal changes. Close monitoring and dose adjustments are necessary.
Third Trimester: Insulin requirements typically continue to increase. Risk of preeclampsia and macrosomia if glycemic control is poor.
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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. It is not expected to cause adverse effects in breastfed infants.

Infant Risk: L1 (Safest)
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Pediatric Use

Insulin NPH is commonly used in pediatric patients with type 1 diabetes. Dosing is highly individualized based on age, weight, pubertal status, and glycemic control. Close monitoring of blood glucose is crucial to prevent hypoglycemia.

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Geriatric Use

Older adults may be more susceptible to hypoglycemia due to impaired renal function, reduced counter-regulatory responses, and polypharmacy. Start with lower doses and titrate slowly. Monitor blood glucose frequently and educate patients/caregivers on hypoglycemia symptoms and management.

Clinical Information

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Clinical Pearls

  • NPH insulin has a pronounced peak effect, which can increase the risk of nocturnal hypoglycemia if the evening dose is too high or not properly timed with a bedtime snack.
  • It is often used in combination with rapid-acting or short-acting insulin to provide both basal and prandial coverage.
  • Patients should be educated on proper injection technique, site rotation, and storage to ensure efficacy and prevent complications like lipodystrophy.
  • Humulin N and Novolin N are interchangeable in terms of active ingredient (NPH insulin) but always confirm with the prescribing physician or pharmacist before switching brands.
  • The suspension must be gently rolled or inverted several times before each injection to ensure uniform mixing, but not shaken vigorously to avoid foaming.
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Alternative Therapies

  • Long-acting insulins (e.g., insulin glargine, insulin detemir, insulin degludec) for basal insulin needs.
  • Rapid-acting insulins (e.g., insulin lispro, insulin aspart, insulin glulisine) for mealtime coverage.
  • Short-acting insulins (e.g., regular insulin) for mealtime coverage or correction doses.
  • Oral antidiabetic agents (for Type 2 Diabetes, often in combination with insulin or as monotherapy for milder cases).
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Cost & Coverage

Average Cost: Varies widely, e.g., $100-$300 per 10 mL vial (100 units/mL)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often preferred generic or preferred brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.