Insulin Aspa Mix 70/30 Inj Sus 10ml

Manufacturer NOVO NORDISK PHARMA Active Ingredient Insulin Aspart Protamine and Insulin Aspart (Vials)(IN soo lin AS part PROE ta meen & IN soo lin AS part) Pronunciation IN soo lin AS part PROE ta meen & 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 analog, rapid-acting/intermediate-acting mix
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Pregnancy Category
Not available
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FDA Approved
May 2001
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Insulin Aspart Mix 70/30 is a type of insulin that helps control blood sugar in people with diabetes. It's a mix of two insulins: a fast-acting one (Insulin Aspart) that works quickly to lower blood sugar after meals, and a longer-acting one (Insulin Aspart Protamine) that provides background control throughout the day. It's given as an injection under the skin.
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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.

Timing of Administration

For individuals with type 1 diabetes, administer this medication within 15 minutes before starting a meal. For those with type 2 diabetes, administer within 15 minutes before or after starting a meal.

Injection Site Selection

Rotate the injection site with each use 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.

Pre-Administration Checks

Before administering the dose, gently roll the container in your hands as instructed by your doctor. Ensure the solution appears cloudy and milky; do not use if it looks clear or contains lumps. Also, check that no powder is stuck to the sides of the container, the solution is not leaking, and there are no particles present. If the solution has changed color, do not use it.

Disposal of Needles and Containers

Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.

Important Administration Guidelines

Do not mix this insulin with other types of insulin in the same syringe. Follow the diet and exercise plan recommended by your doctor, and be aware of the steps to take if you do not eat as usual or skip a meal. This medication is not suitable for use in an insulin pump; if you have questions, consult your doctor. Additionally, do not draw the medication into a syringe and store it for future use.

Storage and Disposal

Store unopened containers in the refrigerator, but do not freeze. If the medication has been frozen, do not use it.

Missed Dose

If you forget to take a dose, be aware of the steps to take. If you are unsure, contact your doctor for guidance.
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Lifestyle & Tips

  • Always follow your healthcare provider's instructions for diet and exercise.
  • Monitor your blood sugar levels regularly as instructed.
  • Learn how to recognize and treat low blood sugar (hypoglycemia).
  • Carry a source of fast-acting sugar (e.g., glucose tablets, juice) with you at all times.
  • Never share insulin pens or syringes with others, even if the needle is changed.
  • Rotate injection sites to prevent skin problems (e.g., lipodystrophy).
  • Store unopened vials in the refrigerator (36°F-46°F [2°C-8°C]). Once opened, store at room temperature (below 86°F [30°C]) for up to 28 days. Do not freeze.
  • Do not use if the suspension appears clear, contains solid particles, or is discolored.

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 twice daily, before breakfast and before dinner. Initial total daily dose often ranges from 0.5 to 1 unit/kg/day, with 70% as intermediate-acting and 30% as rapid-acting insulin.

Condition-Specific Dosing:

type1Diabetes: Initial total daily dose (TDD) is typically 0.5 to 1 unit/kg/day. Approximately 50-70% of TDD is given as basal/intermediate insulin, and the remainder as bolus/rapid insulin. For 70/30 mix, it's usually split into two doses before meals.
type2Diabetes: Initial dose often 0.2 to 0.4 units/kg/day, or 6 to 10 units per dose, adjusted based on blood glucose levels. Typically administered before breakfast and/or dinner.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Highly individualized, similar principles to adults but with careful monitoring to avoid hypoglycemia. Initial doses may be lower (e.g., 0.25-0.5 units/kg/day).
Adolescent: Highly individualized, similar principles to adults. Doses may increase during puberty due to insulin resistance.
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Dose Adjustments

Renal Impairment:

Mild: Dose adjustment may be required; monitor blood glucose closely.
Moderate: Significant dose reduction likely required due to decreased insulin clearance and increased risk of hypoglycemia. Monitor blood glucose frequently.
Severe: Substantial dose reduction required. Frequent blood glucose monitoring and careful titration are essential. Increased risk of severe hypoglycemia.
Dialysis: Dose adjustments are necessary. Insulin requirements may decrease. Administer after dialysis sessions if possible, and monitor blood glucose closely.

Hepatic Impairment:

Mild: Dose adjustment may be required; monitor blood glucose closely.
Moderate: Dose reduction likely required due to impaired gluconeogenesis and decreased insulin clearance. Monitor blood glucose frequently.
Severe: Substantial dose reduction required. Increased risk of hypoglycemia. Frequent blood glucose monitoring and careful titration are essential.

Pharmacology

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Mechanism of Action

Insulin aspart mix 70/30 is a biphasic insulin analog. Insulin aspart (30%) is a rapid-acting insulin that lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin aspart protamine (70%) is an intermediate-acting insulin that provides prolonged glucose control. Insulin binds to insulin receptors on target cells, leading to phosphorylation of the receptor and activation of intracellular signaling pathways that regulate glucose metabolism.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly applicable (subcutaneous administration); absorption rate varies by injection site, dose, and blood flow.
Tmax: Biphasic: Insulin Aspart: 60-120 minutes (range 40-180 minutes); Insulin Aspart Protamine: 6-10 hours.
FoodEffect: Administered before meals to coincide with postprandial glucose rise.

Distribution:

Vd: Approximately 0.26 L/kg (similar to extracellular fluid volume)
ProteinBinding: Minimal (<10%)
CnssPenetration: Limited

Elimination:

HalfLife: Biphasic: Effective half-life of rapid component is 1-3 hours; effective half-life of intermediate component is 8-12 hours, contributing to a duration of action up to 24 hours.
Clearance: Primarily renal clearance, with some hepatic metabolism.
ExcretionRoute: Renal
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: 10-20 minutes (due to insulin aspart component)
PeakEffect: Biphasic: 1-4 hours (insulin aspart) and 6-10 hours (insulin aspart protamine)
DurationOfAction: Up to 24 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 abnormal heartbeat
Unusual burning, numbness, or tingling sensations
Swelling in the arms or legs
Thick skin, pits, or lumps at the injection site
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 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. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Headache
Back pain
Stomach pain or diarrhea
Heartburn
Weight gain
Irritation at the injection site
Flu-like symptoms
* Common cold symptoms

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:

  • Symptoms of low blood sugar (hypoglycemia): sweating, shaking, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat. If these occur, treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision, weight loss. Report persistent high blood sugar to your doctor.
  • Symptoms of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek immediate medical attention.
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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 and its symptoms.
Certain health conditions, including:
+ Acidic blood problems
+ Low blood sugar

This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

This information will help your doctor determine if it is safe for you to take this medication with your existing medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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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.

Low blood sugar (hypoglycemia) is a potential side effect of this drug, and severe cases can lead to seizures, loss of consciousness, permanent brain damage, and even death. It is crucial to discuss this risk with your doctor. Additionally, this medication may cause low blood potassium (hypokalemia), which, if left untreated, can result in abnormal heart rhythms, severe breathing difficulties, and potentially death. 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, particularly when used in combination with insulin. If you are taking one of these medications, discuss this risk with your doctor.

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

Stressful events, such as fever, infection, injury, or surgery, can make it more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar control.

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

Before consuming alcohol or using products containing alcohol, consult your doctor to discuss potential risks. Never 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 (very low blood sugar)
  • Confusion
  • Seizures
  • Loss of consciousness
  • Hypokalemia (low potassium levels)

What to Do:

Immediately consume fast-acting carbohydrates (e.g., glucose tablets, juice, candy). For severe hypoglycemia with unconsciousness, administer glucagon injection 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)
  • Thiazolidinediones (TZDs) - increased risk of fluid retention and heart failure when used with insulin
  • Alcohol (potentiates hypoglycemic effect)
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Moderate Interactions

  • Oral antidiabetic agents (increased risk of hypoglycemia)
  • ACE inhibitors (may enhance insulin's glucose-lowering effect)
  • Angiotensin receptor blockers (ARBs) (may enhance insulin's glucose-lowering effect)
  • Salicylates (e.g., aspirin) (may enhance insulin's glucose-lowering effect)
  • Sulfonamide antibiotics (may enhance insulin's glucose-lowering effect)
  • Monoamine oxidase inhibitors (MAOIs) (may enhance insulin's glucose-lowering effect)
  • Corticosteroids (may decrease insulin's glucose-lowering effect)
  • Diuretics (e.g., thiazides, loop diuretics) (may decrease insulin's glucose-lowering effect)
  • Sympathomimetics (e.g., epinephrine, albuterol) (may decrease insulin's glucose-lowering effect)
  • Atypical antipsychotics (e.g., olanzapine, clozapine) (may decrease insulin's glucose-lowering effect)
  • Growth hormone (may decrease insulin's glucose-lowering effect)
  • Danazol (may decrease insulin's glucose-lowering effect)
  • Somatostatin analogs (e.g., octreotide, lanreotide) (may increase or decrease insulin requirements)
  • Pentamidine (may cause hypoglycemia followed by hyperglycemia)

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 (e.g., eGFR, creatinine)

Rationale: To assess kidney function, as insulin clearance is primarily renal and impairment increases hypoglycemia risk.

Timing: Prior to initiation of therapy

Hepatic Function (e.g., ALT, AST)

Rationale: To assess liver function, as hepatic impairment can affect glucose production and insulin sensitivity.

Timing: Prior to initiation of therapy

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Routine Monitoring

Self-Monitoring Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., pre-meal, 2-hour post-meal, bedtime, overnight) depending on patient needs and glycemic control.

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

Action Threshold: Hypoglycemia (<70 mg/dL): Treat immediately. Hyperglycemia (>180-250 mg/dL): Consider dose adjustment or additional insulin as per care plan.

HbA1c (Glycated Hemoglobin)

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

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

Action Threshold: >7% (or individualized target): Re-evaluate treatment regimen, diet, and exercise.

Signs and Symptoms of Hypoglycemia

Frequency: Daily, ongoing patient education.

Target: N/A

Action Threshold: Any symptoms (e.g., sweating, tremor, confusion, hunger): Check blood glucose and treat immediately.

Signs and Symptoms of Hyperglycemia

Frequency: Daily, ongoing patient education.

Target: N/A

Action Threshold: Any symptoms (e.g., polyuria, polydipsia, fatigue): Check blood glucose, consider dose adjustment, and seek medical advice if severe or persistent.

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Symptom Monitoring

  • Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, anxiety, weakness, slurred speech, seizures, unconsciousness.
  • Symptoms of hyperglycemia: increased thirst (polydipsia), increased urination (polyuria), increased hunger (polyphagia), fatigue, blurred vision, weight loss, dry skin, slow-healing sores, recurrent infections.

Special Patient Groups

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Pregnancy

Insulin is the preferred treatment for diabetes in pregnancy. Well-controlled diabetes is crucial to reduce risks to both mother and fetus. Insulin aspart is generally considered safe and effective during pregnancy. Close monitoring of blood glucose is essential, and insulin requirements may change throughout pregnancy.

Trimester-Specific Risks:

First Trimester: Careful monitoring to avoid hypoglycemia, as insulin sensitivity may increase. Poor glycemic control in early pregnancy increases risk of congenital malformations.
Second Trimester: Insulin requirements typically increase due to increasing insulin resistance.
Third Trimester: Insulin requirements continue to increase. Close monitoring for pre-eclampsia and fetal growth. Insulin requirements usually decrease rapidly after delivery.
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Lactation

Insulin is compatible with breastfeeding. Insulin is a large protein molecule and is not excreted into breast milk in clinically significant amounts. It is considered safe for the nursing infant. Insulin requirements may change during lactation.

Infant Risk: L1 (Safest) - No known adverse effects on the breastfed infant.
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Pediatric Use

Dosing must be highly individualized and carefully monitored due to varying insulin sensitivity, growth spurts, and risk of hypoglycemia. Education of parents/caregivers is crucial. Insulin aspart mix 70/30 is approved for use in children 10 years and older with diabetes mellitus.

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Geriatric Use

Increased risk of hypoglycemia due to potential for impaired renal/hepatic function, reduced counter-regulatory responses, and polypharmacy. Dosing should be conservative, and blood glucose targets may be less stringent to avoid severe hypoglycemia. Careful monitoring and patient education are essential.

Clinical Information

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Clinical Pearls

  • Always ensure the patient understands the difference between rapid-acting and intermediate-acting insulin components and the importance of timing injections relative to meals.
  • Educate patients on proper mixing technique for vials (gently roll between palms) to ensure uniform suspension before injection.
  • Stress the importance of rotating injection sites to prevent lipodystrophy (fat accumulation or atrophy) which can affect insulin absorption.
  • Remind patients that insulin requirements can change due to illness, stress, changes in diet or exercise, and other medications.
  • Emphasize the critical need for immediate treatment of hypoglycemia and recognition of its symptoms.
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Alternative Therapies

  • Basal-bolus insulin regimens (e.g., long-acting insulin + rapid-acting insulin before meals)
  • Basal insulin only (e.g., insulin glargine, insulin detemir, insulin degludec)
  • Oral antidiabetic agents (for Type 2 Diabetes, often in combination with insulin)
  • GLP-1 receptor agonists (for Type 2 Diabetes, often in combination with insulin)
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Cost & Coverage

Average Cost: Varies widely, typically $100-$300 per 10ml vial
Insurance Coverage: Tier 2 or 3 (preferred brand 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.