Drug Catalog - Product Detail
GLIMEPIRIDE TAB 2MG 500CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69543-0124-50 | VIRTUS PHARMACEUTICALS | 500 | 2MG | TABLET |
PACKAGE FILES
Generic Name
GLIMEPIRIDE
Substance Name
GLIMEPIRIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202112
Description
11 DESCRIPTION Glimepiride tablets USP is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24 H 34 N 4 O 5 S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is: Glimepiride tablets USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, polysorbate 80, sodium starch glycolate, povidone, microcrystalline cellulose, and magnesium stearate. In addition, glimepiride 1 mg tablets contain Ferric Oxide Red and glimepiride 2 mg tablets contain Ferric Oxide Yellow. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Glimepiride tablets USP are available in the following strengths and package sizes: • 1 mg (Light pink capsule shaped flat-faced, bevelled edged tablets with breakline on both sides and debossed with ‘I’ and ‘1’ on either side of breakline only on one side) Bottles of 100 (NDC 69543-123-10) Bottles of 500 (NDC 69543-123-50) • 2 mg (Yellow coloured capsule shaped flat-faced, bevelled edged tablets with breakline on both sides and debossed with ‘I’ and ‘2’ on either side of breakline only on one side) Bottles of 100 (NDC 69543-124-10) Bottles of 500 (NDC 69543-124-50) • 4 mg (White capsule shaped flat-faced, bevelled edged tablets with breakline on both sides and debossed with ‘I’ and ‘4’ on either side of breakline only on one side) Bottles of 100 (NDC 69543-125-10) Bottles of 500 (NDC 69543-125-50) Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in well-closed containers with safety closures.
Indications & Usage
1 INDICATIONS AND USAGE 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 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 : • Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
Dosage and Administration
2 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 1-2 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 ) 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 tablets 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 tablets 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 tablets should be administered at least 4 hours prior to colesevelam.