GLIMEPIRIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Proficient Rx LP

INN (Rahvusvaheline Nimetus):

GLIMEPIRIDE

Koostis:

GLIMEPIRIDE 1 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 tablet is contraindicated in patients with a history of a hypersensitivity reaction to: 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. Reported hypersensitivity reactions include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g. anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [see Warnings and Precautions ( 5.2) and Adverse Reactions ( 6.2

Toote kokkuvõte:

Glimepiride tablets USP are available in the following strengths and package sizes: Store at 25°C (77°F); excursions permitted to 20 to 25°C (68 to 77°F) (see USP Controlled Room Temperature). Dispense in well-closed containers with safety closures.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

GLIMEPIRIDE- GLIMEPIRIDE TABLET
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLIMEPIRIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLIMEPIRIDE.
GLIMEPIRIDE TABLETS USP 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 ( 1.1)
Important Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets (scored): 1 mg, 2 mg, 4 mg ( 3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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 ACCORD HEALTHCARE INC.
AT 1-866-941-
7875 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1.1)
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 )
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. Promptly discontinue glimepiride, assess for other
causes, institute appropri