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:

Virtus Pharmaceuticals

INN（国際名）:

Glimepiride

構図:

Glimepiride 1 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 tablets are contraindicated in patients with a history of a hypersensitivity reaction to: Risk Summary Available data from a small number of published studies and postmarketing experience with glimepiride tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glimepiride tablets should be discontinued at least two weeks before expected delivery (see Clinical Considerations) . Poorly controlled diabetes in pre

製品概要:

Glimepiride tablets USP are available in the following strengths and package sizes: Store at 20°C to 25°C (68° to 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
VIRTUS PHARMACEUTICALS
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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 tablets 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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets (scored): 1 mg, 2 mg, 4 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
Common adverse reactions in clinical trials (≥5% and more common
than with placebo) include hypoglycemia, headache,
nausea, and dizziness (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LAMBDA THERAPEUTICS
RESEARCH LTD. AT 1-855-642-
2594 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
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Not for treating type 1 diabetes mellitus or diabetic ketoacidosis
(1).
Recommended starting dose is 1 or 2 mg once daily. Increase in 1 or 2
mg increments no more frequently than
every 1-2 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)
Hypersensitivity to glimepiride or any of the product’s ingredients
(4)
Hypersensitivity to sulfonamide derivatives (4)
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 glimepirid