GLIMEPIRIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)

Mevcut itibaren:

REMEDYREPACK INC.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1)]. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride tablet is contraindicated in patients with a history of a hypersensitivity reaction to: - Glimepiride or any of the product’s ingredients [see Warnings and Precautions ( 5.2)]. - Sulfonamide derivatives: Patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to glimepiride. Do not use glimepiride in patients who have a history of an allergic reaction to sulfonamide derivatives. Risk Summary Available data from a small number of published studies and postmarketing experience with glimepir

Ürün özeti:

Glimepiride tablets, USP are available in the following strengths and package sizes: 4 mg tablets (blue coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 4’ on one side and break line on the other) in NDC: 70518-0296-00 NDC: 70518-0296-01 PACKAGING: 180 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC Store at 25°C (77°F); excursions permitted to 20°C to 25°C (68°F to 77°F) (see USP Controlled Room Temperature). Dispense in well-closed containers with safety closures. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

GLIMEPIRIDE- GLIMEPIRIDE TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLIMEPIRIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GLIMEPIRIDE TABLETS.
GLIMEPIRIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Glimepiride is a sulfonylurea indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes
mellitus ( 1)
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1)
DOSAGE AND ADMINISTRATION
Recommended starting dose is 1 or 2 mg once daily. Increase in 1 or 2
mg increments no more frequently than every 1 to 2 weeks
based on glycemic response. Maximum recommended dose is 8 mg once
daily. ( 2.1)
Administer with breakfast or first meal of the day. ( 2.1)
Use 1 mg starting dose and titrate slowly in patients at increased
risk for hypoglycemia (e.g., elderly, patients with renal
impairment). ( 2.1)
DOSAGE FORMS AND STRENGTHS
Tablets (scored): 1 mg, 2 mg, 4 mg ( 3)
CONTRAINDICATIONS
Hypersensitivity to glimepiride or any of the product’s ingredients
( 4)
Hypersensitivity to sulfonamide derivatives ( 4)
WARNINGS AND PRECAUTIONS
Hypoglycemia: May be severe. Ensure proper patient selection, dosing,
and instructions, particularly in at-risk populations (e.g.,
elderly, renally impaired) and when used with other anti-diabetic
medications ( 5.1).
Hypersensitivity Reactions: Postmarketing reports include anaphylaxis,
angioedema and Stevens-Johnson Syndrome. If a reaction is
suspected, promptly discontinue glimepiride, assess for other
potential causes for the reaction, and institute alternative treatment
for diabetes. ( 5.2).
Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase
(G6PD) deficient. Consider a non-sulfonylurea alternative. (
5.3).
Potential Increased Risk of Cardiovascular Mortality with
Sulfonylureas: Inform patient of risks, benefits and treatment
alternatives.
( 5.4).
Macrovascul