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Why Can't Glargine Insulin Be Mixed

Insulin Glargine (rdna Origin) Injection

Insulin Glargine (rdna Origin) Injection

Insulin glargine is used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). It is also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need insulin to control their diabetes. In people with type 1 diabetes, insulin glargine must be used with another type of insulin (a short-acting insulin). In people with type 2 diabetes, insulin glargine also may be used with another type of insulin or with oral medication(s) for diabetes. Insulin glargine is a long-acting, manmade version of human insulin. Insulin glargine works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar. Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes. Insulin glargine comes as a solution (liquid) to inject subcutaneously (under the Continue reading >>

Page 1 Of 14 Nda 21-081 Draft Package Insert (sponsor Revision #5) Date Of Submission: April 20, 2000

Page 1 Of 14 Nda 21-081 Draft Package Insert (sponsor Revision #5) Date Of Submission: April 20, 2000

Draft1 Prescribing Information as of April 20002 LANTUS®3 (insulin glargine [rDNA origin] injection)4 LANTUS® must not be diluted or mixed with any other insulin or solution.5 DESCRIPTION6 LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use7 as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-8 hour duration of action), parenteral blood-glucose-lowering agent (see CLINICAL9 PHARMACOLOGY). LANTUS is produced by recombinant DNA technology utilizing a non-10 pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine11 differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine12 and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A-Gly-30Ba-L-13 Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular14 weight of 6063. It has the following structural formula:15 Ile Val Glu Gln Cys Cys Thr Ser Ile Cys Ser Leu Tyr Gln Leu Glu Asn Tyr Tyr 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Cys Gly Leu 19 20 21 Leu Val Cys GlySer LeuAlaGluVal Glu HisGlyCysLeu Arg HisGlnAsnValPhe Phe Phe GlyTyrArg Lys Pro ThrThrArg B - chain 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 2223242526272829303132 S S S S S S Gly A - chain 16 LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS17 (insulin glargine injection) contains 100 IU (3.6378 mg) insulin glargine, 30 mcg zinc, 2.7 mg m-18 cresol, 20 mg glycerol 85%, and water for injection. The pH is adjusted by addition of aqueous19 solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4.20 Page 2 of 14 NDA 21-081 Continue reading >>

Insulin Analogs

Insulin Analogs

Insulin analogs mimic the body’s natural pattern of insulin release. Once absorbed, they act on cells like human insulin, but are absorbed from fatty tissue more predictably. An analog refers to something that is “analogous” or similar to something else. Therefore, “insulin” analogs are analogs that have been designed to mimic the body’s natural pattern of insulin release. These synthetic-made insulins are called analogs of human insulin. However, they have minor structural or amino acid changes that give them special desirable characteristics when injected under the skin. Once absorbed, they act on cells like human insulin, but are absorbed from fatty tissue more predictably. In this section, you will find information about: Rapid-acting injected insulin analog The fastest working insulins are referred to as rapid-acting insulin. They include: These insulin analogs enter the bloodstream within minutes, so it is important to inject them within 5 to 10 minutes of eating. They have a peak action period of 60-120 minutes, and fade completely after about four hours. Higher doses may last slightly longer, but will last no more than five or six hours. Rapid acting insulin analogs are ideal for bolus insulin replacement. They are given at mealtimes and for high blood sugar correction. Rapid-acting insulins are used in insulin pumps, also known as continuous subcutaneous insulin infusion (CSII) devices. When delivered through a CSII pump, the rapid-acting insulins provide the basal insulin replacement, as well as the mealtime and high blood sugar correction insulin replacement. The insulins that work for the longest period of time are referred to as long-acting insulin. They provide relatively constant insulin levels that plateau for many hours after injection. Some Continue reading >>

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