displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Glimepiride tablets USP, are an oral blood-glucose-lowering drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral administration. Glimepiride tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake).
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.
The CAS Registry Number is 93479-97-1
The structural formula is:
Molecular Formula: C24H34N4O5S
Molecular Weight: 490.62
Glimepiride is practically insoluble in water.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (See DOSAGE AND ADMINISTRATION section).
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Glimepiride tablets are contraindicated in patients with
1. Known hypersensitivity to the drug.
2. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Overdosage of sulfonylureas, including glimepiride, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization, If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycemia may recur after apparent clinical recovery.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
There is no fixed dosage regimen for the management of diabetes mellitus with glimepiride or any other hypoglycemic agent. The patient’s fasting blood glucose and HbA1c must be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels should be performed to monitor the patient’s response to therapy.
Short-term administration of glimepiride may be sufficient during periods of transient loss of control in patients usually controlled well on diet and exercise.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Glimepiride tablets USP, 1 mg are green, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “320” separating “3” and “20” with bisect line scoring on the other side and are supplied in bottles of 120.
Bottles of 30 NDC 35356-896-30
Bottles of 60 NDC 35356-896-60
Bottles of 90 NDC 35356-896-90
Glimepiride tablets USP, 2 mg are green, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “321” separating “3” and “21” with bisect line scoring on the other side and are supplied in bottles of 30 and 90.
Glimepiride tablets USP, 4 mg are blue, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “322” separating “3” and “22” with bisect line scoring on the other side and are supplied in bottles of 30, 60 and 90.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in well-closed containers with safety closures.
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Reduced serum glucose values and degranulation of the pancreatic beta cells were observed in beagle dogs exposed to 320 mg glimepiride/kg/day for 12 months (approximately 1,000 times the recommended human dose based on surface area). No evidence of tumor formation was observed in any organ. One female and one male dog developed bilateral subcapsular cataracts. Non-GLP studies indicated that glimepiride was unlikely to exacerbate cataract formation. Evaluation of the co-cataractogenic potential of glimepiride in several diabetic and cataract rat models was negative and there was no adverse effect of glimepiride on bovine ocular lens metabolism in organ culture.
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Ophthalmic examinations were carried out in over 500 subjects during long-term studies using the methodology of Taylor and West and Laties et al. No significant differences were seen between glimepiride and glyburide in the number of subjects with clinically important changes in visual acuity, intra-ocular tension, or in any of the five lens-related variables examined.
Ophthalmic examinations were carried out during long-term studies using the method of Chylack et al. No significant or clinically meaningful differences were seen between glimepiride and glipizide with respect to cataract progression by subjective LOCS II grading and objective image analysis systems, visual acuity, intraocular pressure, and general ophthalmic examination.
Dr. Reddy’s Laboratories Limited
Bachepalli – 502 325 INDIA
Image of Label
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4