Novolin Insulin Nph U-100 Human

Manufacturer NOVO NORDISK Active Ingredient Insulin NPH (Vials)(IN soo lin N P H) Pronunciation NO-vo-lin IN-soo-lin N-P-H YOO-wun-hun-dred HYOO-man
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
Category B
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FDA Approved
Jan 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Novolin NPH 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 a day. It's used to control high blood sugar in people with diabetes.
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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 of 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.

Preparing the Medication

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 if powder is stuck to the sides of the container. Additionally, do not use the medication if the solution is leaking, contains particles, or has changed color.

Choosing an Injection Site

When selecting an injection site, avoid areas with thickened skin, 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.

Disposing of Needles and Containers

After use, dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor to ensure optimal results with this medication.

Important Administration Instructions

This medication must not be used in an insulin pump. If you have any 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 in the refrigerator, but do not freeze. If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine the maximum storage time before disposal. Do not use the medication if it has been frozen.

Missed Doses

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Always check your blood sugar levels as directed by your doctor.
  • Follow your meal plan and exercise routine consistently.
  • Learn how to properly inject insulin and rotate injection sites to prevent skin problems.
  • Never share insulin pens, needles, or syringes with others.
  • Always have a source of fast-acting sugar (e.g., glucose tablets, juice) readily available to treat low blood sugar.
  • Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
  • Store unopened insulin in the refrigerator. Once opened, it can be kept at room temperature for a limited time (check package insert for specific duration, typically 28 days).

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's metabolic needs, blood glucose monitoring, and glycemic goals. Typically administered once or twice daily.

Condition-Specific Dosing:

Type 1 Diabetes: Initial total daily dose often 0.5-1.0 units/kg/day, with NPH typically comprising 1/3 to 1/2 of the total daily dose, given in 1-2 injections. Adjusted based on blood glucose levels.
Type 2 Diabetes: Initial dose often 0.1-0.2 units/kg/day or 10 units once daily, adjusted by 2-4 units every 3-7 days until glycemic targets are met. Typically given at bedtime or twice daily.
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Pediatric Dosing

Neonatal: Not established for routine use; highly specialized dosing if used.
Infant: Highly individualized. Initial dose typically 0.25-0.5 units/kg/day, adjusted based on blood glucose levels.
Child: Highly individualized. Initial dose typically 0.5-1.0 units/kg/day, adjusted based on blood glucose levels. Often given as part of a basal-bolus regimen.
Adolescent: Highly individualized. Initial dose typically 0.5-1.2 units/kg/day (may be higher during puberty), adjusted based on blood glucose levels.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment typically required, but monitor blood glucose closely.
Moderate: Dose reduction may be required due to decreased insulin clearance and increased risk of hypoglycemia. Monitor blood glucose frequently.
Severe: Significant dose reduction (e.g., 25-50% or more) is often necessary. Monitor blood glucose very closely and adjust dose based on glycemic control.
Dialysis: Dose reduction is typically required. Administer after dialysis sessions if possible to avoid hypoglycemia. Monitor blood glucose frequently.

Hepatic Impairment:

Mild: No specific dose adjustment typically required, but monitor blood glucose closely.
Moderate: Dose reduction may be required due to impaired gluconeogenesis and decreased insulin clearance. Monitor blood glucose frequently.
Severe: Significant dose reduction may be necessary due to impaired gluconeogenesis and decreased insulin clearance. Monitor blood glucose very closely and adjust dose based on glycemic control.

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 (administered subcutaneously)
Tmax: 4-12 hours (highly variable)
FoodEffect: Food intake should be coordinated with insulin action profile to prevent hypoglycemia or hyperglycemia.

Distribution:

Vd: Not available (distributes throughout extracellular fluid)
ProteinBinding: <10% (minimal)
CnssPenetration: Limited

Elimination:

HalfLife: Not directly measurable due to complex absorption kinetics; functional half-life is longer than physiological insulin due to protamine complex.
Clearance: Not available (complex elimination kinetics)
ExcretionRoute: Renal (metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: 1.5-4 hours
PeakEffect: 4-12 hours
DurationOfAction: Up to 24 hours (typically 18-24 hours, highly variable)
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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
Note: In rare cases, allergic reactions can be life-threatening.
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 immediately. If you have been instructed on what to do in case of low blood sugar, follow those instructions, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Irritation at the injection site
Weight gain

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, blurred vision, headache, rapid heartbeat. If these occur, consume fast-acting sugar immediately.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, increased hunger, fatigue, blurred vision. Contact your doctor if these persist.
  • Signs of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek immediate medical attention.
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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 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 overall health, including any existing medical conditions

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.

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 difficulties, 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, especially when used in combination with insulin. If you are taking one of these medications, consult your doctor to discuss the potential risks.

Ensure you are using the correct insulin product, as they come in various containers, including vials, cartridges, and pens. If you are unsure about measuring or preparing your dose, consult your doctor or pharmacist for guidance.

During periods of stress, such as illness, 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 inform others of your condition in case of an emergency. If you have experienced low blood sugar, do not drive, as this can increase your risk of being involved in an accident.

Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as scheduled. Consult your doctor before consuming alcohol or using products that contain alcohol.

Do not share your insulin product, including pens, cartridge devices, needles, or syringes, with anyone else, even if the needle has been changed. Sharing can transmit infections from one person to another, including those you may not be aware of having.

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:

For mild to moderate hypoglycemia, consume 15-20 grams of fast-acting carbohydrates. For severe hypoglycemia (unconsciousness or inability to swallow), administer glucagon injection if available, and seek immediate medical attention. Call 911 or 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia, prolong recovery from hypoglycemia)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure when co-administered with insulin)
  • Alcohol (can potentiate hypoglycemic effect)
  • Certain atypical antipsychotics (e.g., clozapine, olanzapine) (may cause hyperglycemia, requiring increased insulin dose)
  • Corticosteroids (may cause hyperglycemia, requiring increased insulin dose)
  • Diuretics (e.g., thiazides, loop diuretics) (may cause hyperglycemia, requiring increased insulin dose)
  • Sympathomimetics (e.g., epinephrine, albuterol) (may cause hyperglycemia, requiring increased insulin dose)
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Moderate Interactions

  • ACE inhibitors (may enhance insulin sensitivity, increasing risk of hypoglycemia)
  • Angiotensin Receptor Blockers (ARBs) (may enhance insulin sensitivity, increasing risk of hypoglycemia)
  • Salicylates (e.g., aspirin in high doses) (may enhance insulin sensitivity, increasing risk of hypoglycemia)
  • Sulfonamide antibiotics (may enhance insulin sensitivity, increasing risk of hypoglycemia)
  • Octreotide/Lanreotide (may decrease insulin requirements in some patients, increase in others)
  • Danazol (may cause hyperglycemia, requiring increased insulin dose)
  • Oral contraceptives (may cause hyperglycemia, requiring increased insulin dose)
  • Thyroid hormones (may cause hyperglycemia, requiring increased insulin dose)
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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 therapy.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glucose levels.

Timing: Prior to initiation of therapy.

Renal function (SCr, 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 can be affected by hepatic impairment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

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

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

Action Threshold: Below 70 mg/dL (hypoglycemia), above target range (hyperglycemia) requiring dose adjustment or intervention.

HbA1c

Frequency: Every 3-6 months (or more frequently if glycemic control is suboptimal or therapy is changed).

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

Action Threshold: Above target range, indicating need for therapy adjustment.

Signs and symptoms of hypoglycemia

Frequency: Daily, ongoing patient education and awareness.

Target: N/A

Action Threshold: Any symptoms of hypoglycemia (e.g., sweating, tremor, confusion, hunger) require immediate action (glucose intake).

Injection site inspection

Frequency: Regularly (e.g., daily/weekly)

Target: No redness, swelling, lumps, or signs of lipodystrophy.

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

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat, anxiety, weakness, slurred speech, seizures, unconsciousness)
  • Symptoms of hyperglycemia (e.g., increased thirst, frequent urination, increased hunger, fatigue, blurred vision, weight loss)
  • Signs of allergic reaction (e.g., rash, itching, swelling, difficulty breathing)
  • Signs of injection site reactions (e.g., redness, swelling, itching, pain, lipodystrophy)

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy. Insulin NPH has a long history of safe and effective use during pregnancy. Close monitoring of blood glucose is essential.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations associated with insulin use. Tight glycemic control is crucial to prevent pregnancy complications.
Second Trimester: Insulin requirements may increase. Close monitoring and dose adjustments are necessary.
Third Trimester: Insulin requirements typically continue to increase. Close monitoring and dose adjustments are necessary. Hypoglycemia risk may increase postpartum.
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Lactation

Insulin is considered 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 a breastfed infant.

Infant Risk: L1 (Safest - compatible with breastfeeding)
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Pediatric Use

Insulin NPH is used in pediatric patients with type 1 and sometimes type 2 diabetes. Dosing is highly individualized based on age, weight, pubertal status, and glycemic control. Close monitoring for hypoglycemia is crucial, especially in younger children who may not recognize symptoms.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • NPH insulin is a cloudy suspension and must be gently rolled or inverted several times before each injection to ensure uniform suspension.
  • NPH insulin can be mixed with regular (short-acting) insulin in the same syringe, but it should be drawn up after the regular insulin (clear before cloudy). Administer immediately after mixing.
  • Injection sites should be rotated within the same general area (e.g., abdomen) to minimize lipodystrophy and ensure consistent absorption.
  • Patients should be educated on the signs and symptoms of hypoglycemia and how to treat it promptly.
  • The timing of NPH administration relative to meals is important to optimize glycemic control and minimize hypoglycemia risk.
  • NPH insulin is often used as a basal insulin, providing background glucose control, and may be combined with rapid-acting insulin for mealtime coverage.
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Alternative Therapies

  • Long-acting insulins (e.g., insulin glargine, insulin detemir, insulin degludec) for basal coverage.
  • Rapid-acting insulins (e.g., insulin lispro, insulin aspart, insulin glulisine) for mealtime coverage.
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) for type 2 diabetes.
  • Other injectable non-insulin antidiabetic agents (e.g., GLP-1 receptor agonists, amylin analogs).
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Cost & Coverage

Average Cost: Varies widely, typically $25-$100+ per 10 mL vial (U-100)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred brand/generic) on most formularies
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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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 medication taken, the amount, and the time it occurred.