국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
INSULIN GLARGINE (UNII: 2ZM8CX04RZ) (INSULIN GLARGINE - UNII:2ZM8CX04RZ)
A-S Medication Solutions
INSULIN GLARGINE
INSULIN GLARGINE 100 [iU] in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis. LANTUS is contraindicated: - During episodes of hypoglycemia [see Warnings and Precautions (5.3)] - In patients with hypersensitivity to insulin glargine or any of the excipients in LANTUS [see Warnings and Precautions (5.5)] Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. Overall, the effects of insulin glargine did not generally differ from those observed with regular huma
Product: 50090-0876 NDC: 50090-0876-0 10 mL in a VIAL, GLASS
Biologic Licensing Application
LANTUS- INSULIN GLARGINE INJECTION, SOLUTION A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LANTUS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANTUS. LANTUS (INSULIN GLARGINE) INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. (1) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. (1) DOSAGE AND ADMINISTRATION Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. (2.1, 2.2, 2.3, 2.4) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. (2.1) Do not dilute or mix with any other insulin or solution. (2.1) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. (2.1) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes and how to change to LANTUS from other insulins (2.3, 2.4) Closely monitor glucose when switching to LANTUS and during initial weeks thereafter. (2.4) DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100) available as: 10 mL multiple-dose vial (3) 3 mL single-patient-use SoloStar prefilled pen (3) CONTRAINDICATIONS During episodes of hypoglycemia (4) Hypersensitivity to insulin glargine or any of the excipients in LANTUS (4) WARNINGS AND PRECAUTIONS _Never share_ a LANTUS SoloStar prefilled pen, insulin syringe, or needle between patients, even if the needle is changed. (5.1) _Hyperglycemia or hypoglycemia with changes in insulin regimen_: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 전체 문서 읽기