Insulin Glargine 100u/ml, 10ml

Manufacturer WINTHROP, US Active Ingredient Insulin Glargine (U-100) Vials(IN soo lin GLAR jeen) Pronunciation IN-soo-lin GLAR-jeen
It is used to lower blood sugar in patients with high blood sugar (diabetes).
đŸˇī¸
Drug Class
Antidiabetic agent
đŸ§Ŧ
Pharmacologic Class
Insulin analog, long-acting
🤰
Pregnancy Category
Not available
✅
FDA Approved
Apr 2000
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Insulin glargine is a long-acting insulin that helps your body use sugar for energy. It works by slowly releasing insulin over 24 hours, helping to keep your blood sugar levels stable throughout the day and night. It is typically given once a day by injection under the skin.
📋

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, typically in the thigh, abdominal area, or upper arm. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.

Before use, wash your hands thoroughly. If you take this medication once daily, you can administer it at any time of day, but be sure to take it at the same time every day. Rotate the injection site each time to avoid tissue damage.

Important Administration Guidelines

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.
Do not use the medication if the solution has changed color.
Do not draw the medication into a syringe and store it for future use.
Dispose of needles and syringes in a sharps disposal container. Do not reuse needles or other equipment.

Additional Instructions

Do not mix this insulin with other types of insulin or liquids in the same syringe.
Follow the diet and exercise plan recommended by your doctor.
This medication is not compatible with insulin pumps. If you have questions, consult your doctor or pharmacist.

Storage and Disposal

Store unopened containers in the refrigerator at a temperature between 39°F and 46°F (4°C and 8°C). Do not freeze. If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine the maximum storage time before disposal.

After opening, store the medication in the refrigerator or at room temperature. Discard any unused medication after 28 days.

Missed Dose Instructions

If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you are unsure about what to do if you miss a dose, consult your doctor or pharmacist.
💡

Lifestyle & Tips

  • Administer insulin glargine once daily at the same time each day, usually in the evening.
  • Rotate injection sites within the same general area (e.g., abdomen, thigh, upper arm) to prevent lipodystrophy (skin changes).
  • Do not mix insulin glargine with any other insulin or solution.
  • Do not administer intravenously or intramuscularly.
  • Follow a consistent meal plan and exercise routine as advised by your healthcare provider.
  • Always carry a source of fast-acting sugar (e.g., glucose tablets, fruit juice) to treat mild to moderate hypoglycemia.
  • Inform your healthcare provider about all medications, supplements, and herbal products you are taking.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Individualized, typically 0.2-0.4 units/kg/day, once daily at the same time each day.
Dose Range: 0.2 - 0.4 mg

Condition-Specific Dosing:

Type 1 Diabetes Mellitus: Approximately one-third to one-half of the total daily insulin dose as basal insulin. The remainder is given as short-acting or rapid-acting insulin before meals.
Type 2 Diabetes Mellitus: Initial dose of 10 units once daily or 0.1-0.2 units/kg once daily. Titrate based on fasting plasma glucose (FPG) targets.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Type 1 DM: Initial dose of approximately one-third to one-half of the total daily insulin dose as basal insulin. Total daily dose typically 0.5-1 unit/kg/day. Type 2 DM: Initial dose of 0.1-0.2 units/kg once daily, titrate to FPG target.
Adolescent: Type 1 DM: Initial dose of approximately one-third to one-half of the total daily insulin dose as basal insulin. Total daily dose typically 0.5-1 unit/kg/day. Type 2 DM: Initial dose of 0.1-0.2 units/kg once daily, titrate to FPG target.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor glucose closely.
Moderate: Dose reduction may be required; monitor glucose closely.
Severe: Significant dose reduction likely required; monitor glucose closely and frequently.
Dialysis: Dose reduction likely required; monitor glucose closely and frequently. Insulin requirements may decrease.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor glucose closely.
Moderate: Dose reduction may be required; monitor glucose closely.
Severe: Significant dose reduction likely required; monitor glucose closely and frequently.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Insulin glargine is a long-acting human insulin analog. It 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. The prolonged action is due to its low solubility at neutral pH, leading to the formation of a microprecipitate after subcutaneous injection, from which small amounts of insulin glargine are continuously released.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not directly quantifiable due to subcutaneous administration and slow absorption profile.
Tmax: No pronounced peak; relatively constant concentration-time profile over 24 hours.
FoodEffect: Not applicable (administered subcutaneously, not orally).

Distribution:

Vd: Approximately 0.13 L/kg (similar to human insulin)
ProteinBinding: Low (less than 6%)
CnssPenetration: Limited

Elimination:

HalfLife: Effective half-life is approximately 10-12 hours, but its pharmacodynamic effect extends up to 24 hours due to slow absorption.
Clearance: Not precisely quantifiable due to slow absorption and metabolism.
ExcretionRoute: Renal (metabolites)
Unchanged: Negligible
âąī¸

Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: No pronounced peak; relatively constant effect over 24 hours.
DurationOfAction: Up to 24 hours

Safety & Warnings

âš ī¸

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
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
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
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
+ Rapid 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Irritation at the injection site
Back pain
Diarrhea
Headache
Weight gain
Signs of a common cold
Nose and throat irritation
Flu-like symptoms
Joint pain
* Pain in the arms or legs

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Symptoms of severe hypoglycemia (e.g., seizures, unconsciousness, severe confusion)
  • Symptoms of severe allergic reaction (e.g., widespread rash, difficulty breathing, swelling of face/tongue/throat, rapid heartbeat, severe dizziness)
  • Signs of fluid retention or heart failure (e.g., unusual weight gain, swelling in ankles/feet, shortness of breath) if taking TZDs concurrently.
📋

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.
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

It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
âš ī¸

Precautions & Cautions

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

Be aware that this drug can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not properly managed. Consult your doctor to discuss the risks and prevention strategies. Additionally, this medication can cause low blood potassium levels, which can result in abnormal heart rhythms, severe breathing problems, and death if left untreated. If you experience any symptoms, consult your doctor promptly.

Until you understand how this drug 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, especially when used in combination with insulin. If you are taking one of these medications, discuss the potential risks with your doctor.

Ensure you have the correct insulin product and understand how to measure and prepare your dose. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns, contact your doctor or pharmacist.

Be aware that stress, 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 levels.

Wear a medical alert identification to ensure prompt treatment in case of an emergency. Avoid driving if you have experienced low blood sugar, as it can increase your risk of being involved in an accident.

Monitor your blood sugar levels as directed by your doctor and undergo regular blood tests to ensure your safety while taking this medication. Consult your doctor before consuming alcohol or using products that contain alcohol.

Do not share your insulin product, including pens, cartridge devices, needles, or syringes, with anyone else, even if the needle has been changed. Sharing can transmit infections, including those you may not be aware of having.

When using this medication in children, be aware that they may be more susceptible to side effects. If you are 65 or older, use this medication with caution, as you may be more prone to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (e.g., confusion, disorientation, slurred speech, seizures, coma)
  • Hypokalemia (e.g., muscle weakness, cramps, irregular heart rhythm)

What to Do:

For mild hypoglycemia, consume fast-acting carbohydrates. For severe hypoglycemia, administer glucagon (if available and trained) or seek immediate medical attention. Call 911 or your local emergency number. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

🔴

Major Interactions

  • Beta-blockers (may mask hypoglycemia symptoms)
  • Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure)
  • Corticosteroids (may increase blood glucose, requiring higher insulin doses)
  • Diuretics (thiazide and loop diuretics may increase blood glucose)
  • Sympathomimetics (may increase blood glucose)
  • Atypical antipsychotics (may cause hyperglycemia)
  • Protease inhibitors (may cause hyperglycemia)
  • Somatostatin analogs (e.g., octreotide, may decrease insulin requirements)
  • Salicylates (e.g., aspirin, may enhance insulin effect at high doses)
  • Alcohol (may potentiate or reduce hypoglycemic effect)
🟡

Moderate Interactions

  • ACE inhibitors (may enhance insulin effect)
  • Angiotensin receptor blockers (ARBs) (may enhance insulin effect)
  • Disopyramide (may enhance insulin effect)
  • Fibrates (may enhance insulin effect)
  • Fluoxetine (may enhance insulin effect)
  • MAO inhibitors (may enhance insulin effect)
  • Propoxyphene (may enhance insulin effect)
  • Sulfonamide antibiotics (may enhance insulin effect)
  • Oral contraceptives (may increase blood glucose)
  • Thyroid hormones (may increase blood glucose)

Monitoring

đŸ”Ŧ

Baseline Monitoring

HbA1c

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 and guide initial dosing.

Timing: Prior to initiation of therapy

Renal function (eGFR, BUN, Creatinine)

Rationale: To assess kidney function as insulin requirements may decrease with renal impairment.

Timing: Prior to initiation of therapy

Hepatic function (ALT, AST, Bilirubin)

Rationale: To assess liver function as insulin requirements may decrease with hepatic impairment.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

Frequency: Multiple times daily (e.g., fasting, pre-meal, post-meal, bedtime) or as directed by healthcare provider.

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

Action Threshold: Hypoglycemia (<70 mg/dL) or persistent hyperglycemia (>180 mg/dL) requiring dose adjustment.

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 indicating need for therapy adjustment.

Weight

Frequency: Regularly (e.g., monthly or at each visit).

Target: Stable or within healthy range.

Action Threshold: Significant unexplained weight gain or loss.

Injection sites

Frequency: At each visit and with patient self-assessment.

Target: Absence of lipodystrophy or irritation.

Action Threshold: Presence of lipohypertrophy or lipoatrophy, requiring rotation of sites.

đŸ‘ī¸

Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, shakiness, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss)
  • Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Signs of fluid retention/heart failure (e.g., unusual weight gain, swelling in ankles/feet, shortness of breath) if co-administered with TZDs.

Special Patient Groups

🤰

Pregnancy

Insulin glargine is generally considered safe and effective for use in pregnancy to manage gestational diabetes or pre-existing diabetes. Insulin requirements may change throughout pregnancy. Close monitoring of blood glucose is essential.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital malformations compared to general population when diabetes is well-controlled.
Second Trimester: Insulin requirements typically increase.
Third Trimester: Insulin requirements typically increase, then may decrease shortly before delivery.
🤱

Lactation

Insulin glargine is considered compatible with breastfeeding. Insulin is a normal component of breast milk and is not expected to cause adverse effects in a breastfed infant. Maternal insulin requirements may decrease during lactation.

Infant Risk: L1 (Safest) - No adverse effects expected.
đŸ‘ļ

Pediatric Use

Safety and effectiveness have been established in pediatric patients (6 years and older) with Type 1 diabetes and in adolescents (10 years and older) with Type 2 diabetes. Dosing must be individualized and carefully titrated based on glycemic control and weight.

👴

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity to insulin's effects and increased risk of hypoglycemia may occur in some older individuals. Renal and hepatic function should be monitored, and dose adjustments made as needed.

Clinical Information

💎

Clinical Pearls

  • Insulin glargine (U-100) is a basal insulin that provides a relatively constant glucose-lowering effect over 24 hours with no pronounced peak.
  • It should be administered once daily at the same time each day, regardless of meal times.
  • Never mix insulin glargine with any other insulin or solution in the same syringe, as this can alter its time-action profile and lead to precipitation.
  • Patients should be educated on proper injection technique, site rotation, and signs/symptoms of hypoglycemia and hyperglycemia.
  • Patients transitioning from other basal insulins may require dose adjustments and close monitoring.
  • The 10 mL vial is for use with a U-100 insulin syringe only. Do not use with insulin pens.
🔄

Alternative Therapies

  • Other long-acting insulins (e.g., insulin detemir, insulin degludec)
  • Intermediate-acting insulins (e.g., NPH insulin)
  • Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) for Type 2 Diabetes.
  • Other injectable non-insulin antidiabetic agents (e.g., GLP-1 receptor agonists, amylin analogs).
💰

Cost & Coverage

Average Cost: $250 - $350 per 10 mL vial (U-100)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand/biosimilar)
📚

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.