Insulin Lispro 100u/ml Vial 10ml

Manufacturer LILLY Active Ingredient Insulin Lispro (U-100) Vials(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
Category B
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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. It starts working quickly, usually within 15-30 minutes, and is taken right before or after meals to help control your blood sugar after you eat. It's used to treat diabetes by replacing the insulin your body isn't making enough of.
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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 under the skin. If you will be self-administering the injection, your doctor or nurse will instruct you 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 tissue damage.
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.

Safe Disposal and Handling

Dispose of used needles in a designated sharps disposal container.
Do not reuse needles or other equipment.
When the disposal container is full, follow local regulations for proper disposal.
If you have any questions, consult your doctor or pharmacist.

Diet and Exercise

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

Special Considerations

Do not draw the medication into a syringe and store it for future use.
Some brands of this medication may be mixed with insulin NPH, but be sure to verify this with your doctor or pharmacist. Do not mix this medication with any other type of insulin.
If using an insulin pump, follow your doctor's instructions and the manufacturer's guidelines. Regularly change the medication and pump parts as directed.
If the pump malfunctions, have a backup plan for insulin administration and consult your doctor.

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 Doses

Be aware of what to do if you forget to take a dose. If you are unsure, contact your doctor for guidance.
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Lifestyle & Tips

  • Always check your blood sugar levels as instructed by your doctor.
  • Administer insulin lispro subcutaneously (under the skin) 5-10 minutes before a meal, or immediately after a meal if preferred by your doctor.
  • Rotate injection sites (abdomen, thigh, upper arm, buttocks) to prevent lipodystrophy (skin changes).
  • Do not inject into skin that is red, bruised, scaly, or hard.
  • Never share needles, syringes, or insulin pens with others.
  • Follow your prescribed diet and exercise plan consistently.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar (hypoglycemia).
  • Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
  • Store unopened vials in the refrigerator (36°F-46°F [2°C-8°C]). Once opened, store at room temperature (up to 86°F [30°C]) for up to 28 days. Do not freeze.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's metabolic needs, blood glucose monitoring results, and glycemic control goal. Administered subcutaneously 5-10 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 prandial (bolus) insulin. Insulin lispro is used as prandial insulin.
Type 2 Diabetes: Initial dose may be 4 units or 0.1 units/kg or 10% of basal insulin dose, adjusted based on blood glucose levels.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, highly individualized)
Infant: Not established (use with extreme caution, highly individualized)
Child: Highly individualized based on metabolic needs, similar principles to adults for prandial dosing. Typically 0.5-1 unit/kg/day total insulin, with lispro as prandial component.
Adolescent: Highly individualized based on metabolic needs, similar principles to adults for prandial dosing. Typically 0.5-1 unit/kg/day total insulin, with lispro as prandial component.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor glucose closely.
Moderate: Insulin requirements may decrease; monitor glucose closely and adjust dose as needed.
Severe: Insulin requirements often decrease significantly; monitor glucose closely and adjust dose as needed. Risk of hypoglycemia increased.
Dialysis: Insulin requirements often decrease significantly; monitor glucose closely and adjust dose as needed. Risk of hypoglycemia increased.

Hepatic Impairment:

Mild: No specific dose adjustment, but monitor glucose closely.
Moderate: Insulin requirements may decrease; monitor glucose closely and adjust dose as needed. Risk of hypoglycemia increased.
Severe: Insulin requirements often decrease significantly; monitor glucose closely and adjust dose as needed. Risk of hypoglycemia increased.

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 the release of glucose from the liver. It also inhibits lipolysis and proteolysis, and enhances protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: High (subcutaneous)
Tmax: 0.5-1.5 hours (subcutaneous)
FoodEffect: Administered before or immediately after meals to coincide with postprandial glucose rise.

Distribution:

Vd: Approximately 0.26-0.36 L/kg
ProteinBinding: Very low (<10%)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1 hour (functional half-life, reflecting duration of action, is longer)
Clearance: Not available (complex, involves degradation)
ExcretionRoute: Renal (metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: 0.5-2.5 hours
DurationOfAction: Up to 5 hours
Confidence: High

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 medical attention immediately:

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 changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures
If you experience any of these symptoms, contact your doctor right away. If you have low blood sugar, follow your doctor's instructions, which may include taking glucose tablets, liquid glucose, or some fruit juices.

Other Possible Side Effects

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

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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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. Seek immediate medical attention or consume fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, dry mouth, fatigue, blurred vision. Contact your doctor if these symptoms persist.
  • Symptoms of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing. Seek emergency medical help.
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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), as this may affect your treatment plan.

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

All prescription and over-the-counter (OTC) medications you are currently 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 that it is safe to do so. This will help prevent potential interactions or adverse effects.
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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.

Low blood sugar (hypoglycemia) is a potential side effect of this drug, and severe cases can lead to 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 levels (hypokalemia), which, if left untreated, can result in abnormal heart rhythms, severe breathing difficulties, and potentially death. If you experience any symptoms, consult your doctor promptly.

Until you understand how this medication affects you, avoid driving and other activities that require your full attention. Certain diabetes medications, such as pioglitazone or rosiglitazone, may increase the risk of heart failure, especially when 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.

It is recommended that you wear a medical alert identification (ID) to inform others of your condition. If you have experienced low blood sugar, do not drive, as this can increase your risk of being involved in an accident. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as scheduled.

Before consuming alcohol or using products containing alcohol, consult your doctor to discuss potential interactions. Do not share your insulin product, including pens, cartridge devices, needles, or syringes, with others, 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:

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

What to Do:

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

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia, prolong recovery from hypoglycemia)
  • Thiazolidinediones (TZDs) - e.g., pioglitazone, rosiglitazone (increased risk of fluid retention and heart failure when used with insulin)
  • Alcohol (potentiates hypoglycemic effect)
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Moderate Interactions

  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Diuretics (thiazide and loop diuretics may increase blood glucose)
  • Sympathomimetics (e.g., epinephrine, albuterol, terbutaline - may increase blood glucose)
  • Growth hormone (may increase blood glucose)
  • Danazol (may increase blood glucose)
  • Oral contraceptives (may increase blood glucose)
  • Thyroid hormones (may increase blood glucose)
  • Atypical antipsychotics (e.g., olanzapine, clozapine - may increase blood glucose)
  • Protease inhibitors (may increase blood glucose)
  • Somatostatin analogs (e.g., octreotide, lanreotide - may decrease or increase insulin requirements)
  • Salicylates (e.g., aspirin - may enhance hypoglycemic effect at high doses)
  • Sulfonamide antibiotics (may enhance hypoglycemic effect)
  • MAO inhibitors (may enhance hypoglycemic effect)
  • ACE inhibitors (may enhance hypoglycemic effect)
  • Angiotensin receptor blockers (ARBs) (may enhance hypoglycemic effect)
  • Fibrates (may enhance hypoglycemic effect)

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 (SCr, eGFR)

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

Timing: Prior to initiation of therapy

Hepatic function (ALT, AST)

Rationale: To assess liver function, as insulin requirements may decrease in 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), Hyperglycemia (>180-250 mg/dL depending on target)

HbA1c

Frequency: Every 3-6 months (or more frequently if glycemic control is unstable)

Target: Individualized, typically <7% for most adults

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

Signs and symptoms of hypoglycemia

Frequency: Daily, ongoing patient education

Target: N/A

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

Injection site inspection

Frequency: Regularly (e.g., daily/weekly)

Target: N/A

Action Threshold: Presence of lipodystrophy, redness, swelling, or pain

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Symptom Monitoring

  • Hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat, anxiety, weakness, slurred speech, seizures, unconsciousness.
  • Hyperglycemia: increased thirst, increased urination, dry mouth, fatigue, blurred vision, fruity breath odor (ketoacidosis), nausea, vomiting, abdominal pain.

Special Patient Groups

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Pregnancy

Insulin lispro is generally considered safe and is often the preferred insulin for managing diabetes during pregnancy. Insulin requirements may change throughout pregnancy.

Trimester-Specific Risks:

First Trimester: Insulin requirements may decrease. Close monitoring of blood glucose is essential.
Second Trimester: Insulin requirements typically increase.
Third Trimester: Insulin requirements typically continue to increase.
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Lactation

Insulin lispro is compatible with breastfeeding. Insulin is a normal component of breast milk and is not harmful to the infant. Insulin requirements may be lower in breastfeeding mothers.

Infant Risk: L1 (Safest - compatible with breastfeeding, no known adverse effects on infant)
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Pediatric Use

Insulin lispro is approved for use in pediatric patients with diabetes mellitus. Dosing is highly individualized based on age, weight, and metabolic needs. Close monitoring for hypoglycemia is crucial, especially in younger children.

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Geriatric Use

Use with caution in elderly patients due to increased risk of hypoglycemia, particularly in those with renal or hepatic impairment. Initial doses should be conservative, and dose adjustments should be made gradually with close glucose monitoring. May have impaired awareness of hypoglycemia.

Clinical Information

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Clinical Pearls

  • Insulin lispro is a rapid-acting insulin, meaning it should be taken very close to mealtime (5-10 minutes before or immediately after) to cover the postprandial glucose rise.
  • Patients should be educated on proper injection technique, site rotation, and storage to ensure efficacy and prevent complications like lipodystrophy.
  • Always ensure patients have access to and understand how to use glucagon for severe hypoglycemia.
  • Insulin requirements can vary significantly due to diet, exercise, stress, illness, and other medications; emphasize the importance of consistent blood glucose monitoring and communication with healthcare providers.
  • Be aware of the 'lag time' between injection and meal if injecting before eating; this can be adjusted based on pre-meal glucose levels and anticipated meal size.
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Alternative Therapies

  • Other rapid-acting insulin analogs (e.g., insulin aspart, insulin glulisine, faster-acting insulin aspart, ultra-rapid insulin lispro)
  • Short-acting human insulin (e.g., Regular insulin)
  • Intermediate-acting insulin (e.g., NPH insulin)
  • Long-acting insulin analogs (e.g., insulin glargine, insulin detemir, insulin degludec)
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, SGLT2 inhibitors, GLP-1 receptor agonists - for Type 2 Diabetes)
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Cost & Coverage

Average Cost: $100 - $300+ per 10ml vial (U-100)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred brand or non-preferred brand, biosimilars may be Tier 1/2)
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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's a good idea 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.