Sanofi-Aventis U.S., based in Bridgewater, NJ, and employing 15,000 people across the country, is part of a leading global pharmaceutical company that discovers, develops, and produces markets innovative therapies that enhance people’s lives. Their extensive research and development efforts are focused on health care challenges in cardiology, oncology and internal medicine, as well as metabolic diseases, central nervous system disorders and vaccines. LANTUS is one of the major key products of Sanofi-Aventis that is used for treating Diabetes.
LANTUS is a long- acting human insulin analog indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. LANTUS (insulin glargine [rDNA origin] injection) is a solution for subcutaneous injection. * LANTUS (insulin glargine [recombinant DNA origin]) is long-acting insulin. Because LANTUS is made by recombinant DNA technology (rDNA) and is chemically different from the insulin made by the human body, it is called insulin analog. LANTUS is used to treat patients with diabetes for the control of high blood sugar. It is used once a day to lower blood sugar. * LANTUS is a clear, colorless, sterile solution for injection under the skin (subcutaneously). * The active ingredient in LANTUS is insulin glargine. The concentration of insulin glargine is 100 units per milliliter (mL), or U-100. LANTUS also contains zinc, metacresol, glycerol, polysorbate 20 and water for injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The primary activity of insulin, including insulin glargine, 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. Insulin glargine is a human insulin analog that has been designed to have low aqueous solubility at neutral pH. At pH 4, as in the LANTUS injection solution, insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of micro precipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows once-daily dosing as basal insulin. LANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagines at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21A-Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. Insulin glargine has the following structural formula:
The most common side effect of insulin, including LANTUS®, is hypoglycemia, which may be serious. Other possible side effects may include injection site reactions, including changes in fat tissue at the injection site reactions, including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening. You should not use LANTUS® if you are allergic to insulin. LANTUS® is long-acting insulin you inject just once a day, at the same time each day. You must test your blood sugar levels while using an...
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