Semglee

Semglee is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Insulin Glargine is a sterile solution, use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analogue that is a long-acting (up to 24-hour duration of action), parenteral blood glucose lowering agent. Insulin Glargine is produced by recombinant DNA technology. Primary function of insulin glargine is regulation of glucose metabolism. Insulin and its analogues lower blood glucose by stimulation peripheral glucose uptake, primarily by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhances protein synthesis.

Insulin Glargine exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing. Potency of insulin glargine is approximately the same as human insulin. Insulin Glargine is recommended for once daily subcutaneous administration & may be administered at any time during the day. However, once started should be administered at the same time every day. The dose of Insulin Glargine must be individualized based on clinical response. Blood glucose monitoring is essential in all patients with diabetes. In patients with type 1 diabetes, Insulin Glargine must be used in regimens with short-acting insulin. Insulin Glargine is not recommended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. Initiation of Insulin Glargine therapy:

The recommended starting dose of Insulin Glargine in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.

The recommended starting dose of Insulin Glargine in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient's needs.

Converting to Insulin Glargine from other insulin therapies: If changing from a treatment regimen with an intermediate-or long-acting insulin to a regimen with Insulin Glargine , the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.

If transferring patients from once-daily NPH insulin to once-daily Insulin Glargine , the recommended initial Insulin Glargine dose is the same as the dose of NPH that is being discontinued.

If transferring patients from twice-daily NPH insulin to once-daily Insulin Glargine , the recommended initial Insulin Glargine dose is 80% of the total NPH dose that is being discontinued.

A number of drugs affect glucose metabolism and may require dose adjustment. The following substances may reduce the Semglee as well as Semglee requirements : Oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamide antibiotics. The following substances may increase the Semglee as well as Semglee requirements : Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.

Insulin glargine is contraindicated in patients with hypersensitivity to insulin glargine or any of its excipients.

Side effects of Semglee are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.

Pregnancy category C. Insulin glargine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether insulin glargine is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when Insulin glargine is administered to a nursing woman. Lactating women may require adjustments in insulin dose & diet.

Dose adjustment and monitoring : Blood glucose should be monitored in all patients treated with insulin. Semglee regimens should be modified cautiously and only under medical supervision. Administration : Semglee must not be diluted or mixed with any other insulin or solution. It should not be administered subcutaneously via an insulin pump or intravenously because severe hypoglycemia can occur. Renal or hepatic impairment : Reduction in the Semgleedose may require in these cases.

Semglee overdose may result in hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Severe hypoglycemia may be treated with parenteral glucose or injections of glucagon. Adjustments in drug dosage, meal patterns, or exercise may be needed.

Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.