What are the main side effects of Novolin 70/30. How should Novolin 70/30 be administered. What precautions should be taken when using Novolin 70/30. How does Novolin 70/30 work to control blood sugar. What are the proper storage requirements for Novolin 70/30.

Understanding Novolin 70/30: Composition and Mechanism of Action

Novolin 70/30 is a combination insulin medication used to manage blood sugar levels in individuals with diabetes mellitus. This pharmaceutical formulation consists of two types of insulin:

• 70% insulin isophane (intermediate-acting insulin)
• 30% insulin regular (short-acting insulin)

The dual-action nature of Novolin 70/30 provides both immediate and prolonged blood glucose control. How does this combination work to regulate blood sugar levels? The short-acting insulin component begins to lower blood glucose within 10 to 20 minutes after injection, reaching its peak effectiveness around 2 hours post-administration. Meanwhile, the intermediate-acting insulin maintains glucose control for up to 24 hours, ensuring a more stable blood sugar profile throughout the day.

Proper Administration and Dosage Guidelines for Novolin 70/30

Administering Novolin 70/30 correctly is crucial for its effectiveness and safety. Healthcare providers typically provide detailed instructions on proper usage, but here are some key points to remember:

1. Inject the insulin subcutaneously (under the skin).
2. Rotate injection sites to prevent tissue damage.
3. Use the medication exactly as prescribed by your doctor.
4. Consume a meal within 30 to 45 minutes after injection.
5. Never share injection devices, even if the needle has been changed.

Can the dosage of Novolin 70/30 be adjusted? Your healthcare provider may adjust your dosage based on various factors, including your blood sugar levels, diet, exercise routine, and overall health status. It’s essential to follow their guidance closely and not make changes to your dosage without consulting them first.

Potential Side Effects and Risk Management

While Novolin 70/30 is generally well-tolerated, it can cause side effects in some individuals. Common side effects may include:

• Hypoglycemia (low blood sugar)
• Injection site reactions
• Weight gain
• Allergic reactions (rare)

How can you manage the risk of hypoglycemia? Recognizing the symptoms of low blood sugar is crucial. These may include hunger, dizziness, irritability, confusion, anxiety, or shakiness. To quickly treat hypoglycemia, consume a fast-acting source of sugar, such as fruit juice, hard candy, or non-diet soda. In severe cases, a glucagon injection may be necessary. Ensure that your family members or close friends know how to administer this emergency treatment.

Hyperglycemia: The Other Side of the Coin

While hypoglycemia is a common concern, it’s also important to be aware of hyperglycemia (high blood sugar). Signs of hyperglycemia include increased thirst and urination. Regular blood sugar monitoring and adhering to your prescribed treatment plan can help prevent these fluctuations.

Storage and Handling: Ensuring Medication Efficacy

Proper storage of Novolin 70/30 is essential to maintain its effectiveness. Here are the key storage guidelines:

• Unopened insulin: Refrigerate until the expiration date or store at room temperature for a specified period.
• Opened vials: Can be stored in the refrigerator or at room temperature.
• Injection pens: Store at room temperature, never with a needle attached.
• Never freeze insulin or store it near the refrigerator’s cooling element.

How long can you use opened insulin? The stability of opened insulin varies, so always check the specific instructions provided with your medication. Generally, in-use insulin remains stable for a certain number of days, after which it should be discarded.

Interactions and Precautions: Maximizing Safety and Efficacy

Novolin 70/30 can interact with various medications and substances, potentially affecting its efficacy or increasing the risk of side effects. Some important interactions to be aware of include:

• Other diabetes medications
• Beta-blockers
• Corticosteroids
• Certain antibiotics
• Alcohol

Is it safe to consume alcohol while using Novolin 70/30? Alcohol can affect blood sugar levels and may increase the risk of hypoglycemia. If you choose to drink, do so in moderation and always with a meal. Monitor your blood sugar closely and be prepared to treat low blood sugar if necessary.

Special Considerations for Certain Populations

Certain groups may require special attention when using Novolin 70/30:

• Pregnant women: Insulin requirements often change during pregnancy.
• Elderly patients: May be more sensitive to the effects of insulin.
• Individuals with kidney or liver problems: May require dosage adjustments.

Always inform your healthcare provider of any medical conditions or medications you’re taking to ensure the safe and effective use of Novolin 70/30.

Lifestyle Considerations: Optimizing Novolin 70/30 Treatment

While Novolin 70/30 is a crucial component of diabetes management, it’s most effective when combined with lifestyle modifications. Consider the following aspects:

1. Diet: Follow a balanced meal plan as recommended by your healthcare provider or dietitian.
2. Exercise: Regular physical activity can help improve insulin sensitivity.
3. Stress management: Stress can affect blood sugar levels, so developing coping strategies is important.
4. Regular monitoring: Keep track of your blood sugar levels as advised by your doctor.

How does exercise affect insulin requirements? Physical activity generally increases insulin sensitivity, potentially lowering your insulin needs. However, intense exercise can sometimes cause a temporary spike in blood sugar. Work with your healthcare team to develop an exercise plan that complements your insulin regimen.

Emergency Preparedness: Handling Diabetes-Related Crises

Being prepared for diabetes-related emergencies is crucial when using Novolin 70/30. Consider the following measures:

• Wear medical identification indicating you have diabetes.
• Keep a glucagon emergency kit on hand and ensure others know how to use it.
• Carry fast-acting glucose sources for treating hypoglycemia.
• Have a sick-day management plan in place.

What should you do if you miss a dose of Novolin 70/30? If you miss a dose, check your blood sugar level and consult your healthcare provider for guidance. Never double up on doses to make up for a missed one, as this can lead to dangerous blood sugar fluctuations.

Long-Term Considerations: Managing Diabetes with Novolin 70/30

Long-term use of Novolin 70/30 requires ongoing management and periodic reassessment. Consider the following aspects of long-term care:

1. Regular check-ups: Schedule routine visits with your healthcare provider to assess your diabetes management.
2. HbA1c testing: This test provides insight into your average blood sugar levels over the past 2-3 months.
3. Complication screening: Regular screenings for diabetes-related complications such as retinopathy, neuropathy, and nephropathy.
4. Insulin regimen adjustments: Your insulin needs may change over time due to various factors, including weight changes, lifestyle modifications, or the progression of diabetes.

How often should you have your HbA1c levels checked? The American Diabetes Association recommends HbA1c testing at least twice a year for individuals meeting treatment goals and with stable glycemic control. Those not meeting goals or with changing therapy may require more frequent testing, typically quarterly.

Continuous Glucose Monitoring: A Valuable Tool

Continuous glucose monitoring (CGM) systems can provide real-time information about blood sugar trends, potentially improving diabetes management when using Novolin 70/30. These devices can help:

• Identify patterns in blood sugar fluctuations
• Detect nocturnal hypoglycemia
• Guide insulin dosing decisions
• Improve overall glycemic control

Discuss with your healthcare provider whether CGM could be beneficial in your diabetes management plan.

Patient Education: Empowering Effective Self-Management

Education plays a crucial role in the successful use of Novolin 70/30 and overall diabetes management. Key areas of patient education include:

• Proper insulin injection technique
• Blood glucose monitoring
• Recognizing and treating hypoglycemia and hyperglycemia
• Nutrition and meal planning
• Exercise and diabetes management
• Sick day rules

How can you stay informed about diabetes management? Consider joining diabetes education programs, support groups, or online communities. These resources can provide valuable information, tips, and emotional support for living with diabetes.

The Role of Technology in Diabetes Management

Various technological tools can assist in managing diabetes while using Novolin 70/30:

• Smartphone apps for tracking blood sugar, meals, and medication
• Smart insulin pens that record dosing information
• Telemedicine platforms for remote consultations with healthcare providers
• Online resources for diabetes education and support

Explore these options and discuss with your healthcare team which tools might be most beneficial for your individual needs.

Navigating Insurance and Cost Considerations

Managing the cost of Novolin 70/30 and other diabetes-related expenses can be challenging. Consider the following strategies:

1. Understand your insurance coverage for insulin and diabetes supplies
2. Explore patient assistance programs offered by pharmaceutical companies
3. Consider generic or biosimilar insulin options if available
4. Discuss cost-saving strategies with your healthcare provider
5. Look into state-specific insulin cost-capping laws

Are there ways to reduce the cost of Novolin 70/30? Some potential options include using manufacturer coupons, exploring patient assistance programs, or considering alternative insulin formulations. Always consult with your healthcare provider before making any changes to your insulin regimen based on cost considerations.

The Importance of Adherence

Adhering to your prescribed Novolin 70/30 regimen is crucial for effective diabetes management. Strategies to improve adherence include:

• Using medication reminders or alarms
• Incorporating insulin administration into your daily routine
• Addressing any concerns or side effects with your healthcare provider promptly
• Understanding the importance of consistent insulin use in managing your diabetes

Remember, effective diabetes management is a collaborative effort between you and your healthcare team. Open communication about any challenges or concerns you face can lead to better outcomes and improved quality of life.

Novolin 70/30 (Insulin Isophane And Insulin Regular) – Side Effects, Interactions, Uses, Dosage, Warnings

Use Novolin 70/30 (Insulin Isophane And Insulin Regular) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Insulin is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

Do not give insulin isophane and insulin regular with an insulin pump.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

This insulin should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject this medicine. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using insulin isophane and insulin regular, you should eat a meal within 30 to 45 minutes.

If you use an injection pen, use only the injection pen that comes with this insulin. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin isophane and insulin regular:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days specified in the Instructions for Use provided with your medicine.

Storing opened (in use) insulin isophane and insulin regular:

• Store the vial in a refrigerator or at room temperature.
• Store the injection pen at room temperature (do not refrigerate). Do not store the injection pen with a needle attached.
• In-use insulin is stable for only a certain number of days. Throw away any medicine not used within that time. Follow all storage directions provided with your medicine.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

Novolin 70/30 Uses, Side Effects & Warnings

Generic Name: insulin isophane and insulin regular (IN su lin EYE soe fane and IN su lin REG ue lar)
Brand Name: HumuLIN 70/30, HumuLIN 70/30 KwikPen, NovoLIN 70/30, ReliOn/NovoLIN 70/30

Medically reviewed by Drugs. com on April 6, 2020. Written by Cerner Multum.

What is Novolin 70/30?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin isophane is a intermediate-acting insulin. Insulin regular is an short-acting insulin. This combination insulin starts to work within 10 to 20 minutes after injection, peaks in 2 hours, and keeps working for up to 24 hours.

Novolin 70/30 is a combination medicine used to improve blood sugar control in adults with diabetes mellitus.

Novolin 70/30 may also be used for purposes not listed in this medication guide.

Warnings

You should not use Novolin 70/30 if you are having an episode of low blood sugar.

Never share an injection pen or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use this medicine if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

This medicine is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I use Novolin 70/30?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Insulin is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

Do not give Novolin 70/30 with an insulin pump.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

This insulin should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject Novolin 70/30. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using Novolin 70/30, you should eat a meal within 30 to 45 minutes.

If you use an injection pen, use only the injection pen that comes with this insulin. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Novolin 70/30:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within the number of days specified in the Instructions for Use provided with your medicine.

Storing opened (in use) Novolin 70/30:

• Store the vial in a refrigerator or at room temperature.

• Store the injection pen at room temperature (do not refrigerate). Do not store the injection pen with a needle attached.

• In-use insulin is stable for only a certain number of days. Throw away any medicine not used within that time. Follow all storage directions provided with your medicine.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

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What happens if I miss a dose?

Since this medicine is used with a meal, you may not be on a timed dosing schedule. Whenever you use this insulin, be sure to eat a meal within 45 minutes. Do not use extra medicine to make up a missed dose.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using Novolin 70/30?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how Novolin 70/30 will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Novolin 70/30 side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, chest tightness, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention–weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• low blood sugar;

• weight gain, swelling in your hands or feet;

• itching, mild skin rash; or

• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Novolin 70/30?

This insulin may not work as well when you use other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.

Frequently asked questions

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2021 Cerner Multum, Inc. Version: 8.03.

Novolin 70/30 U-100 Insulin subcutaneous: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Read the Patient Information Leaflet provided by your pharmacist before you start using combination isophane/regular insulin and each time you get a refill. If you have any questions, ask your doctor, diabetes educator, or pharmacist.

Learn all preparation and usage instructions from your health care professional and the product package.

Before using, gently roll the vial or cartridge, turning it upside down and back 10 times to mix the medication. Do not shake the container. Check this product visually for particles or discoloration. If either is present, do not use the insulin. Combination isophane/regular insulin should look evenly cloudy/milky after mixing. Do not use if you see clumps of white material, a “frosty” appearance, or particles stuck to the sides of the vial or cartridge.

Before injecting each dose, clean the injection site with rubbing alcohol. Change where you inject each time to lessen the risk of problems or damage under the skin (for example, pits/lumps or thickened skin). Inject this medication under the skin as directed by your doctor, usually once or twice a day. This insulin product may be injected in the stomach area, the thigh, the buttocks, or the back of the upper arm. Do not inject into a vein or muscle because very low blood sugar (hypoglycemia) may occur. Do not rub the area after the injection. Do not inject into skin that is red, swollen, itchy, or damaged. Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature.

This product should not be mixed with any other insulin.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition and response to treatment. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar.

Check your blood sugar regularly as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens (your blood sugar is too high or too low).

Insulin NPH and Insulin Regular

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

HumuLIN 70/30; HumuLIN 70/30 KwikPen; NovoLIN 70/30; NovoLIN 70/30 FlexPen; NovoLIN 70/30 FlexPen Relion

Brand Names: Canada

Humulin 70/30; Novolin ge 30/70; Novolin ge 40/60; Novolin ge 50/50

What is this drug used for?

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

What do I need to tell my doctor BEFORE I take this drug?

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have low blood sugar.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Low blood sugar may happen with this drug. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
• Low blood potassium may happen with this drug. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
• Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
• Be sure you have the right insulin product. Insulin products come in many containers like vials, cartridges, and pens. Be sure that you know how to measure and get your dose ready. If you have any questions, call your doctor or pharmacist.
• It may be harder to control blood sugar during times of stress such as fever, infection, injury, or surgery. A change in physical activity, exercise, or diet may also affect blood sugar.
• Wear disease medical alert ID (identification).
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Talk with your doctor before you drink alcohol or take products that have alcohol in them.
• Follow the diet and workout plan that your doctor told you about.
• Do not share your insulin product with another person. This includes any pens, cartridge devices, needles, or syringes, even if the needle has been changed. Sharing may pass infections from one person to another. This includes infections you may not know you have.
• If you are 65 or older, use this drug with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Anxiety.
• Change in eyesight.
• Chills.
• Very bad dizziness or passing out.
• Mood changes.
• Seizures.
• Slurred speech.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Thick skin, pits, or lumps where the injection was given.
• Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Weight gain.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• It is given as a shot into the fatty part of the skin in the upper arm, thigh, buttocks, or stomach area.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• This drug needs to be mixed before use. Follow how to mix as you were told by the doctor.
• This drug will look cloudy and milky when ready to use. Do not use if the solution looks clear or has lumps in it. Do not use if powder is stuck to the sides of the container.
• Take 30 to 45 minutes before meals.
• Move the site where you give the shot with each shot.
• Do not give into skin that is thickened, or has pits or lumps.
• Do not give into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
• Do not use if the solution is leaking or has particles.
• Do not use if solution changes color.
• Do not mix this insulin in the same syringe with other types of insulin.
• Do not mix with other liquids.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• Be sure you know what to do if you do not eat as much as normal or if you skip a meal.
• This drug must not be used in an insulin pump. If you have questions, talk with the doctor.

Vials:

• Do not draw into a syringe and store for future use.

Cartridges and prefilled pens:

• Remove all pen needle covers before injecting a dose (there may be 2). If you are not sure what type of pen needle you have or how to use it, talk with the doctor.
• Take off the needle after each shot. Do not store this device with the needle on it.
• This product may make a clicking sound as you prepare the dose. Do not prepare the dose by counting the clicks. Doing so could lead to using the wrong dose.

What do I do if I miss a dose?

• Be sure you know what to do if you forget to take a dose.
• If you are not sure what to do if you miss a dose, call your doctor.

How do I store and/or throw out this drug?

• Store unopened containers in a refrigerator. Do not freeze.
• Do not use if it has been frozen.
• If an unopened container has been stored at room temperature, be sure you know how long you can leave this drug at room temperature before you need to throw it away. If you are not sure, talk with the doctor or pharmacist.
• After opening, be sure you know how long the product is good for and how to store it. Ask the doctor or pharmacist if you are not sure.
• Protect from heat and light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. The use of this information is governed by the Lexicomp End User License Agreement, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Last Reviewed Date

2019-12-09

Copyright

© 2021 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

Novolin 70/30: Uses, Taking, Side Effects, Warnings

What is Novolin 70/30?

Novolin 70/30 is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

What is the most important information I should know about Novolin 70/30?

Do not share your Novolin 70/30 FlexPen or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Who should not take Novolin 70/30?

Do not use Novolin 70/30 if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to human insulin isophane, human insulin or any of the ingredients in Novolin 70/30. See the end of this Patient Information guide for a complete list of ingredients in Novolin 70/30.

What should I tell my healthcare provider before taking Novolin 70/30?

Before using Novolin 70/30, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems.
• take other medicines, especially ones called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Novolin 70/30.
• are pregnant or plan to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breastfeeding or plan to breastfeed. Novolin 70/30 may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using Novolin 70/30.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Before you start using Novolin 70/30, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Novolin 70/30?

• Read the detailed Instructions for Use that comes with your Novolin 70/30.
• Use Novolin 70/30 exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Novolin 70/30 to use and when to use it.
• Use Novolin 70/30 about 30 minutes before eating a meal.
• Know the type, strength, and amount of insulin you use. Do not change the type, or amount of insulin you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you use different types of insulin.
• Check your insulin label each time you give your injection to make sure you are using the correct insulin.
• Inject Novolin 70/30 under the skin (subcutaneously) in your stomach area, buttocks, upper legs (thighs) or upper arms. Do not inject Novolin 70/30 into your vein (intravenously) or muscle (intramuscularly) or use in an insulin infusion pump.
• Do not mix Novolin 70/30 with any other insulins or liquids.
• Change (rotate) your injection site within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Keep Novolin 70/30 and all medicines out of the reach of children.

Your dose of Novolin 70/30 may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What should I avoid while taking Novolin 70/30?

While using Novolin 70/30 do not:

• drive or operate heavy machinery until you know how Novolin 70/30 affects you.
• drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Novolin 70/30?

Novolin 70/30 may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include:
  • dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger.
    • Your healthcare provider may prescribe a glucagon emergency kit so that others can give you an injection if your blood sugar becomes too low (hypoglycemia) and you are unable to take sugar by mouth.

• severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
  • a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.

• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Novolin 70/30 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Novolin 70/30. Your healthcare provider should monitor you closely while you are taking TZDs with Novolin 70/30. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

Get emergency medical help if you have:

• severe hypoglycemia needing hospitalization or emergency room care, and be sure to tell the hospital staff the units of Novolin 70/30 your healthcare provider has prescribed for you.
• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Novolin 70/30 include:

• low blood sugar (hypoglycemia), allergic reactions including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling (edema) in hands or feet.

These are not all of the possible side effects of Novolin 70/30. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Novolin 70/30

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Novolin 70/30 for a condition for which it was not prescribed. Do not give Novolin 70/30 to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information guide summarizes the most important information about Novolin 70/30. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Novolin 70/30 that is written for healthcare providers. For more information, call 1-800-727-6500 or go to www.novonordisk-us.com.

How should I store Novolin 70/30?

Vials

• Do not freeze Novolin 70/30. Do not use Novolin 70/30 if it has been frozen.
• Keep Novolin 70/30 away from heat or light.
• All unopened vials:
  • Store unopened Novolin 70/30 vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
  • Unopened vials should be thrown away after 42 days, if they are stored at room temperature below 77°F (25°C).

After vials have been opened:

• Opened Novolin 70/30vials can be stored at room temperature below 77°F (25°C). Do not refrigerate.
• Throw away all opened Novolin 70/30vials after 42 days, even if they still have insulin left in them.

FlexPen

• Do not freeze Novolin 70/30. Do not use Novolin 70/30 if it has been frozen.
• Keep Novolin 70/30 away from heat and light.
• Until first use:
  • Store unused Novolin 70/30 FlexPen in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unused Novolin 70/30 FlexPen may be used until the expiration date printed on the label, if kept in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unused Novolin 70/30 FlexPen stored at room temperature should be thrown away after 28 days.

• In-use:
  • Store the Novolin 70/30 FlexPen you are currently using out of the refrigerator at room temperature below 86°F (30°C) for up to 28 days.
  • The Novolin 70/30 FlexPen you are using should be thrown away after 28 days, even if it still has insulin left in it.
  • Store the Novolin 70/30 FlexPen without the needle attached.

What are the ingredients in Novolin 70/30?

Active ingredient: 70% human insulin isophane and 30% human insulin

Inactive ingredients: glycerol, metacresol, zinc, phenol, disodium phosphate dihydrate, protamine sulfate, water for injection, hydrochloric acid and sodium hydroxide.

Source: National Library of Medicine. Last updated November 15, 2019.

Novolin ge 30/70 – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Insulin is a naturally occurring hormone made by the pancreas that helps our body use or store blood glucose (sugar) it gets from food. For people with diabetes, either the pancreas does not make enough insulin to meet the body’s requirements, or the body cannot properly use the insulin that is made. As a result, glucose cannot be used or stored properly and accumulates in the bloodstream. Insulin injected under the skin helps to lower blood glucose levels.

There are many different types of insulin that are absorbed at different rates and work for varying periods of time. This type of premixed insulin contains a mixture of fast-acting insulin (insulin regular) and intermediate-acting insulin (insulin NPH). This premixed insulin is used by people with diabetes who have their blood glucose under control and have found a particular ratio of fast-acting to intermediate-acting insulin that works best for them. This premixed insulin starts working 30 to 60 minutes after injection, has its maximum effect between 2 and 8 hours, and stops working after about 18 to 24 hours.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Vial
Each mL contains 100 units of insulin (30 units of regular insulin and 70 units of insulin isophane, human biosynthetic – NPH insulin). Nonmedicinal ingredients: disodium phosphate dihydrate, glycerol, hydrochloric acid and/or sodium hydroxide, metacresol, phenol, protamine sulphate, water for injection, and zinc chloride

Penfill cartridge
Each mL contains 100 units of insulin (30 units of regular insulin and 70 units of insulin isophane, human biosynthetic – NPH insulin). Nonmedicinal ingredients: disodium phosphate dihydrate, glycerol, hydrochloric acid and/or sodium hydroxide, metacresol, phenol, protamine sulphate, water for injection, and zinc chloride.

How should I use this medication?

Your required dose of insulin depends on how much natural insulin your pancreas is producing and how well your body is able to use the insulin.  Your doctor or diabetes educator will determine the appropriate dose according to various lifestyle issues and the blood glucose values obtained while monitoring your blood glucose.

Your dose of insulin should be injected subcutaneously (under the skin) exactly as instructed by your doctor or diabetes educator. Do not inject premixed insulin into the vein and do not use premixed insulin in insulin infusion pumps. The dose of insulin is measured in international units (IU). Each mL of insulin contains 100 IU. This premixed insulin is injected about 30 minutes before certain meals. The most common schedule is to use the premixed insulin before breakfast and supper. There are many variations of insulin dosing.

Mix premixed insulin by slowly rolling the bottle or pen between your hands. Premixed insulin suspension should appear cloudy and white. Do not use the insulin if it looks lumpy or grainy, seems unusually thick, sticks to the bottle or vial, or appears discoloured. Do not use the insulin if it contains crystals, if the bottle or vial looks frosted, or if the suspension remains clear after being rolled between your hands.

Keep unopened bottles of insulin in the refrigerator until needed. They may be used until the expiry date on the label. Never allow insulin to freeze. Insulin that is currently in use may be kept at room temperature for no more than 28 days and then discarded. Insulin must not be exposed to extremely hot temperatures or to sunlight. Keep insulin out of the reach of children.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. The timing of insulin with respect to your meals is crucial to keeping blood glucose under control and preventing unwanted side effects.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Insulin premixed 30/70 should not be used by anyone who:

• is allergic to insulin premixed 30/70 or to any of the ingredients of the medication
• has diabetic coma
• has low blood glucose (hypoglycemia)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• redness, itching, or swelling at the site of injection

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• signs of low blood glucose:
• anxiety
• blurred vision
• confusion
• difficulty concentrating
• difficulty speaking
• dizziness
• drowsiness
• fast heartbeat
• headache
• hunger
• nausea
• nervousness
• numbness or tingling of the lips, fingers, or tongue
• sweating
• tiredness
• trembling
• weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• rash or blisters all over the body
• seizures
• symptoms of a serious allergic reaction (e.g., swelling of face or throat, difficulty breathing, wheezing, or itchy skin rash)
• unconsciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: If you notice signs of a serious allergic reaction (swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash), stop using the medication and seek immediate medical attention.

Appearance of insulin: The contents of the vial of this insulin should be cloudy and white. Do not use the insulin if it looks lumpy or grainy, seems unusually thick, sticks to the bottle or vial, or appears discoloured. Do not use the insulin if it contains crystals, if the bottle or vial looks frosted, or if the suspension remains clear after being rolled between your hands.

Blood glucose monitoring: It is important for anyone using insulin to monitor their blood glucose levels regularly, as recommended by their doctor or diabetes educator. It is especially important to test blood glucose more often when your insulin dose or schedule changes, or when you are ill or under stress. If blood tests consistently show high or low blood glucose levels, contact your doctor or diabetes educator.

Changes at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Changes in insulin requirements: Many things can affect blood glucose levels and insulin requirements. These include:

• certain medical conditions (e.g., infections, thyroid conditions, or kidney or liver disease)
• certain medications that increase or decrease blood glucose levels
• diet
• exercise
• illness
• injury
• stress
• surgery
• travelling over time zones

It is important your doctor know your current health situation and any changes that may affect the amount of insulin you need. Blood glucose should be monitored regularly as recommended by your doctor or diabetes educator.

Diabetes identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking insulin.

Drowsiness/reduced alertness: Low blood sugar may affect the mental or physical abilities needed to drive or operate machinery. It is important to avoid driving, operating machinery, or performing other potentially hazardous tasks if you are experiencing low blood sugar.

Family and friends: Educate your family and friends about the signs and symptoms of hypoglycemia (low blood glucose). Keep a glucagon kit available and instruct them on its proper use in case you experience severe low blood glucose and you lose consciousness.

Low blood glucose (hypoglycemia): Hypoglycemia may occur if too much insulin is used, if meals are missed, or if you exercise more than usual. Symptoms of mild to moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling (tongue, lips, or fingers. Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. People taking insulin should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks).

Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures. People who are unable to take sugar by mouth or who are unconscious may require an injection of glucagon or treatment with intravenous (into the vein) glucose. Therefore, contact your doctor if you are pregnant or are thinking about pregnancy.

Low potassium: Insulin can cause low levels of potassium in the body. This is more likely to happen if you are taking medications that reduce potassium or you are experiencing excessive loss of potassium through vomiting or diarrhea. Symptoms of low potassium include leg cramps, tiredness, constipation, and slowed heartbeat. Report any of these effects to your doctor as soon as possible, as very low potassium levels can be life-threatening.

Pregnancy: It is essential to maintain good blood glucose control throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters.

Breast-feeding: Breast-feeding mothers may require adjustments in insulin dose or diet.

What other drugs could interact with this medication?

There may be an interaction between insulin premixed 30/70 and any of the following:

• ACE inhibitors (e.g., ramipril, enalapril, lisinopril)
• alcohol
• androgens (e.g., testosterone)
• atypical antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
• beta-blockers (e.g., atenolol, metoprolol, pindolol, propranolol, sotalol)
• birth control pills
• corticosteroids (e.g., prednisone, prednisolone)
• dabrafenib
• danazol
• decongestants (e.g., pseudoephedrine)
• other diabetes medications (e.g., canagliflozin, chlorpropamide, gliclazide, glyburide, metformin, rosiglitazone, sitagliptin)
• disopyramide
• diuretics (e.g., furosemide, hydrochlorothiazide)
• epinephrine
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• exenatide
• glucagon
• growth hormone
• hepatitis C antivirals (e.g., daclatasvir, dasabuvir, ledipasvir, paritaprevir, ombitasvir, sofosbuvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• liraglutide
• mifepristone
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• niacin
• octreotide
• pasireotide
• pentamidine
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• salicylates (e.g., ASA)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• somatostatin acetate
• sulfa antibiotics (e.g., sulfamethoxazole, sulfadiazine)
• sunitinib
• tacrolimus
• vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Novolin-ge-3070

About NovoLog® Mix 70/30 | NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart injectable suspension) 100 U/mL

NovoLog

^® Mix 70/30 (insulin aspart protamine and insulin aspart injectable suspension) 100 U/mL Indications and Usage

Do not share your NovoLog^® Mix 70/30 FlexPen^® with other people, even if the needle has been changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.

Before taking NovoLog^® Mix 70/30, tell your healthcare provider about all your medical conditions including, if you are:

• pregnant, planning to become pregnant, or are breastfeeding.
• taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about how to manage low blood sugar.

Serious side effects can lead to death, including:
Low blood sugar. Some signs and symptoms include:

• anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache.

Your insulin dose may need to change because of:

• weight gain or loss, increased stress, illness, or change in diet or level of physical activity.

Other common side effects may include:

• low potassium in your blood, injection site reactions, itching, rash, serious whole body allergic reactions, skin thickening or pits at the injection site, weight gain, and swelling of your hands and feet and if taken with thiazolidinediones (TZDs), possible heart failure.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please click here for NovoLog^® Mix 70/30 Prescribing Information.

NovoLog^® Mix 70/30 is a prescription medication.

Insulin NPH and Insulin Regular

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

HumuLIN 70/30; HumuLIN 70/30 KwikPen; NovoLIN 70/30; NovoLIN 70/30 FlexPen; NovoLIN 70/30 FlexPen Relion

Trade names: Canada

Humulin 70/30; Novolin ge 30/70; Novolin ge 40/60; Novolin ge 50/50

What is this drug used for?

• The drug is used to lower blood sugar in diabetics.

What should I tell my doctor BEFORE taking this drug?

• If you are allergic to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergy and how it manifested itself.
• For low blood sugar.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Tell your doctor and pharmacist about all medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems.You need to make sure that this drug is safe for your medical condition and in combination with other drugs you are already taking. Do not start or stop taking any medication or change the dosage without your doctor’s approval.

What do I need to know or do while taking this drug?

• Tell all healthcare providers that you are taking this drug.These are doctors, nurses, pharmacists and dentists.
• Allergic reactions have happened with this drug. Some reactions, in rare cases, can be very severe or life-threatening. Consult your doctor.
• Low blood sugar may happen with this drug. Very low blood sugar levels can lead to seizures, fainting, lasting brain damage, and sometimes death.Consult your doctor.
• Low blood potassium levels may happen with this drug. Left untreated, this problem can lead to irregular heartbeats, severe breathing problems, and sometimes death. Consult your doctor.
• Avoid driving and other activities that require increased attention until you see how this drug affects you.
• Heart failure may develop or pre-existing heart failure may worsen with antidiabetic drugs such as pioglitazone or rosiglitazone.This risk may be higher when insulin is used concomitantly with these drugs. Talk to your doctor if you are also taking any of these medications.
• Make sure you have the correct insulin product. Insulin products come in different containers such as ampoules, cartridges or pens. Make sure you know how to measure and prepare your dose. If you have questions, ask your doctor or pharmacist.
• It may be difficult to control blood sugar levels during times of stress, such as fever, infection, injury, or surgery.Blood sugar levels can also be affected by changes in physical activity or exercise and diet.
• Carry information that identifies the disease with you.
• Check your blood sugar as directed by your doctor.
• Perform blood tests as directed by your doctor. Please consult your doctor.
• Do not drive a car if your blood sugar is low. The risk of an accident increases.
• Consult a healthcare professional before consuming alcoholic beverages or products containing alcohol.
• Follow your doctor’s recommended diet and exercise program.
• Insulin medications you are prescribed must not be passed on to others. This prohibition applies to pens, cartridges, needles and syringes (even if the needle has been replaced in them). Sharing these items can lead to the transmission of infections from one person to another. This also applies to infections that you may not even be aware of.
• If you are 65 years of age or older, use this drug with caution.You may have more side effects.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can have serious and sometimes deadly side effects. Call your doctor or get medical help right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Signs of low potassium, such as muscle pain or weakness, muscle cramps, or a feeling of an irregular heartbeat.
• Anxiety.
• Change of vision.
• Chills.
• Severe dizziness or fainting.
• Mood swings.
• Convulsions.
• Slurred speech.
• Shortness of breath, sudden weight gain, or swelling of the arms or legs.
• Thickening of the skin, appearance of pits or bumps at the injection sites.
• A decrease in blood sugar levels may occur. Symptoms may include dizziness, headache, drowsiness, feeling weak, shaking, tachycardia, confusion, hunger, or sweating. If you experience any of these symptoms, see your doctor immediately. If your blood sugar is lowered, follow the directions given for such situations. Such directions may include taking tablets or glucose solution or some fruit juices.

What are some other side effects of this drug?

Any medicine can have side effects.However, many people have little or no side effects. Call your doctor or get medical help if these or any other side effects bother you or do not go away:

• Weight gain.
• Injection site irritation.

This list of potential side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Office.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your healthcare practitioner. Read all the information provided to you. Follow all instructions strictly.

All forms of issue:

• The drug is injected into the subcutaneous fatty tissue of the shoulder, thigh, buttocks or abdomen.
• If you give yourself injections, your doctor or nurse will teach you how to inject.
• This drug must be mixed before it is taken. Follow your doctor’s instructions for mixing the drug.
• When ready to use, this drug has a cloudy appearance and a milky white color.Do not use solution if it looks clear or contains clots. Do not use the drug if the powder has adhered to the walls of the vial.
• Take 30-45 minutes before meals.
• Change the injection site with each injection.
• Avoid areas with thick skin, pits, or bumps.
• Avoid areas of skin irritation or soreness, bruising, redness, flaking, hardening, scarring and stretch marks.
• Do not use the drug if the solution leaks or contains foreign particles.
• Do not use if solution changes color.
• Do not mix this insulin in the same syringe with other types of insulin.
• Do not mix with other fluid.
• Dispose of needles in the sharps / needles container. Needles and other items cannot be reused. When the container is full, dispose of it according to local regulations. If you have questions, ask your doctor or pharmacist.
• You should definitely know what to do if your food intake is less than normal, or if you skip one meal.
• This medication should not be used in an insulin pump. If you have any questions, please consult your doctor.

Vials:

• Do not store the syringe for future use.

Cartridges and pre-filled syringes:

• Before injection, remove all tips (there may be 2) from the needle of the syringe pen. If you are not sure what type of pen the needle belongs to or how to use the needle correctly, ask your doctor for an explanation.
• Remove the needle after each injection. Do not store the device with the needle.
• You may hear clicks while preparing a dose. Do not measure the dose by counting clicks. This can lead to the wrong dose being administered.

What should I do if a dose of a drug is missed?

• You should clearly know what to do if you forget to take the next dose of the drug.
• If you miss a dose and are not sure what to do, contact your doctor.

How do I store and / or discard this drug?

• Unopened packages should be refrigerated. Do not freeze.
• Do not use this medicine if it has been frozen.
• If unopened packaging is stored at room temperature, you must know exactly how long the drug can be stored at room temperature and when to discard it. If in doubt, consult your doctor or pharmacist.
• You should find out how long the drug can be stored and how to store it after opening the package.If in doubt, consult your doctor or pharmacist.
• Do not expose to heat and light.
• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, please consult your pharmacist.Your area may have drug recycling programs.

General information on medicinal products

• If your health does not improve or even worsens, see your doctor.
• You should not give your medicine to anyone and take other people’s medicines.
• Some medicines may have different patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• Some medicines may have different patient information sheets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• If you think there has been an overdose of a drug, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional. Please consult your doctor for complete information on the possible risks and benefits of taking this drug.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

Novolin 70/30 Injectable / Novolin Injectable in Russian – Product

Novolin 70/30 Penfill subcutaneous: uses, side effects, interactions, pictures, warnings and dosing

Benefits

Benefits

The isophane / regular insulin combination is used with a proper diet and exercise program to control high blood sugar levels in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nervous disorders, loss of limbs, and problems with sexual function.Managing your diabetes properly can also reduce your risk of heart attack or stroke.

This artificial insulin product is the same as human insulin. It replaces the insulin your body normally produces. It is a mixture of 70% intermediate acting insulin (isophane) and 30% short acting insulin (regular). It starts working as quickly as regular insulin, but lasts longer. This insulin product helps blood sugar (glucose) enter cells so that your body can use it for energy.This product can be used alone or with other oral diabetes medications (such as metformin).

How to use Penfill Novolin 70/30 cartridge

Read the patient information leaflet provided by your pharmacist before using the isophane / regular insulin combination and each time you receive a supplement. If you have any questions, ask your doctor, diabetes educator, or pharmacist.

Consult your healthcare professional for all preparation and use instructions and product packaging.

Before use, carefully twist the vial or cartridge, invert it 10 times, and invert to mix the medicine. Do not shake the container. Check this product visually for particles or discoloration. If any of these are present, do not use insulin. The isophane / regular insulin combination should look evenly cloudy / milky after mixing.Do not use if you see lumps of white material, a “frosty” appearance, or particles adhering to the sides of the vial or cartridge.

Clean the injection site with alcohol before injecting each dose. Change the injection site each time to reduce trauma under the skin and avoid developing problems under the skin (lipodystrophy). Inject this medication under your skin as directed by your doctor, usually once or twice a day. This insulin product can be injected into the abdomen, thigh, buttocks, or back of the forearm.Do not inject into a vein or muscle because very low blood sugar (hypoglycemia) may occur. Do not rub the area after injection. Do not inject into skin that is red, swollen, or itchy. Do not inject cold insulin as it can be painful. The insulin container you are currently using can be stored at room temperature.

This product should not be mixed with any other insulin.

Do not change brands or types of insulin without your doctor’s instructions on how to do it.

Do not share your pen with another person, even if the stylus is changed. You can give other people a serious infection or get a serious infection from them. Learn how to safely store and dispose of medicines.

The dosage depends on your medical condition and response to treatment. Measure each dose carefully because even small changes in the amount of insulin can have a dramatic effect on your blood sugar.

Check your blood sugar regularly as directed by your doctor.Track your results and share them with your doctor. This is very important in determining the correct dose of insulin.

Use this medication regularly to get the most out of it. To help you remember, use it at the same time every day.

Tell your doctor if your condition does not improve or worsens (blood sugar is too high or too low).

Related links

What conditions does Novolin 70/30 Penfill cartridge treat?

Side effects

Side effects

Injection site reactions (such as pain, redness, irritation) may occur.If any of these effects persist or worsen, tell your doctor or pharmacist right away.

Remember that your doctor prescribed this medication for you because he or she thought the benefit to you was greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of low potassium levels in your blood (such as muscle cramps, weakness, irregular heartbeat).

This medicine may cause low blood sugar (hypoglycemia) if you do not consume enough calories from food or if you are doing unusually strenuous exercise. Symptoms of low blood sugar include sudden sweating, tremors, rapid heartbeat, hunger, blurred vision, dizziness, or tingling of the hands / feet. It is a good habit to wear glucose tablets or gel to treat low blood sugar.If you don’t have these reliable forms of glucose, quickly raise your blood sugar by eating a fast source of sugar, such as table sugar, honey, or candy, or by drinking fruit juice or diet-free soda. Tell your doctor right away about your reaction and use of this product. To help prevent low blood sugar, eat food on a regular basis and do not skip meals. Check with your doctor or pharmacist to find out what to do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching / swelling (especially of the face / tongue / throat), severe dizziness, trouble breathing.

This is not a complete listing of potential side effects. If you notice other effects not listed above, ask your doctor or pharmacist.

In the USA –

Ask your doctor about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You can report side effects to Health Canada at 1-866-234-2345.

Related links

List of side effects of Penfill Novolin 70/30 cartridge by likelihood and severity.

Precautions

Precautions

Before using the isophane / regular insulin combination, tell your doctor or pharmacist if you are allergic to it; or to other types of insulin; or if you have any other allergies. This product may contain inactive ingredients that may cause allergic reactions or other problems.Talk to your pharmacist for more details.

Do not use this medication if you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially about: adrenal / pituitary gland, kidney disease, liver disease, thyroid gland.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels.Do not drive, operate machines, or perform any activity requiring alertness or clear vision, unless you are confident that you can do it safely.

Limit alcohol consumption while using this medication because it may increase your risk of developing low blood sugar.

It may be more difficult to control blood sugar levels when your body is under stress (for example, due to fever, infection, injury, or surgery).Check with your doctor as this may require changes to your treatment plan, medication, or blood sugar test.

Before surgery, tell your doctor or dentist about all products you use (including prescription, non-prescription, and herbal products).

Check your blood sugar before and after exercise. You may need to have a pre-workout snack.

If you travel to time zones, ask your doctor about how to set up your insulin schedule.Take extra insulin and supplies with you.

Elderly people may be more sensitive to the side effects of this drug, especially low blood sugar.

Children may be more sensitive to the side effects of this drug, especially low blood sugar.

Tell your doctor right away if you are pregnant. Pregnancy can cause or worsen diabetes. Talk with your doctor about a plan for managing your blood sugar during pregnancy.Your doctor may change your treatment for diabetes during pregnancy (such as diet and medications, including insulin).

This medication passes into breast milk but is unlikely to harm a nursing baby. Talk to your doctor before breastfeeding. Your insulin needs may change while you are breastfeeding.

Related links

What should I know about pregnancy, care and use of the Penfill Novolin 70/30 cartridge for children or the elderly?

interactions

interactions

Drug interactions may alter how your medications work or increase your risk of serious side effects.This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription / over-the-counter drugs and herbal products) and share with your doctor and pharmacist. Do not start, stop, or change the dosage of any medication without your doctor’s approval.

Some foods that can interact with this drug include: repaglinide, rosiglitazone.

Beta blockers (such as metoprolol, propranolol, eye drops for glaucoma such as timolol) can prevent the rapid heartbeat you usually feel when your blood sugar drops too low (hypoglycemia).These symptoms do not affect other symptoms of low blood sugar, such as dizziness, hunger, or sweating.

Many medications can affect blood sugar levels, making it difficult to control blood sugar levels. Before you start, stop, or change any medicine, talk to your doctor or pharmacist about how the medicine might affect your blood sugar. Check your blood sugar regularly as directed by your doctor. Tell your doctor about the results and any symptoms of high or low blood sugar.(See also the “Side Effects” section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Related links

Novolin 70/30 Penfill cartridge interacts with other drugs?

overdose

overdose

If someone has overdosed and has severe symptoms such as fainting or trouble breathing, call 911. Otherwise, contact a Poison Control Center immediately. US residents can call their local poison control center at 1-800-222-1222.Residents of Canada can call the provincial poison control center. Overdose symptoms may include: signs of low blood sugar such as sweating, tremors, loss of consciousness, heart palpitations.

Notes

Do not share this medicine, needles, or syringes with others.

Visit the diabetes education program to learn more about how to manage diabetes through medication, diet, exercise, and regular check-ups.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.

Lab and / or medical tests (such as liver and kidney function tests, fasting blood glucose, hemoglobin A1c, CBC) must be done while you are taking this medication. Keep all medical and laboratory appointments.

Keep additional supplies of insulin, syringes and needles on hand.

Missed dose

It is very important to adhere to your insulin regimen precisely. Ask your doctor ahead of time what you should do if you miss a dose of insulin.

Storage

Different brands of this medicine have different storage needs. Check product packaging for instructions on how to store your brand, or ask your pharmacist. Protect insulin from light and heat. Do not store in the bathroom. Do not freeze or use frozen insulin.Throw away all insulin products after the expiration date printed on the package or after the specified number of days after opening or storing it at room temperature, whichever comes first. Keep all medicines out of the reach of children and pets.

Do not flush medicines down the toilet or pour them down the drain unless directed to do so. Correctly discard this product when it has expired or is no longer needed.Check with your pharmacist or local waste disposal company. Last revised July 2016. Copyright (c) 2016 First Databank, Inc.

Images

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Humulin 70/30 preparation, instruction and description of the medicine humulin_70-30 Ukraine

1. Important information
2. Before taking this medicine
3. How should I take Humulin 70/30?
4. What happens if I miss a dose?
5. What happens if I overdose?
6. What should I avoid while taking Humulin 70/30?
7. Humulin 70/30 side effects
8. What other drugs will affect Humulin 70/30?
9. Where can I get more information?
10. Video about Humulin 70/30

Pronunciation

Generic name: insulin isophane and insulin regularly (IN su lin EYE soe fane and IN su lin REG ue lar)
Trade name: HumuLIN 70/30, HumuLIN 70/30 KwikPen, NovoLIN 70/30, ReliOn / NovoLIN 70/30

What is Humulin 70/30?

Humulin 70/30 contains a combination of insulin isophane and regular insulin.Insulin is a hormone that works by lowering glucose (sugar) levels in the blood. Insulin isophane is an intermediate acting insulin. The insulin regulator is a short-acting insulin. This combined insulin starts working within 10-20 minutes after injection, peaks after 2 hours, and continues to work for up to 24 hours.

Humulin 70/30 is used to improve blood sugar control in adults with diabetes.

Humulin 70/30 may also be used for purposes not listed in this medication guide.

Important Information

Do not use Humulin 70/30 if you have an episode of hypoglycemia (low blood sugar).

Hypoglycemia or low blood sugar is the most common side effect of Humulin 70/30. Symptoms of low blood sugar may include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or concentrating. Watch for signs of low blood sugar.Bring a piece of non-diet caramel or glucose tablets with you if you have low blood sugar.

Slideshow Watch the scary (but dead serious) side effects of the drugs

Never use an injection pen or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use Humulin 70/30 if you are allergic to insulin or if you have an episode of hypoglycemia (low blood sugar).

Humulin 70/30 is not approved for use by anyone under the age of 18.

To make sure this medicine is safe for you, tell your doctor if you have:

Tell your doctor if you are also taking pioglitazone or rosiglitazone (sometimes in combination with glimepiride or metformin). Taking certain oral diabetes medications while you are using insulin can increase your risk of serious heart problems.

Follow your doctor’s instructions for using Humulin 70/30 if you are pregnant or breastfeeding.Blood sugar control is very important during pregnancy, and your dose of Humulin 70/30 may vary during each trimester of pregnancy. Your doses may also be different while you are breastfeeding.

How should I take Humulin 70/30?

Use Humulin 70/30 exactly as prescribed for you. Follow all directions on the prescription label. Do not use this medicine in larger or smaller amounts, or for longer than recommended.

Insulin is injected under the skin.You will be shown how to use the injections at home. Do not give yourself this medicine if you do not understand how to use an injection and how to properly dispose of used needles and syringes.

Humulin 70/30 must not be given with an insulin pump or mixed with other insulins. Do not inject Humulin 70/30 into a vein or muscle.

Your healthcare professional will show you the best places on your body to inject Humulin 70/30. Use a different site each time you give the injection. Do not enter in the same place twice in a row.

After using Humulin 70/30, you should eat your food within 30-45 minutes.

If you are using an injection pen, only use the injection pen that comes with Humulin 70/30. Attach a new needle before each use. Do not transfer insulin from the pen to the syringe.

Never use the Humulin 70/30 injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infection or disease to pass from one person to another.

Use disposable needles or syringes only once. Follow any state or local laws to discard used needles and syringes. Use a punctured “sharps” container (ask your pharmacist where to get it and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to anyone with diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or unsteady.To treat low blood sugar quickly, always keep a fast-acting source of sugar with you, such as fruit juice, caramel, crackers, raisins, or non-baking soda.

Your doctor may prescribe an emergency glucagon injection kit for use if you have severe hypoglycemia and cannot eat or drink. Make sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia), such as increased thirst or urination, blurred vision, headache, and fatigue.

Blood sugar may be affected by stress, illness, surgery, exercise, alcohol, or skipping. Ask your doctor before changing your insulin dose or schedule.

Insulin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very carefully.

Store Humulin 70/30 in its original packaging, protected from heat and light.Do not add insulin from the vial to the syringe until you are ready to inject. Do not freeze insulin or store it next to the cooling pad in the refrigerator. Throw away any frozen insulin.

Storage unopened (unused) Humulin 70/30:

• Refrigerate and use until expiration date; or

• Store at room temperature and use the vial within 31 days or use an injection pen within 10 days.

Storage open (in use) Humulin 70/30:

• Store vial in refrigerator or at room temperature and use within 31 days.

• Store the injection pen at room temperature (do not refrigerate) and use within 10 days. Do not store the injection pen with the needle attached.

Humulin 70/30 should look cloudy after mixing. Do not use the mixture if it looks transparent or contains particles.Call your pharmacist a new drug.

Read all patient information, medication guides, and instructions provided to you. If you have any questions, ask your doctor or pharmacist.

In an emergency, wear a diabetes medication tag. Any doctor who treats you should know that you have diabetes.

See Also: Dosing Information (for more details)

What happens if I miss a dose?

Since Humulin 70/30 is used with food, you may not be on your dosing schedule.Whenever you use this insulin, be sure to eat your food within 45 minutes. Do not use complementary medicine to receive the missed dose.

Keep insulin handy at all times. Get a prescription filled before you run out of medication completely.

Read also about the drug Moxeza eye drops.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help Line at 1-800-222-1222.Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in the mouth, trouble expressing muscle weakness, clumsy or convulsive movements, seizures (convulsions), or loss of consciousness.

What should I avoid while taking Humulin 70/30?

Insulin can cause low blood sugar. Avoid driving or operating a car until you know how this medication will affect you.

Avoid treatment errors by always checking the medication label before injecting your insulin.

Avoid drinking alcohol. This can cause low blood sugar and can interfere with your diabetes.

Read also about the drug Luza.

Humulin 70/30 side effects

Get emergency medical help if you have signs of an allergy to insulin to Humulin 70/30: redness or swelling where the injection was ordered, itchy skin rash all over your body, difficulty breathing, wheezing breathing, fast heart rate, sweating, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• Fluid retention – weight gain, swelling in your hands or feet, no breathing; or

• Low potassium – leg cramps, constipation, irregular heartbeats, fluttering in the chest, increased thirst or urination, numbness or tingling, muscle weakness, or a feeling of limp.

Common Humulin 70/30 side effects may include:

• Low blood sugar;

• Itching, mild skin rash; or

• Thickening or gouging of the skin where you injected the medicine.

This is not a complete list of side effects and others may arise. Ask your doctor about side effects. You can report side effects to the FDA at the 1-800-FDA-1088 level.

See Also: Side effects (in more detail)

What other drugs will affect Humulin 70/30?

Many other medicines can affect blood sugar levels and some medicines can increase or decrease the effect of insulin. Some drugs can also cause fewer symptoms of hypoglycemia, making it difficult to measure blood sugar levels.Tell each of your health care providers about all medicines you are using now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

• Your pharmacist can provide more information about Humulin 70/30.

Video about Humulin 70/30

Side effects of Duresol (Difluprednate ophthalmic emulsion), warnings, application

• Generic Name: Difluprednate Ophthalmic Emulsion
• Brand Name: Durezol

Durezol Side Effects Center

Medical Editor: John P.Cunya, DO, FACOEP

Last viewed on RxList06.08.2019

Durezol (difuprednate) Ophthalmic Ophthalmic Emulsion 0.05% (for the eyes) is a topical anti-inflammatory corticosteroid used to treat surgical edema of the eyes. Common side effects of Durezol Ophthalmic include:

• temporary blurred vision,
• Headache,
• burning / tingling / itchy eyes,
• dry or watery eyes,
• feeling like something got in your eye, or
• Increased eye sensitivity to light.

Use of Durezol for prolonged or repeated periods may lead to new fungal infection. Tell your doctor if you have the unlikely but serious side effects of Durezol, including:

what is st. St. John’s wort

• new or increased eye pain / swelling / discharge / redness,
• eye pain or discomfort in bright light, or
• vision changes.

A dose of duresol is one drop instilled into the conjunctival sac of the affected eye (s) 4 times a day, starting 24 hours after surgery and continuing for the first 2 weeks of the postoperative period, then 2 times a day for a week, and then taper based on the answer.It is unlikely that other drugs that you take by mouth or by injection will have an effect on Durezol Ophthalmic. But many medicines can interact with each other. Tell your doctor about all prescription and over-the-counter medications and supplements you are taking. During pregnancy, Durezol should only be used as directed. It is not known if this medicine passes into breast milk. Talk to your doctor before breastfeeding.

Our Durezol Side Effects Center (Difuprednate Ophthalmic Emulsion) provides a comprehensive overview of the available drug information about the potential side effects of this drug.

This is not a complete list of side effects and they may arise. Ask your doctor about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088.

Durezol Consumer Information

Get emergency medical help if you have signs of an allergic reaction : hives; labored breathing; swelling of the face, lips, tongue, or throat.

Call your doctor right away if you have:

• pain behind the eyes, sudden changes in vision;
• slow healing after eye surgery;
• Pain in eyes, tunnel vision or halos around lights; or
• signs of a new eye infection, such as swelling, drainage, or crusting of the eyes.

Common side effects may include:

difference between white and orange suboxone

• itching or eye irritation;
• blurred vision;
• watery eyes;
• Headache;
• Feeling as if something got into the eye; or
• Your eyes may be more sensitive to light.

This is not a complete list of side effects and they may arise. Ask your doctor about side effects.You can report side effects to the FDA by calling 1-800-FDA-1088.

Read all detailed patient monograph for Durezol (Difluprednate Ophthalmic Emulsion)

Learn More ‘Durezol Professional Information

ADVERSE EFFECTS

Adverse reactions associated with ophthalmic steroids may include increased intraocular pressure, which may be associated with acute ocular nerve pressure. vision and visual field defects; posterior subcapsular cataract formation; secondary ocular infection caused by pathogens, including herpes simplex; and perforation of the eyeball with thinning of the cornea or sclera.

Eye surgery

Ocular adverse reactions occurring in 5-15% of patients in clinical trials with DUREZOL included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, aggravation of the anterior chamber, conjunctival edema and blepharitis. Other ocular adverse reactions, occurring in 1-5% of patients, included decreased visual acuity, punctate keratitis, ocular inflammation, and iritis. Ocular adverse reactions occurring in

Endogenous anterior uveitis

A total of 200 people participated in clinical studies of endogenous anterior uveitis, of whom 106 were exposed to DUREZOL.The most common adverse reactions in individuals exposed to DUREZOL, occurring in 5-10% of subjects, included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. Adverse reactions occurring in 2-5% of patients included exacerbation of the anterior chamber, corneal edema, dry eyes, iridocyclitis, photophobia, and decreased visual acuity.

what Keppra medicine is used for

Read all FDA Prescribing Information for Durezol (Difluprednate Ophthalmic Emulsion)

Learn More ‘Related Resources for Durezol

Related Drugs

Read Durezol User Reviews »

Patient Information for Durezol is provided by Cerner Multum, Inc.and Durezol consumer information is provided by First Databank, Inc., used under license and subject to their respective copyrights.

Clinical Study Diabetic Peripheral Neuropathy: Novolin Insulin Toronto, Saline – Clinical Trials Registry

Diabetic polyneuropathy (DPN) is a common complication of type I and II diabetes in humans. mellitus, found in 50% of patients with diabetes mellitus, regardless of age or type of diabetes.As the global burden of diabetes increases due to the type II diabetes epidemic, the prevalence of DPN will rise concurrently. Clinical signs of DPN include loss of sensation, a tendency to injury, neuropathic pain, motor weakness, and falls.

Currently, there is no specific therapy for stopping or canceling DPN. Previous work has demonstrated not only an absolute decrease in plasma insulin levels in type I diabetes, but also in type II diabetics.Current therapy for neuropathic pain associated with DPN. available, but only aimed at relieving symptoms and only partially effective.

Intranasal insulin administration is a new approach to the treatment of diabetic polyneuropathy (DPN), based on reliable fundamental scientific research. Intranasal insulin is currently being studied in other settings and has completed Phase II in subjects with cognitive impairment and mild Alzheimer’s disease. Intranasal administration of insulin results in increased penetration into the cerebrospinal fluid and peripheral nervous system while avoiding systemic absorption.Lack of systemic absorption leads to maintenance of normal blood glucose levels in normal healthy individuals.

The objectives of this study are as follows:

1. Primary: To determine the safety and tolerability of intranasal insulin administration in subjects with type 1 diabetes and DPN.

2. Secondary: to determine the effectiveness of intranasal insulin in slowing the progression of DPN.

This study was designed as a double-blind, placebo-controlled, randomized, controlled dosing.a pilot phase 2 escalation clinical trial.

The study duration for each subject is 11 weeks with 6 weeks of blinded study. treatment. The investigational treatment is either the active investigational drug (insulin Toronto Novolin) or placebo (saline).

The stages of the study are as follows:

1. Screening phase (3 weeks): potential subjects undergo screening procedures to determine eligibility. Procedures include informed consent, medical history, anthropometric measurements, vital signs, physical examination (including neurological evaluation), and blood tests.

2. Baseline Phase (2 weeks): Subjects eligibility confirmed and Subjects commence work. daily collection of blood glucose data according to the protocol. Nerve conduction tests Confocal microscopy of the cornea is completed before the next phase begins.

3. Treatment Phase (6 weeks): Subjects begin treatment with study drug at a minimum. the dose specified in the protocol. If insulin Novolin Toronto is prescribed, it is 20 international units (IU) twice a day (BID).Follow-up visits to the clinic are made every two weeks to increase the dose. The dose increase is 40 IU twice a day, then 80 IU twice a day. Subjects assigned to saline receive a volume equivalent to the total volume provided to subjects taking insulin. Visits during the treatment phase also include safety blood tests, serial blood glucose measurements every 15 minutes for 2 hours, review of any hypoglycemia, side effects, changes in concomitant medications, neuropathy assessments, questionnaires, training and treatment research, accountability / compliance assessment …The study ends in 11 weeks. immediately before which the second nerve conduction study is performed and the confocal microscopy is completed.

The study protocol was developed to monitor hypoglycemia throughout the entire period of treatment and treatment. period for all subjects. Any severe hypoglycemia or significant increase in hypoglycemia. (& gt; 30% compared to baseline) will be considered by the investigator on a case-by-case basis as to the basis for determining the continuation of the investigational treatment.Any subject who undergoes discontinuation of investigational drug use will continue until 11 weeks (without investigational treatment).

Study of the effect and action of liraglutide in diabetes mellitus (LEADTM) Expert Rev. Endocrinol. Metab. 4 (2), 119-129 (2009) | Madsbad

Study of the mechanism of action of incretins in the pathophysiology of type 2 diabetes mellitus (DM type 2) led
to the development of new antihyperglycemic agents. Glucagon-like peptide-1 (GLP-1) receptor agonist – Exenatide was registered with the FDA in April 2005
and launched in Europe in May 2007 for the treatment of patients with type 2 diabetes.Another modern group of drugs to improve insulin secretion and suppress secretion
glucagon are dipeptidyl peptidase inhibitors
(DPP) -4, two DPP-4 inhibitors are already on the market: sitagliptin (Januvia®) and vildagliptin (Galvus®
(Galvus®).

Liraglutide is an analogue of the human GLP-1 of the Novo
Nordisk® ”(Novo Nordisk®) for administration once a day with a duration of 24 hours. This review will discuss the efficacy and safety of liraglutide.

Incretin effect in healthy people and patients with type 2 diabetes

β-cell dysfunction is the main disorder, characteristic
for people with type 2 diabetes. The number of β-cells decreases and by the time of diagnosis, the function of β-cells
impaired by about 50% in comparison with healthy
people with good glucose tolerance [1,2]. A UKPDS study conducted in the UK showed that this disorder progresses over time,
despite treatment with sulfonylurea derivatives, metformin or insulin [1,2].One of the factors contributing to the dysfunction of β-cells in type 2 diabetes,
is the termination of the action of incretins [3]. Incretin
effect – an increase in glucose-stimulated insulin secretion under the influence of intestinal insulinotropic peptides (discussed in [4]), among which the most important [4]
are glucose-dependent insulinotropic polypeptide
(GIP) and GLP-1 secreted by endocrine K- and L-cells
in response to food intake. Together, they are responsible for postprandial insulin production, which accounts for 60-70% of the total postprandial insulin secretion [4].Both
hormones stimulate glucose-dependent insulin secretion,
this means that they do not cause hypoglycemia [4]. Some
studies have shown that a reduced effect
incretins in patients with type 2 diabetes is a consequence of impaired sensitivity of β-cells to GIP even at doses exceeding physiological, while insulinotropic
the effect of GLP-1 remains relatively better [4]. Indeed, infusion of GLP-1, in doses slightly exceeding
physiological, can increase glucose-dependent insulin secretion to normal values ​​[4,5].An additional factor that reduces the incretin effect may
be weakening of GLP-1 secretion induced by intake
food with type 2 diabetes, while the GIP response is impaired
to a lesser extent [4]. It is believed that the violation of the incretin effect slows down and weakens the insulin response time
food intake in patients with type 2 diabetes [4].

In addition to improving glucose-dependent insulin secretion,
GLP-1 suppresses excessively increased secretion of glucagon, slows down gastric emptying, reduces appetite and energy consumption, and therefore body weight.Moreover,
animal studies have shown that GLP-1
inhibits apoptosis of β-cells, promotes neogenesis, proliferation and an increase in the cell mass of β-cells [4,6]. If incretin-based treatment can also restore
β-cell function in humans, this will have a significant effect
for the treatment of type 2 diabetes.

Clinical proof of concept that GLP-1
able to effectively treat obesity in people with type 2 diabetes,
provided by Zander and colleagues, demonstrating that
the background of continuous subcutaneous injection of GLP-1 during
6 weeks there was an improvement in glycemic control, function
β-cells and insulin sensitivity, as well as a decrease in
body weight per 1.9 kg [7].

Native GLP-1 is rapidly cleaved by the DPP4 enzyme. As a result, its half-life is only
1-2 minutes, which limits the therapeutic potential [4,6].
In this regard, a stable, DPP-4-resistant analogue of GLP-1 with a long half-life was developed.

Market Watch

More than 200 million people suffer from type 2 diabetes, this number continues to increase significantly and has already reached
epidemic level [8].By 2030, the total
people with diabetes worldwide will be estimated at
370 million people [8]. Available to date
drugs act by increasing secretion
insulin (sulfonylurea or clay), decrease insulin resistance (glitazone or metformin) or slow down
absorption of glucose in the intestine (acarbose) [9,10]. Neither of
of the listed drugs does not stop the progressive
deterioration of β-cell function, although the ADOPT study and other shorter-term studies have shown that glitazone
can maintain β-cell function in comparison with metformin and sulfonylurea [11].None of the drugs
eliminates the increased secretion of glucagon, characteristic of
patients with diabetes. Current incretin-based treatments include DPP-4 inhibitors sitagliptin and vildagliptin, which reduce glycosylated
hemoglobin A1c (HbA1c) by approximately 0.7-1.0%
and do not affect body weight [12-14]. Exenatid (“Byetta”
– DPP-4 resistant GLP-1 receptor agonist – reduces
the HbA1c level is approximately 0.7-1.0%, and also induces
weight loss [12,13].You should pay attention to the fact
that the effectiveness of the various groups of MSSP is very difficult
compare, since on the one hand, the initial glycemic status of patients determines a further decrease in HbA1c,
on the other hand, due to the fact that over the past ten years the average
baseline HbA1c decreased significantly [15]. In addition, the use of previous generations of PSSP is associated with side effects.
effects such as weight gain (sulfonylureas, clays, and glitazones), hypoglycemia (sulfonylureas and clays), lactic acidosis, and side effects
from the intestine (metformin), as well as peripheral
edema and fractures (glitazones) [9,10].Side effects
when taking Exenatide, they predominantly appear in the form
disorders of the gastrointestinal tract,
while the use of DPP-4 inhibitors is associated
with more frequent infections [10,12-14]. Insulin can reduce any baseline HbA1c level to or near the therapeutic target [10]. Insulin prescription
often carries the risk of weight gain and hypoglycemia, although the use of insulin analogs reduces the risk of hypoglycemia compared to insulin-neutral
protamine Hagedorn, as well as with ordinary human insulin [10].Taking into account the above data, today
Today, there is a need for new classes of drugs that lower blood glucose levels, reduce body weight and minimize the risk of hypoglycemia.

Liraglutide

Mechanism of action and metabolism

Liraglutide – analogue of human GLP-1, used
once a day, based on the structure of native GLP-1 with amino acid substitution (lysine for arginine at position C34)
and the addition of the acyl chain C16 through glutamic
spacer to lysine at position C26 [16].The composition of the drug
is an isotonic solution for subcutaneous
introduction using a syringe pen 31G. The maximum concentration of the drug in the blood is observed after 10-14 hours,
and the half-life is 11-13 hours, providing
24 h duration of action [16]. Liraglutide is relatively resistant to DPP-4 degradation, both due to internal
properties (it can form micelle-like aggregates),
and due to binding to albumin [16].He is
a full agonist of the GLP-1 receptor, while the incidence of hypoglycemia while taking liraglutide is similar to that
have a placebo. Gender, age or site of administration have no effect on the pharmacokinetics of the drug [17]. After starting treatment
equilibrium concentrations are reached in 3-4 days [16].
The action of liraglutide in patients with type 2 diabetes is directed
to increase glucose-dependent insulin secretion and suppress glucagon secretion, as well as slow down emptying
stomach.Subcutaneous administration of liraglutide against the background of hypoglycemia does not cause impairment of the glucagon response or general
hypoglycemic regulation [18]. No clinically
No significant drug interactions associated with the inhibition or induction of cytochrome P450 have been reported during the clinical trial program. but
slowdown in gastric emptying observed during
liraglutide treatment led to small changes
Cmax, as well as to small delays Tmax of paracetamol,
atorvastatin, griseofulvin, lisinopril, digoxin, ethinyl estradiol, and levonogestrel when used simultaneously with liraglutide [19].

Clinical efficacy

Phase II Studies

In one study, 190 patients (average age
56.6 years; body mass index (BMI) ~ 31 kg / m2; the average duration of diabetes is 3-4 years; baseline HbA1c 7.5%) was administered one
from five fixed doses of liraglutide (0.045-0.75 mg), placebo or sulfonylurea derivative. Maximum
doses of liraglutide reduced HbA1c by 0.75%, and body weight
by 1.2 kg after 12 weeks of therapy [20]. The results of this study, as previous pilot studies have shown,
that doses of liraglutide up to 0.75 mg were insignificant to fully realize the potential of action to control hyperglycemia [21,22].

In a study of patients with type 2 diabetes (mean age
55 years; body mass index (BMI) ~ 32 kg / m2; the duration of diabetes is 8 years; average initial HbA1c 9.4%), dose of liraglutide
titrated from 0.5 to 2.0 mg / day for 5 weeks in combination
with metformin. Fasting glycemia decreased by 3.9 mmol / L,
and HbA1c by 0.8%, body weight decreased by 2.9 kg compared
with monotherapy with metformin [23].

In a recent Phase 2 study,
comparison of three doses of liraglutide (0.65, 1.25 and 1.9 mg) with placebo for 14 weeks in patients with type 2 diabetes (age
55 years; body mass index (BMI) 30 kg / m2; average duration
diabetes ~ 5 years) [24].The decrease in HbA1c was 1.45% in the group
liraglutide 1.9 mg versus placebo
(HbA1c + 0.29%) (1.74% placebo-adjusted reduction). In 46% of patients treated with liraglutide, the HbA1c level
was <7.0% (initial HbA1c 8.5%) [24]. Glucose level in fasting plasma decreased by 3.4 mmol / L compared with placebo [24]. Body weight in the liraglutide 1.9 mg group decreased 2.9 kg (1.2 kg in the placebo group). Hypoglycemic reports or antibodies to liraglutide were absent.Side effects from the gastrointestinal tract were registered in 37, 29, 39 and 23% of patients in three groups receiving liraglutide (0.65, 1.25 and 1.9 mg) and in the placebo group, respectively [24]. Liraglutide also caused a significant improvement in β-cell function, assessed by the ratio proinsulin / insulin, maximum secretory capacity and the first phase of insulin secretion [25].

The use of liraglutide was also accompanied by a decrease in
systolic (7.8 mm.rt. Art.) and diastolic blood pressure [24], as well as an improvement in cardiovascular risk factors, inhibitor of plasminogen activator-1, C-reactive protein and natriuretic peptide B-type [26].

Program “Study of the effect and action of liraglutide in diabetes”

Phase III liraglutide research program “Study of the effect and action of liraglutide in diabetes (LEADTM)”
was completed in 2007. However, in two of these studies
there are current extended phases (LEAD3 and 6).Program
includes about 6,500 patients in 41 countries of the world, of which approximately 4,445 patients received liraglutide. The aim of the program was to determine the indications for use
liraglutide for the treatment of type 2 diabetes in monotherapy
and in combination with traditional antihyperglycemic drugs (Table 1). The LEAD program compared
the efficacy and safety of liraglutide with a derivative
sulfonylureas, glitazone, insulin glargine and exenatide. The LEAD program includes six studies
(Table 1).In all studies, the initial dose of liraglutide
weekly, gradually increased from 0.6 to 1.8 mg / day.

Monotherapy with liraglutide

LEAD3

In this 52-week randomized trial
compared two doses of liraglutide (1.2 and 1.8 mg / day)
with glimepiride (8 mg per day) [27]. A total of 746 patients who were previously dieting and exercising (36%) or who received PADS on a regimen
monotherapy were randomized into three therapeutic
group [27].Demographic data are shown in Table 2.
Liraglutide at doses of 1.2 and 1.8 mg reduced HbA1c levels more significantly than glimepiride (Table 2); in most patients in the liraglutide groups, a decrease in HbA1c of ≤6.5% was observed
and <7.0% (Table 2). In addition, the decrease in HbA1c against the background of liraglutide at a dose of 1.8 mg was significantly more pronounced. than in the liraglutide 1.2 mg group (Table 2). Decrease in level HbA1c was most significant in the group that did not receive no drugs (liraglutide 1.2 mg: 1.2%; liraglutide 1.8 mg: 1.6%; glimepiride: 0.9%).At the end of the study, there was significant decrease in body weight in the groups receiving liraglutide (-3.2-3.6 kg) compared with weight gain in the group glimepiride (Table 2) [27]. In the liraglutide 1.8 mg group, nausea was observed in 29% of patients, while it was of a transient nature, compared with 9% in the group receiving glimepiride. The incidence of mild hypoglycemic episodes (blood glucose <56 mg / dL [3.0 mmol / L]) was significantly lower in the 1.2-1.8 mg liraglutide groups compared with the glimepiride (Table 2).There were no cases of severe hypoglycemic episodes in patients. Approximately 320 of 440 patients who completed the full course the LEAD 3 trials were included in an open-label extension study in which they will continue treatment for 4 years 2-year data indicate that liraglutide monotherapy leads to a 1.1% decrease in HbA1c compared with 0.6% while taking glimepiride (p <0.05). Among the patients who received liraglutide at a dose of 1.8 mg, 60% reached the target American Diabetes Association HbA1c Level (ADA) equal to 7.0%.A decrease in body weight (-3 kg) was also observed in patients in the liraglutide group [101]. In this way, the results of the study showed that monotherapy with liraglutide was more effective in reducing the level of HbA1c than glimepiride, at the same time led to weight loss and was accompanied by lower incidence of hypoglycemia [27].

Liraglutide in combination therapy

In the LEAD 1 and 2 studies, liraglutide was administered in combination with glimepiride or metformin, respectively.

LEAD 1

In this randomized 26-week study
with five groups, the effect of three doses of liraglutide was evaluated
(0.6; 1.2 or 1.8 mg) for glycemic control when added
to glimepiride 4 mg daily versus glimepiride
4 mg plus placebo, or glimepiride 4 mg plus rosiglitazone
8 mg daily [28].

The study included 1,041 patients with type 2 diabetes,
previously, these patients received PSPs in monotherapy regimen
(30%) or as part of a combination therapy.At screening
selected patients with HbA1c level from 7 to 11% against the background of monotherapy or from 7 to 10% against the background of combination therapy
PSSP. During the 4-week introductory period, the
current therapy and glimepiride 4 mg was prescribed. Then patients
with a fasting plasma glucose level of 7-12.8 mmol / L were randomized to approximately 228 patients in the group for
excluding the placebo group in which
114 patients. Demographic data are presented in Table 3.All doses of liraglutide reduced HbA1c more effectively than glimepiride plus placebo. Decreased HbA1c levels
against the background of two maximum doses of liraglutide, it was significantly
higher than while taking rosiglitazone. Decrease in level
fasting glucose in the three groups of liraglutide was 0.7;
1.6 and 1.6 mmol / L versus 1.0 mmol / L increase
in the placebo group and a 0.9 mmol / L decrease in the rosiglitazone group. Body weight remained stable or slightly increased in the liraglutide plus glimepiride group
versus rosiglitazone and glimepiride group (Table
3).The main side effect of liraglutide was nausea
(<11%), while it was not pronounced and had a transient character. Mild hypoglycemic episodes have been observed in <10% of patients receiving a combination of liraglutide and glimepiride. Antibodies to liraglutide were found in 9-13% of patients. Thus, liraglutide in combination with glimepiride provided more effective control glycemia compared to rosiglitazone, along with a beneficial effect on body weight and good tolerance [28].

LEAD 2

This placebo-controlled, double-blind, randomized, 26-week, five-arm study assessed the effect of three doses on glycemic control
liraglutide (0.6; 1.2 or 1.8 mg) when added to metformin
at a dose of 1 g twice daily, compared with monotherapy with metformin plus placebo or metformin plus glimepiride 4 mg
daily [29]. The study included 1,091 patients with diabetes
Type 2, who previously received PSP in monotherapy regimen (35%)
or combination therapy.The study design was similar to LEAD 1, except that glimepiride was substituted for metformin. Demographic data are given
in Table 4.

In all groups of liraglutide, a more pronounced
lower HbA1c levels than metformin plus placebo
(Table 4) [29]. The decrease in HbA1c was not different between the metformin plus glimepiride and liraglutide 1.2 mg, 1.8 mg groups (Table 4). The maximum decrease in the level of HbA1c was observed
in the group of patients who received monotherapy earlier (-1.3%
– for dosages of liraglutide 1.2 mg, 1.8 mg in comparison with the group of patients receiving metformin plus glimepiride – 1.1%).Weight loss in the 1.2 mg and 1.8 mg liraglutide groups
was more pronounced than with the combination
metformin plus placebo (Table 4). In the group receiving
glimepiride, body weight increased by an average of 1.0 kg.
In 0.8-3.7% of patients treated with metformin and liraglutide,
mild hypoglycemic episodes have been reported,
compared with 17% of patients in the glimepiride group. Nausea
was initially observed in 6-12% of patients in the liraglutide groups and decreased to 2% after 8-16 weeks of treatment [29].Two subsequent studies evaluated the efficacy of liraglutide in patients who received two PADs simultaneously – metformin plus rosiglitazone
(LEAD 4) or metformin plus a sulfonylurea derivative (LEAD 5).

LEAD 4

A total of 533 patients with type 2 diabetes within
11-week introductory period, dose titration was performed
rosiglitazone up to 4 mg twice a day and metformin up to 1 g
twice a day. Before screening, 20% of patients received monotherapy, while 80% received combination therapy
PSSP [30].Patients with fasting plasma glucose levels from
7.5 to 12.8 mmol / L were randomized to liraglutide 1.2 mg (n = 178), 1.8 mg (n = 178), or placebo (n = 177). Demographic data are shown in Table 5. For the period
studies in both groups of liraglutide baseline HbA1c
decreased by 1.5% compared with the placebo group (-0.5%). An HbA1c level <7.0 was achieved in 58%, 54%, and 28% of patients treated with liraglutide 1.2 mg, 1.8 mg and placebo, respectively. The corresponding values ​​for the HbA1c level <6.5 were 36, 37 and 14%.80% of patients who received monotherapy before by inclusion in the study, achieved an HbA1c level <7.0% after 26 weeks from the start of the study The decrease in fasting plasma glucose was 2.2 in three groups; 2.4 and 0.4 mmol / l. There was a significant decrease in body weight in the liraglutide group compared to the placebo group (Table 5). Nausea was observed in approximately 30% of patients treated with liraglutide [30].

LEAD 5

Efficacy and safety of liraglutide once daily
(1.8 mg) in combination with metformin (1 g twice daily) plus
glimepiride (2-4 mg once daily) compared with placebo or
insulin glargine for 26 weeks (Table 6) [31].581 patients were randomized after an induction titration period
metformin and glimepiride for 6 weeks. Most
patients (94%) at the time of inclusion were receiving combination therapy with PADS. Insulin glargine was titrated according to the published Lantus® study protocol
(Lantus®) until normoglycemia and glucose levels are reached
fasting plasma <100 mg / dL (AT.LANTUS) [32]. In the liraglutide group, the average decrease in the HbA1c level was significant higher than in the placebo or insulin glargine groups (Table 6).More than half of patients treated with liraglutide achieved target HbA1c ADA values ​​<7.0%, and 37% achieved target HbA1c values ​​≤6.5%, which turned out to be more significant. than in the group receiving insulin glargine (Table 6). Level fasting plasma glucose decreased in the groups receiving liraglutide and glargine. Weight loss in the liraglutide group was pronounced (-3.5 kg) in comparison with the group receiving insulin glargine (Table 6). Nausea was recorded in 14% patients in the liraglutide group, but its frequency decreased during study time up to 2-4% after the first 12 weeks of therapy.Five (2.2%) patients in the liraglutide 1.8 mg group had severe hypoglycemic episodes have been reported; there were no similar cases in other groups. The number of minor episodes did not differ between groups (Table 6). 10% patients were found to have antibodies to liraglutide [30].

Efficacy of liraglutide versus exenatide

LEAD 6

464 patients treated with metformin, sulfonylurea derivatives or a combination of metformin and a derivative
sulfonylureas were randomized to either liraglutide 1.8 mg once daily or exenatide (Byetta)
10 mcg twice a day.This 26-week study directly compares the efficacy and safety of two
agonists of the GLP-1 receptor [33]. Demographic data
are presented in Table 7. In patients treated with liraglutide, there was a decrease in HbA1c> 1.1%, compared with the exenatide group <0.8%, while the difference was statistically significant [33]. In the liraglutide group, 54% of patients had HbA1c levels <7% compared to 43% in the exenatide group, which was also statistically significant.HbA1c ≤6.5% was achieved in 35% and 21% of patients, respectively. In both groups, there was a decrease in body weight by about 3 kg, while in the group receiving liraglutide, there was a trend towards further weight loss. Among patients previously treated with metformin alone, this difference was 1 kg in favor of liraglutide (4.08 vs. 3.05 kg; p = 0.08) [33]. Most Reported Side Effect both liraglutide and exenatid had nausea - 25% (with this nausea has been reported by all patients at least once).Through 8-10 weeks of therapy, the percentage of patients who were observed nausea during liraglutide therapy was <10%, while as in the exenatide group - 10%. The frequency of mild hypoglycemic episodes, mainly observed during combination therapy with sulfonylurea derivatives, was significantly lower in the group receiving liraglutide (Table 7), but in general, the incidence of hypoglycemia can be characterized as low in both groups. Β-cell functions, assessed using the homeostasis model (HOMA-B), and triglyceride levels significantly improved against the background taking liraglutide [33].

Meta-analysis of studies LEAD 1, 2 and 5

The baseline HbA1c level is an indicator that determines the response to glucose-lowering therapy. Patients from studies LEAD 1, 2 and 5 were divided into groups
depending on the initial quartiles of HbA1c [34]. Appointment
liraglutide led to a decrease in HbA1c from 0.4-0.9% in 1 quartile (average HbA1c ~ 7.3%) to a decrease of 1.3-2.3% in the 4th quartile (average HbA1c ~ 9.7%) [ 34].

Another study evaluated the effect of liraglutide
per body weight as measured by LEAD 1, 2, and 5 over a 26-week period [35].The most pronounced decrease in body weight
was observed in patients with a BMI> 35 kg / m2. Weight reduction
body in patients with BMI <25 kg / m2 was 0-2 kg and increased to 1-4.5 kg in patients with BMI ≤35 kg / m2. Lowest weight loss was observed in LEAD 1 during metformin withdrawal and the purpose of the sulfonylurea derivative. Most a significant decrease in body weight was observed against the background of a combination of liraglutide and metformin [35].

In LEAD 1, 2 and 5 in the liraglutide 1.8 mg groups, systolic blood pressure decreased by 1.9-4.5 mm Hg.Art.
in comparison with other groups [36]. A decrease in blood pressure was observed already after 2 weeks of therapy before weight loss. No change in diastolic
no blood pressure was observed [36].

Finally, liraglutide in LEAD 1, 2 and 5
significantly improved β-cell function, which was assessed
using the HOMA index and the proinsulin / insulin ratio [37]. However, additional studies are needed to assess the effect of liraglutide on β-cell function and the course of type 2 diabetes.

Safety and tolerability of liraglutide

Liraglutide was well tolerated and was associated with a low risk of hypoglycemia even in patients receiving concomitant sulfonylurea derivatives. number
cases of nausea that were observed during the first few weeks of therapy were tolerable, and then became minimal or completely disappeared. Emergence
nausea in rare cases can probably be explained by a fairly even profile of liraglutide action, as well as a 3-week titration scheme, which was used in all
research.Antibodies were found in <15% of patients to liraglutid, but they did not have a negative effect on glycemic control.

Regarding side effects of receptor agonists
GLP-1, some attention was paid to the appearance of C-cell neoplasms in the thyroid gland. Changes observed in rodents and mice with the introduction of liraglutide,
were absent in humans [24].

Thus, Phase II studies and the LEAD program
Phase III proved the efficacy and safety of liraglutide
– analogue of human GLP-1, for administration once a day,
in the treatment of type 2 diabetes.The program is clinically relevant and demonstrates the superiority of liraglutide over others
hypoglycemic drugs, including insulin glargine
and exenatids. The program also demonstrated that liraglutide was effective in reducing both HbA1c and patient weight. The decrease in HbA1c and mass was maximal in the group
patients with baseline high HbA1c and BMI at the time
inclusion in the study. Liraglutide was well tolerated,
nausea was rare.

In the LEAD 3 study, patients with type 2 diabetes received
liraglutide or glimepiride for 1 year in monotherapy regimen [27].Liraglutide reduced HbA1c more pronounced,
than glimepiride (decrease in HbA1c by 1.2-1.6%), while
50% of patients in the liraglutide group experienced a decrease
HbA1c <7.0% (baseline HbA1c - 8.3%). Moreover, in the group liraglutide there was a decrease in blood pressure and significantly fewer cases of hypoglycemia compared with the group receiving glimepiride. Weight loss in the liraglutide group was 3-4 kg compared to the group glimepiride [27].

When combined with metformin
(LEAD 2) liraglutide reduced HbA1c similar to the combination of metformin and glimepiride (~ 1.0%) with minimal risk of hypoglycemia [29]. During the LEAD 1 study, the combination
liraglutide and glimepiride reduced the level of HbA1c much more pronouncedly than the combination of glimepiride and rosiglitazone [28]. Decreased HbA1c in the liraglutide group
after 26 weeks of therapy was 1.5% against the background of the maximum
dose. Weight loss was more pronounced with the addition of liraglutide to metformin, in contrast to the combination with glimepiride.A total of 42% of HbA1c patients
was <7.0% (> 60% among patients previously treated with PSSP monotherapy). When prescribing liraglutide to the combination
metformin and rosiglitazone decrease in HbA1c occurred
by 1.5% compared with a decrease of 0.5% in patients in the group
placebo, while the decrease in body weight (-2.6 kg) was
also in favor of liraglutide (LEAD 4) [30]. In research
LEAD 5 in patients treated with metformin and a sulfonylurea drug, with liraglutide, more
low HbA1c values ​​compared to the insulin glargine group [31].In addition, the decrease in body weight in the liraglutide group was 3.0-3.5 kg. Against the background of the use of liraglutide
there was a significant decrease in systolic blood pressure compared with insulin glargine [31].
The incidence of hypoglycemia did not differ between groups. The results of the LEAD 6 study indicate that liraglutide in therapy, one injection per day, reduces HbA1c more
effective than exenatide administered twice [33]. Weight
body in patients treated with liraglutide or exenatide,
did not differ significantly [33].

LEAD research results also show
about the beneficial effect of liraglutide on systolic blood pressure and β-cell function, which is consistent with the data of phase II clinical trials.

Specialist Comment

Liraglutide is the first analogue of human GLP-1
once daily, designed for the treatment of type 2 diabetes
type. It is attractive for the treatment of people with type 2 diabetes because drug regulation of insulin and glucagon secretion
is glucose-dependent, which significantly reduces the risk of hypoglycemia.In particular, when liraglutide is used together with metformin or glitazone, the risk of hypoglycemia
is minimal. Liraglutide also causes a decrease
body weight, which is very important since most patients with type 2 diabetes are overweight,
while the use of sulfonylurea derivatives,
glitazones and insulin are accompanied by weight gain. Liraglutide is convenient in terms of the timing of the injection and its
the introduction does not depend on food intake.The need for self-monitoring of blood glucose levels is minimal, especially when compared with insulin therapy.

The liraglutide research program is optimally designed to obtain multiple indications for use at once
liraglutide in patients with type 2 diabetes. Effectiveness of control
glycemia with liraglutide in type 2 diabetes at present
already proven, both in monotherapy and in humans
with a long course of type 2 diabetes, receiving one or two
PSSP. Liraglutide, administered once a day, is more effective in lowering HbA1c than exenatide given twice.Compared to DPP-4 inhibitors, a decrease in HbA1c can
be done in favor of liraglutide, although to confirm
this requires a comparative study
[12,13]. In addition, liraglutide helps to reduce
body weight, which is also known to lead to a certain decrease in HbA1c. DPP-4 inhibitors are believed to be
have no effect on body weight [12,13].

However, some questions require clarification. Of interest is information on the duration of glycemic
control, especially when compared with other PSSPs.Also
Long-term studies evaluating the effect of liraglutide on β-cell function in humans are very important. Unknown
whether liraglutide can contribute to the progression of the disease by preventing failure of function
β-cells. The duration and degree of weight loss while using liraglutide should be established.
It will also be interesting to know if the 2.4 mg / day dose is
more optimal, not so much in terms of glycemic
control how much in relation to the correction of excess weight.Novo Nordisk investigated the effect of liraglutide on body weight in obese patients,
not suffering from diabetes mellitus. Indeed, in this study, weight loss at 30 and 52 weeks was
6-8 kg when taking two maximum doses of liraglutide
(2.4 and 3.0 mg) [102].

Evidence that GLP-1 receptor agonists improve
myocardial function in people who have had myocardial infarction,
and also improve endothelial function and reduce systolic blood pressure, emphasize the need for studies aimed at assessing the outcome of cardiovascular diseases [4,6].Liraglutide can be
effective in patients with type 2 diabetes and heart failure, since GLP-1 promotes renal excretion
water, sodium and lowers blood pressure [24,36,38].
The LEAD program also answered many questions regarding the efficacy and safety of liraglutide. Liraglutide caused transient nausea in 20% of patients at doses
1.2-1.8 mg / day. Most patients had nausea
transient nature, and a gradual weekly dose increase minimized this side effect.Both liraglutide and DPP-4 inhibitors can be used in the same groups of patients and be prescribed in the regimen
monotherapy or in combination with other drugs. Liraglutide
may be especially effective in overweight patients who also wish to lose weight, or in patients who are reluctant to start insulin therapy because of the risk
weight gain and fear of hypoglycemia. In the future, liraglutide
it may also be prescribed for patients already receiving insulin.Nevertheless, liraglutide may not be the best option for long-term treatment of patients
with type 2 diabetes with minimal β-cell function requiring
insulin administration [39].

Bolen and colleagues, in their review of articles based on standardized analysis, concluded that metformin had the best benefit-risk profile.
providing the same or better glycemic control as
compared with other PSSP [9]. In the latest ADA guides
and EASD are recommended to start metformin treatment together
with a lifestyle correction program from the moment of establishment
diagnosis [10].Further treatment includes additional
use of sulfonylurea drugs or basal insulin therapy. Liraglutide can rightfully be considered the next most attractive drug that can be added to treatment with metformin, especially when the risk of hypoglycemia and the need for weight loss. However
less, the final position of liraglutide in the treatment algorithm for type 2 diabetes will be determined only after long-term studies with end-point cardiovascular
points, as well as after obtaining data on the effect of analogs
GLP-1 and DPP-4 inhibitors for the progression of type 2 diabetes.

Highlights

• Incretins are peptide hormones that are secreted by the intestines during food intake.
• Glucagon-like peptide (GLP) -1 stimulates insulin secretion, inhibits glucagon secretion, slows down gastric emptying, reduces appetite, reduces energy consumption and reduces body weight.
• Liraglutide:
  • First analogue of human GLP-1 for once daily administration;
  • Reduces the level of glycated hemoglobin A1c (HbA1c) in monotherapy mode or in conjunction with one or more oral antihyperglycemic drugs;
  • Induces a decrease in body weight;
  • Reduces the level of HbA1c to the level of insulin glargine, and changes in body weight during treatment are in favor of liraglutide, which potentiates weight loss;
  • The drug is well tolerated and has a low risk of hypoglycemia.The number of cases of nausea is acceptable and it is transient in most patients.

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