Novolin 70/30 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
Insulin, intermediate-acting and short-acting combination
Pregnancy Category
Category B
FDA Approved
Jan 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Novolin 70/30 is a combination insulin that helps control blood sugar in people with diabetes. It contains two types of insulin: NPH (intermediate-acting) and Regular (short-acting). This combination helps manage blood sugar levels throughout the day and after meals.
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 provide guidance on the proper technique.
Preparation and Administration
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 or contains lumps. Additionally, do not use the medication if powder is stuck to the sides of the container.
Administer the injection 30 to 45 minutes before meals. Rotate the injection site with each dose to avoid injecting into the same area repeatedly. 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 leaking, has particles, or has changed color. Do not mix this insulin with other types of insulin or liquids in the same syringe. Dispose of needles and other sharp objects in a designated disposal box, and do not reuse them. When the disposal box is full, follow local regulations for proper disposal.
Special Considerations
If you have questions or concerns about using this medication, consult your doctor or pharmacist. Be aware of what to do if you skip a meal or do not eat as much as usual. This medication is not intended for use in an insulin pump. If you have questions, consult your doctor.
Using the Pen Device
Before injecting a dose, remove all pen needle covers (there may be two). If you are unsure about the type of pen needle you have or how to use it, consult your doctor. After each injection, remove the needle and do not store the device with the needle attached. Note that the device may make a clicking sound when preparing the dose, but do not rely on the clicks to determine the correct dose.
Storage and Disposal
Store unopened containers of this medication in the refrigerator, but do not freeze. Do not use the medication if it has been frozen.
Missed Doses
If you forget to take a dose, be aware of what to do. If you are unsure, consult your doctor for guidance.
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 provide guidance on the proper technique.
Preparation and Administration
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 or contains lumps. Additionally, do not use the medication if powder is stuck to the sides of the container.
Administer the injection 30 to 45 minutes before meals. Rotate the injection site with each dose to avoid injecting into the same area repeatedly. 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 leaking, has particles, or has changed color. Do not mix this insulin with other types of insulin or liquids in the same syringe. Dispose of needles and other sharp objects in a designated disposal box, and do not reuse them. When the disposal box is full, follow local regulations for proper disposal.
Special Considerations
If you have questions or concerns about using this medication, consult your doctor or pharmacist. Be aware of what to do if you skip a meal or do not eat as much as usual. This medication is not intended for use in an insulin pump. If you have questions, consult your doctor.
Using the Pen Device
Before injecting a dose, remove all pen needle covers (there may be two). If you are unsure about the type of pen needle you have or how to use it, consult your doctor. After each injection, remove the needle and do not store the device with the needle attached. Note that the device may make a clicking sound when preparing the dose, but do not rely on the clicks to determine the correct dose.
Storage and Disposal
Store unopened containers of this medication in the refrigerator, but do not freeze. Do not use the medication if it has been frozen.
Missed Doses
If you forget to take a dose, be aware of what to do. If you are unsure, consult your doctor for guidance.
Lifestyle & Tips
- Follow your prescribed diet and exercise plan.
- Monitor your blood glucose levels regularly as instructed by your doctor.
- Learn proper injection technique and rotate injection sites to prevent skin problems.
- Always carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat mild to moderate hypoglycemia.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
- Do not share your FlexPen with others, even if the needle is changed, due to risk of infection.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized, typically 0.5-1 unit/kg/day, divided into 1-2 doses, adjusted based on blood glucose monitoring.
Condition-Specific Dosing:
Type 1 Diabetes:
Individualized based on carbohydrate intake, blood glucose levels, and activity.
Type 2 Diabetes:
Individualized based on blood glucose levels, often initiated at 0.1-0.2 units/kg/day or 10 units/day, adjusted as needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Highly individualized, typically 0.5-1 unit/kg/day, adjusted based on blood glucose levels.
Child:
Highly individualized, typically 0.5-1 unit/kg/day, adjusted based on blood glucose levels.
Adolescent:
Highly individualized, typically 0.5-1.2 units/kg/day (may be higher during puberty), adjusted based on blood glucose levels.
Dose Adjustments
Renal Impairment:
Mild:
Insulin requirements may be reduced; close glucose monitoring and dose adjustment are necessary.
Moderate:
Insulin requirements may be reduced; close glucose monitoring and dose adjustment are necessary.
Severe:
Insulin requirements may be significantly reduced; close glucose monitoring and dose adjustment are necessary.
Dialysis:
Insulin requirements may be significantly reduced; close glucose monitoring and dose adjustment are necessary, often requiring lower doses.
Hepatic Impairment:
Mild:
Insulin requirements may be reduced; close glucose monitoring and dose adjustment are necessary.
Moderate:
Insulin requirements may be reduced; close glucose monitoring and dose adjustment are necessary.
Severe:
Insulin requirements may be significantly reduced; close glucose monitoring and dose adjustment are necessary.
Pharmacology
Mechanism of Action
Insulin 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:
Varies by injection site, dose, and individual; generally high for subcutaneous administration.
Tmax:
Regular Insulin: 1.5-3.5 hours; NPH Insulin: 4-12 hours
FoodEffect:
Timing of injection relative to meals is critical for the regular insulin component to match post-prandial glucose excursions.
Distribution:
Vd:
Approximately 0.1 L/kg
ProteinBinding:
<10%
CnssPenetration:
Limited
Elimination:
HalfLife:
Regular Insulin: 5-10 minutes (plasma half-life); NPH Insulin: 10-18 hours (effective duration of action due to delayed absorption)
Clearance:
Approximately 0.8-1.2 L/min (total body clearance)
ExcretionRoute:
Renal (minor amount of intact insulin)
Unchanged:
<2%
Pharmacodynamics
OnsetOfAction:
Regular Insulin: 30-60 minutes; NPH Insulin: 1-2 hours
PeakEffect:
Regular Insulin: 2-4 hours; NPH Insulin: 6-12 hours
DurationOfAction:
Regular Insulin: 6-8 hours; NPH Insulin: 18-24 hours
Confidence:
Medium
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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
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: Some allergic reactions can be life-threatening.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
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. Many people may not experience any side effects or may only have mild ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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, contact 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
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: Some allergic reactions can be life-threatening.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
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. Many people may not experience any side effects or may only have mild ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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, contact 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 Hypoglycemia (low blood sugar): sweating, shakiness, dizziness, confusion, hunger, irritability, rapid heartbeat. If these occur, consume fast-acting sugar immediately.
- Symptoms of Hyperglycemia (high blood sugar): increased thirst, increased urination, fatigue, blurred vision, dry skin. Contact your doctor if these symptoms persist.
- Signs of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek immediate medical attention.
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 medication can interact with other drugs and health conditions. 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, 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 medication can interact with other drugs and health conditions. 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, 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.
When using this drug, you may be at risk for low blood sugar (hypoglycemia), which can lead to severe complications, including seizures, loss of consciousness, permanent brain damage, and even death. It is crucial to discuss this risk with your doctor.
Additionally, this medication may cause low blood potassium (hypokalemia), which, if left untreated, can result in abnormal heart rhythms, severe breathing difficulties, and potentially be fatal. You should talk to your doctor about this potential risk.
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.
To ensure safe use, verify that you have the correct insulin product and are familiar with the proper technique for measuring and preparing your dose. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns, contact your doctor or pharmacist.
Your blood sugar levels may be more challenging to control during periods of stress, such as when you have a fever, infection, injury, or surgery. Changes in your physical activity, exercise routine, or diet can also impact your blood sugar levels.
It is recommended that you wear a medical alert identification (ID) to inform others of your condition. Regularly check your blood sugar levels as directed by your doctor and undergo blood tests as scheduled to monitor your condition.
Do not operate a vehicle if you have experienced low blood sugar, as this can increase your risk of being involved in an accident. Before consuming alcohol or using products that contain alcohol, consult your doctor to discuss the potential risks.
Adhere to the diet and exercise plan recommended by your doctor to maintain optimal blood sugar control. Do not share your insulin product or any related devices, such as pens, cartridge devices, needles, or syringes, with others, 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.
When using this drug, you may be at risk for low blood sugar (hypoglycemia), which can lead to severe complications, including seizures, loss of consciousness, permanent brain damage, and even death. It is crucial to discuss this risk with your doctor.
Additionally, this medication may cause low blood potassium (hypokalemia), which, if left untreated, can result in abnormal heart rhythms, severe breathing difficulties, and potentially be fatal. You should talk to your doctor about this potential risk.
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.
To ensure safe use, verify that you have the correct insulin product and are familiar with the proper technique for measuring and preparing your dose. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns, contact your doctor or pharmacist.
Your blood sugar levels may be more challenging to control during periods of stress, such as when you have a fever, infection, injury, or surgery. Changes in your physical activity, exercise routine, or diet can also impact your blood sugar levels.
It is recommended that you wear a medical alert identification (ID) to inform others of your condition. Regularly check your blood sugar levels as directed by your doctor and undergo blood tests as scheduled to monitor your condition.
Do not operate a vehicle if you have experienced low blood sugar, as this can increase your risk of being involved in an accident. Before consuming alcohol or using products that contain alcohol, consult your doctor to discuss the potential risks.
Adhere to the diet and exercise plan recommended by your doctor to maintain optimal blood sugar control. Do not share your insulin product or any related devices, such as pens, cartridge devices, needles, or syringes, with others, 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.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (extremely low blood sugar)
- Confusion, disorientation
- Seizures
- Loss of consciousness
- Brain damage (if prolonged)
What to Do:
Call 911 or emergency medical services immediately. If the patient is conscious, give oral glucose. If unconscious, administer glucagon injection (if available and trained) or seek immediate medical attention. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Major Interactions
- Beta-blockers (may mask symptoms of hypoglycemia)
- Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure when co-administered with insulin)
- Sulfonylureas, Meglitinides (increased risk of hypoglycemia)
- ACE inhibitors, Angiotensin Receptor Blockers (ARBs) (increased risk of hypoglycemia)
Moderate Interactions
- Corticosteroids (may increase blood glucose, requiring higher insulin doses)
- Diuretics (thiazide and loop diuretics may increase blood glucose)
- Sympathomimetics (e.g., decongestants, beta-2 agonists; may increase blood glucose)
- Atypical antipsychotics (may increase blood glucose)
- Protease inhibitors (may affect glucose metabolism)
- Somatostatin analogs (e.g., octreotide, lanreotide; may decrease insulin requirements)
Monitoring
Baseline Monitoring
HbA1c
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation of therapy.
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation of therapy.
Renal Function (e.g., eGFR, creatinine)
Rationale: To assess kidney function, as insulin requirements may decrease with renal impairment.
Timing: Prior to initiation of therapy.
Hepatic Function (e.g., ALT, AST)
Rationale: To assess liver function, as insulin metabolism occurs in the liver.
Timing: Prior to initiation of therapy.
Routine Monitoring
Self-Monitoring Blood Glucose (SMBG)
Frequency: Multiple times daily (e.g., pre-meal, 2-hour post-meal, bedtime, overnight) as directed by healthcare provider.
Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL post-meal.
Action Threshold: Hypoglycemia (<70 mg/dL) or Hyperglycemia (>180-250 mg/dL depending on target).
HbA1c
Frequency: Every 3-6 months.
Target: Individualized, typically <7% for most adults.
Action Threshold: >7% (or individualized target) indicates need for therapy adjustment.
Renal Function
Frequency: Annually, or more frequently if impairment is present.
Target: Stable eGFR.
Action Threshold: Significant decline in eGFR may necessitate insulin dose reduction.
Symptom Monitoring
- Symptoms of Hypoglycemia: sweating, shakiness, dizziness, confusion, hunger, irritability, rapid heartbeat, blurred vision, headache, weakness, seizures, unconsciousness.
- Symptoms of Hyperglycemia: increased thirst, increased urination, fatigue, blurred vision, dry skin, fruity breath odor, nausea, vomiting, abdominal pain (signs of DKA).
Special Patient Groups
Pregnancy
Insulin is the preferred treatment for diabetes in pregnancy. Novolin 70/30 can be used, but close monitoring of blood glucose is essential, and insulin requirements may change throughout pregnancy.
Trimester-Specific Risks:
First Trimester:
Insulin requirements may decrease.
Second Trimester:
Insulin requirements typically increase.
Third Trimester:
Insulin requirements typically increase significantly.
Lactation
Insulin is considered safe for use during lactation. It is not excreted into breast milk in clinically significant amounts and poses no risk to the breastfed infant.
Infant Risk:
Minimal to no risk (L1 - Safest).
Pediatric Use
Dosing is highly individualized based on age, weight, and glycemic control. Close monitoring is crucial due to varying insulin sensitivity and growth spurts. Risk of hypoglycemia may be higher in younger children.
Geriatric Use
Increased risk of hypoglycemia due to potential for impaired renal/hepatic function, reduced food intake, and cognitive impairment. Lower starting doses and careful titration are often necessary. Education on hypoglycemia recognition is critical.
Clinical Information
Clinical Pearls
- Always verify the insulin type and concentration before administration to avoid medication errors.
- Instruct patients on proper injection technique, including site rotation (abdomen, thigh, upper arm, buttocks) to prevent lipodystrophy.
- Emphasize the importance of consistent meal times and carbohydrate intake, especially with the regular insulin component.
- Educate patients and caregivers on the signs and symptoms of hypoglycemia and how to treat it effectively.
- Stress the importance of not skipping meals or delaying meals after insulin injection.
- Novolin 70/30 should be stored in the refrigerator (unopened) and at room temperature (opened) for up to 28 days. Do not freeze.
Alternative Therapies
- Basal-bolus insulin regimens (e.g., long-acting insulin + rapid-acting insulin)
- Other premixed insulin analogs (e.g., Novolog Mix 70/30, Humalog Mix 75/25)
- Oral antidiabetic agents (for Type 2 Diabetes, often in combination with insulin or as monotherapy)
- GLP-1 receptor agonists
- SGLT2 inhibitors
Cost & Coverage
Average Cost:
Varies, check current pharmacy prices (e.g., $100-$300) per 5 FlexPens (3ml each)
Insurance Coverage:
Tier 2 or 3, often preferred formulary for many insurance plans.
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 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.