GLIMEPIRIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Direct_Rx

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. 8.1 Pregnancy Risk Summary Available data from a small number of published studies and postmarketing experience with glimepiride use in pregnancy over decades have not identified any drug associated risks for major birth defects,

Rezumat produs:

Glimepiride tablets, USP are available in the following strengths and package sizes: 1 mg tablets (pink coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 1’ on one side and break line on the other) in bottles of 100 , 500 and 1,000 2 mg tablets (green coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 2’ on one side and break line on the other) in bottles of 100 , 500 and 1,000 4 mg tablets (blue coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 4’ on one side and break line on the other) in bottles of 100, 500 and 1,000 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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

GLIMEPIRIDE- GLIMEPIRIDE TABLET
DIRECT_RX
----------
GLIMEPIRIDE
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.
2.1 Recommended Dosing
Glimepiride tablets should be administered with breakfast or the first
main meal of the day.
The recommended starting dose of glimepiride tablet is 1 mg or 2 mg
once daily. Patients at increased
risk for hypoglycemia (e.g., the elderly or patients with renal
impairment) should be started on 1 mg
once daily [see Warnings and Precautions ( 5.1) and Use in Specific
Populations ( 8.5, 8.6)].
After reaching a daily dose of 2 mg, further dose increases can be
made in increments of 1 mg or 2 mg
based upon the patient’s glycemic response. Uptitration should not
occur more frequently than every 1
to 2 weeks. A conservative titration scheme is recommended for
patients at increased risk for
hypoglycemia [see Warnings and Precautions ( 5.1) and Use in Specific
Populations ( 8.5, 8.6)].
The maximum recommended dose is 8 mg once daily.
Patients being transferred to glimepiride from longer half-life
sulfonylureas (e.g., chlorpropamide) may
have overlapping drug effect for 1 to 2 weeks and should be
appropriately monitored for
hypoglycemia.
When colesevelam is coadministered with glimepiride, maximum plasma
concentration and total
exposure to glimepiride is reduced. Therefore, glimepiride should be
administered at least 4 hours
prior to colesevelam.
Glimepiride tablets, USP are formulated as tablets of:
1 mg tablets (pink coloured, oval shaped, biconvex, uncoated tablets
debossed with ‘AHI 1’ on one side
and break line on the other)
2 mg tablets (green coloured, oval shaped, biconvex, uncoated tablets
debossed with ‘AHI 2’ on one
side and break line on the other)
4 mg tablets (blue coloured,