Humalog Insulin (vl-7510) 10ml

Manufacturer LILLY Active Ingredient Insulin Lispro (U-100) Vials(IN soo lin LYE sproe) Pronunciation HYOO-mah-log 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, rapid-acting 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?

Humalog is a fast-acting insulin that helps your body use sugar for energy. It starts working very quickly, usually within 15 minutes, and is taken right before or after meals to help control blood sugar spikes after eating. It's used to treat diabetes.
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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 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 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 injection equipment.
When the disposal container 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 aware of the steps to take if you miss a meal or do not eat as much as usual.

Important Administration Notes

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, ensure you understand how to operate it and follow your doctor's instructions or the package insert. Regularly change the medication and pump parts as directed.
If the pump malfunctions, have an alternative method of insulin administration available 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 the steps to take 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 directed by your doctor.
  • Follow your meal plan and carbohydrate counting instructions.
  • Engage in regular physical activity as advised by your healthcare provider.
  • Rotate injection sites to prevent skin problems (lipodystrophy).
  • Never share needles, pens, or vials with others.
  • Always have a source of fast-acting sugar (e.g., glucose tablets, juice) readily available to treat low blood sugar (hypoglycemia).

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Administered subcutaneously 5-15 minutes before a meal or immediately after a meal. Total daily insulin requirements typically range from 0.5 to 1 unit/kg/day, with rapid-acting insulin often comprising 50-70% of the total daily dose, divided before meals.

Condition-Specific Dosing:

Type 1 Diabetes: Individualized, often as part of a basal-bolus regimen.
Type 2 Diabetes: Individualized, often in combination with oral antidiabetic agents or basal insulin.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution and expert guidance)
Infant: Individualized, based on blood glucose monitoring and metabolic needs. Close monitoring required.
Child: Individualized, based on blood glucose monitoring and metabolic needs. Often 0.5 to 1 unit/kg/day, adjusted for growth and activity.
Adolescent: Individualized, based on blood glucose monitoring and metabolic needs. Doses may increase during puberty.
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Dose Adjustments

Renal Impairment:

Mild: May require dose adjustment; monitor glucose closely.
Moderate: Dose reduction often required; monitor glucose closely.
Severe: Significant dose reduction required; monitor glucose closely and frequently.
Dialysis: Dose reduction required; monitor glucose closely, especially post-dialysis.

Hepatic Impairment:

Mild: May require dose adjustment; monitor glucose closely.
Moderate: Dose reduction often required; monitor glucose closely.
Severe: Significant dose reduction required; monitor glucose closely and frequently.

Pharmacology

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Mechanism of Action

Insulin lispro is a rapid-acting insulin analog that lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. It also increases transport of amino acids into cells and accelerates protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (subcutaneous administration)
Tmax: 0.5-1.5 hours (subcutaneous)
FoodEffect: Administered 5-15 minutes before a meal or immediately after a meal to cover postprandial glucose excursions.

Distribution:

Vd: Not available (similar to endogenous insulin)
ProteinBinding: Minimal (<10%)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1 hour (functional half-life is longer due to absorption kinetics)
Clearance: Not available (similar to endogenous insulin)
ExcretionRoute: Renal (metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within 15 minutes
PeakEffect: 0.5-1.5 hours
DurationOfAction: Up to 5 hours

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
Rarely, allergic reactions can be fatal.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal 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 (hypoglycemia), 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. Follow your doctor's instructions for managing low blood sugar, 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:

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 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 severe low blood sugar (hypoglycemia): severe confusion, seizures, loss of consciousness. Seek immediate medical help.
  • Symptoms of high blood sugar (hyperglycemia) or diabetic ketoacidosis (DKA): extreme thirst, frequent urination, nausea, vomiting, fruity breath, confusion. Contact your doctor.
  • Signs of allergic reaction: rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing. Seek immediate medical help.
  • Signs of heart failure (if taking TZDs): unusual weight gain, swelling in ankles/feet, shortness of breath.
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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 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 currently taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have or have had in the past

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe for you 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.

You are at risk for low blood sugar (hypoglycemia) while taking this drug. Severe hypoglycemia can lead to seizures, loss of consciousness, permanent brain damage, and even death. Discuss this risk with your doctor to understand how to manage it.

Additionally, this medication may cause low blood potassium levels (hypokalemia). If left untreated, hypokalemia can result in abnormal heart rhythms, severe breathing difficulties, and potentially death. Consult your doctor if you have concerns about this potential side effect.

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

Ensure you are using the correct insulin product, as they come in various containers, including vials, cartridges, and pens. Understand how to measure and prepare your dose correctly. If you have any questions or concerns, contact your doctor or pharmacist for guidance.

Be aware that stress, such as fever, infection, injury, or surgery, can make it 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 it can increase your risk of being involved in an accident. Monitor your blood sugar levels as directed by your doctor.

Regular blood tests are necessary to ensure your safety while taking this medication. Follow your doctor's instructions for getting your blood work checked and discuss any concerns or questions you may have.

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

Never share your insulin product, including pens, cartridge devices, needles, or syringes, with another person, even if the needle has been changed. Sharing can spread 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 of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (low blood sugar)
  • Confusion
  • Dizziness
  • Sweating
  • Tremor
  • Blurred vision
  • Seizures
  • Loss of consciousness
  • Hypokalemia (low potassium levels)

What to Do:

For mild to moderate hypoglycemia, consume 15-20 grams of fast-acting carbohydrates (e.g., glucose tablets, fruit juice, regular soda). Recheck blood glucose in 15 minutes and repeat if necessary. For severe hypoglycemia (unconsciousness, seizures), administer glucagon if available and call emergency services (e.g., 911). After recovery, consume a snack or meal to prevent recurrence. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia)
  • Thiazolidinediones (TZDs) - increased risk of fluid retention and heart failure when used with insulin
  • Alcohol (can potentiate hypoglycemic effect)
  • Certain atypical antipsychotics (may cause hyperglycemia, requiring increased insulin dose)
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Moderate Interactions

  • Oral antidiabetic agents (additive hypoglycemic effect)
  • ACE inhibitors (may enhance insulin sensitivity)
  • Angiotensin receptor blockers (ARBs) (may enhance insulin sensitivity)
  • Salicylates (e.g., aspirin) (may enhance insulin sensitivity)
  • Sulfonamide antibiotics (may enhance insulin sensitivity)
  • Monoamine oxidase inhibitors (MAOIs) (may enhance insulin sensitivity)
  • Somatostatin analogs (e.g., octreotide) (may decrease insulin requirements)
  • Corticosteroids (may increase blood glucose, requiring increased insulin dose)
  • Diuretics (e.g., thiazides, loop diuretics) (may increase blood glucose, requiring increased insulin dose)
  • Sympathomimetics (e.g., decongestants, beta-2 agonists) (may increase blood glucose, requiring increased insulin dose)
  • Growth hormone (may increase blood glucose, requiring increased insulin dose)
  • Danazol (may increase blood glucose, requiring increased insulin dose)
  • Oral contraceptives (may increase blood glucose, requiring increased insulin dose)
  • Thyroid hormones (may increase blood glucose, requiring increased insulin dose)

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, serum creatinine)

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

Timing: Prior to initiation and periodically thereafter.

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

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

Timing: Prior to initiation and periodically thereafter.

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Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

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

Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL 1-2 hours post-meal.

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

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.

Signs and symptoms of hypoglycemia

Frequency: Daily, ongoing patient education.

Target: N/A

Action Threshold: Any symptoms (e.g., sweating, tremor, confusion, hunger) require immediate glucose intake.

Injection site inspection

Frequency: Daily

Target: N/A

Action Threshold: Presence of lipodystrophy (lipoatrophy or lipohypertrophy) indicates need for site rotation.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, weight loss)
  • Signs of allergic reaction (e.g., rash, itching, swelling, difficulty breathing)
  • Injection site reactions (e.g., redness, swelling, itching, pain, lipodystrophy)

Special Patient Groups

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Pregnancy

Insulin lispro is generally considered safe and is often the preferred insulin for managing gestational diabetes or pre-existing diabetes in pregnancy. Careful glycemic control is crucial during pregnancy to minimize risks to both mother and fetus.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations directly attributed to insulin lispro. Strict glycemic control is important to prevent early pregnancy complications.
Second Trimester: Dose adjustments may be needed as insulin resistance typically increases.
Third Trimester: Dose adjustments may be needed. Close monitoring of blood glucose is essential to prevent macrosomia and other complications.
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Lactation

Insulin lispro is considered compatible with breastfeeding. Insulin is a normal component of breast milk and is not expected to cause adverse effects in a breastfed infant. Maternal insulin requirements may change during lactation.

Infant Risk: L1 (Safest - compatible with breastfeeding)
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Pediatric Use

Insulin lispro is approved for use in pediatric patients with diabetes mellitus. Dosing must be carefully individualized based on age, weight, activity level, and glycemic control goals. Close monitoring for hypoglycemia is essential.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity to insulin's effects and increased risk of hypoglycemia may occur in some older individuals. Renal and hepatic function should be monitored, and dose adjustments may be necessary.

Clinical Information

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Clinical Pearls

  • Insulin lispro is a rapid-acting insulin; instruct patients to administer it 5-15 minutes before a meal or immediately after a meal to optimize postprandial glucose control.
  • Emphasize the importance of consistent carbohydrate intake and meal timing relative to insulin administration.
  • Educate patients on recognizing and treating hypoglycemia promptly.
  • Stress the importance of proper injection technique and site rotation to prevent lipodystrophy.
  • Patients should always carry a source of fast-acting carbohydrate.
  • Humalog U-100 vials are for subcutaneous injection only; do not administer intravenously unless under strict medical supervision in a hospital setting (e.g., for DKA management).
  • Unopened vials should be stored in a refrigerator (2°C to 8°C [36°F to 46°F]). Once opened, vials can be stored at room temperature (below 30°C [86°F]) for up to 28 days.
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Alternative Therapies

  • Other rapid-acting insulins: Insulin aspart (Novolog, Fiasp), Insulin glulisine (Apidra)
  • Short-acting insulins: Regular human insulin (Humulin R, Novolin R)
  • Long-acting insulins: Insulin glargine (Lantus, Toujeo, Basaglar), Insulin detemir (Levemir), Insulin degludec (Tresiba)
  • Intermediate-acting insulins: NPH insulin (Humulin N, Novolin N)
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, SGLT2 inhibitors, GLP-1 receptor agonists - often used in Type 2 diabetes, sometimes in combination with insulin)
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Cost & Coverage

Average Cost: $200 - $350 per 10ml vial (U-100)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred brand 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 for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.