Humalog Tempo Pen 100u/ml Inj 3ml

Manufacturer LILLY Active Ingredient Insulin Lispro (U-100) Cartridges and Pens(IN soo lin LYE sproe) Pronunciation 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
Rapid-acting insulin analog
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Pregnancy Category
Not available
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FDA Approved
Jun 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Insulin Lispro is a fast-acting insulin that helps your body use sugar for energy. It starts working quickly, usually within 15-30 minutes, to lower your blood sugar after meals. It's used to manage diabetes by replacing the insulin your body isn't making or isn't using effectively.
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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 under the skin. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.

Administration Guidelines

Take the medication within 15 minutes before or immediately after a meal.
Rotate the injection site each time to avoid damaging the skin.
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 appears cloudy, is leaking, or contains particles, or if the solution has changed color.

Preparing the Dose

Remove all pen needle covers before injecting a dose. If you have two covers, remove both.
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
You may hear a clicking sound as you prepare the dose. 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.

Storage and Disposal

Do not transfer the medication from the pen to a syringe or mix it with other types of insulin.
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
If you have any questions, consult your doctor or pharmacist.

Diet and Exercise

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

Storage

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

  • Administer insulin lispro immediately before or within 20 minutes after starting a meal.
  • Always check your blood glucose levels as directed by your healthcare provider.
  • Follow a consistent meal plan and carbohydrate counting if advised.
  • Engage in regular physical activity as recommended.
  • Learn proper injection technique and rotate injection sites to prevent skin problems (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 mild to moderate hypoglycemia.

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 5-15 minutes before a meal. Total daily insulin dose often ranges from 0.5 to 1 unit/kg/day, with rapid-acting insulin covering prandial needs (e.g., 50% of total daily dose as prandial insulin, divided among meals). Dosing is adjusted based on carbohydrate intake, pre-meal blood glucose, and anticipated physical activity.
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Pediatric Dosing

Neonatal: Not established
Infant: Dosing is highly individualized and requires careful titration based on blood glucose levels, carbohydrate intake, and growth. Typically initiated at lower doses.
Child: Dosing is highly individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. Similar principles to adult dosing, adjusted for weight and activity.
Adolescent: Dosing is highly individualized based on metabolic needs, blood glucose monitoring, and glycemic control goals. May require higher doses during puberty due to insulin resistance.
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Dose Adjustments

Renal Impairment:

Mild: Careful monitoring of blood glucose and dose adjustment may be required due to decreased insulin clearance.
Moderate: Dose reduction often required due to decreased insulin clearance and reduced gluconeogenesis. Close monitoring of blood glucose is essential.
Severe: Significant dose reduction often required. Frequent blood glucose monitoring and careful titration are critical to avoid hypoglycemia.
Dialysis: Insulin requirements may be significantly reduced. Dosing must be carefully adjusted based on dialysis schedule and frequent blood glucose monitoring.

Hepatic Impairment:

Mild: Careful monitoring of blood glucose and dose adjustment may be required.
Moderate: Dose reduction often required due to decreased gluconeogenesis and reduced insulin degradation. Close monitoring of blood glucose is essential.
Severe: Significant dose reduction often required. Frequent blood glucose monitoring and careful titration are critical to avoid hypoglycemia.

Pharmacology

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Mechanism of Action

Insulin lispro is a rapid-acting human insulin analog that 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.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (subcutaneous injection)
Tmax: 0.5-1.5 hours (subcutaneous)
FoodEffect: Administered immediately before or within 20 minutes after starting a meal to optimize postprandial glucose control.

Distribution:

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

Elimination:

HalfLife: Approximately 1 hour (functional half-life is longer due to absorption kinetics)
Clearance: Not available (highly variable)
ExcretionRoute: Primarily renal
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: 0.5-2.5 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 immediate medical attention:

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 fatal.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
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 your doctor's instructions, which may include taking glucose tablets, liquid glucose, or certain 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 don't go away, contact your doctor:

Weight gain
Flu-like symptoms
Nose or throat irritation
Common cold symptoms
Headache
Cough
Upset stomach
Stomach pain or diarrhea
Feeling tired or weak
* Irritation at the injection site

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, shakiness, dizziness, confusion, hunger, irritability, blurred vision, rapid heartbeat. Treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, increased hunger, fatigue, blurred vision, unexplained weight loss. Contact your doctor if persistent.
  • Symptoms of allergic reaction: rash, itching, swelling (especially 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 you experienced, including any symptoms that occurred.
If you have low blood sugar (hypoglycemia), as this may affect your treatment plan.

This medication can interact with other medications and health conditions. 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 supplements you are using
Vitamins you are taking
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 potential interactions and ensure the safe use of this medication.
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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 problems, 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.

During stressful events, such as fever, infection, injury, or surgery, it may be 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. 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 recommended.

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 to both you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

For mild to moderate hypoglycemia, consume 15-20 grams of fast-acting carbohydrates (e.g., glucose tablets, fruit juice, regular soda). Recheck blood sugar in 15 minutes and repeat if necessary. For severe hypoglycemia (unconsciousness, seizures), administer glucagon if available and call emergency medical services (e.g., 911 or 1-800-222-1222 for Poison Control).

Drug Interactions

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Major Interactions

  • Beta-blockers (can mask symptoms of hypoglycemia)
  • Alcohol (can potentiate hypoglycemic effect)
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Moderate Interactions

  • Oral antidiabetic agents (increased risk of hypoglycemia)
  • ACE inhibitors (increased risk of hypoglycemia)
  • Angiotensin receptor blockers (increased risk of hypoglycemia)
  • Disopyramide (increased risk of hypoglycemia)
  • Fibrates (increased risk of hypoglycemia)
  • Fluoxetine (increased risk of hypoglycemia)
  • MAOIs (increased risk of hypoglycemia)
  • Pentoxifylline (increased risk of hypoglycemia)
  • Propoxyphene (increased risk of hypoglycemia)
  • Salicylates (e.g., aspirin, increased risk of hypoglycemia)
  • Somatostatin analogs (e.g., octreotide, increased risk of hypoglycemia)
  • Sulfonamide antibiotics (increased risk of hypoglycemia)
  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Danazol (may increase blood glucose, requiring higher insulin doses)
  • Diazoxide (may increase blood glucose, requiring higher insulin doses)
  • Diuretics (e.g., thiazides, loop diuretics; may increase blood glucose, requiring higher insulin doses)
  • Glucagon (may increase blood glucose, requiring higher insulin doses)
  • Isoniazid (may increase blood glucose, requiring higher insulin doses)
  • Estrogens (e.g., oral contraceptives; may increase blood glucose, requiring higher insulin doses)
  • Phenothiazines (may increase blood glucose, requiring higher insulin doses)
  • Somatropin (may increase blood glucose, requiring higher insulin doses)
  • Sympathomimetics (e.g., epinephrine, albuterol; may increase blood glucose, requiring higher insulin doses)
  • Thyroid hormones (may increase blood glucose, requiring higher insulin doses)
  • Atypical antipsychotics (e.g., olanzapine, clozapine; may increase blood glucose, requiring higher insulin doses)
  • Protease inhibitors (may increase blood glucose, requiring higher insulin doses)

Monitoring

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Baseline Monitoring

HbA1c

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

Timing: Prior to initiation of therapy

Fasting Blood Glucose (FBG)

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 can be affected by renal impairment.

Timing: Prior to initiation of therapy

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

Rationale: To assess liver function, as insulin degradation occurs in the liver.

Timing: Prior to initiation of therapy

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Routine Monitoring

Self-Monitoring of Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., pre-meal, 1-2 hours post-meal, bedtime, overnight if needed)

Target: Individualized based on patient goals (e.g., 80-130 mg/dL pre-meal, <180 mg/dL post-meal)

Action Threshold: Adjust insulin dose based on blood glucose readings and carbohydrate intake; treat hypoglycemia if <70 mg/dL.

HbA1c

Frequency: Every 3-6 months

Target: Individualized based on patient goals (e.g., <7% for most adults)

Action Threshold: Adjust overall diabetes management plan if target not met.

Symptoms of Hypoglycemia/Hyperglycemia

Frequency: Continuously

Target: N/A

Action Threshold: Prompt treatment of hypoglycemia; dose adjustment for persistent hyperglycemia.

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Symptom Monitoring

  • Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, palpitations, headache, weakness.
  • Symptoms of hyperglycemia: increased thirst (polydipsia), frequent urination (polyuria), increased hunger (polyphagia), fatigue, blurred vision, unexplained weight loss.

Special Patient Groups

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Pregnancy

Insulin lispro is generally considered safe and is often the preferred insulin for managing diabetes during pregnancy, including gestational diabetes. Careful monitoring of blood glucose is essential to achieve optimal glycemic control and reduce risks to both mother and fetus.

Trimester-Specific Risks:

First Trimester: No known increased risk of congenital malformations directly attributable to insulin lispro. Strict glycemic control is crucial to prevent adverse outcomes.
Second Trimester: Insulin requirements may increase during the second trimester. Close monitoring and dose adjustments are necessary.
Third Trimester: Insulin requirements typically continue to increase. Close monitoring and dose adjustments are necessary to maintain glycemic control.
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Lactation

Insulin lispro is compatible with breastfeeding. Insulin is a normal component of breast milk, but the amount transferred is negligible and not expected to harm the breastfed infant. Maternal insulin requirements may change during lactation.

Infant Risk: L1 (Safest - no known risk to the infant)
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Pediatric Use

Insulin lispro is approved for use in pediatric patients with diabetes. Dosing is highly individualized based on age, weight, activity level, and glycemic control goals. Careful monitoring of blood glucose is crucial to prevent hypoglycemia.

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Geriatric Use

Older adults may be at increased risk of hypoglycemia due to age-related changes in renal function, hepatic function, and counter-regulatory hormone responses. Lower starting doses and careful titration with frequent blood glucose monitoring are recommended. May also have impaired cognitive function or vision affecting self-administration.

Clinical Information

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Clinical Pearls

  • Humalog Tempo Pen is a prefilled pen designed for ease of use, but proper training on injection technique is crucial.
  • Always check the insulin label carefully before each injection to ensure the correct type of insulin is being used.
  • Insulin lispro should be clear and colorless; do not use if it appears cloudy, discolored, or contains particles.
  • Rotate injection sites within the same region (e.g., abdomen) to minimize the risk of lipodystrophy (fat accumulation or atrophy at injection sites).
  • Never reuse or share needles or insulin pens.
  • Store unopened pens in the refrigerator (2°C to 8°C). Once opened, store at room temperature (below 30°C) and use within 28 days. Do not freeze.
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Alternative Therapies

  • Other rapid-acting insulins: Insulin aspart (Novolog, Fiasp), Insulin glulisine (Apidra)
  • Short-acting insulins: Regular human insulin (Humulin R, Novolin R)
  • Intermediate-acting insulins: NPH human insulin (Humulin N, Novolin N)
  • Long-acting insulins: Insulin glargine (Lantus, Toujeo, Basaglar), Insulin detemir (Levemir), Insulin degludec (Tresiba)
  • Oral antidiabetic agents (for Type 2 Diabetes): Metformin, Sulfonylureas, SGLT2 inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists, Thiazolidinediones, Alpha-glucosidase inhibitors, Meglitinides.
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Cost & Coverage

Average Cost: Varies significantly by pharmacy, insurance plan, and specific product (e.g., pen vs. vial). Typically ranges from $100-$300+ per 3ml pen. per 3ml pen
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand-name insulin), Tier 1 or 2 (Biosimilar insulin)
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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 occurred.