Insulin Glargine-Aldy (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: SUBCUTANEOUS.
Brand Names
- LANGLARA
Related Conditions
Indications and Usage
LANGLARA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Contraindications
LANGLARA is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.3)] In patients with hypersensitivity to any insulin glargine product or any of the inactive ingredients of LANGLARA [see Warnings and Precautions (5.5)]
Adverse Reactions
The following adverse reactions are discussed elsewhere: Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions (5.2)] Hypoglycemia [see Warnings and Precautions (5.3)] Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4)] Hypersensitivity Reactions [see Warnings and Precautions (5.5)] Hypokalemia [see Warnings and Precautions (5.6)]
Drug Interactions
Table 8 includes clinically significant drug interactions with LANGLARA. Table 8: Clinically Significant Drug Interactions with LANGLARA Drugs that May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when LANGLARA is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of LANGLARA Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when LANGLARA is coadministered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of LANGLARA Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dosage adjustment and increased frequency of glucose monitoring may be required when LANGLARA is coadministered with these drugs. Drugs that May Blunt Signs and Symptoms of Hypoglycemia Drugs: Beta-blockers, clonidine, guanethidine, and reserpine. Intervention: Increased frequency of glucose monitoring may be required when LANGLARA is coadministered with these drugs.
Mechanism of Action
The primary activity of insulin, including insulin glargine products, is regulation of glucose metabolism. Insulin and its analogs lower 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.
Overdosage
Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)] . Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Lowering the insulin dosage, and adjustments in meal patterns or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with glucagon for emergency use or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.