GLIMEPIRIDE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

St Marys Medical Park Pharmacy

INN（国際名）:

GLIMEPIRIDE

構図:

GLIMEPIRIDE 2 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Glimepiride tablets USP 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) ] . Glimepiride tablets USP 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 tablets are contraindicated in patients with a history of a hypersensitivity reaction to: - Glimepiride tablets 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 tablets. Do not use glimepiride tablets in patients who have a history of an allergic reaction to sulfonamide derivatives. Reported hypersensitivity reactions include cutaneous eruptions with or without pruritus as well as more serio

製品概要:

Glimepiride tablets USP, 4 mg are blue, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “322” separating “3” and “22” with bisect line scoring on the other side NDC 60760-230-90 BOTTLES OF 90 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in well-closed containers with safety closures.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

GLIMEPIRIDE- GLIMEPIRIDE TABLET
ST MARYS MEDICAL PARK PHARMACY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLIMEPIRIDE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLIMEPIRIDE TABLETS
USP. GLIMEPIRIDE TABLETS USP FOR ORAL
USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Glimepiride tablets USP are a sulfonylurea indicated as an adjunct to
diet and exercise to improve glycemic control in adults
with type 2 diabetes mellitus ( 1.1).
Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1.1).
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 tablets 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.
Promptly discontinue glimepiride, assess for other causes, institute
appropriate monitoring and treatment, and initiate
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, ben