Insulin Aspart 100/ml Inj,10ml

Manufacturer NOVO NORDISK Active Ingredient Insulin Aspart (Vials) (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
Rapid-acting insulin analog
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Pregnancy Category
Category B
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FDA Approved
Jun 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Insulin aspart is a man-made insulin that works very quickly to lower your blood sugar after meals. It helps your body use sugar for energy and is used to treat diabetes.
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How to Use This Medicine

Proper Administration of This Medication

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically 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.

Injection Technique and Timing

Inject the dose within 5 to 10 minutes before a meal. To minimize the risk of lipodystrophy, rotate the injection site with each use. Do not draw the medication into a syringe and store it for future use.

Mixing with Other Insulins

Certain brands of this medication may be mixed with insulin NPH, but it is essential to confirm with your doctor or pharmacist whether your specific brand can be mixed. Do not mix this medication with any other type of insulin.

Use in an Insulin Pump

If using this medication in an insulin pump, ensure you understand the proper operation and maintenance of the pump, as instructed by your doctor or outlined in the package insert. Regularly change the medication and pump parts as directed. In the event of pump failure, have an alternative method of insulin administration available and consult with your doctor.

Storage and Disposal

Store unopened containers of this medication in the refrigerator, avoiding freezing temperatures. Do not use the medication if it has been frozen.

Missed Dose

If you forget to take a dose, consult with your doctor for guidance on the appropriate course of action. If you are unsure about what to do in the event of a missed dose, contact your doctor for advice.
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Lifestyle & Tips

  • Always check your blood sugar levels as instructed by your doctor.
  • Administer insulin aspart 5-10 minutes before a meal.
  • Rotate injection sites (abdomen, thigh, upper arm, buttocks) to prevent skin problems like lipodystrophy.
  • Follow a healthy diet and exercise plan as recommended by your healthcare provider.
  • Do not skip meals or delay eating after injecting insulin.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat low blood sugar.
  • Never share needles, syringes, or insulin pens with others.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Typically administered subcutaneously 5-10 minutes before a meal. Often used in a basal-bolus regimen.

Condition-Specific Dosing:

Type 1 Diabetes: Initial total daily dose (TDD) typically 0.5-1 unit/kg/day, with 50-70% as prandial (bolus) insulin divided before meals.
Type 2 Diabetes: Initial dose often 4 units or 0.1 units/kg or 10% of basal insulin dose before the largest meal, adjusted based on blood glucose levels.
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Pediatric Dosing

Neonatal: Not established
Infant: Individualized, typically 0.5-1 unit/kg/day total insulin, adjusted based on blood glucose.
Child: Individualized, typically 0.5-1 unit/kg/day total insulin, adjusted based on blood glucose.
Adolescent: Individualized, typically 0.5-1 unit/kg/day total insulin, adjusted based on blood glucose.
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Dose Adjustments

Renal Impairment:

Mild: Monitor blood glucose closely; dose adjustment may be required.
Moderate: Dose reduction often required due to decreased insulin clearance; monitor closely.
Severe: Significant dose reduction required; monitor closely for hypoglycemia.
Dialysis: Dose reduction required; monitor closely for hypoglycemia, especially post-dialysis.

Hepatic Impairment:

Mild: Monitor blood glucose closely; dose adjustment may be required.
Moderate: Dose reduction often required due to decreased insulin clearance; monitor closely.
Severe: Significant dose reduction required; monitor closely for hypoglycemia.

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: Highly variable (subcutaneous), generally 50-80%
Tmax: 30-90 minutes (subcutaneous)
FoodEffect: Administered 5-10 minutes before a meal to coincide with postprandial glucose rise.

Distribution:

Vd: Approximately 0.26 L/kg
ProteinBinding: Low (<10%)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 80 minutes (subcutaneous)
Clearance: Not readily quantifiable due to complex metabolism and distribution
ExcretionRoute: Primarily renal (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

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 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
Injection site reactions, such as:
+ Thick skin
+ Pits or lumps
+ Changes in skin color
Swelling in the arms or legs
Pain or blood while urinating
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. 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:

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, 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, shakiness, dizziness, confusion, hunger, irritability, rapid heartbeat, blurred vision, headache, slurred speech. Seek immediate medical attention or consume fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, increased hunger, blurred vision, fatigue, headache. Contact your doctor if persistent.
  • Symptoms of allergic reaction: rash, itching, swelling (especially of the 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 your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems

with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Administration Precautions

Do not administer 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, inspect the solution for any visible signs of damage or contamination. Do not use the medication if the solution is cloudy, leaking, or contains particles. The solution should be clear and colorless; if it has changed color, do not use it.

Diet and Exercise

Follow the diet and exercise plan recommended by your doctor. It is crucial to understand how to manage your condition if you skip a meal or do not eat as much as usual.

Low Blood Sugar Risk

This medication may cause low blood sugar, which can lead to seizures, loss of consciousness, long-term brain damage, and even death. Consult your doctor to discuss the risks and how to manage them.

Low Blood Potassium Risk

This medication may also cause low blood potassium, which can lead to abnormal heart rhythms, severe breathing problems, and even death if left untreated. Consult your doctor to discuss the risks and how to manage them.

Caution with Other Activities

Avoid driving and engaging in 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 medications may increase the risk of heart failure. If you are taking one of these medications, consult your doctor to discuss the risks.

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 correctly. If you have any questions, consult your doctor or pharmacist.

Blood Sugar Control During Stressful Situations

It may be more challenging to control blood sugar levels during stressful situations such as fever, infection, injury, or surgery. Changes in physical activity, exercise, or diet can also affect blood sugar levels.

Medical Alert Identification

Wear a medical alert identification to inform others of your condition in case of an emergency.

Driving Precautions

Do not drive if you have experienced low blood sugar, as this can increase 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 consult with them to discuss the results.

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, even if the needle has been changed, 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 any 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 to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (extremely low blood sugar)
  • Loss of consciousness
  • Seizures

What to Do:

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

Drug Interactions

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Major Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia)
  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Thiazide diuretics (may increase blood glucose, requiring higher insulin doses)
  • Sympathomimetics (may increase blood glucose, requiring higher insulin doses)
  • Atypical antipsychotics (may increase blood glucose, requiring higher insulin doses)
  • Protease inhibitors (may increase blood glucose, requiring higher insulin doses)
  • Sulfonylureas (increased risk of hypoglycemia)
  • GLP-1 receptor agonists (increased risk of hypoglycemia)
  • Pramlintide (increased risk of hypoglycemia)
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Moderate Interactions

  • Alcohol (may potentiate hypoglycemic effect)
  • Salicylates (may enhance insulin's glucose-lowering effect)
  • MAO inhibitors (may enhance insulin's glucose-lowering effect)
  • ACE inhibitors (may enhance insulin's glucose-lowering effect)
  • Somatostatin analogs (e.g., octreotide, may increase or decrease insulin requirements)

Monitoring

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Baseline Monitoring

HbA1c (Glycated Hemoglobin)

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

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

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Routine Monitoring

Self-Monitoring Blood Glucose (SMBG)

Frequency: Multiple times daily (pre-meal, 1-2 hours post-meal, bedtime, overnight as needed)

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

Action Threshold: Hypoglycemia (<70 mg/dL) or persistent hyperglycemia (>180-250 mg/dL)

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7% for most adults

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

Signs and Symptoms of Hypoglycemia/Hyperglycemia

Frequency: Daily, ongoing

Target: N/A

Action Threshold: Any occurrence requires immediate attention and potential dose adjustment.

Injection Site Inspection

Frequency: Regularly (e.g., weekly)

Target: No signs of lipodystrophy, redness, swelling

Action Threshold: Presence of lipodystrophy or irritation indicates need for site rotation.

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Symptom Monitoring

  • Symptoms of hypoglycemia: sweating, shakiness, dizziness, confusion, hunger, irritability, rapid heartbeat, blurred vision, headache, slurred speech.
  • Symptoms of hyperglycemia: increased thirst, frequent urination, increased hunger, blurred vision, fatigue, headache.

Special Patient Groups

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Pregnancy

Insulin aspart is generally considered safe and is often the preferred treatment for diabetes in pregnancy. 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.
Second Trimester: No specific risks identified; continued close monitoring and dose adjustments as pregnancy progresses.
Third Trimester: No specific risks identified; continued close monitoring and dose adjustments as pregnancy progresses, especially as insulin resistance increases.
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Lactation

Insulin aspart is compatible with breastfeeding. Insulin is a normal component of human milk and is not expected to cause adverse effects in a breastfed infant.

Infant Risk: Low risk (L1)
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Pediatric Use

Insulin aspart is approved for use in pediatric patients with diabetes. Dosing must be individualized based on age, weight, and glycemic control goals. Close monitoring for hypoglycemia is crucial.

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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. Monitor closely for signs and symptoms of hypoglycemia, which may be less obvious in older adults.

Clinical Information

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Clinical Pearls

  • Always verify the correct insulin type (rapid-acting, short-acting, intermediate, long-acting) before administration to avoid medication errors.
  • Insulin aspart should be clear and colorless; do not use if it appears cloudy, discolored, or contains particles.
  • Administer insulin aspart subcutaneously into the abdomen, thigh, upper arm, or buttocks. Rotate injection sites within the same region to reduce the risk of lipodystrophy.
  • Do not mix insulin aspart with other insulins unless specifically instructed by a healthcare professional (e.g., NPH insulin, but not recommended for routine mixing).
  • Patients should be educated on proper injection technique, storage, and disposal of needles and syringes.
  • Stress the importance of consistent meal times and carbohydrate intake to match insulin action and prevent hypoglycemia.
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Alternative Therapies

  • Other rapid-acting insulins (e.g., insulin lispro, insulin glulisine)
  • Short-acting insulins (e.g., regular human insulin)
  • Intermediate-acting insulins (e.g., NPH insulin)
  • Long-acting insulins (e.g., insulin glargine, insulin detemir, insulin degludec)
  • 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 $250-$350 per 10ml vial (1000 units)
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 for more information. If you have any questions or concerns about this 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 overdose, including the medication taken, the amount, and the time it occurred.