Insulin Glarg Solostar Pen Inj 3ml

Manufacturer WINTHROP, US Active Ingredient Insulin Glargine (U-100) Cartridge Systems and Pens(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
Long-acting insulin analog
🤰
Pregnancy Category
Not assigned (Insulin is preferred for diabetes in pregnancy)
✅
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 is given once a day, usually at the same time each day, to provide a steady level of insulin throughout the day and night. This helps to keep your blood sugar levels stable.
📋

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, typically in the thigh, belly 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 each day. Rotate the injection site with each use to avoid damaging the skin.

Important Administration Guidelines

Do not inject 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.
Remove all pen needle covers before injecting a dose (note that there may be two covers).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
Do not transfer the medication from the pen to a syringe.
You may hear a clicking sound when preparing the dose, but do not rely on the clicks to determine the correct dose.
Remove the needle after each injection and do not store the device with the needle attached.
Dispose of used needles in a designated sharps disposal container and do not reuse needles or other items.

Additional Precautions

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 suitable for use in an insulin pump. If you have questions, consult your doctor.

Storage and Disposal

Store unopened containers in the refrigerator, but do not freeze.
Do not use the medication if it has been frozen.
If an unopened container has been stored at room temperature, consult your doctor or pharmacist to determine how long it can be safely stored.
After opening, store the medication at room temperature for up to 28 days. Discard any unused portion 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 injection, 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.
💡

Lifestyle & Tips

  • Always check your blood sugar levels as directed by your doctor.
  • Follow your prescribed diet plan and exercise regularly.
  • Do not skip meals, even if you feel well.
  • Rotate injection sites to prevent skin problems (lipodystrophy).
  • Never share your insulin pen or needles with anyone else, even if the needle is changed.
  • Always have a source of fast-acting sugar (e.g., glucose tablets, fruit juice, hard candy) available to treat low blood sugar.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Individualized. Typically initiated at 0.2 units/kg/day for Type 1 Diabetes or 10 units once daily for Type 2 Diabetes, adjusted based on blood glucose levels.

Condition-Specific Dosing:

Type 1 Diabetes: Approximately one-third of the total daily insulin dose, given once daily. The remainder is given as rapid-acting insulin with meals.
Type 2 Diabetes: Initial dose of 10 units once daily, or 0.1-0.2 units/kg once daily. Adjust dose by 2-4 units once weekly until target fasting plasma glucose is achieved.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (use with extreme caution and close monitoring if necessary)
Infant: Not established (use with extreme caution and close monitoring if necessary)
Child: Individualized, similar to adults for Type 1 Diabetes, typically starting at 0.2 units/kg/day and adjusted based on glucose levels.
Adolescent: Individualized, similar to adults for Type 1 Diabetes, typically starting at 0.2 units/kg/day and adjusted based on glucose levels.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor glucose closely.
Moderate: Dose reduction may be required due to decreased insulin clearance and increased risk of hypoglycemia. Monitor glucose closely.
Severe: Significant dose reduction likely required. Monitor glucose closely and frequently.
Dialysis: Dose reduction likely required. Monitor glucose closely and frequently, as insulin requirements may fluctuate.

Hepatic Impairment:

Mild: No specific dose adjustment, but monitor glucose closely.
Moderate: Dose reduction may be required due to decreased gluconeogenesis and insulin clearance. 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 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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not applicable (subcutaneous injection, bioavailability is high but variable due to absorption rate)
Tmax: No pronounced peak (relatively constant concentration over 24 hours)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Approximately 0.13 L/kg
ProteinBinding: Low (approximately 6%)
CnssPenetration: Limited

Elimination:

HalfLife: Functional half-life of approximately 10-24 hours due to slow absorption from the subcutaneous depot.
Clearance: Not precisely defined for subcutaneous administration due to absorption kinetics.
ExcretionRoute: Renal (metabolites)
Unchanged: Negligible
âąī¸

Pharmacodynamics

OnsetOfAction: 1-2 hours
PeakEffect: No pronounced peak (relatively constant effect over 24 hours)
DurationOfAction: Up to 24 hours (U-100)

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 low blood sugar, follow your doctor's instructions, which may include taking glucose tablets, liquid glucose, or consuming fruit juices.

Other Possible Side Effects

Most people experience few or no side effects when taking this medication. However, some individuals may encounter the following side effects. If they bother you or persist, contact your doctor:

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

This is not an exhaustive list of potential side effects. If you have questions or concerns, consult 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 low blood sugar (hypoglycemia): sweating, shaking, dizziness, confusion, hunger, irritability, headache, blurred vision, slurred speech. Treat immediately with fast-acting sugar.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, frequent urination, fatigue, blurred vision, headache. Contact your doctor if persistent.
  • Signs of allergic reaction: rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing. Seek immediate medical attention.
📋

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 combination with all your other medications and health conditions. Never start, stop, or adjust 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.

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. Consult your doctor to discuss ways to prevent and manage low blood sugar.

Additionally, this medication may cause low blood potassium levels. If left untreated, this can result in abnormal heart rhythms, severe breathing difficulties, and potentially death. It is crucial to discuss this risk with your doctor.

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, consult your doctor to discuss the potential risks.

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.

Your blood sugar levels may be more challenging to control during periods of stress, such as illness, infection, injury, or surgery. Changes in your physical activity, exercise routine, or diet can also impact your blood sugar levels.

It is recommended that you 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. Regular blood tests will also be necessary to ensure the medication is not causing any adverse effects. Consult your doctor to discuss the best approach for managing your blood sugar levels.

Before consuming alcohol or using products that contain alcohol, consult your doctor to discuss the potential risks. Do not share your insulin product or any related devices, such as pens, cartridges, needles, or syringes, with others, as this can increase the risk of transmitting infections.

When using this medication in children, it is essential to exercise caution, as they may be more susceptible to side effects. Consult your doctor to discuss the potential risks and benefits.

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 they will need to discuss the potential benefits and risks with you.
🆘

Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (very low blood sugar)
  • Confusion
  • Seizures
  • Loss of consciousness (coma)

What to Do:

If conscious, consume fast-acting carbohydrates (e.g., glucose tablets, fruit juice, regular soda). If unconscious or unable to swallow, administer glucagon injection (if available and trained) and seek immediate emergency medical attention. Call 911 or your local emergency number. Call 1-800-222-1222 for Poison Control.

Drug Interactions

🟡

Moderate Interactions

  • Beta-blockers (may mask symptoms of hypoglycemia)
  • 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 cause hyperglycemia)
  • Sympathomimetics (may cause hyperglycemia)
  • Growth hormone (may cause hyperglycemia)
  • Danazol (may cause hyperglycemia)
  • Oral contraceptives (may cause hyperglycemia)
  • Protease inhibitors (variable effects on glucose)
  • Atypical antipsychotics (variable effects on glucose)
  • Salicylates (high doses may lower blood glucose)
  • Sulfonamide antibiotics (may lower blood glucose)
  • MAO inhibitors (may lower blood glucose)
  • ACE inhibitors (may lower blood glucose)
  • Angiotensin receptor blockers (ARBs) (may lower blood glucose)
  • Alcohol (may potentiate hypoglycemic effect)

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 (SCr, eGFR)

Rationale: To assess kidney function, as insulin clearance may be affected in renal impairment.

Timing: Prior to initiation of therapy.

Hepatic function (LFTs)

Rationale: To assess liver function, as insulin metabolism and glucose production may be affected in hepatic impairment.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Self-monitoring of Blood Glucose (SMBG)

Frequency: Daily, multiple times per day (e.g., fasting, pre-meal, post-meal, bedtime) as directed by healthcare provider.

Target: Individualized, typically 80-130 mg/dL fasting/pre-meal, <180 mg/dL 1-2 hours post-meal.

Action Threshold: Below target range (hypoglycemia) or above target range (hyperglycemia) requiring dose adjustment or intervention.

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 dose adjustment or therapy modification.

Signs and symptoms of hypoglycemia

Frequency: Continuously, patient education is key.

Target: N/A

Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger) requires immediate action (consume fast-acting carbohydrates).

Injection site inspection

Frequency: Daily, with each injection.

Target: N/A

Action Threshold: Presence of lipodystrophy, redness, swelling, or pain requires site rotation or medical evaluation.

đŸ‘ī¸

Symptom Monitoring

  • Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, slurred speech, anxiety, rapid heartbeat, weakness, seizures, unconsciousness.
  • Symptoms of hyperglycemia: increased thirst, increased urination, fatigue, blurred vision, headache, nausea, vomiting, fruity breath odor (ketoacidosis).

Special Patient Groups

🤰

Pregnancy

Insulin glargine is generally considered safe and is often the preferred treatment for diabetes in pregnancy when diet and exercise are insufficient. Insulin requirements may change throughout pregnancy. Close monitoring of blood glucose is essential.

Trimester-Specific Risks:

First Trimester: Insulin requirements may decrease. Close monitoring to avoid hypoglycemia.
Second Trimester: Insulin requirements typically increase due to increasing insulin resistance.
Third Trimester: Insulin requirements continue to increase, often peaking in the late third trimester. Close monitoring to avoid hyperglycemia and hypoglycemia.
🤱

Lactation

Insulin glargine is considered compatible with breastfeeding. Insulin is a large protein and is not excreted into breast milk in clinically significant amounts. It is not expected to cause adverse effects in a breastfed infant. Insulin requirements may be lower in breastfeeding mothers.

Infant Risk: Low risk. No adverse effects on breastfed infants are expected.
đŸ‘ļ

Pediatric Use

Insulin glargine (U-100) is approved for use in pediatric patients 6 years of age and older with Type 1 Diabetes and Type 2 Diabetes. Dosing must be individualized and carefully titrated based on blood glucose monitoring. Younger children may be more susceptible to hypoglycemia.

👴

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 may be necessary. Start with lower doses and titrate carefully.

Clinical Information

💎

Clinical Pearls

  • Insulin glargine (U-100) is a basal insulin, meaning it provides a steady, long-lasting effect to control fasting and between-meal glucose levels. It does not cover mealtime glucose excursions.
  • Administer insulin glargine once daily at the same time each day, regardless of meals. Consistency in timing is important for optimal glycemic control.
  • Never mix insulin glargine with other insulins or solutions in the same syringe or pen, as this can alter its time-action profile and lead to precipitation.
  • Patients should be educated on proper injection technique, site rotation, and storage of the pen/vial.
  • Hypoglycemia is the most common adverse effect. Patients should be aware of symptoms and how to treat them.
  • Solostar pen is a disposable prefilled pen. Patients should be instructed on how to attach a new needle for each injection and perform a safety shot (air shot) before injecting.
🔄

Alternative Therapies

  • Other long-acting insulins: Insulin detemir (Levemir), Insulin degludec (Tresiba), Insulin glargine U-300 (Toujeo)
  • Intermediate-acting insulin: NPH insulin
  • Rapid-acting insulins (for mealtime coverage): Insulin lispro, insulin aspart, insulin glulisine
  • Short-acting insulins (for mealtime coverage): Regular insulin
  • Oral antidiabetic agents (for Type 2 Diabetes): Metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists (injectable, but not insulin), TZDs, meglitinides, alpha-glucosidase inhibitors.
💰

Cost & Coverage

Average Cost: Varies widely, typically $300-$500+ per 5 x 3ml pens (U-100)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred brand or non-preferred brand, depending on formulary). Biosimilars may be Tier 1 or 2.
📚

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.