Humulin 70/30 U-100 Kwikpen Inj 3ml

Manufacturer LILLY Active Ingredient Insulin NPH and Insulin Regular (InnoLets, Pens, and PenFills)(IN soo lin N P H & IN soo lin REG yoo ler) Pronunciation IN soo lin N P H & IN soo lin REG yoo ler
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, intermediate-acting and short-acting combination
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Pregnancy Category
Category B
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FDA Approved
Oct 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Humulin 70/30 is a mixture of two types of insulin: a fast-acting insulin (Regular) and a longer-acting insulin (NPH). It helps your body use sugar for energy and lowers your blood sugar levels. It's given as an injection under the skin, usually before meals, to help manage 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 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 provide guidance on the proper technique.

Preparing the Medication

Before use, this medication must be mixed according to your doctor's instructions. The solution should appear cloudy and milky when ready for use. Do not use the medication if the solution is clear or contains lumps. Additionally, do not use the medication if powder is stuck to the sides of the container.

Administration

Take this medication 30 to 45 minutes before meals. Rotate the injection site with each dose to avoid injecting into the same area repeatedly. 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 is leaking, has particles, or has changed color.

Important Safety Precautions

Do not mix this insulin with other types of insulin or liquids in the same syringe. Dispose of needles and other sharp objects in a designated container. Do not reuse needles or other items, and follow local regulations for disposing of the container when it is full. If you have any questions or concerns, consult your doctor or pharmacist.

Special Instructions

If you skip a meal or do not eat as much as usual, be aware of the necessary steps to take. This medication is not suitable for use in an insulin pump. If you have questions, consult your doctor.

Using the Pen Device

Before injecting a dose, remove all pen needle covers (there may be two). If you are unsure about the type of pen needle or how to use it, consult your doctor. After each injection, remove the needle and do not store the device with the needle attached. Note that the device may produce a clicking sound when preparing the dose, but do not rely on the clicks to determine the correct dose. Do not transfer the medication from the pen to a syringe.

Storage and Disposal

Store unopened containers in the refrigerator, but 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 necessary steps to take. If you are unsure, consult your doctor.
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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 sugar levels as instructed by your healthcare provider.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar.
  • Rotate injection sites to prevent skin problems (lipodystrophy).
  • Never share your KwikPen with another person, even if the needle is changed, due to risk of infection.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's metabolic needs, blood glucose monitoring, and glycemic goals. Typically administered subcutaneously 30-45 minutes before a meal, once or twice daily.

Condition-Specific Dosing:

Type 1 Diabetes Mellitus: Initial total daily dose often 0.5 to 1 unit/kg/day, divided. Humulin 70/30 may be used as part of a basal-bolus regimen or as a twice-daily regimen.
Type 2 Diabetes Mellitus: Initial dose often 0.2 to 0.6 units/kg/day, or 10-20 units once or twice daily, adjusted based on blood glucose response. May be used alone or in combination with oral antidiabetic agents.
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Pediatric Dosing

Neonatal: Not established (use of single insulin types preferred, e.g., regular insulin infusions)
Infant: Not established (use of single insulin types preferred)
Child: Highly individualized. Initial dose typically 0.5 to 1 unit/kg/day, divided. Dosing must be carefully titrated based on blood glucose monitoring and glycemic goals.
Adolescent: Highly individualized. Initial dose typically 0.5 to 1.2 units/kg/day, divided, especially during puberty. Dosing must be carefully titrated based on blood glucose monitoring and glycemic goals.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment typically required, but monitor blood glucose closely.
Moderate: Dose reduction may be required due to decreased insulin clearance and increased risk of hypoglycemia. Monitor blood glucose closely.
Severe: Significant dose reduction likely required (e.g., 25-50% reduction). Monitor blood glucose frequently and adjust dose cautiously.
Dialysis: Dose reduction required. Administer after dialysis session if possible to avoid hypoglycemia. Monitor blood glucose closely.

Hepatic Impairment:

Mild: No specific dose adjustment typically required, but monitor blood glucose closely.
Moderate: Dose reduction may be required due to impaired gluconeogenesis and decreased insulin clearance. Monitor blood glucose closely.
Severe: Significant dose reduction likely required. Monitor blood glucose frequently and adjust dose cautiously.

Pharmacology

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Mechanism of Action

Insulin 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. Insulin NPH (Isophane) is an intermediate-acting insulin, and Insulin Regular is a short-acting insulin. The combination provides both rapid onset and prolonged duration of action.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (administered subcutaneously, not orally)
Tmax: Insulin Regular: 1.5-3.5 hours; Insulin NPH: 4-12 hours (for the combination, peak effect is a composite)
FoodEffect: Food intake is critical for timing of administration relative to meals to prevent hypoglycemia or hyperglycemia.

Distribution:

Vd: Approximately 0.1-0.2 L/kg (similar to extracellular fluid volume)
ProteinBinding: Minimal (<10%)
CnssPenetration: Limited

Elimination:

HalfLife: Insulin Regular: 1-2 hours; Insulin NPH: 10-16 hours (apparent half-life from subcutaneous injection is longer due to absorption kinetics)
Clearance: Approximately 0.8-1.2 L/min (renal and hepatic clearance)
ExcretionRoute: Renal excretion of metabolites and intact insulin (minor)
Unchanged: Not available (primarily metabolized)
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Pharmacodynamics

OnsetOfAction: Insulin Regular: 30-60 minutes; Insulin NPH: 2-4 hours (for the combination, onset is driven by regular insulin)
PeakEffect: Insulin Regular: 2-5 hours; Insulin NPH: 4-12 hours (for the combination, peak effect is a composite, often 4-8 hours)
DurationOfAction: Insulin Regular: 6-8 hours; Insulin NPH: 14-24 hours (for the combination, duration is up to 24 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 life-threatening.
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
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 the instructions you have 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 unusual symptoms, contact your doctor or seek medical help:

Weight gain
Irritation at the injection site

This is not a comprehensive list of all 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. Treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision. Contact your doctor if persistent.
  • Signs of allergic reaction: rash, itching, swelling 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 allergic reaction you experienced, including any symptoms that occurred.
If you have low blood sugar (hypoglycemia), as this may affect your treatment plan.

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 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

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 any 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.

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. It is crucial to discuss this risk with your doctor. 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. 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 or worsen existing heart failure, especially when combined with insulin. If you are taking one of these medications, consult your doctor to discuss the potential risks.

Ensure you are using the correct insulin product, as they come in various containers, including vials, cartridges, and pens. If you are unsure about measuring or preparing your dose, consult your doctor or pharmacist for guidance.

Stressful situations, such as fever, infection, injury, or surgery, may make it 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. Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests as scheduled.

Avoid driving if you have experienced low blood sugar, as it increases the risk of accidents. Before consuming alcohol or using products containing alcohol, consult your doctor to discuss potential risks.

Adhere to the diet and exercise plan recommended by your doctor. 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 (extremely low blood sugar)
  • Confusion, disorientation
  • Seizures
  • Loss of consciousness (diabetic coma)

What to Do:

Immediately consume fast-acting carbohydrates (e.g., glucose tablets, juice, candy). If unconscious, administer glucagon injection (if available and trained) and seek emergency medical attention. Call 911 or 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

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

  • Oral antidiabetic agents (sulfonylureas, metformin, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) (increased risk of hypoglycemia)
  • Corticosteroids (may increase insulin requirements)
  • Diuretics (thiazide and loop) (may increase blood glucose, requiring insulin dose adjustment)
  • Sympathomimetics (e.g., epinephrine, albuterol) (may increase blood glucose)
  • Thyroid hormones (may increase insulin requirements)
  • Salicylates (e.g., aspirin, high doses) (may enhance hypoglycemic effect)
  • ACE inhibitors/ARBs (may enhance hypoglycemic effect)
  • Somatostatin analogs (e.g., octreotide) (may increase or decrease insulin requirements)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and set treatment goals.

Timing: Prior to initiation of insulin therapy.

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of insulin therapy.

Renal function (SCr, eGFR)

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

Timing: Prior to initiation and periodically thereafter.

Hepatic function (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, 2-hour post-meal, bedtime, overnight) depending on patient needs and regimen.

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

Action Threshold: Hypoglycemia (<70 mg/dL) requires immediate action; Hyperglycemia (>180-250 mg/dL) may require dose adjustment or further evaluation.

HbA1c

Frequency: Every 3-6 months.

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.

Action Threshold: Significant, unexplained weight gain may indicate fluid retention or over-insulinization.

Signs/symptoms of hypoglycemia

Frequency: Daily, ongoing.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms requires immediate action (e.g., consume fast-acting carbohydrates).

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Symptom Monitoring

  • Hypoglycemia: sweating, dizziness, tremor, hunger, confusion, irritability, headache, blurred vision, rapid heartbeat, anxiety, weakness, slurred speech, seizures, unconsciousness.
  • Hyperglycemia: increased thirst, increased urination, fatigue, blurred vision, dry mouth, fruity breath odor (ketoacidosis).
  • Injection site reactions: redness, swelling, itching, pain, lipodystrophy (lipoatrophy or lipohypertrophy).

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy. Humulin 70/30 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: Increased risk of congenital malformations with poor glycemic control. Insulin requirements may decrease.
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 essential.
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Lactation

Insulin is compatible with breastfeeding. It is a large protein molecule and is not excreted into breast milk in clinically significant amounts. Insulin requirements may decrease during lactation.

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

Humulin 70/30 can be used in children and adolescents with diabetes, but dosing requires careful individualization and frequent monitoring due to varying insulin sensitivity, growth spurts, and activity levels. Risk of hypoglycemia is a significant concern.

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Geriatric Use

Older adults may be more susceptible to hypoglycemia due to impaired renal/hepatic function, polypharmacy, and reduced counter-regulatory responses. Lower starting doses and slower titration may be necessary. Glycemic targets may be less stringent to avoid hypoglycemia.

Clinical Information

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Clinical Pearls

  • Always ensure the patient understands how to properly mix (roll) the pen before injection to ensure consistent dosing of both insulin components.
  • Emphasize the importance of consistent meal times and carbohydrate intake to match the insulin's action profile and prevent hypoglycemia.
  • Educate patients on the signs and symptoms of hypoglycemia and how to treat it immediately.
  • Stress the importance of rotating injection sites to prevent lipodystrophy, which can affect insulin absorption.
  • Humulin 70/30 is a fixed combination; it does not allow for independent adjustment of the rapid-acting and intermediate-acting components, which can limit flexibility compared to basal-bolus regimens.
  • Patients should be advised to always have a spare pen or vial available and to store insulin properly (refrigerated until opened, then at room temperature for up to 28 days).
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Alternative Therapies

  • Basal insulins (e.g., insulin glargine, insulin detemir, insulin degludec)
  • Bolus/prandial insulins (e.g., insulin aspart, insulin lispro, insulin glulisine, insulin regular)
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, SGLT2 inhibitors, GLP-1 receptor agonists)
  • Non-insulin injectable agents (e.g., GLP-1 receptor agonists, amylin analogs)
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Cost & Coverage

Average Cost: $100 - $200 per 3ml KwikPen (U-100)
Insurance Coverage: Tier 2 or Tier 3 (preferred brand or non-preferred brand, depending on plan)
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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.