LANTUS- insulin glargine injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

REMEDYREPACK INC.

관리 경로:

SUBCUTANEOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 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 LANTUS or one of its excipients [see Warnings and Precautions (5.5)]. There are no well-controlled clinical studies of the use of LANTUS in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or

제품 요약:

LANTUS (insulin glargine injection) is supplied as a clear solution containing 100 units per mL (U-100) of insulin glargine and is available in: The LANTUS SoloStar prefilled pen dials in 1-unit increments. Needles are not included in the packs. BD Ultra-Fine™ needles 1 to be used in conjunction with SoloStar are sold separately and are manufactured by BD. LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen. Protect LANTUS from direct heat and light. Storage conditions are summarized in the following table.

승인 상태:

New Drug Application

제품 특성 요약

LANTUS- INSULIN GLARGINE INJECTION, SOLUTION
REMEDYREPACK INC.
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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 INJECTION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Dosage and Administration ( 2.1)
11/2018
INDICATIONS AND USAGE
LANTUS is a long-acting human insulin analog indicated to improve
glycemic control in adults and pediatric patients with
type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
( 1)
Limitations of Use
Not recommended for treating diabetic ketoacidosis. ( 1)
DOSAGE AND ADMINISTRATION
Individualize dosage based on metabolic needs, blood glucose
monitoring, glycemic control, type of diabetes prior
insulin use. ( 2.1, 2.3, 2.4)
Administer subcutaneously 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 the risk of lipodystrophy. ( 2.2)
Closely monitor glucose when changing to LANTUS and during initial
weeks thereafter. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL insulin glargine is 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 LANTUS or one of its excipients ( 4)
WARNINGS AND PRECAUTIONS
_Never share_ a LANTUS SoloStar prefilled pen between patients, even
if the needle is changed. ( 5.1)
_Hyperglycemia or hypoglycemia with changes in insulin regimen:_ Carry
out under close medical supervision. ( 5.2)
_Hypoglycemia:_ May be life-threatening. Increase frequency of glucose
monitoring with changes to: insulin dosage,
coadministered glucose lowering medications, meal pattern, physical
activity; and in patients with renal or hepatic
impairment and hypoglycemia unawareness. ( 5.3, 6.1)
_Medication Errors:_ Accidental mix-ups between insul