Insulin Lispro Prt Mix 75/25kwikpen

Manufacturer LILLY Active Ingredient Insulin Lispro Protamine and Insulin Lispro (Pens)(IN soo lin LYE sproe PROE ta meen & IN soo lin LYE sproe) Pronunciation IN soo lin LYE sproe PROE ta meen & IN soo lin LYE sproe
It is used to lower blood sugar in patients with high blood sugar (diabetes).
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Drug Class
Antidiabetic agent
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Pharmacologic Class
Insulin analog, intermediate-acting/rapid-acting combination
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Pregnancy Category
Category B
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FDA Approved
May 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a type of insulin that helps your body use sugar for energy. It's a mix of two insulins: one that works quickly (lispro) and one that works for a longer time (lispro protamine). This combination helps control your blood sugar after meals and throughout the day. It comes in a pre-filled pen for easy injection under the skin.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin in the upper arm, thigh, buttocks, or stomach area. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.

Preparing the Medication

Before use, this medication must be mixed according to the instructions provided by your doctor. Use the medication immediately after mixing. It is recommended to take the medication within 15 minutes before a meal.

Injection Site Selection

When administering the injection, choose a different site each time to minimize the risk of skin irritation. Avoid injecting into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.

Inspecting the Medication

Before use, inspect the medication to ensure it appears cloudy and milky. Do not use the medication if the solution is clear or contains lumps. Additionally, do not use the medication if powder is stuck to the sides of the container, the solution is leaking, or it contains particles. If the solution changes color, do not use it.

Using the Pen Needle

Remove all pen needle covers before injecting a dose. If you are unsure about the type of pen needle you have or how to use it, consult your doctor. After each injection, remove the needle and do not store the device with the needle attached.

Important Administration Instructions

This product may produce a clicking sound when preparing the dose. However, do not rely on the clicks to determine the dose, as this may result in an incorrect dose. Do not transfer the medication from the pen to a syringe. After use, dispose of the needle in a needle/sharp disposal box and do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor. Be aware of the procedures to follow if you do not eat as much as usual or if you skip a meal.

Mixing with Other Insulins

Do not mix this insulin with other types of insulin in the same syringe. Additionally, this medication is not suitable for use in an insulin pump. If you have any questions or concerns, consult your doctor.

Storage and Disposal

Store unopened containers in the refrigerator, but do not freeze. Do not use the medication if it has been frozen.

Missing a Dose

If you forget to take a dose, be aware of the procedures to follow. If you are unsure about what to do, consult your doctor.
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Lifestyle & Tips

  • Always check your blood sugar levels as instructed by your doctor, especially before meals and at bedtime.
  • Follow a consistent meal plan and exercise routine as advised by your healthcare provider.
  • Learn how to properly inject the medication, rotate injection sites to prevent skin problems, and store your pens correctly.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, juice, candy) to treat low blood sugar (hypoglycemia).
  • Inform your healthcare provider about all other medications, supplements, and herbal products you are taking.
  • Do not share your insulin pens or needles with anyone else, even if the needle is changed, as this carries a risk of infection.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on metabolic needs, blood glucose monitoring, and glycemic goals. Typically administered subcutaneously 15 minutes before a meal or immediately after a meal. Dosing frequency is usually once or twice daily.

Condition-Specific Dosing:

Type 1 Diabetes: Initial total daily dose often 0.5-1.0 units/kg/day, with 50-70% as basal/intermediate insulin and the remainder as bolus. Humalog Mix 75/25 can cover both.
Type 2 Diabetes: Initial dose often 0.2-0.6 units/kg/day, or 6-10 units once or twice daily, adjusted based on blood glucose levels.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Dosing is highly individualized based on metabolic needs, blood glucose monitoring, and glycemic goals. Typically administered subcutaneously 15 minutes before a meal or immediately after a meal. Initial doses are often lower than adults and titrated carefully.
Adolescent: Dosing is highly individualized based on metabolic needs, blood glucose monitoring, and glycemic goals. Typically administered subcutaneously 15 minutes before a meal or immediately after a meal. Dosing may be similar to adults but requires careful titration.
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Dose Adjustments

Renal Impairment:

Mild: Insulin requirements may decrease; monitor blood glucose closely and adjust dose as needed.
Moderate: Insulin requirements often decrease; monitor blood glucose closely and adjust dose as needed.
Severe: Insulin requirements significantly decrease; monitor blood glucose closely and adjust dose as needed. Frequent monitoring is crucial.
Dialysis: Insulin requirements typically decrease. Administer after dialysis. Monitor blood glucose closely and adjust dose as needed.

Hepatic Impairment:

Mild: Insulin requirements may decrease; monitor blood glucose closely and adjust dose as needed.
Moderate: Insulin requirements often decrease; monitor blood glucose closely and adjust dose as needed.
Severe: Insulin requirements significantly decrease; monitor blood glucose closely and adjust dose as needed. Frequent monitoring is crucial.
Confidence: Medium

Pharmacology

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Mechanism of Action

Insulin lispro protamine and insulin lispro are human insulin analogs that lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. The protamine component prolongs the action of insulin lispro, providing an intermediate-acting effect, while the unbound insulin lispro provides a rapid-acting effect.
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Pharmacokinetics

Absorption:

Bioavailability: High (subcutaneous administration)
Tmax: Insulin Lispro: 0.5-1.5 hours; Insulin Lispro Protamine: 6-8 hours (for the combination, there are two peaks)
FoodEffect: Administered before or immediately after a meal to coincide with postprandial glucose rise.

Distribution:

Vd: Approximately 0.26-0.36 L/kg (similar to extracellular fluid volume)
ProteinBinding: Minimal (<10%)
CnssPenetration: Limited

Elimination:

HalfLife: Insulin Lispro: Approximately 1 hour; Insulin Lispro Protamine: Effective half-life is longer due to slow absorption from the injection site, contributing to its prolonged action.
Clearance: Renal clearance is significant, but hepatic metabolism is the primary route.
ExcretionRoute: Renal (primarily metabolites, small amount unchanged)
Unchanged: <2%
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Pharmacodynamics

OnsetOfAction: Approximately 15-30 minutes (due to insulin lispro)
PeakEffect: Dual peaks: 1-2 hours (lispro) and 6-8 hours (lispro protamine)
DurationOfAction: Up to 18-24 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Some allergic reactions can be life-threatening, so prompt medical attention is crucial.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
Shortness of breath
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures

If you experience any of these symptoms, call your doctor right away. If you have low blood sugar, follow the instructions you have been given, which may include taking glucose tablets, liquid glucose, or some fruit juices.

Other Possible Side Effects

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

Irritation at the injection site
* Weight gain

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, talk to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of low blood sugar (hypoglycemia): sweating, shaking, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat. Treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision, unexplained weight loss. Report to your doctor.
  • Signs of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek emergency medical attention.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have low blood sugar (hypoglycemia), as this may affect your treatment plan.

This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you use
Vitamins you take
Existing health problems or conditions

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety and the effectiveness of your treatment plan.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Be aware that this medication can cause low blood sugar (hypoglycemia), which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not properly managed. Consult your doctor to discuss the risks and prevention strategies.

Additionally, this medication can cause low blood potassium (hypokalemia), which, if left untreated, may result in abnormal heart rhythms, severe breathing difficulties, and potentially death. Discuss this risk with your doctor.

If you are taking other diabetes medications like pioglitazone or rosiglitazone, be aware that they may increase the risk of heart failure or worsen existing heart failure. Using insulin with these medications may further increase this risk. If you are taking one of these medications, consult your doctor to discuss the potential risks.

Ensure you have the correct insulin product and understand how to properly measure and prepare your dose. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns, contact your doctor or pharmacist.

During times of stress, such as fever, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar control.

Wear a medical alert identification (ID) to inform others of your condition in case of an emergency.

Do not drive if you have experienced low blood sugar, as this can increase your risk of being involved in an accident. Monitor your blood sugar levels as directed by your doctor.

Regularly undergo blood tests as recommended by your doctor to ensure your blood sugar levels are within a healthy range. Discuss any concerns or questions with your doctor.

Before consuming alcohol or using products containing alcohol, consult your doctor to discuss the potential risks and interactions.

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

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (very low blood sugar)
  • Confusion
  • Seizures
  • Loss of consciousness
  • Hypokalemia (low potassium levels)

What to Do:

Immediate administration of oral glucose (if conscious) or glucagon injection (if unconscious). Seek emergency medical attention. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Non-selective beta-blockers (may mask symptoms of hypoglycemia and prolong hypoglycemic episodes)
  • Thiazolidinediones (TZDs) - e.g., pioglitazone, rosiglitazone (increased risk of fluid retention and heart failure when used with insulin)
  • Alcohol (can potentiate or diminish the hypoglycemic effect of insulin)
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Moderate Interactions

  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Thiazide diuretics (may increase blood glucose, requiring higher insulin doses)
  • Sympathomimetics (e.g., albuterol, epinephrine) (may increase blood glucose)
  • Oral contraceptives (may increase blood glucose)
  • Growth hormone (may increase blood glucose)
  • Danazol (may increase blood glucose)
  • Sulfonylureas, Meglitinides, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors (increased risk of hypoglycemia when co-administered with insulin)
  • Salicylates (e.g., aspirin in high doses) (may enhance hypoglycemic effect)
  • ACE inhibitors, Angiotensin Receptor Blockers (ARBs) (may enhance hypoglycemic effect)
  • Octreotide, Lanreotide (may increase or decrease insulin requirements)
  • Certain antipsychotics (e.g., olanzapine, clozapine) (may increase blood glucose)
  • Protease inhibitors (may affect glucose metabolism)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and guide initial dosing.

Timing: Prior to initiation of therapy.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of therapy.

Renal Function (e.g., eGFR, creatinine)

Rationale: To assess kidney function, as insulin requirements may decrease in renal impairment.

Timing: Prior to initiation and periodically thereafter.

Hepatic Function (e.g., ALT, AST)

Rationale: To assess liver function, as insulin metabolism occurs in the liver.

Timing: Prior to initiation and periodically thereafter.

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Routine Monitoring

Self-Monitoring Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., pre-meal, 2-hour post-meal, bedtime, overnight) depending on patient needs and glycemic control.

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

Action Threshold: Hypoglycemia (<70 mg/dL) or persistent hyperglycemia (>180-250 mg/dL) requiring dose adjustment or medical attention.

HbA1c

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

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

Action Threshold: Above target range indicates need for therapy adjustment.

Weight

Frequency: Periodically (e.g., every 3-6 months).

Target: Stable or within healthy range.

Action Threshold: Significant unexplained weight gain or loss.

Signs/Symptoms of Hypoglycemia

Frequency: Daily, with each injection and throughout the day.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms (e.g., sweating, tremor, confusion, hunger) requiring immediate treatment.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy (pre-existing or gestational diabetes) due to its efficacy and safety profile. Insulin lispro is generally considered safe for use during pregnancy. Close monitoring of blood glucose is essential to achieve optimal glycemic control and reduce risks to both mother and fetus.

Trimester-Specific Risks:

First Trimester: Tight glycemic control is crucial to reduce the risk of congenital malformations.
Second Trimester: Insulin requirements may increase due to hormonal changes.
Third Trimester: Insulin requirements typically continue to increase, then may decrease rapidly after delivery.
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Lactation

Insulin is compatible with breastfeeding. Insulin is a large protein molecule and is not excreted into breast milk in clinically significant amounts. It is not expected to cause adverse effects in breastfed infants.

Infant Risk: Low risk to infant.
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Pediatric Use

Dosing must be carefully individualized and titrated based on age, weight, pubertal status, activity level, and glycemic targets. Children and adolescents may have varying insulin sensitivities and are at higher risk for hypoglycemia, especially during growth spurts or changes in activity. Close monitoring and education for patients and caregivers are essential.

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Geriatric Use

Older adults may be more susceptible to hypoglycemia due to impaired renal/hepatic function, polypharmacy, and reduced counter-regulatory responses. Dosing should be initiated cautiously with careful titration. Glycemic targets may be less stringent to avoid hypoglycemia. Assess for cognitive impairment and ability to self-administer.

Clinical Information

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Clinical Pearls

  • Always ensure the patient understands the difference between rapid-acting, intermediate-acting, and combination insulins to prevent dosing errors.
  • Instruct patients to always check the insulin label carefully before each injection to ensure they are using the correct type of insulin.
  • Remind patients to rotate injection sites within the same general area (e.g., abdomen) to minimize lipodystrophy and improve absorption.
  • Humalog Mix 75/25 should be gently rolled between the palms 10 times and inverted 10 times immediately before each injection to ensure the suspension is uniformly mixed.
  • Patients should be educated on the symptoms and management of hypoglycemia, including carrying a fast-acting carbohydrate source.
  • This insulin is typically given 15 minutes before a meal or immediately after a meal. Consistency in timing relative to meals is important.
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Alternative Therapies

  • Basal insulins (e.g., insulin glargine, insulin detemir, insulin degludec)
  • Bolus/prandial insulins (e.g., insulin lispro, insulin aspart, insulin glulisine, regular human insulin)
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists)
  • Other injectable non-insulin antidiabetic agents (e.g., GLP-1 receptor agonists, amylin analogs)
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Cost & Coverage

Average Cost: Highly variable, typically $100-$300+ per KwikPen (3 mL, 100 units/mL)
Insurance Coverage: Tier 2 or Tier 3 (preferred brand or non-preferred brand) on most commercial and Medicare Part D plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.