LANTUS- insulin glargine injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

INSULIN GLARGINE (UNII: 2ZM8CX04RZ) (INSULIN GLARGINE - UNII:2ZM8CX04RZ)

Dostupné z:

A-S Medication Solutions

INN (Medzinárodný Name):

INSULIN GLARGINE

Zloženie:

INSULIN GLARGINE 100 [iU] in 1 mL

Spôsob podávania:

SUBCUTANEOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

Product: 50090-0876 NDC: 50090-0876-0 10 mL in a VIAL, GLASS

Stav Autorizácia:

Biologic Licensing Application

Súhrn charakteristických

LANTUS- INSULIN GLARGINE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
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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. (