Insulin Glargine Solostar

Insulin Glargine is a long-acting, basal insulin analog used to improve glycemic control in adults and pediatric patients with diabetes mellitus. It provides a steady level of insulin for approximately 24 hours.

Dosage of Insulin Glargine must be highly individualized based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goals.

• Type 1 Diabetes: Insulin Glargine is typically used as the basal component of a multidose injection regimen. For insulin-naive patients, the starting dose is usually approximately one-third to one-half of the total daily insulin requirement. The remainder of the daily dose should be administered as a short-acting, pre-meal insulin.
• Type 2 Diabetes: For patients not currently on insulin, a common starting dose is 0.2 units/kg or 10 units once daily. The dose is then titrated (adjusted) by 2 units every few days based on fasting plasma glucose levels until the target range is reached.
• Switching from other insulins: When switching from once-daily NPH to Insulin Glargine, the initial dose is usually the same. When switching from twice-daily NPH to once-daily Insulin Glargine, the initial dose is often reduced by 20% to avoid hypoglycemia.

Insulin Glargine is approved for use in pediatric patients with Type 1 diabetes.

• Age 2 to 17 years (U-100): Dosing is individualized similarly to adults. Clinical trials have shown that the safety and efficacy profiles in children are comparable to those in adults.
• Type 2 Diabetes in Children: While primarily studied in Type 1, healthcare providers may prescribe it for Type 2 in adolescents if oral agents are insufficient, following adult titration guidelines modified for weight.

Renal Impairment

Patients with kidney disease may require lower doses of Insulin Glargine. The kidneys play a role in insulin clearance; therefore, as renal function declines, insulin may stay in the system longer, increasing the risk of hypoglycemia. Frequent glucose monitoring is essential.

Hepatic Impairment

In patients with liver disease, insulin requirements may be reduced because the liver's capacity for gluconeogenesis and insulin metabolism is diminished. Dose adjustments should be made conservatively under medical supervision.

Elderly Patients

In the elderly (65 years and older), the initial dosing, increments, and maintenance dosages should be conservative. This population is at a higher risk for unrecognized hypoglycemia due to potential age-related declines in renal function and cognitive awareness.

1. 1Timing: Administer subcutaneously once daily at the same time every day. It does not matter what time of day is chosen, as long as it is consistent.
2. 2Injection Sites: Inject into the abdominal area, thigh, or deltoid (upper arm). Rotate injection sites within the same region to reduce the risk of lipodystrophy (thickening or pitting of the skin).
3. 3Preparation: The solution should be clear and colorless. Do not use if it is cloudy, colored, or contains particles.
4. 4Mixing: NEVER mix Insulin Glargine in the same syringe with any other insulin or solution. Mixing can change its absorption profile and lead to unpredictable blood sugar control.
5. 5Storage: Unopened vials and pens should be stored in the refrigerator (36°F–46°F). Once in use, vials and pens can typically be kept at room temperature for up to 28 days (refer to specific brand labeling, as some U-300 pens last up to 56 days).

If a dose is missed, take it as soon as you remember. However, if it is almost time for the next scheduled dose, skip the missed dose and return to the regular schedule. Never inject a double dose to make up for a missed one, as this significantly increases the risk of severe hypoglycemia.

An overdose of Insulin Glargine can lead to severe, life-threatening hypoglycemia.

• Signs: Extreme hunger, dizziness, confusion, tremors, sweating, palpitations, blurred vision, and seizure.
• Emergency Measures: If the patient is conscious, administer fast-acting carbohydrates (glucose tabs, juice, regular soda). If the patient is unconscious, glucagon should be administered by a trained caregiver, and emergency medical services (911) must be called immediately.

> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.

• Hypoglycemia (Low Blood Sugar): This is the most frequent side effect of all insulin therapies, including Insulin Glargine. It occurs when blood glucose levels drop below the target range (typically <70 mg/dL). Patients may feel shaky, sweaty, anxious, or irritable. It often happens if a meal is skipped, during intense exercise, or if the dose is too high.
• Injection Site Reactions: Redness, swelling, itching, or pain at the site of injection. These are usually transient and resolve within a few days or weeks of continued use.
• Weight Gain: As insulin improves glycemic control and prevents glucose from being excreted in the urine, the body retains more calories, which can lead to weight gain. This is a common pharmacological effect of insulin therapy.

Insulin Glargine is a potent medication that requires careful management. The most critical safety point is the prevention and recognition of hypoglycemia. Patients must be educated on the symptoms of low blood sugar and always carry a source of fast-acting carbohydrate. Furthermore, Insulin Glargine should never be used during episodes of hypoglycemia or in patients with a known hypersensitivity to the drug or its components.

No FDA black box warnings for Insulin Glargine.

• Never Share Pens or Syringes: Insulin Glargine pre-filled pens must never be shared between patients, even if the needle is changed. Sharing poses a critical risk for the transmission of bloodborne pathogens, including Hepatitis and HIV.
• Hypoglycemia Risk

There are no specific drugs that are absolutely contraindicated with Insulin Glargine in the sense of a 'never-use' chemical reaction, but it must NEVER be mixed in the same syringe with any other insulin or injectable medication. Mixing alters the pH-dependent absorption of Glargine, rendering its long-acting properties unpredictable and potentially causing dangerous fluctuations in blood sugar.

• Thiazolidinediones (TZDs): Drugs like pioglitazone can cause dose-related fluid retention when used with insulin. This increases the risk of congestive heart failure. Patients should be monitored for sudden weight gain, edema, and shortness of breath.
• Pramlintide: When starting this amylin analog, the dose of Insulin Glargine may need to be reduced by 50% to prevent severe hypoglycemia.

1. 1Hypersensitivity: Insulin Glargine is strictly contraindicated in patients who have had a severe allergic reaction (e.g., anaphylaxis) to Insulin Glargine or any of its inactive ingredients (such as zinc, m-cresol, or glycerol). A severe reaction can be life-threatening and requires immediate medical intervention.
2. 2Episodes of Hypoglycemia: Insulin Glargine must never be administered during an active episode of hypoglycemia. Doing so will further lower blood sugar levels, potentially leading to coma, seizures, or death.

• Hypokalemia: Patients with untreated low potassium levels should be stabilized before starting or increasing the dose of Insulin Glargine, as insulin can further lower potassium levels.

Insulin Glargine is widely used in pregnancy. According to the FDA-approved labeling and various clinical registries, data from randomized controlled trials and observational studies have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Maintaining optimal glycemic control is critical during pregnancy, as poorly controlled diabetes increases the risk of macrosomia (large baby), neonatal hypoglycemia, and preeclampsia. Insulin Glargine is often preferred over some other analogs due to its long history of use and documented safety profile in pregnant women.

Insulin Glargine is excreted in human milk, but it is not expected to cause adverse effects in the nursing infant. Insulin is a large protein molecule that is mostly degraded in the infant's digestive tract if swallowed. Breastfeeding mothers may require adjustments in their insulin dose and caloric intake, as lactation significantly increases energy expenditure and can lower maternal blood sugar levels.

Insulin Glargine (U-100) is approved for use in children aged 2 years and older with Type 1 diabetes. Its use in children under 2 years of age or in children with Type 2 diabetes has not been extensively studied in clinical trials, although it is often used off-label in the latter group. Growth, pubertal development, and lifestyle changes in children require frequent dose adjustments. Healthcare providers must ensure that caregivers are thoroughly trained in pediatric-specific hypoglycemia management.

Insulin Glargine is a human insulin analog produced by recombinant DNA technology using Escherichia coli. The primary activity of insulin, including insulin glargine, is the regulation of glucose metabolism. It binds to insulin receptors on muscle and fat cells, facilitating glucose uptake, and simultaneously inhibits glucose output from the liver. Glargine is unique because of two specific modifications to the human insulin molecule: the substitution of the amino acid glycine for asparagine at position A21 and the addition of two arginines to the C-terminus of the B-chain. These changes shift the isoelectric point from a pH of 5.4 to 6.7, making the molecule more soluble at an acidic pH and less soluble at the neutral pH of the subcutaneous tissue.

After subcutaneous injection, Insulin Glargine acts over a period of approximately 24 hours. Its pharmacodynamic profile is characterized by a 'peakless' curve, which provides a more stable and predictable glucose-lowering effect compared to NPH insulin. This stability reduces glycemic variability, which is a key factor in preventing long-term diabetic complications. The duration of action is dose-dependent but generally lasts 20 to 24 hours for U-100 and up to 36 hours for U-300.