GLIMEPIRIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

MedVantx, Inc.

INN (Kansainvälinen yleisnimi):

GLIMEPIRIDE

Koostumus:

GLIMEPIRIDE 2 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome, dyspnea) [see Warnings and Precauti

Tuoteyhteenveto:

Glimepiride tablets USP are available as: 1 mg - mottled pink, round tablet, bisected on both sides. One side of the tablet is debossed with “9” on one side of score and “3” on the other. The other side of the tablet is debossed with “72” on one side of score and “54” on the other. Available in bottles of 100 and 1000. 2 mg - mottled green, round tablet, bisected on both sides. One side of the tablet is debossed with “9” on one side of score and “3” on the other. The other side of the tablet is debossed with “72” on one side of score and “55” on the other. Available in bottles of 100 and 1000. 4 mg - mottled light blue, round tablet, bisected on both sides. One side of the tablet is debossed with “9” on one side of score and “3” on the other. The other side of the tablet is debossed with “72” on one side of score and “56” on the other. Available in bottles of 100, 250, and 1000. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

GLIMEPIRIDE- GLIMEPIRIDE TABLET
MEDVANTX, INC.
----------
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, benefits and treatment
alterna