Novolin Insulin Nph U-100 Human
Overview
What is this medicine?
How to Use This Medicine
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.
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).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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.
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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)
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)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline glycemic control and set treatment goals.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline glucose levels.
Timing: Prior to initiation of therapy.
Rationale: To assess kidney function, as insulin clearance can be affected by renal impairment.
Timing: Prior to initiation of therapy.
Rationale: To assess liver function, as insulin metabolism can be affected by hepatic impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
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.
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.
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).
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.
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
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:
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.
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.
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
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.
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).