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LANTUS (INSULIN GLARGINE): PRESCRIBING INFORMATION
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 asparagine 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.
Lantus consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of Lantus (Insulin Glargine injection) contains 100 units (3.6378 mg) insulin glargine.
The 10 mL vial presentation contains the following inactive ingredients per mL: 30 mcg zinc, 20 mg glycerol 85%, 2.7 mg m-cresol, 20 mcg polysorbate 20, and water for injection.
The 3 mL cartridge presentation contains the following inactive ingredients per mL: 2.7 mg m-cresol, 30 mcg zinc, 20 mg glycerol 85%, and water for injection.
The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. Lantus insulin injections has a pH of approximately 4.
INDICATIONS AND USAGE
Lantus (Insulin Glargine) is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Important Limitations of Use:
Lantus Insulin is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin is the preferred treatment for this condition.
DOSAGE AND ADMINISTRATION
Lantus dosage and administration
DOSAGE FORMS AND STRENGTHS
Lantus insulin solution for injection 100 units per ml is available as:
10 ml Vial (1000 IU / 10 ml)
3 ml Cartridge systems for use only in OptiClik (300 IU / 3 ml)
3 mL SoloStar disposable insulin device (300 IU / 3 ml)
Lantus (Insulin Glargine) injections 100 IU / ml is contraindicated in patients with hypersensitivity to this medicine or one of its excipients.
Lantus warnings for hypoglycemia
Lantus adverse reactions
Lantus drug interactions
USE IN SPECIFIC POPULATIONS
Lantus use in specific populations
An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed.
More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular / subcutaneous glucagon or concentrated intravenous glucose. After
apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia.
Lantus clinical pharmacology
Lantus nonclinical toxicology
Lantus clinical studies
HOW SUPPLIED / STORAGE AND HANDLING
Lantus how supplied / storage and handling
Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.
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