Insulin Glargine 100u/ml, 10ml
Overview
What is this medicine?
How to Use This Medicine
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.
Available Forms & Alternatives
Available Strengths:
- Insulin Aspart 100/ml Inj,10ml
- Insulin Aspa Mix 70/30 Inj Sus 10ml
- Insulin Aspart Penfill Inj, 3ml
- Insulin Aspart Flexpen Inj, 3ml
- Insulin Aspa Mix 70/30 Flexpen, 3ml
- Insulin Lispro Junior Kwikpen 5x3ml
- Insulin Lispro Prt Mix 75/25kwikpen
- Insulin Lispro 100u/ml Vial 10ml
- Insulin Lispro 100u/ml Kwikpen 3ml
- Insulin Glarg-Yfgn 100u/ml Sol 10ml
- Insulin Glarg-Yfgn 100u/ml Pen Inj
- Insulin Glarg Solostar Pen Inj 3ml
- Insulin Glargine 100u/ml, 10ml
- Insulin Degludec U100 Inj Vial 10ml
- Insuln Glargne Solstr U300 PN 1.5ml
- Insulin Glarg U300 Max Solstr Inj
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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
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.
Precautions & Cautions
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
Baseline Monitoring
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy
Rationale: To establish baseline glucose levels and guide initial dosing.
Timing: Prior to initiation of therapy
Rationale: To assess kidney function as insulin requirements may decrease with renal impairment.
Timing: Prior to initiation of therapy
Rationale: To assess liver function as insulin requirements may decrease with hepatic impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
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.
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.
Frequency: Regularly (e.g., monthly or at each visit).
Target: Stable or within healthy range.
Action Threshold: Significant unexplained weight gain or loss.
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.
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:
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.
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).