Humalog Cartridge 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
Insulin analog, 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 rapid-acting insulin that helps lower your blood sugar quickly after meals. It's used to manage diabetes by helping your body use sugar for energy. You inject it under your skin, usually right before you eat.
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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 injections, your doctor or nurse will instruct you on the proper technique.

Administration Guidelines

Take your dose 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 solution if it appears cloudy, is leaking, or contains particles, or if the color has changed.

Preparing Your Dose

Remove all pen needle covers before injecting a dose. If you have two covers, remove both.
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
You may hear a clicking sound as you prepare your dose. Do not rely on the clicks to determine your dose, as this could result in an incorrect dose.
After each injection, remove the needle from the pen.
Do not store the device with the needle attached.

Important Safety Precautions

Do not transfer this medication from the pen to a syringe or mix it with other types of insulin.
Dispose of used needles in a designated sharps disposal container. Do not reuse needles or other items.
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 what to do if you miss a meal or do not eat as much as usual.

Storage and Disposal

Store unopened containers in the refrigerator. Do not freeze.
Do not use the medication 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 what to do in the event of a missed dose, contact your doctor.
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Lifestyle & Tips

  • Always take Humalog 5-15 minutes before a meal, or immediately after, to match your body's natural insulin release after eating.
  • Learn carbohydrate counting to accurately dose your insulin based on your food intake.
  • Maintain a consistent meal schedule and healthy diet as advised by your healthcare provider or dietitian.
  • Engage in regular physical activity, but be aware that exercise can lower blood sugar, potentially requiring insulin dose adjustments.
  • Rotate injection sites (abdomen, thigh, upper arm, buttocks) to prevent skin problems like lipodystrophy (lumps or indentations).
  • Never share your insulin pen or cartridge with another person, even if the needle is changed, as this carries a risk of transmitting blood-borne pathogens.
  • Always check your blood sugar regularly as instructed by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on metabolic needs, typically administered 5-15 minutes before a meal or immediately after a meal. Dosing is often part of a basal-bolus regimen, with bolus doses calculated based on carbohydrate intake, pre-meal blood glucose, and individual insulin sensitivity factor.

Condition-Specific Dosing:

Type 1 Diabetes: Total daily insulin dose typically 0.5-1.0 units/kg/day, with 40-60% as basal insulin and 40-60% as prandial (bolus) insulin. Prandial doses are adjusted based on carbohydrate intake and blood glucose levels.
Type 2 Diabetes: Initial dosing may be 4-6 units before the largest meal, or 0.1-0.2 units/kg/day, adjusted based on blood glucose response. Often used in combination with basal insulin or oral antidiabetic agents.
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution and close monitoring if clinically indicated.
Infant: Individualized, typically starting at lower doses (e.g., 0.25-0.5 units/kg/day total insulin) and titrated based on blood glucose monitoring. Close supervision required.
Child: Individualized, similar principles to adults but often with lower total daily insulin requirements (e.g., 0.5-1.0 units/kg/day total insulin) and careful titration.
Adolescent: Individualized, often higher insulin requirements during puberty (e.g., 0.8-1.2 units/kg/day total insulin) due to insulin resistance.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor blood glucose closely due to increased risk of hypoglycemia.
Moderate: Dose reduction may be required due to decreased insulin clearance. Monitor blood glucose frequently and adjust dose as needed.
Severe: Significant dose reduction often required (e.g., 25-50% reduction) due to markedly decreased insulin clearance and increased risk of severe hypoglycemia. Close monitoring is essential.
Dialysis: Dose adjustments are highly individualized and depend on the type of dialysis and residual renal function. Frequent blood glucose monitoring is critical.

Hepatic Impairment:

Mild: Monitor blood glucose closely; dose adjustment may be needed.
Moderate: Dose reduction may be required due to impaired hepatic glucose production and decreased insulin degradation. Monitor blood glucose frequently.
Severe: Significant dose reduction often required due to increased risk of hypoglycemia. Close monitoring and careful titration are essential.

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. It also inhibits lipolysis and proteolysis, and enhances protein synthesis. Its rapid action is due to a reversal of proline and lysine at positions B28 and B29 of the insulin B-chain, which reduces self-association into hexamers, allowing for faster absorption from the subcutaneous injection site.
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Pharmacokinetics

Absorption:

Bioavailability: Not typically expressed as a percentage for subcutaneous insulin; designed for rapid absorption.
Tmax: 0.5-1.5 hours (median 0.75 hours)
FoodEffect: Administered before or immediately after meals to cover postprandial glucose excursions.

Distribution:

Vd: Approximately 0.1-0.2 L/kg
ProteinBinding: Minimal (<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: Renal (primary), Hepatic
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 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
+ Abnormal 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
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
+ Fatigue or weakness
+ Shaking
+ Rapid 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 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
Nasal 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:

  • **Hypoglycemia (low blood sugar):** Sweating, shakiness, dizziness, confusion, hunger, irritability, blurred vision, rapid heartbeat. If these occur, treat immediately with a fast-acting sugar (e.g., glucose tablets, fruit juice, regular soda).
  • **Hyperglycemia (high blood sugar):** Increased thirst, frequent urination, fatigue, blurred vision, unexplained weight loss. Report persistent high blood sugar to your doctor.
  • **Allergic reactions:** Rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek immediate medical attention.
  • **Injection site reactions:** Redness, swelling, itching, pain, or changes in skin appearance at the injection site. Rotate sites to minimize this.
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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.

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 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 and ensure the best possible treatment outcome.
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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 severe complications, including 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 drug 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 assess the risks.

Ensure you have the correct insulin product and are familiar with its administration, as insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns, contact your doctor or pharmacist.

Stressful situations, such as fever, infection, injury, or surgery, may affect your blood sugar control. 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 increases the risk of accidents.

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 containing alcohol.

Do not share your insulin product or any related devices, including pens, cartridges, needles, or syringes, with others, 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 (extremely low blood sugar)
  • Confusion
  • Seizures
  • Loss of consciousness
  • Coma

What to Do:

For conscious individuals, administer oral glucose (e.g., glucose tablets, fruit juice, regular soda). For unconscious individuals, administer glucagon injection (if available and trained) and/or seek immediate emergency medical attention. Call 911 or 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Major Interactions

  • Pramlintide (increased risk of severe hypoglycemia; reduce insulin dose)
  • Beta-blockers (can mask symptoms of hypoglycemia and delay recovery)
  • Alcohol (can potentiate hypoglycemic effect)
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Moderate Interactions

  • Oral antidiabetic agents (sulfonylureas, metformin, SGLT2 inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists - increased risk of hypoglycemia)
  • ACE inhibitors (e.g., captopril, enalapril - increased risk of hypoglycemia)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan - increased risk of hypoglycemia)
  • Disopyramide (increased risk of hypoglycemia)
  • Fibrates (e.g., gemfibrozil - increased risk of hypoglycemia)
  • Fluoxetine (increased risk of hypoglycemia)
  • MAOIs (e.g., phenelzine, tranylcypromine - increased risk of hypoglycemia)
  • Pentoxifylline (increased risk of hypoglycemia)
  • Salicylates (e.g., aspirin - increased risk of hypoglycemia at high doses)
  • Somatostatin analogs (e.g., octreotide, lanreotide - can increase or decrease insulin requirements)
  • Sulfonamide antibiotics (e.g., sulfamethoxazole/trimethoprim - increased risk of hypoglycemia)
  • Corticosteroids (e.g., prednisone - decreased hypoglycemic effect of insulin)
  • Diuretics (e.g., thiazides, loop diuretics - decreased hypoglycemic effect of insulin)
  • Sympathomimetics (e.g., epinephrine, albuterol - decreased hypoglycemic effect of insulin)
  • Growth hormone (decreased hypoglycemic effect of insulin)
  • Danazol (decreased hypoglycemic effect of insulin)
  • Isoniazid (decreased hypoglycemic effect of insulin)
  • Phenothiazine derivatives (e.g., chlorpromazine - decreased hypoglycemic effect of insulin)
  • Thyroid hormones (e.g., levothyroxine - decreased hypoglycemic effect of insulin)
  • Estrogens and Progestins (e.g., oral contraceptives - decreased hypoglycemic effect of insulin)
  • Protease inhibitors (e.g., ritonavir - decreased hypoglycemic effect of insulin)
  • Atypical antipsychotics (e.g., olanzapine, clozapine - decreased hypoglycemic effect of insulin)

Monitoring

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Baseline Monitoring

Glycated Hemoglobin (HbA1c)

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

Timing: Prior to initiation of insulin therapy.

Fasting Plasma Glucose (FPG)

Rationale: To assess baseline glucose levels.

Timing: Prior to initiation of insulin therapy.

Renal Function (eGFR, BUN, Creatinine)

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

Timing: Prior to initiation and periodically during therapy, especially in patients with risk factors for kidney disease.

Hepatic Function (ALT, AST, Bilirubin)

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

Timing: Prior to initiation and periodically during therapy, especially in patients with risk factors for liver disease.

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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) depending on individual needs and regimen.

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

Action Threshold: Below target range (hypoglycemia) or above target range (hyperglycemia) requiring dose adjustment or intervention.

Glycated Hemoglobin (HbA1c)

Frequency: Every 3-6 months, or more frequently if glycemic control is suboptimal or therapy is being adjusted.

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: Maintain healthy weight; monitor for significant weight gain or loss.

Action Threshold: Significant, unexplained weight changes may indicate issues with glycemic control or other medical conditions.

Injection Sites

Frequency: With each injection

Target: Rotate sites to prevent lipodystrophy.

Action Threshold: Presence of lumps, indentations, or redness indicates need for site rotation or evaluation.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, palpitations, hunger, confusion, dizziness, irritability, blurred vision, slurred speech, seizures, unconsciousness)
  • Symptoms of hyperglycemia (e.g., polyuria, polydipsia, polyphagia, fatigue, blurred vision, weight loss)
  • Symptoms of allergic reactions (e.g., rash, itching, swelling, difficulty breathing)
  • Symptoms of injection site reactions (e.g., redness, swelling, itching, pain, lipodystrophy)

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for glycemic control in pregnant women with pre-existing diabetes or gestational diabetes. Insulin lispro is generally considered safe and effective during pregnancy. Close monitoring of blood glucose is essential, and insulin doses may need frequent adjustment throughout pregnancy.

Trimester-Specific Risks:

First Trimester: Insulin requirements may decrease due to nausea/vomiting. Strict glycemic control is crucial to prevent congenital anomalies.
Second Trimester: Insulin requirements typically increase due to increasing insulin resistance.
Third Trimester: Insulin requirements continue to increase, often peaking in the late third trimester. Close monitoring for hypoglycemia is important as delivery approaches.
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Lactation

Insulin lispro is considered compatible with breastfeeding (L1 - Safest). Insulin is a large protein and is not excreted into breast milk in clinically significant amounts. It is not expected to cause adverse effects in a breastfed infant. Insulin requirements may be lower during lactation.

Infant Risk: Low risk; not expected to cause adverse effects.
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Pediatric Use

Insulin lispro is approved for use in children with diabetes. Dosing must be individualized based on age, weight, pubertal status, and metabolic needs. Close monitoring for hypoglycemia is crucial, especially in younger children who may not recognize symptoms.

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Geriatric Use

Older adults may be at increased risk of hypoglycemia due to age-related decline in renal/hepatic function, reduced counter-regulatory responses, and polypharmacy. Start with lower doses and titrate slowly. Emphasize education on hypoglycemia recognition and management. Consider less stringent glycemic targets for frail older adults.

Clinical Information

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Clinical Pearls

  • Humalog is a rapid-acting insulin; it must be taken with food (within 15 minutes before or immediately after a meal) to prevent hypoglycemia.
  • Always verify the correct insulin type (rapid-acting, long-acting, etc.) and concentration (U-100, U-200, U-500) before administration to avoid dosing errors.
  • Rotate injection sites to prevent lipohypertrophy (lumps) or lipoatrophy (indentations), which can impair insulin absorption.
  • Do not mix Humalog with other insulins in the same syringe unless specifically instructed by a healthcare professional (e.g., NPH insulin, but this practice is less common with rapid analogs).
  • Unopened cartridges should be stored in the refrigerator (2°C to 8°C). Once opened or in use, they can be stored at room temperature (below 30°C) for up to 28 days. Do not freeze.
  • Patients should always carry a source of fast-acting glucose to treat hypoglycemia.
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Alternative Therapies

  • Other types of insulin (e.g., long-acting insulins like insulin glargine, insulin detemir, insulin degludec; intermediate-acting insulin NPH)
  • Oral antidiabetic medications (e.g., metformin, sulfonylureas, SGLT2 inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists)
  • Non-insulin injectable medications (e.g., GLP-1 receptor agonists, pramlintide)
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Cost & Coverage

Average Cost: Varies widely, typically $100-$300+ per 5 x 3mL cartridges per 5 x 3mL cartridges (U-100)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand), or Tier 1 for biosimilars/authorized generics on some 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.