Product Description

**Larsulin (Insulin Glargine) Summary**

**Indications**

* **Type 1 Diabetes Mellitus:** Glycemic control in adults and pediatric patients (used alongside short/rapid-acting insulin).

* **Type 2 Diabetes Mellitus:** Glycemic control in adults requiring long-acting insulin coverage.

**Mechanism & Pharmacology**

* **Class:** Long-acting human insulin analogue (recombinant DNA origin).

* **Action:** Regulates glucose metabolism by stimulating peripheral glucose uptake (primarily in skeletal muscle and fat) and inhibiting hepatic glucose production. Suppresses lipolysis and proteolysis while enhancing protein synthesis.

* **Pharmacokinetics:** Formulated for once-daily subcutaneous administration. Releases gradually to provide a relatively constant, peakless glucose-lowering effect over approximately 24 hours. Potency is comparable to human insulin.

**Dosage & Initiation Guidelines**

* **General Administration:** Administer subcutaneously once daily at any time of day, but strictly at the same time every day. Never administer intravenously or via an insulin pump (risk of severe hypoglycemia).

* **Type 1 Diabetes Initiation:** Starting dose is approximately one-third (1/3) of the total daily insulin requirement; the remainder is supplied by short-acting pre-meal insulin.

* **Type 2 Diabetes Initiation (Insulin-Naïve):** Standard starting dose is 10 Units once daily (or 0.2 Units/kg/day), adjusted based on blood glucose response.

* **Switching from Other Insulins:**

* *From Once-Daily NPH:* Start Larsulin at a 1:1 ratio (same dose as discontinued NPH).

* *From Twice-Daily NPH:* Reduce total daily dose by 20% (start Larsulin at 80% of total daily NPH dose) to minimize risk of hypoglycemia.

**Administration & Handling**

* **Preparation:**

* *Vials / Cartridges:* Rotate gently to mix uniformly. Inspect for normal appearance.

* *Purity:* Must **never** be diluted or mixed with any other insulin or solution in the same syringe.

* **Site Rotation:** Inject into areas with looser skin (e.g., abdomen, thighs, upper arms, or buttocks). Rotate sites by at least 1 cm from previous injection sites to prevent lipodystrophy or tissue damage.

* **Technique:** Cleanse site with alcohol, inject at a 45° angle, withdraw needle, and apply gentle pressure. **Do not rub** the injection site.

**Drug Interactions**

* **Increased Hypoglycemic Risk (Lowers Blood Glucose / Reduces Insulin Needs):** Oral antidiabetics, ACE inhibitors, fibrates, fluoxetine, MAO inhibitors, salicylates, sulfonamide antibiotics.

* **Decreased Hypoglycemic Effect (Raises Blood Glucose / Increases Insulin Needs):** Thiazide diuretics, corticosteroids, thyroid hormones, growth hormone, sympathomimetics.

* **Variable Effects:** Beta-blockers, clonidine, alcohol, and lithium can either enhance or diminish insulin's glucose-lowering activity. Beta-blockers may also mask warning signs of hypoglycemia.

**Contraindications**

* Known hypersensitivity to Insulin Glargine or any excipients.

* Episodes of hypoglycemia.

**Side Effects & Safety Precautions**

* **Adverse Effects:** Hypoglycemia, injection site reactions (redness, pain, swelling), lipodystrophy (localized fat hypertrophy/atrophy), pruritus, and allergic skin rash.

* **Renal / Hepatic Impairment:** Clearance may be reduced; dose reductions and closer blood glucose monitoring may be required.

* **Overdose Management:** Mild hypoglycemia responds to oral carbohydrates. Severe hypoglycemia requires intravenous glucose or intramuscular/subcutaneous glucagon injection.

**Pregnancy & Lactation**

* **Pregnancy:** Pregnancy Category C. Use only if clinical benefit clearly outweighs potential risk to the fetus.

* **Lactation:** Use with caution in nursing mothers; insulin dosage and meal plans may require adjustments during lactation.

**Storage Conditions**

* **Unopened/Unused:** Store refrigerated between 2°C and 8°C. **Do not freeze.** Protect from direct light.