Insuln Glargne Solstr U300 PN 1.5ml

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.

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
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ 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 immediately. If you have low blood sugar, follow your doctor's instructions, which may include taking glucose tablets, liquid glucose, or consuming certain 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

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 list is not exhaustive, and you may experience other 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.

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 with all your other medications and health conditions. Do not initiate, discontinue, or modify the dose of any medication without first consulting your doctor.

Important Warnings and Cautions

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

Correct Use and Dosage

This brand of insulin has a concentrated formula, containing 3 times as much insulin as other brands. It is available in a prefilled pen, which must be used to administer the correct dose. Do not attempt to remove insulin from the pen using a syringe, as this can lead to severe side effects or life-threatening hypoglycemia (low blood sugar). To ensure safe use, consult with your doctor to confirm the correct dosage.

Risks and Side Effects

Hypoglycemia (Low Blood Sugar): This medication can cause hypoglycemia, which may lead to seizures, loss of consciousness, permanent brain damage, or even death if left untreated. Discuss your risk with your doctor.
Hypokalemia (Low Blood Potassium): This medication can also cause hypokalemia, which may result in abnormal heart rhythms, severe breathing difficulties, or death if not treated promptly. Consult with your doctor if you have concerns.
Increased Risk of Heart Failure: When used with certain diabetes medications, such as pioglitazone or rosiglitazone, this insulin may increase the risk of heart failure or worsen existing heart failure. If you are taking one of these medications, discuss this risk with your doctor.

Precautions and Safety Measures

Avoid Driving and Other Hazardous Activities: Until you understand how this medication affects you, avoid driving and other tasks that require alertness.
Verify Insulin Product and Dosage: Ensure you have the correct insulin product and understand how to measure and prepare your dose. If you have questions, consult your doctor or pharmacist.
Stress and Blood Sugar Control: During times of stress, such as illness, injury, or surgery, your blood sugar levels may be more challenging to control. Changes in physical activity, exercise, or diet can also impact blood sugar levels.
Medical Alert Identification: Wear a medical alert ID to inform others of your condition in case of an emergency.
Blood Sugar Monitoring: Check your blood sugar levels as directed by your doctor.
Regular Blood Work: Have regular blood tests as recommended by your doctor to monitor your condition.

Special Considerations

Alcohol Consumption: Consult with your doctor before consuming alcohol or using products containing alcohol.
Sharing Insulin Products: Do not share your insulin product, including pens, cartridge devices, needles, or syringes, as this can transmit infections.
Use in Children and Older Adults: This medication should be used with caution in children, as they may experience more side effects. Older adults (65 and older) should also use this medication with caution, as they may be more susceptible to side effects.
* Pregnancy and Breastfeeding: If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.

• Beta-blockers (may mask symptoms of hypoglycemia, prolong recovery from hypoglycemia)
• Thiazolidinediones (TZDs) - e.g., pioglitazone, rosiglitazone (increased risk of fluid retention and heart failure when used with insulin)
• Corticosteroids (may increase blood glucose, requiring higher insulin doses)
• Diuretics (especially thiazide and loop diuretics, may cause hyperglycemia)
• Sympathomimetics (e.g., albuterol, epinephrine, may increase blood glucose)
• Atypical antipsychotics (e.g., olanzapine, clozapine, may cause hyperglycemia)

• 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 at high doses)
• Sulfonamide antibiotics (may enhance insulin's glucose-lowering effect)
• Monoamine Oxidase Inhibitors (MAOIs) (may enhance insulin's glucose-lowering effect)
• Alcohol (can potentiate or diminish insulin's effect, increasing risk of hypoglycemia or hyperglycemia)

• Not specifically categorized as minor for insulin, as most interactions affect glucose levels significantly.

• Symptoms of hypoglycemia: sweating, dizziness, lightheadedness, tremor, palpitations, anxiety, hunger, confusion, irritability, headache, blurred vision, slurred speech, weakness, seizures, unconsciousness.
• Symptoms of hyperglycemia: increased thirst, increased urination, dry mouth, fatigue, blurred vision, nausea, vomiting, abdominal pain (especially in DKA).
• Symptoms of fluid retention/heart failure (if co-administered with TZDs): unusual weight gain, swelling in ankles/feet, shortness of breath.

Insulin glargine is generally considered safe and effective for use during pregnancy. Available data from published observational studies and postmarketing reports have not reported an association with major birth defects, miscarriage, or adverse maternal or fetal outcomes. Careful monitoring of blood glucose is essential, and insulin requirements may change throughout pregnancy.

Insulin glargine is compatible with breastfeeding. Insulin is a normal component of human milk and is not orally absorbed by the infant. No adverse effects on the breastfed infant are expected. Maternal insulin requirements may decrease during lactation.

Approved for children 6 years and older with Type 1 or Type 2 diabetes. Dosing must be individualized and carefully titrated based on blood glucose monitoring. Increased risk of hypoglycemia, especially in younger children who may not recognize symptoms.

No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to the hypoglycemic effects of insulin and may have impaired renal or hepatic function, which can affect insulin requirements. Close glucose monitoring and careful dose titration are recommended.

• Insulin Glargine U-300 (Toujeo) has a more prolonged and stable glucose-lowering effect (up to 36 hours) compared to U-100 glargine (Lantus/Basaglar), which lasts up to 24 hours. This can provide more consistent basal coverage.
• Patients transitioning from U-100 glargine to U-300 glargine typically require a 10-15% higher dose of U-300 to achieve similar glycemic control due to differences in absorption characteristics.
• U-300 glargine is available in Solostar (1.5 mL) and Max Solostar (3 mL) pens. Both deliver U-300 insulin, but the Max Solostar pen delivers a higher maximum single dose (160 units vs 80 units for Solostar).
• Always instruct patients to dial the dose in units, not volume. The pen automatically converts the dose to the correct volume of U-300 insulin.
• Emphasize the importance of injecting at the same time each day to maintain consistent basal insulin levels.
• Educate patients on proper injection technique and rotation of injection sites to prevent lipohypertrophy, which can impair insulin absorption.
• Stress the importance of never sharing pens or needles due to infection risk.

• Other classes of antidiabetic agents (e.g., Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, Thiazolidinediones, Meglitinides, Alpha-glucosidase inhibitors, Amylin analogs)
• Other insulin regimens (e.g., multiple daily injections of rapid-acting insulin with U-100 basal insulin, insulin pumps)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.