GLIMEPIRIDE TABLETS USP, 7254, 7255, 7256, Rx only

/GLIMEPIRIDE TABLETS USP, 7254, 7255, 7256, Rx only
GLIMEPIRIDE TABLETS USP, 7254, 7255, 7256, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

GLIMEPIRIDE TABLETS USP, 7254, 7255, 7256, Rx only

ID:

b2688fe1-f2f1-4c67-8420-0647a0ff0694

Code:

34391-3

DESCRIPTION


id: 35073cd4-7808-4384-8a0d-72bc8740ab39
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 USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. In addition, glimepiride tablets USP 1 mg contain ferric oxide red, glimepiride tablets USP 2 mg contain ferric oxide yellow and FD&C Blue #2 aluminum lake, and glimepiride tablets USP 4 mg contain FD&C Blue #2 aluminum 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: C24H34N4O5S M.W. 490.62 Glimepiride is practically insoluble in water.

INDICATIONS AND USAGE


id: 8f036ea4-7d72-48f3-9799-508863848fee
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).

CONTRAINDICATIONS


id: bffcd79a-6fc7-4cdf-8333-38c27e40b536
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Glimepiride tablets are contraindicated in patients with Known hypersensitivity to the drug.
Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

OVERDOSAGE


id: 37801fb3-7ba7-4f78-9178-d45794073a05
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


id: 58889c5f-13e2-4281-ba9f-955b61b4186e
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.

HOW SUPPLIED


id: 734dda10-76e8-4c82-93af-2cccc2fbe134
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Glimepiride tablets USP are available in the following strengths and package sizes: 1 mg (mottled pink, round tablet, bisected on both sides. One side of the tablet debossed with “9” on one side of score and “3” on the other. The other side of the tablet debossed with “72” on one side of score and “54” on the other.)

Bottles of 30 NDC 54868-3327-0
Bottles of 90 NDC 54868-3327-1

2 mg (mottled green, round tablet, bisected on both sides. One side of the tablet debossed with “9” on one side of score and “3” on the other. The other side of the tablet debossed with “72” on one side of score and “55” on the other.)

Bottles of 30 NDC 54868-5457-0
Bottles of 60 NDC 54868-5457-2
Bottles of 90 NDC 54868-5457-1

4 mg (mottled light blue, round tablet, bisected on both sides. One side of the tablet debossed with “9” on one side of score and “3” on the other. The other side of the tablet debossed with “72” on one side of score and “56” on the other.)

Bottles of 30 NDC 54868-3377-0
Bottles of 60 NDC 54868-3377-1
Bottles of 90 NDC 54868-3377-2
Bottles of 180 NDC 54868-3377-3

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).

ANIMAL TOXICOLOGY


id: 190bf45a-e831-470b-b9de-69f23f10534e
displayName: ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION
FDA Article Code: 34091-9

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.

HUMAN OPHTHALMOLOGY DATA


id: 1df279bc-77b0-425a-a2d2-8b86df5990f8
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.

PRINCIPAL DISPLAY PANEL


id: c1e43902-3b29-4d6e-9f5e-bdbb58ec399d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: 40a51860-bd3d-4115-82df-81a471eac507
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: 4caef704-9a40-4883-844a-5d9ff29072ff
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4