Humalog Mix 75/25 Vial 10ml

Manufacturer LILLY Active Ingredient Insulin Lispro Protamine and Insulin Lispro (Vials)(IN soo lin LYE sproe PROE ta meen & IN soo lin LYE sproe) Pronunciation HYOO-mah-log Mix seventy-five twenty-five (IN-soo-lin LYE-sproe PROE-tah-meen & 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/intermediate-acting combination
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Pregnancy Category
Category B
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FDA Approved
May 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Humalog Mix 75/25 is an insulin medicine that helps control blood sugar in people with diabetes. It's a mix of two types of insulin: one that works quickly (lispro) to cover meals, and one that works longer (lispro protamine) to provide background insulin. You inject it under your skin, usually before breakfast and dinner.
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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 of the skin in the upper arm, thigh, buttocks, or stomach area. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.

Before use, this medication must be mixed according to the instructions provided by your doctor. Use the medication immediately after mixing. It is recommended to take the medication 15 minutes before a meal. Rotate the injection site each time to avoid tissue damage.

Important Administration Guidelines

Do not inject into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
The medication should appear cloudy and milky when ready to use. Do not use if the solution is clear or contains lumps.
Do not use if powder is stuck to the sides of the container or if the solution is leaking, has particles, or has changed color.
Dispose of needles and syringes in a designated sharps disposal container. Do not reuse needles or other items, and follow local regulations for disposing of the container when it is full.

Additional Instructions

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.
Do not mix this insulin with other types of insulin in the same syringe.
Do not draw the medication into a syringe and store it for future use.
* This medication is not compatible with insulin pumps. If you have questions, consult your doctor.

Storage and Disposal

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

Missed Dose

If you forget to take a dose, follow the plan discussed with your doctor. If you are unsure what to do, contact your doctor for guidance.
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Lifestyle & Tips

  • Always rotate injection sites to prevent skin problems (lipodystrophy).
  • Follow a consistent meal plan and exercise routine as advised by your doctor or dietitian.
  • Monitor your blood sugar levels regularly as instructed by your healthcare provider.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar.
  • Never share needles or insulin pens with others.
  • Store unopened vials in the refrigerator; opened vials can be kept at room temperature for a limited time (check package insert).

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Typically administered subcutaneously 15 minutes before a meal or immediately after a meal. Dosing should be adjusted based on blood glucose levels.

Condition-Specific Dosing:

Type 1 Diabetes: Initial total daily dose often 0.5-1.0 units/kg/day, with Humalog Mix 75/25 contributing to both basal and prandial needs, typically split before breakfast and dinner.
Type 2 Diabetes: Initial dose may be 0.2-0.6 units/kg/day, or 6-10 units once or twice daily, adjusted based on glycemic response.
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Pediatric Dosing

Neonatal: Not established for routine use; individualized by specialist.
Infant: Not established for routine use; individualized by specialist.
Child: Dosing is highly individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Similar principles to adults, but often lower doses and more frequent monitoring.
Adolescent: Dosing is highly individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Similar principles to adults.
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Dose Adjustments

Renal Impairment:

Mild: Insulin requirements may decrease; monitor glucose closely.
Moderate: Insulin requirements often decrease; monitor glucose closely and adjust dose as needed.
Severe: Insulin requirements significantly decrease; monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.
Dialysis: Insulin requirements may be reduced. Close monitoring of blood glucose is essential, and dose adjustments are frequently required.

Hepatic Impairment:

Mild: Insulin requirements may decrease; monitor glucose closely.
Moderate: Insulin requirements often decrease; monitor glucose closely and adjust dose as needed.
Severe: Insulin requirements significantly decrease; monitor glucose closely and adjust dose as needed. Increased risk of hypoglycemia.
Confidence: Medium

Pharmacology

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Mechanism of Action

Insulin lispro protamine is an intermediate-acting insulin, and insulin lispro is a rapid-acting insulin. Both components lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100% (subcutaneous injection, but rate varies)
Tmax: Insulin Lispro: 0.5-1.5 hours; Insulin Lispro Protamine: 6-8 hours
FoodEffect: Administered before or immediately after a meal to coincide with postprandial glucose rise.

Distribution:

Vd: Approximately 0.1-0.2 L/kg
ProteinBinding: Low (less than 10%)
CnssPenetration: Limited

Elimination:

HalfLife: Insulin Lispro: 1 hour; Insulin Lispro Protamine: 5-10 hours (functional half-life due to absorption kinetics)
Clearance: Approximately 10 mL/kg/min
ExcretionRoute: Renal (primarily)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Insulin Lispro: 15-30 minutes; Insulin Lispro Protamine: 1-2 hours
PeakEffect: Insulin Lispro: 0.5-2.5 hours; Insulin Lispro Protamine: 6-10 hours
DurationOfAction: Insulin Lispro: 3-5 hours; Insulin Lispro Protamine: 14-24 hours (total for mix: up to 24 hours)
Confidence: Medium

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
Some allergic reactions can be life-threatening, so it's essential to seek help right away.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
Shortness of breath
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, call your doctor right away. If you have low blood sugar, follow the instructions you've been given, 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 do 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 do not go away, contact your doctor or seek medical help:

Irritation at the injection site
* Weight gain

This is not a complete list of possible side effects. If you have questions or concerns about side effects, talk to 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, fast heartbeat. Treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, increased hunger, fatigue, blurred vision, weight loss. Contact your doctor if persistent.
  • Symptoms of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek immediate medical attention.
  • Symptoms of heart failure (if taking certain other diabetes medicines): unusual weight gain, swelling in hands/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).

This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have or have had in the past.

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure that you can take this medication safely with your other medications and health conditions.
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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. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Be aware that this medication can cause low blood sugar (hypoglycemia), which may 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 can cause low blood potassium levels (hypokalemia), which, if left untreated, can result in abnormal heart rhythms, severe breathing difficulties, and potentially death. Discuss this risk with your doctor.

If you are taking other diabetes medications like pioglitazone or rosiglitazone, be aware that they may increase the risk of heart failure or worsen existing heart failure. Using insulin with these medications may further increase this risk. 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 understand how to 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.

Be aware that stress, such as fever, infection, injury, or surgery, can make it more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also impact 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 the risk of accidents. Monitor your blood sugar levels as directed by your doctor.

Regular blood tests are necessary to ensure safe use. Follow your doctor's instructions for blood work and discuss any concerns or questions with them.

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

Do not share your insulin product, including pens, cartridge devices, 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 you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (very low blood sugar)
  • Confusion
  • Seizures
  • Loss of consciousness
  • Coma

What to Do:

Treat mild hypoglycemia with oral glucose. For severe hypoglycemia, administer glucagon injection or intravenous glucose. Seek immediate medical attention. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask hypoglycemia symptoms)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure)
  • Alcohol (can potentiate hypoglycemic effect)
  • Other antidiabetic agents (increased risk of hypoglycemia)
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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 (may increase blood glucose)
  • Thyroid hormones (may increase blood glucose)
  • Salicylates (high doses may enhance insulin's effect)
  • Sulfonamide antibiotics (may enhance insulin's effect)
  • ACE inhibitors (may enhance insulin's effect)
  • Angiotensin Receptor Blockers (ARBs) (may enhance insulin's effect)

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glucose levels.

Timing: Prior to initiation.

Renal function (eGFR, BUN, Creatinine)

Rationale: To assess kidney function, as insulin clearance is renal and dose adjustments may be needed.

Timing: Prior to initiation.

Hepatic function (ALT, AST, Bilirubin)

Rationale: To assess liver function, as insulin is metabolized in the liver.

Timing: Prior to initiation.

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Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., pre-meal, 2-hour post-meal, bedtime, overnight) as directed by healthcare provider.

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

Action Threshold: Below 70 mg/dL (hypoglycemia) or above 180-250 mg/dL (hyperglycemia), depending on target.

HbA1c

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

Target: Individualized, typically <7% for most adults.

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

Weight

Frequency: Regularly (e.g., monthly or at each visit).

Target: Maintain healthy weight; monitor for unexpected changes.

Action Threshold: Significant unexplained weight gain or loss.

Injection sites

Frequency: At each injection.

Target: Rotate sites to prevent lipodystrophy.

Action Threshold: Presence of lumps, indentations, or redness.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, palpitations)
  • Symptoms of hyperglycemia (e.g., increased thirst, frequent urination, increased hunger, fatigue, blurred vision, weight loss)
  • Symptoms of allergic reactions (e.g., rash, itching, swelling, difficulty breathing)
  • Symptoms of fluid retention/heart failure (e.g., sudden weight gain, swelling in ankles/feet, shortness of breath) if used with TZDs

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy. Humalog Mix 75/25 can be used, but careful monitoring and dose adjustments are crucial to maintain strict glycemic control and minimize risks to both mother and fetus.

Trimester-Specific Risks:

First Trimester: Strict glycemic control is important to reduce risk of congenital malformations.
Second Trimester: Insulin requirements often increase; close monitoring needed.
Third Trimester: Insulin requirements may continue to increase or stabilize; close monitoring needed to prevent macrosomia and other complications.
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Lactation

Insulin is compatible with breastfeeding. It does not pass into breast milk in clinically significant amounts and is not expected to harm the breastfed infant. Insulin requirements may change during lactation.

Infant Risk: L1 (Safest)
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Pediatric Use

Humalog Mix 75/25 is approved for use in pediatric patients with diabetes. Dosing must be highly individualized based on age, weight, pubertal status, and glycemic control goals. Close monitoring for hypoglycemia is essential.

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Geriatric Use

Elderly patients may be at increased risk for hypoglycemia due to impaired renal/hepatic function, reduced counter-regulatory responses, and polypharmacy. Dosing should be conservative, and blood glucose targets may be less stringent to avoid hypoglycemia.

Clinical Information

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Clinical Pearls

  • Humalog Mix 75/25 is a pre-mixed insulin, meaning it contains both rapid-acting and intermediate-acting insulin in a fixed ratio. This simplifies dosing but offers less flexibility than separate insulin injections.
  • Always ensure patients understand the difference between Humalog Mix 75/25 and other insulin formulations to prevent medication errors.
  • Instruct patients to gently roll the vial between their palms 10 times and invert it 10 times immediately before each injection to ensure the insulin is evenly mixed.
  • Emphasize the importance of administering this insulin within 15 minutes before a meal or immediately after a meal to optimize postprandial glucose control and minimize hypoglycemia risk.
  • Patients should be educated on recognizing and treating hypoglycemia, and family members/caregivers should also be aware.
  • Regular follow-up with a healthcare provider is essential for dose adjustments and monitoring for complications.
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Alternative Therapies

  • Basal insulins (e.g., Insulin Glargine, Insulin Detemir, Insulin Degludec)
  • Rapid-acting insulins (e.g., Insulin Lispro, Insulin Aspart, Insulin Glulisine)
  • Short-acting insulins (e.g., Regular Insulin)
  • Oral antidiabetic agents (e.g., Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists)
  • Other injectable non-insulin antidiabetic agents (e.g., GLP-1 receptor agonists, Amylin analogs)
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Cost & Coverage

Average Cost: $150 - $350 per 10ml vial
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'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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.