Humalog 100u/ml Vial 3ml

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
Insulin, rapid-acting
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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's used to lower high blood sugar levels, especially after meals, in people with diabetes. It starts working very quickly and lasts for a few hours.
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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 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 needle/sharp disposal box.
Do not reuse needles or other equipment.
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 aware of the steps to take 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 confirm this with your doctor or pharmacist. Do not mix this medication with any other type of insulin.
If using an insulin pump, follow the doctor's instructions or the package insert for proper use. 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 procedures to follow if you miss a dose. If you are unsure, contact your doctor for guidance.
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Lifestyle & Tips

  • Follow your prescribed diet plan consistently.
  • Engage in regular physical activity as advised by your doctor.
  • Monitor your blood glucose levels frequently as instructed.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat mild to moderate hypoglycemia.
  • Never share insulin pens or syringes with others, even if the needle is changed, due to risk of bloodborne pathogen transmission.
  • Rotate injection sites to prevent lipodystrophy (skin changes).

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 within 15 minutes before a meal or immediately after a meal.

Condition-Specific Dosing:

Type 1 Diabetes: Typically 0.5 to 1 unit/kg/day total insulin, with 50-70% as basal and 30-50% as prandial (mealtime) insulin. Lispro is used for prandial coverage.
Type 2 Diabetes: Initial dosing may be 4 units or 0.1 units/kg or 10% of basal insulin dose before the largest meal. Adjust based on blood glucose levels.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, highly individualized by specialist)
Infant: Highly individualized, typically lower doses than adults, adjusted based on blood glucose monitoring.
Child: Highly individualized, adjusted based on blood glucose monitoring and growth. Similar principles to adult Type 1 diabetes dosing.
Adolescent: Highly individualized, adjusted based on blood glucose monitoring and pubertal changes. Similar principles to adult Type 1 diabetes dosing.
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Dose Adjustments

Renal Impairment:

Mild: May require dose reduction due to decreased insulin clearance and increased risk of hypoglycemia. Monitor blood glucose closely.
Moderate: Requires dose reduction. Monitor blood glucose closely and adjust as needed.
Severe: Requires significant dose reduction. Monitor blood glucose closely and adjust as needed. Increased risk of hypoglycemia.
Dialysis: Requires significant dose reduction. Insulin is not significantly removed by dialysis. Monitor blood glucose closely.

Hepatic Impairment:

Mild: May require dose reduction due to decreased gluconeogenesis and insulin clearance. Monitor blood glucose closely.
Moderate: Requires dose reduction. Monitor blood glucose closely and adjust as needed.
Severe: Requires significant dose reduction. Monitor blood glucose closely and adjust as needed. Increased risk of hypoglycemia.

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. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: Approximately 1 hour (functional half-life, due to rapid absorption and degradation)
Clearance: Approximately 10-15 mL/kg/min
ExcretionRoute: Renal (primary route for metabolites)
Unchanged: Not available (rapidly metabolized)
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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 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 injection site reactions, 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
+ Feeling sleepy or weak
+ Shaking
+ Fast 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 some 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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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, 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, headache, blurred vision. Treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision. Contact your doctor if persistent.
  • Symptoms of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek immediate 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 disclose all the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Vitamins you are taking
Any health problems you have

To ensure your safety, it is vital to verify that this medication is compatible with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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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.

This drug may cause low blood sugar, which can 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 may cause low blood potassium levels, which can result in abnormal heart rhythms, severe breathing difficulties, and potentially death if left untreated. It is crucial to discuss this risk with your doctor.

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 used in combination with insulin. 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 periods of stress, such as illness, 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 levels.

Wear a medical alert identification to ensure prompt care in case of an emergency. Avoid driving 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 and undergo regular blood tests as scheduled. Consult your doctor before consuming alcohol or using products that contain alcohol.

Do not share your insulin product or any related devices, including pens, cartridge devices, needles, or syringes, with others. Sharing can lead to the transmission of 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 potential benefits and risks to 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:

Seek immediate medical attention. For conscious individuals, administer oral glucose. For unconscious individuals, administer glucagon subcutaneously or intramuscularly, or intravenous glucose. Call 911 or your local emergency number. Contact Poison Control at 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Pramlintide (increased risk of severe hypoglycemia)
  • Certain atypical antipsychotics (may cause hyperglycemia, requiring increased insulin dose)
  • Corticosteroids (may cause hyperglycemia, requiring increased insulin dose)
  • Diuretics (thiazides, loop diuretics - may cause hyperglycemia, requiring increased insulin dose)
  • Sympathomimetics (e.g., albuterol, epinephrine - may cause hyperglycemia, requiring increased insulin dose)
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Moderate Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia, prolong recovery from hypoglycemia)
  • 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)
  • Alcohol (may potentiate hypoglycemic effect, especially with fasting)
  • Oral Contraceptives (may cause hyperglycemia, requiring increased insulin dose)
  • Thyroid hormones (may cause hyperglycemia, 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 (SCr, eGFR)

Rationale: To assess kidney function, as insulin clearance may be reduced in renal impairment.

Timing: Prior to initiation of therapy

Hepatic function (ALT, AST)

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

Frequency: Multiple times daily (pre-meal, post-meal, bedtime, overnight as needed)

Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL 1-2 hours 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: >7% (consider dose adjustment or therapy change)

Signs and symptoms of hypoglycemia

Frequency: Daily, ongoing

Target: N/A

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

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Insulin Lispro is considered a Category B drug in pregnancy. It is the preferred treatment for glycemic control in pregnant women with diabetes (pre-existing or gestational) as it does not cross the placenta in significant amounts. Strict glycemic control is crucial to prevent adverse maternal and fetal outcomes.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital anomalies associated with insulin use. Strict glycemic control is important to prevent early pregnancy complications.
Second Trimester: Insulin requirements may increase due to hormonal changes and increased insulin resistance. Close monitoring and dose adjustments are necessary.
Third Trimester: Insulin requirements typically continue to increase. Close monitoring and dose adjustments are necessary to maintain glycemic targets and prevent macrosomia and other complications.
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Lactation

Insulin Lispro is considered safe for use during lactation (L1). Insulin is a normal component of breast milk and is not expected to cause adverse effects in a breastfed infant. Insulin requirements may change during lactation, requiring dose adjustments.

Infant Risk: Low risk to infant.
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Pediatric Use

Insulin Lispro is approved for use in pediatric patients with diabetes mellitus. Dosing must be highly individualized based on age, weight, metabolic needs, and blood glucose monitoring. Close supervision and education for parents/caregivers are essential.

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Geriatric Use

Geriatric patients may be at increased risk of hypoglycemia due to age-related decline in renal function, cognitive impairment, and polypharmacy. Dosing should be initiated cautiously with careful titration and frequent blood glucose monitoring. Lower glycemic targets may be appropriate for some elderly patients to minimize hypoglycemia risk.

Clinical Information

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Clinical Pearls

  • Insulin Lispro should be administered within 15 minutes before a meal or immediately after a meal to optimize postprandial glucose control.
  • Always check the insulin label carefully before each injection to ensure the correct type of insulin is being used.
  • Rotate injection sites within the same region (e.g., abdomen) to reduce the risk of lipodystrophy.
  • Patients should be educated on the signs and symptoms of hypoglycemia and how to treat it promptly.
  • Never mix Humalog U-100 with other insulins in the same syringe, except for NPH insulin. If mixing, draw Humalog first.
  • Vials should be stored in a refrigerator (2°C to 8°C) until first use. After first use, vials can be stored at room temperature (up to 30°C) 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)
  • Intermediate-acting insulins: NPH Human Insulin (Humulin N, Novolin N)
  • Long-acting insulins: Insulin Glargine (Lantus, Toujeo, Basaglar), Insulin Detemir (Levemir), Insulin Degludec (Tresiba)
  • 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: Varies widely, typically $100-$300 per 10ml vial (U-100)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (varies by insurance plan and formulary)
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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. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.