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:

TYA Pharmaceuticals

INN (국제 이름):

insulin glargine

구성:

insulin glargine 100 [iU] in 1 mL

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. Important Limitations of Use: - LANTUS is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin is the preferred treatment for this condition. LANTUS is contraindicated - In patients with hypersensitivity to LANTUS or one of its excipients [See ]. Warnings and Precautions (5.4) Pregnancy Category C: Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m . In rabbits, doses of 0.072 mg/kg/day, which is approx

제품 요약:

NDC:64725-2220-1 in a VIAL, GLASS of 10 INJECTION, SOLUTIONS LANTUS solution for injection 100 units per mL (U-100) is available as: Needles are not included in the packs. BD Ultra-Fine™ needles to be used in conjunction with SoloStar are sold separately and are manufactured by BD. 1 LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen. Unopened Vial/ SoloStar disposable insulin device: Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial: Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) SoloStar disposable insulin device: The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened. These storage conditions are summarized in the following table: Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. LANTUS must only be used if the solution is clear and colorless with no particles visible. Mixing and diluting: LANTUS must NOT be diluted or mixed with any other insulin or solution [S . ee ] Warnings and Precautions (5.2) The syringes must not contain any other medicinal product or residue. Vial: : If SoloStar disposable insulin device, malfunctions, LANTUS may be drawn from the cartridge system or from SoloStar into a U-100 syringe and injected. SoloStar

승인 상태:

New Drug Application

제품 특성 요약

LANTUS- INSULIN GLARGINE INJECTION, SOLUTION
TYA PHARMACEUTICALS
----------
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 [RDNA
ORIGIN] INJECTION) SOLUTION FOR
SUBCUTANEOUS INJECTION INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions ( ) 5.8
10/2013
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
Important Limitations of Use:
Not recommended for treating diabetic ketoacidosis. Use intravenous,
short-acting insulin instead.
DOSAGE AND ADMINISTRATION
Individualize dose based on the type of diabetes and whether the
patient is insulin-naïve ( , , ) 2.12.22.3
Administer subcutaneously once daily at any time of day, but at the
same time every day. ( ) 2.1
Rotate injection sites within an injection area (abdomen, thigh, or
deltoid) to reduce the risk of lipodystrophy. ( ) 2.1
Converting from other insulin therapies may require adjustment of
timing and dose of LANTUS. Closely monitor
glucoses especially upon converting to LANTUS and during the initial
weeks thereafter. ( ) 2.3
DOSAGE FORMS AND STRENGTHS
Solution for injection 100 units/mL (U-100) in
10 mL vials
3 mL SoloStar disposable insulin device ( ) 3
CONTRAINDICATIONS
In patients with hypersensitivity to LANTUS or one of its excipients (
) 4
WARNINGS AND PRECAUTIONS
Dose adjustment and monitoring: Monitor blood glucose in all patients
treated with insulin. Modify insulin regimen
cautiously and only under medical supervision ( ) 5.1
Administration: Do not dilute or mix with any other insulin or
solution. Do not administer subcutaneously via an insulin
pump or intravenously because severe hypoglycemia can occur ( ) 5.2
Do not share reusable or disposable insulin devices or needles between
patients ( ) 5.2
Hypoglycemia: