Insulin Glargine Injection

Drug therapy classification: Diabetes treatment. Long-acting insulin and its analogs. ATC code: A10AE. Glargine insulin is a human insulin analog with low solubility in neutral pH liquid. It is completely dissolved in the acidic pH (pH=4) injection of this product. After injection into the subcutaneous tissue, the fine sediment formed by the neutralization of the acidic solution can continuously release a small amount of glargine insulin, thereby producing a predictable, long-acting, stable, and non-peak blood drug concentration/time characteristic. Insulin receptor binding: In terms of the kinetics of insulin binding to its receptor, glargine insulin is very similar to human insulin. Therefore, it can be considered that it is the same as the action of insulin mediated through the insulin receptor. The main function of insulin, including glargine insulin, is to regulate glucose metabolism. Insulin and its analogs lower blood sugar by promoting the uptake of glucose by peripheral tissues such as skeletal muscle and fat and inhibiting the production of glucose in the liver. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis, and promotes protein synthesis. Clinical pharmacology studies have shown that the potency of equal doses of glargine insulin and human insulin injected intravenously is the same. Like all insulins, the course of action of insulin glargine may be affected by physical activity and other factors. Euglycemic clamp studies in healthy volunteers and patients with type 1 diabetes have shown that the onset of action of subcutaneous insulin glargine is slower than that of neutral protamine human insulin (NPH), but the action characteristics of insulin glargine are smooth, peak-free, and long-lasting. The longer duration of action of insulin glargine is directly related to its slower absorption rate, which supports a once-daily dosing regimen. The course of action of insulin and insulin analogs such as insulin glargine can vary greatly between individuals and within the same body. Clinical study results in healthy volunteers and patients with type 1 diabetes have shown that the symptoms of hypoglycemia or the response to counterregulatory hormones are similar when insulin glargine or human insulin is injected intravenously.

The main ingredient of this product is insulin glargine. Excipients: zinc chloride, M-cresol, glycerol, hydrochloric acid, sodium hydroxide, water for injection.

3ml:300 units (refill/prefilled)

Treating diabetes

This product is an insulin analog with a long-acting effect. It should be injected once a day in the evening. The dose adjustment range of the OptiSet injection device is 2IU, and the maximum single injection dose is 40IU. The dosage of insulin glargine should be different for each patient. Patients with type 2 diabetes can also use insulin glargine and oral hypoglycemic drugs together. When changing from other insulin treatments to insulin glargine treatment, it may be necessary to change the dose of basal insulin and adjust other concurrent diabetes medications (the dose and time of injection of regular insulin or rapid-acting insulin analogs, or the dose of oral hypoglycemic drugs). In order to reduce the risk of hypoglycemia at night and in the early morning, when patients who originally used NPH insulin twice a day are changed to a treatment regimen of insulin glargine once a day, their daily basal insulin dosage should be reduced by 20-30% in the first week of treatment. During the first week of reducing the basal insulin dosage, some patients may need to compensate by adding insulin during meals, and the subsequent treatment regimen should be different for each patient. Patients who use high doses of insulin because of anti-human insulin antibodies may have an increased insulin response when switched to insulin glargine, as with other insulin analogs. Metabolic changes should be closely monitored during the switch and the first few weeks of starting insulin glargine. As metabolic control improves and insulin sensitivity increases, further adjustments to the dosage regimen may be required. Dose adjustments may also be required if the patient's weight or lifestyle changes, or if they are prone to hypoglycemia or hyperglycemia (see \Precautions\). Usage: Insulin glargine should be administered subcutaneously. Never inject insulin glargine intravenously. The long-acting effect of insulin glargine is related to its injection into the subcutaneous tissue. If the dose of the drug that is usually injected subcutaneously is injected intravenously, severe hypoglycemia may occur. No clinical difference in serum insulin or glucose levels was observed after subcutaneous injection in the abdomen, deltoid muscle, or thigh. Within a given injection area, the site of each injection must be rotated. Due to limited experience, the safety and effectiveness of insulin glargine in the following patient groups has yet to be evaluated: children, patients with impaired liver function or moderate to severe renal impairment (see \Precautions\).

Hypoglycemic reactions: In general, hypoglycemia is the most common adverse reaction to insulin therapy. If the dose of insulin injected is higher than the patient's insulin requirement, hypoglycemic reactions may occur. Severe hypoglycemia, especially recurrent hypoglycemia, may cause damage to the nervous system. Prolonged or severe hypoglycemic episodes may be life-threatening. In many patients, signs of adrenergic counterregulation appear before the symptoms and signs of neurogenic hypoglycemia. In general, the greater and faster the drop in blood sugar, the more obvious the signs and symptoms of adrenergic counterregulation. Eyes: When blood sugar control is significantly changed, transient visual impairment may occur due to swelling of the lens and temporary changes in the refractive index. Long-term improvements in blood sugar control reduce the risk of progression of diabetic retinopathy. However, diabetic retinopathy may temporarily worsen due to rapid improvements in blood sugar control caused by intensive insulin therapy. Patients with proliferative retinopathy, especially those who have not yet been treated with laser coagulation, may develop transient amaurosis during severe hypoglycemic episodes. Lipodystrophy: As with other insulin therapies, lipodystrophy may occur at the injection site, delaying local insulin absorption. In clinical studies of therapies such as insulin glargine, it was observed that 1-2% of patients had thickening of adipose tissue, while adipose tissue atrophy was rare. Frequent rotation of injection sites within a certain injection area may help reduce or prevent the above changes. Injection site and allergic reactions: In clinical studies of treatment with insulin glargine, 3-4% of patients were observed to have reactions at the injection site. These reactions include redness, pain, itching, urticaria, swelling or inflammation. Most mild reactions at the injection site of insulin usually recover within a few days or weeks. Rapid allergic reactions to insulin are rare. Rapid allergic reactions to insulin (including insulin glargine) or excipients include systemic skin reactions, angioedema, bronchospasm, hypotension and shock, and may even be life-threatening. Other reactions: Insulin treatment may induce the production of insulin antibodies. In clinical studies, the frequency of antibodies that cross-react with human insulin and insulin glargine was the same as that in the neutral low-protein human insulin (NPH) and insulin glargine treatment groups. In rare cases, due to the presence of the above insulin antibodies, the insulin dose should be adjusted to correct the trend of high or low blood sugar. Rare insulin-induced sodium retention and edema, especially with intensive insulin therapy to improve the previous poor metabolic control, should be paid attention to.

Patients who are allergic to insulin glargine or any of its excipients are contraindicated in taking this medicine.

Precautions for children: Due to limited experience, the safety and effectiveness of insulin glargine in pediatric patients have yet to be evaluated. Precautions for pregnancy and lactation: To date, no accurate epidemiological data on the use of insulin glargine during pregnancy have been obtained. Animal studies have not shown that insulin glargine has a direct damaging effect on pregnancy, embryonic and fetal development, delivery, or postpartum development. It is crucial for patients with pre-existing diabetes or gestational diabetes to maintain good metabolic control throughout pregnancy. The need for insulin may decrease in the first 3 months, while the second and third trimesters usually increase. The need for insulin decreases rapidly after delivery (with an increased risk of hypoglycemia). Glucose control must be carefully monitored. Breastfeeding women may need to adjust insulin doses and diet. Precautions for the elderly: Due to progressive renal decline, the need for insulin in the elderly may gradually decrease.

Many substances affect glucose metabolism, and the dose of insulin glargine may need to be adjusted as appropriate. Substances that may promote blood sugar reduction and increase the incidence of hypoglycemia include oral hypoglycemic drugs, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, oxoxifylline, propoxyphene, salicylic acid, and sulfonamide antibiotics. Substances that may weaken the glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progesterone, phenothiazine derivatives, growth hormone, sympathomimetics (such as epinephrine, salbutamol, terbutaline), and thyroid hormones. Beta-blockers, clonidine, lithium salts, or alcohol may enhance or weaken the glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, sometimes with secondary hyperglycemia. In addition, signs of adrenergic counterregulation may be diminished or absent following use of drugs that affect the sympathetic nervous system, such as beta-blockers, clonidine, guanethidine, and reserpines.

Store at 2-8°C. Keep in outer packaging and do not freeze. Do not allow the injection device to come into contact with ice or freezer. Once used, store at a temperature not exceeding 25°C. Do not store the injection device in the refrigerator while it is in use.

3 ml: 300 units/refill/prefilled (SoloStar)

36 months, opened injection device: 4 weeks.