Insulin Aspart Penfill Inj, 3ml

Manufacturer NOVO NORDISK PHARMA Active Ingredient Insulin Aspart (Cartridges & Prefilled Pens) (NovoLog)(IN soo lin AS part) Pronunciation IN-soo-lin AS-part
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
Not available
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FDA Approved
Aug 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Insulin Aspart is a fast-acting insulin that helps your body use sugar for energy. It starts working quickly, usually within 10-20 minutes, and is typically taken right before or shortly after meals to control blood sugar spikes.
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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.

Administration Instructions

Inject the dose within 5 to 10 minutes before a meal.
Rotate the injection site each time to avoid tissue damage.
Before injecting, remove all pen needle covers (there may be two).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
After use, replace the cap on the pen.
Note that the device may produce a clicking sound when preparing the dose. However, do not rely on the clicks to determine the dose, as this could result in an incorrect dose.
Remove the needle after each injection and do not store the device with the needle attached.
Do not transfer this medication from the pen to a syringe or mix it with other types of insulin.

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 Dose

If you miss a dose, be aware of the steps to take.
If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
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Lifestyle & Tips

  • Always check your blood sugar levels as directed by your doctor.
  • Follow your prescribed diet plan and exercise regularly.
  • Rotate injection sites to prevent skin problems (e.g., lipodystrophy).
  • Never share insulin pens or needles with others, even if the needle is changed.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar.
  • Inform your healthcare provider about all medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Administered subcutaneously 5-10 minutes before a meal or within 20 minutes after starting a meal.

Condition-Specific Dosing:

Type 1 Diabetes: Typically 0.5 to 1 unit/kg/day total insulin, with 50-70% as basal insulin and 30-50% as prandial insulin (insulin aspart).
Type 2 Diabetes: Initial dose often 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
Infant: Individualized, based on metabolic needs and blood glucose monitoring. Generally lower doses than adults.
Child: Individualized, based on metabolic needs and blood glucose monitoring. Generally lower doses than adults.
Adolescent: Individualized, based on metabolic needs and blood glucose monitoring. Doses may be similar to adults during growth spurts.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but increased glucose monitoring recommended.
Moderate: Dose reduction may be required; increased glucose monitoring recommended.
Severe: Significant dose reduction likely required; increased glucose monitoring and close medical supervision essential.
Dialysis: Dose reduction required; timing of dose relative to dialysis session should be considered. Close glucose monitoring.

Hepatic Impairment:

Mild: No specific dose adjustment, but increased glucose monitoring recommended.
Moderate: Dose reduction may be required; increased glucose monitoring recommended.
Severe: Significant dose reduction likely required; increased glucose monitoring and close medical supervision essential.

Pharmacology

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Mechanism of Action

Insulin aspart is a rapid-acting insulin analog that lowers blood glucose by stimulating peripheral glucose uptake 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: 40-50 minutes
FoodEffect: Administered 5-10 minutes before a meal or within 20 minutes after starting a meal to optimize postprandial glucose control.

Distribution:

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

Elimination:

HalfLife: Approximately 80 minutes (after subcutaneous administration)
Clearance: Not available (similar to endogenous insulin)
ExcretionRoute: Renal excretion of metabolites
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: 10-20 minutes
PeakEffect: 1-3 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
Some 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
Change in skin color at the injection site
Swelling in the arms or legs
Pain when urinating or blood in the urine
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 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. 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 symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Weight gain
Irritation at the injection site
Nose or throat irritation
Signs of a common cold

This is not a complete 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 low blood sugar (hypoglycemia): sweating, trembling, dizziness, confusion, hunger, irritability, blurred vision, slurred speech, headache, rapid heartbeat. Treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, increased urination, fatigue, blurred vision, nausea, vomiting, fruity breath odor. Contact your doctor if severe or persistent.
  • Symptoms of serious allergic reaction: rash over the whole body, shortness of breath, wheezing, fast heartbeat, sweating, swelling of your face or tongue, feeling dizzy or faint. Seek immediate medical attention.
  • Symptoms of heart failure (if taking with certain diabetes pills like pioglitazone): unusual weight gain, swelling in your ankles or 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 allergic reaction you experienced, including any symptoms that occurred.
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 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

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Administration Precautions

Do not inject this medication into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.

Solution Inspection

Before use, check the solution for cloudiness, leakage, or particles. The solution should be clear and colorless. Do not use if the solution has changed color or appears abnormal.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor. Understand what to do if you miss a meal or do not eat as much as usual.

Low Blood Sugar Risk

This medication can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, or even death. Discuss this risk with your doctor.

Low Blood Potassium Risk

This medication can also cause low blood potassium, which may lead to abnormal heart rhythms, severe breathing problems, or death if left untreated. Consult your doctor if you have concerns.

Alertness and Activities

Avoid driving and other activities that require alertness until you understand how this medication affects you.

Interactions with Other Diabetes Medications

If you are taking diabetes medications like pioglitazone or rosiglitazone, using insulin with these drugs may increase the risk of heart failure. Discuss this risk with your doctor if you are taking one of these medications.

Insulin Product Identification

Ensure you have the correct insulin product, as they come in various containers such as vials, cartridges, and pens. Understand how to measure and prepare your dose. If you have questions, consult your doctor or pharmacist.

Blood Sugar Control During Stressful Situations

Stressful situations like fever, infection, injury, or surgery may make it more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also affect blood sugar control.

Medical Alert Identification

Wear a medical alert ID to inform others of your condition.

Driving Precautions

Do not drive if you have experienced low blood sugar, as this increases the risk of accidents.

Blood Sugar Monitoring

Monitor your blood sugar levels as directed by your doctor.

Blood Work and Doctor Consultations

Have your blood work checked as recommended by your doctor and discuss the results with them.

Alcohol Consumption

Consult your doctor before consuming alcohol or products containing alcohol.

Insulin Product Sharing

Do not share your insulin product, including pens, cartridge devices, needles, or syringes, with others, as this can transmit infections.

Needle Disposal

Dispose of needles in a needle/sharp disposal box. Do not reuse needles or other items. Follow local regulations for disposing of the box when it is full. If you have questions, consult your doctor or pharmacist.

Special Precautions for Older Adults

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

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 you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (low blood sugar)
  • Hypokalemia (low potassium levels)
  • Loss of consciousness
  • Seizures

What to Do:

For mild hypoglycemia, consume fast-acting carbohydrates. For severe hypoglycemia, administer glucagon or seek immediate medical attention. Call 1-800-222-1222 (Poison Control) or emergency services.

Drug Interactions

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Major Interactions

  • Pioglitazone (and other Thiazolidinediones): Increased risk of fluid retention and heart failure.
  • Pramlintide: Increased risk of severe hypoglycemia.
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Moderate Interactions

  • Beta-blockers: May mask symptoms of hypoglycemia (e.g., tremor, palpitations) and delay recovery from hypoglycemia.
  • Corticosteroids: May increase blood glucose, requiring higher insulin doses.
  • Diuretics (Thiazide and Loop): May increase blood glucose, requiring higher insulin doses.
  • Sympathomimetics (e.g., albuterol, epinephrine): May increase blood glucose.
  • Atypical antipsychotics (e.g., olanzapine, clozapine): May increase blood glucose.
  • Protease inhibitors: May alter glucose metabolism.
  • Somatostatin analogs (e.g., octreotide, lanreotide): May decrease or increase insulin requirements.
  • Danazol: May increase blood glucose.
  • Diazoxide: May increase blood glucose.
  • Glucagon: May increase blood glucose.
  • Isoniazid: May increase blood glucose.
  • Niacin: May increase blood glucose.
  • Oral contraceptives: May increase blood glucose.
  • Phenothiazines: May increase blood glucose.
  • Thyroid hormones: May increase blood glucose.
  • Growth hormone: May increase blood glucose.
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Minor Interactions

  • Alcohol: May potentiate the glucose-lowering effect of insulin, increasing risk of hypoglycemia.
  • Salicylates (e.g., aspirin): May enhance the glucose-lowering effect of insulin.
  • Sulfonamide antibiotics: May enhance the glucose-lowering effect of insulin.
  • ACE inhibitors: May enhance the glucose-lowering effect of insulin.
  • Angiotensin Receptor Blockers (ARBs): May enhance the glucose-lowering effect of insulin.

Monitoring

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Baseline Monitoring

HbA1c (Glycated Hemoglobin)

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 (eGFR, BUN, Creatinine)

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

Timing: Prior to initiation of therapy

Hepatic function (ALT, AST, Bilirubin)

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

Timing: Prior to initiation of therapy

Potassium levels

Rationale: To establish baseline, as insulin can cause hypokalemia.

Timing: Prior to initiation of therapy, especially in patients at risk for hypokalemia

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Routine Monitoring

Blood Glucose (Self-Monitoring 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 2-hour post-meal.

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

HbA1c

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

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 weight gain.

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

Injection site inspection

Frequency: Daily with each injection.

Target: No redness, swelling, lumps, or signs of lipodystrophy.

Action Threshold: Presence of abnormalities requires site rotation or medical evaluation.

Potassium levels

Frequency: Periodically, especially in patients at risk for hypokalemia (e.g., on diuretics, severe renal impairment).

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L requires intervention.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, trembling, dizziness, confusion, hunger, irritability, blurred vision, slurred speech, headache, rapid heartbeat)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, nausea, vomiting, fruity breath odor)
  • Symptoms of allergic reactions (e.g., rash, itching, swelling, difficulty breathing)
  • Symptoms of heart failure (e.g., unusual weight gain, swelling in ankles/feet, shortness of breath)

Special Patient Groups

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Pregnancy

Insulin aspart is generally considered safe and is often the preferred insulin for managing diabetes in pregnancy due to its rapid onset and short duration, which helps control postprandial glucose. Close monitoring of blood glucose is essential.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations compared to general population when blood glucose is well-controlled. Poorly controlled diabetes in early pregnancy increases risk of congenital anomalies.
Second Trimester: Insulin requirements typically increase during the second and third trimesters.
Third Trimester: Insulin requirements continue to increase. Close monitoring for hypoglycemia and hyperglycemia is crucial.
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Lactation

Insulin aspart is compatible with breastfeeding. 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.

Infant Risk: Low risk to infant.
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Pediatric Use

Insulin aspart is approved for use in pediatric patients with diabetes mellitus. Dosing must be individualized based on age, weight, and metabolic needs. Close monitoring for hypoglycemia is crucial, especially in younger children.

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Geriatric Use

Use with caution in elderly patients due to increased risk of hypoglycemia, particularly in those with renal or hepatic impairment. Start with lower doses and titrate slowly. Increased monitoring of blood glucose and renal function is recommended.

Clinical Information

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Clinical Pearls

  • Insulin aspart should be administered 5-10 minutes before a meal or within 20 minutes after starting a meal for optimal postprandial glucose control.
  • Always verify the insulin type (rapid-acting, short-acting, intermediate-acting, long-acting) before administration to avoid medication errors.
  • Patients should be educated on proper injection technique, including site rotation to prevent lipodystrophy (lumps or depressions at injection sites).
  • Never mix insulin aspart with other insulins in the same syringe unless specifically instructed by a healthcare professional (e.g., NPH insulin, but not recommended for Penfill cartridges).
  • Stress, illness, or changes in diet or exercise can significantly impact insulin requirements; patients should be advised to monitor blood glucose more frequently during these times.
  • Ensure patients understand the symptoms and treatment of hypoglycemia and have a plan for managing it.
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Alternative Therapies

  • Other rapid-acting insulins: Insulin lispro (Humalog, Admelog, Lyumjev), Insulin glulisine (Apidra)
  • Other types of insulin: Regular insulin (short-acting), NPH insulin (intermediate-acting), Insulin glargine (long-acting), Insulin detemir (long-acting), Insulin degludec (ultra long-acting)
  • Oral antidiabetic agents (for Type 2 Diabetes): Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, etc.
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Cost & Coverage

Average Cost: Varies widely per 3ml Penfill cartridge (5 x 3ml pack)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (preferred brand or non-preferred brand, depending on formulary)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 your 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.