Novolin N U-100 Flexpen Inj 3ml
It is used to lower blood sugar in patients with high blood sugar (diabetes).
Drug Class
Antidiabetic agent
Pharmacologic Class
Intermediate-acting insulin
Pregnancy Category
Category B
FDA Approved
Jan 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Novolin N is an intermediate-acting insulin that helps your body use sugar for energy. It starts working a few hours after you inject it and lasts for about half a day. It's used to control high blood sugar in people with diabetes.
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. The solution should appear cloudy and milky when ready for use. Do not use the medication if the solution is clear, has lumps, or if powder is stuck to the sides of the container. Additionally, do not use the medication if the solution is leaking, has particles, or has changed color.
Selecting the Injection Site
Choose a different injection site for each dose, avoiding areas with thickened skin, pits, lumps, irritation, tenderness, bruising, redness, scaliness, hardness, scarring, or stretch marks.
Disposing of Needles and Supplies
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other supplies. When the box is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Diet and Exercise
Follow the diet and exercise plan recommended by your doctor.
Important Administration Instructions
This medication must not be used in an insulin pump. If you have questions, consult your doctor.
Remove all pen needle covers before injecting a dose (there may be two covers).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
Remove the needle after each injection and do not store the device with the needle attached.
Be aware that this product may make a clicking sound when preparing the dose. Do not prepare the dose by counting the clicks, as this could result in an incorrect dose.
Do not transfer this medication from the pen to a syringe.
Storage and Disposal
Store unopened containers in the refrigerator. Do not freeze. If the medication has been frozen, do not use it. If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine how long it can be stored before disposal.
Missed Doses
If you miss a dose, take it as soon as you remember. If it is close to the time for your next injection, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses.
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. The solution should appear cloudy and milky when ready for use. Do not use the medication if the solution is clear, has lumps, or if powder is stuck to the sides of the container. Additionally, do not use the medication if the solution is leaking, has particles, or has changed color.
Selecting the Injection Site
Choose a different injection site for each dose, avoiding areas with thickened skin, pits, lumps, irritation, tenderness, bruising, redness, scaliness, hardness, scarring, or stretch marks.
Disposing of Needles and Supplies
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other supplies. When the box is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Diet and Exercise
Follow the diet and exercise plan recommended by your doctor.
Important Administration Instructions
This medication must not be used in an insulin pump. If you have questions, consult your doctor.
Remove all pen needle covers before injecting a dose (there may be two covers).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
Remove the needle after each injection and do not store the device with the needle attached.
Be aware that this product may make a clicking sound when preparing the dose. Do not prepare the dose by counting the clicks, as this could result in an incorrect dose.
Do not transfer this medication from the pen to a syringe.
Storage and Disposal
Store unopened containers in the refrigerator. Do not freeze. If the medication has been frozen, do not use it. If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine how long it can be stored before disposal.
Missed Doses
If you miss a dose, take it as soon as you remember. If it is close to the time for your next injection, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Always check your blood sugar levels as instructed by your doctor.
- Follow your prescribed diet and exercise plan.
- Rotate injection sites to prevent skin problems (lipodystrophy).
- Never share your insulin pens or needles with others.
- Carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Typically administered once or twice daily.
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
Type 1 Diabetes:
Initial total daily dose often 0.5-0.8 units/kg/day, with NPH typically comprising 30-70% of the total daily dose, split into two injections.
Type 2 Diabetes:
Initial dose often 0.1-0.2 units/kg/day or 10 units once daily, adjusted based on blood glucose levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Individualized, typically lower doses than older children, based on blood glucose monitoring.
Child:
Initial total daily dose often 0.5-1.0 units/kg/day, with NPH typically comprising 30-70% of the total daily dose, split into two injections.
Adolescent:
Initial total daily dose often 0.5-1.2 units/kg/day (may be higher during puberty), with NPH typically comprising 30-70% of the total daily dose, split into two injections.
Dose Adjustments
Renal Impairment:
Mild:
May require dose reduction; monitor glucose closely.
Moderate:
Requires dose reduction; monitor glucose closely.
Severe:
Requires significant dose reduction; monitor glucose closely.
Dialysis:
Requires significant dose reduction; monitor glucose closely, as insulin clearance may be altered.
Hepatic Impairment:
Mild:
May require dose reduction; monitor glucose closely.
Moderate:
Requires dose reduction; monitor glucose closely.
Severe:
Requires significant dose reduction; monitor glucose closely.
Pharmacology
Mechanism of Action
Insulin NPH (Isophane Insulin Suspension) is an intermediate-acting insulin that lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (subcutaneous administration)
Tmax:
4-12 hours (peak effect)
FoodEffect:
Not directly affected by food intake, but dosing should be coordinated with meals.
Distribution:
Vd:
Not available (distributes widely throughout the body)
ProteinBinding:
Minimal
CnssPenetration:
Limited
Elimination:
HalfLife:
Not directly measurable due to complex absorption and degradation kinetics; functional half-life related to duration of action.
Clearance:
Primarily renal and hepatic clearance.
ExcretionRoute:
Metabolites excreted renally.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
1.5-4 hours
PeakEffect:
4-12 hours
DurationOfAction:
12-18 hours
Safety & Warnings
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 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
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 right away. If you have low blood sugar, follow your doctor's instructions, 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. 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 a complete list of possible side effects. If you have questions or concerns about side effects, talk to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 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
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 right away. If you have low blood sugar, follow your doctor's instructions, 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. 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 a complete list of possible side effects. If you have questions or concerns about side effects, talk to 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:
- Signs of low blood sugar (hypoglycemia): sweating, shaking, fast heartbeat, dizziness, confusion, hunger, irritability, blurred vision. Treat immediately.
- Signs of high blood sugar (hyperglycemia): increased thirst, frequent urination, increased hunger, fatigue, blurred vision. Contact your doctor.
- Signs of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek emergency medical help.
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.
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.
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.
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
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 can cause low blood potassium levels, which, if left untreated, may result in abnormal heart rhythms, severe breathing difficulties, and potentially death. If you experience any symptoms, consult your doctor promptly.
Until you understand how this medication affects you, avoid driving and engaging in 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.
Stressful situations, such as fever, infection, injury, or surgery, may affect your blood sugar control. 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 scheduled.
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 others, 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.
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 can cause low blood potassium levels, which, if left untreated, may result in abnormal heart rhythms, severe breathing difficulties, and potentially death. If you experience any symptoms, consult your doctor promptly.
Until you understand how this medication affects you, avoid driving and engaging in 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.
Stressful situations, such as fever, infection, injury, or surgery, may affect your blood sugar control. 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 scheduled.
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 others, 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.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (very low blood sugar)
- Confusion
- Seizures
- Loss of consciousness
- Coma
What to Do:
Immediately consume fast-acting carbohydrates (e.g., glucose tablets, juice, candy). If unconscious, 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
Moderate Interactions
- Corticosteroids (may increase blood glucose, requiring higher insulin doses)
- Diuretics (thiazide and loop diuretics may increase blood glucose)
- Sympathomimetics (may increase blood glucose)
- Sulfonylureas (increased risk of hypoglycemia)
- GLP-1 receptor agonists (increased risk of hypoglycemia, especially when initiating)
- SGLT2 inhibitors (increased risk of hypoglycemia, especially when initiating)
- Salicylates (e.g., aspirin, may enhance hypoglycemic effect at high doses)
- ACE inhibitors (may enhance hypoglycemic effect)
- Angiotensin Receptor Blockers (ARBs) (may enhance hypoglycemic effect)
Monitoring
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 (eGFR, creatinine)
Rationale: To assess kidney function, as insulin clearance can be affected.
Timing: Prior to initiation and periodically thereafter.
Hepatic function (ALT, AST)
Rationale: To assess liver function, as insulin metabolism can be affected.
Timing: Prior to initiation and periodically thereafter.
Routine Monitoring
Self-monitoring of Blood Glucose (SMBG)
Frequency: Multiple times daily (e.g., pre-meal, bedtime, post-meal, before exercise, when symptomatic for hypoglycemia).
Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL 1-2 hours post-meal.
Action Threshold: Adjust insulin dose based on trends and specific targets; treat hypoglycemia (<70 mg/dL).
HbA1c
Frequency: Every 3-6 months.
Target: Individualized, typically <7% for most adults.
Action Threshold: Adjust therapy if target not met.
Signs/symptoms of hypoglycemia
Frequency: Daily, ongoing.
Target: N/A
Action Threshold: Prompt treatment of hypoglycemia; re-evaluation of insulin regimen if frequent or severe.
Injection site inspection
Frequency: Regularly (e.g., daily/weekly).
Target: Absence of lipodystrophy, redness, swelling.
Action Threshold: Rotate injection sites to prevent lipodystrophy.
Symptom Monitoring
- Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, palpitations)
- 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, lipodystrophy)
Special Patient Groups
Pregnancy
Insulin is the preferred treatment for diabetes in pregnancy. Insulin NPH has a long history of safe and effective use during pregnancy. Dosing requirements may change throughout pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital malformations associated with insulin use.
Second Trimester:
Insulin requirements typically increase.
Third Trimester:
Insulin requirements typically increase, then may decrease shortly before delivery.
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 not expected to cause adverse effects in a breastfed infant.
Infant Risk:
Low risk to infant.
Pediatric Use
Insulin NPH is commonly used in pediatric patients with type 1 and type 2 diabetes. Dosing must be carefully individualized based on age, weight, pubertal status, and glycemic control. Close monitoring for hypoglycemia is essential.
Geriatric Use
Use with caution in elderly patients due to increased risk of hypoglycemia, especially in those with renal or hepatic impairment. Start with lower doses and titrate slowly. Monitor blood glucose closely.
Clinical Information
Clinical Pearls
- NPH insulin is a cloudy suspension; it must be gently rolled or inverted several times before each injection to ensure uniform suspension.
- It is typically given once or twice daily, often before breakfast and/or at bedtime.
- The intermediate duration of action means it covers glucose needs between meals and overnight.
- Patients should be educated on proper injection technique, site rotation, and signs/symptoms of hypoglycemia.
- NPH can be mixed with regular insulin (short-acting) in the same syringe, but regular insulin should be drawn up first (clear before cloudy).
- Hypoglycemia is the most common and serious side effect.
Alternative Therapies
- Long-acting insulins (e.g., insulin glargine, insulin detemir, insulin degludec)
- Basal-bolus insulin regimens (using long-acting and rapid-acting insulins)
- Oral antidiabetic medications (for Type 2 diabetes)
- GLP-1 receptor agonists
- SGLT2 inhibitors
Cost & Coverage
Average Cost:
$100 - $200 per 10mL vial or 5 x 3mL pens
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often preferred formulary due to lower cost)
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 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 information about the medication taken, the amount, and the time it happened.