Insulin Lispro 100u/ml Kwikpen 3ml

Manufacturer LILLY Active Ingredient Insulin Lispro (U-100) Cartridges and Pens(IN soo lin LYE sproe) Pronunciation 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
Rapid-acting insulin analog
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Pregnancy Category
Not available
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FDA Approved
Jun 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Insulin Lispro is a fast-acting insulin that helps your body use sugar for energy and lowers high blood sugar levels. It's typically taken right before or after meals to manage the rise in blood sugar from food.
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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 layer of the skin. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.

Administration Guidelines

Take the medication within 15 minutes before or immediately after a meal.
Rotate the injection site each time to avoid repeated use of the same area.
Avoid injecting into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Do not use the medication if the solution appears cloudy, is leaking, or contains particles, or if the solution has changed color.

Preparing the Dose

Remove all pen needle covers before injecting a dose (note that there may be two covers).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
Be aware that the product may produce a clicking sound as you prepare the dose. However, do not rely on the clicks to determine the correct dose.
Remove the needle after each injection and do not store the device with the needle attached.

Important Safety Precautions

Do not transfer the medication from the pen to a syringe or mix it with other types of insulin.
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
If you have any questions or concerns, consult your doctor or pharmacist.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor.
Be prepared for situations where you may not eat as much as usual or skip a meal, and know how to adjust your medication accordingly.

Storage and Disposal

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

Missed Dose

If you forget to take a dose, be aware of the proper course of action. If you are unsure, contact your doctor for guidance.
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Lifestyle & Tips

  • Administer insulin exactly as prescribed by your doctor, usually 5-15 minutes before a meal or immediately after.
  • Rotate injection sites within the same general area (e.g., abdomen) to prevent lipodystrophy (skin changes).
  • Never share insulin pens or needles with others, even if the needle is changed, due to risk of blood-borne pathogen transmission.
  • Monitor blood glucose levels regularly as instructed by your healthcare provider.
  • Follow a consistent meal plan and exercise routine as advised by your doctor or dietitian.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat mild to moderate hypoglycemia.
  • Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
  • Store unopened pens in the refrigerator (36°F-46°F [2°C-8°C]). Once opened, store at room temperature (up to 86°F [30°C]) and use within 28 days. Do not freeze.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on metabolic needs, blood glucose monitoring results, and glycemic control goal. Administered subcutaneously 5-15 minutes before a meal or immediately after a meal.

Condition-Specific Dosing:

Type 1 Diabetes: Typically 0.5-1 unit/kg/day total insulin, with 50-70% as basal and 30-50% as bolus (mealtime) insulin. Lispro is used for bolus.
Type 2 Diabetes: Starting dose often 4-6 units before the largest meal, or 10% of basal insulin dose, adjusted based on pre-meal glucose targets.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution and expert guidance)
Infant: Individualized, based on blood glucose and metabolic needs. Close monitoring required.
Child: Individualized, similar to adults, based on blood glucose and metabolic needs. Typically 0.5-1 unit/kg/day total insulin, with Lispro as bolus.
Adolescent: Individualized, similar to adults, based on blood glucose and metabolic needs. Doses may be higher during puberty.
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Dose Adjustments

Renal Impairment:

Mild: Dose adjustment may be required; monitor glucose closely.
Moderate: Dose reduction often required due to decreased insulin clearance; monitor glucose closely.
Severe: Significant dose reduction often required; monitor glucose closely and frequently.
Dialysis: Dose adjustment required; monitor glucose closely, especially post-dialysis.

Hepatic Impairment:

Mild: Dose adjustment may be required; monitor glucose closely.
Moderate: Dose reduction often required due to decreased gluconeogenesis and insulin clearance; monitor glucose closely.
Severe: Significant dose reduction often required; monitor glucose closely and frequently.

Pharmacology

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Mechanism of Action

Insulin Lispro is a rapid-acting human insulin analog that lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. It binds to insulin receptors on cells, facilitating the cellular uptake of glucose and inhibiting lipolysis and proteolysis.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly quantifiable due to subcutaneous administration; absorption is rapid.
Tmax: 0.5-1.5 hours (subcutaneous)
FoodEffect: Not applicable; administered subcutaneously before or after meals.

Distribution:

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

Elimination:

HalfLife: Approximately 1 hour (functional half-life is longer due to absorption kinetics)
Clearance: Not readily quantifiable for subcutaneous administration; primarily renal and hepatic clearance.
ExcretionRoute: Primarily renal (metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: 0.5-2.5 hours
DurationOfAction: 3-5 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Local reactions at the injection site, including:
+ Thick skin
+ Pits or lumps
Swelling in the arms or legs
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Fatigue or weakness
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures
If you experience any of these symptoms, contact your doctor immediately. If you have low blood sugar, follow your doctor's instructions, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Weight gain
Flu-like symptoms
Nose or throat irritation
Common cold symptoms
Headache
Cough
Upset stomach
Stomach pain or diarrhea
Fatigue or weakness
* Irritation at the injection site

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

  • Symptoms of severe hypoglycemia (e.g., confusion, seizures, loss of consciousness) require immediate medical attention.
  • Symptoms of hyperglycemia (e.g., excessive thirst, frequent urination, fatigue, blurred vision) indicate high blood sugar and may require dose adjustment.
  • Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing) require immediate medical attention.
  • Symptoms of heart failure (e.g., unusual weight gain, swelling in ankles/feet, shortness of breath) if taking with TZDs.
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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 symptoms you experienced as a result of the allergy.
If you have low blood sugar (hypoglycemia).

This medication may interact with other medications or health conditions. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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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.

When taking this drug, you are at risk for low blood sugar (hypoglycemia), which can lead to severe complications, including seizures, loss of consciousness, permanent brain damage, and even death. It is crucial to discuss this risk with your doctor. Additionally, this medication may cause low blood potassium (hypokalemia), which, if left untreated, can result in abnormal heart rhythms, severe breathing difficulties, and potentially be fatal. If you experience any symptoms, consult your doctor promptly.

Until you understand how this medication affects you, avoid driving and other activities that require your full attention. Certain diabetes medications, such as pioglitazone or rosiglitazone, may increase the risk of heart failure or worsen existing heart failure, especially when combined with insulin. If you are taking one of these medications, consult your doctor to discuss the potential risks.

To ensure safe use, verify that you have the correct insulin product and are familiar with its administration. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns about measuring or preparing your dose, contact your doctor or pharmacist.

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

For your safety, wear a medical alert identification (ID) that indicates your condition. If you have experienced low blood sugar, do not drive, as this increases your risk of being involved in an accident. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as scheduled.

Before consuming alcohol or using products containing alcohol, consult your doctor to discuss potential risks. Never share your insulin product, including pens, cartridge devices, needles, or syringes, with another person, even if the needle has been changed, as this can transmit infections.

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

Overdose Symptoms:

  • Hypoglycemia (mild to severe)
  • Neuroglycopenic symptoms (e.g., confusion, disorientation, slurred speech, behavioral changes, seizures, coma)
  • Hypokalemia (rare, but possible with severe overdose)

What to Do:

For mild hypoglycemia, consume fast-acting carbohydrates (e.g., glucose tablets, juice). For severe hypoglycemia, administer glucagon (if available and trained) or seek immediate medical attention. Call 911 or 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Pramlintide (increased risk of severe hypoglycemia)
  • Beta-blockers (may mask symptoms of hypoglycemia)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure when co-administered with insulin)
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Moderate Interactions

  • Oral antidiabetic agents (additive hypoglycemic effect)
  • ACE inhibitors (may enhance insulin's glucose-lowering effect)
  • Angiotensin Receptor Blockers (ARBs) (may enhance insulin's glucose-lowering effect)
  • Salicylates (e.g., aspirin) (may enhance insulin's glucose-lowering effect)
  • Sulfonamide antibiotics (may enhance insulin's glucose-lowering effect)
  • Monoamine Oxidase Inhibitors (MAOIs) (may enhance insulin's glucose-lowering effect)
  • Alcohol (may potentiate or diminish insulin's glucose-lowering effect)
  • Corticosteroids (may decrease insulin's glucose-lowering effect)
  • Diuretics (e.g., thiazides, loop diuretics) (may decrease insulin's glucose-lowering effect)
  • Sympathomimetics (e.g., epinephrine, albuterol) (may decrease insulin's glucose-lowering effect)
  • Growth hormone (may decrease insulin's glucose-lowering effect)
  • Danazol (may decrease insulin's glucose-lowering effect)
  • Oral contraceptives (may decrease insulin's glucose-lowering effect)
  • Thyroid hormones (may decrease insulin's glucose-lowering effect)
  • Atypical antipsychotics (e.g., olanzapine, clozapine) (may decrease insulin's glucose-lowering effect)

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and set treatment goals.

Timing: Prior to initiation of therapy

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glucose levels.

Timing: Prior to initiation of therapy

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

Rationale: To assess kidney function, as insulin clearance can be affected by renal impairment.

Timing: Prior to initiation of therapy

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

Rationale: To assess liver function, as insulin metabolism can be affected by hepatic impairment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Self-Monitoring Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., pre-meal, 1-2 hours post-meal, bedtime, overnight as needed)

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

Action Threshold: Hypoglycemia (<70 mg/dL) or hyperglycemia (>180-250 mg/dL depending on target)

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7%

Action Threshold: >7% (consider dose adjustment or therapy change)

Weight

Frequency: Regularly (e.g., monthly or quarterly)

Target: Maintain healthy weight

Action Threshold: Significant unexplained weight gain or loss

Signs/symptoms of hypoglycemia

Frequency: Daily, with each dose and throughout the day

Target: Absence of symptoms

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

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, palpitations, anxiety, hunger, confusion, dizziness, headache, blurred vision, slurred speech, irritability, mood changes, unsteadiness, seizures, unconsciousness)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss)
  • Injection site reactions (e.g., redness, swelling, itching, pain, lipodystrophy)

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for managing diabetes in pregnant women. Available data from published studies and postmarketing reports of insulin use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Tight glycemic control is crucial during pregnancy to reduce risks to both mother and fetus.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects identified with insulin use.
Second Trimester: Dose requirements may increase due to hormonal changes and insulin resistance.
Third Trimester: Dose requirements may continue to increase. Close monitoring of blood glucose is essential.
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Lactation

Insulin is considered compatible with breastfeeding. Insulin is a normal component of human milk and is not orally absorbed by the infant. No adverse effects on the breastfed infant are expected. Maternal insulin requirements may change during lactation.

Infant Risk: Low risk (L1)
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Pediatric Use

Insulin Lispro is safe and effective for use in pediatric patients with diabetes mellitus. Dosing must be individualized based on age, weight, and metabolic needs, with careful monitoring to prevent hypoglycemia.

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Geriatric Use

Use with caution in elderly patients due to increased susceptibility to hypoglycemia, potential for renal/hepatic impairment, and comorbidities. Start with lower doses and titrate carefully. Monitor blood glucose more frequently.

Clinical Information

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Clinical Pearls

  • Insulin Lispro is a rapid-acting insulin, meaning it starts working quickly and has a short duration. It's crucial to administer it close to mealtime (5-15 minutes before or immediately after) to match the glucose rise from food.
  • Always verify the insulin type (rapid, short, intermediate, long-acting) before administration to avoid dosing errors.
  • Educate patients on proper injection technique, site rotation, and safe disposal of needles/pens.
  • Stress the importance of consistent carbohydrate intake and meal timing when using mealtime insulin to prevent hypoglycemia.
  • Patients should be advised to carry a source of fast-acting carbohydrates for hypoglycemia treatment.
  • Be aware of factors that can affect insulin absorption (e.g., injection site, temperature, exercise).
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Alternative Therapies

  • Other rapid-acting insulins (e.g., Insulin Aspart, Insulin Glulisine, faster-acting Insulin Aspart, ultra-rapid Insulin Lispro)
  • Short-acting insulins (e.g., Regular Human Insulin)
  • Intermediate-acting insulins (e.g., NPH Human Insulin)
  • Long-acting insulins (e.g., Insulin Glargine, Insulin Detemir, Insulin Degludec)
  • Oral antidiabetic agents (e.g., Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) for Type 2 Diabetes.
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Cost & Coverage

Average Cost: $100 - $300 per 3ml KwikPen (U-100)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult with 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 overdose, including the medication taken, the amount, and the time it occurred.