AMARYL- glimepiride tablet
Sanofi-Aventis U.S. LLC
DESCRIPTION
AMARYL 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 (C24 H34 N4 O5 S) with molecular weight of 490.62. Glimepiride is white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water.
INDICATIONS AND USAGE
AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type diabetes mellitus
Important Limitations of Use
AMARYL should not be used for the treatment of type diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
AMARYL should be administered with breakfast or the first main meal of the day.
The recommended starting dose of AMARYL is mg or mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on mg once daily
After reaching daily dose of mg, further dose increases can be made in increments of mg or mg based upon the patient?s glycemic response. Uptitration should not occur more frequently than every 1?2 weeks. conservative titration scheme is recommended for patients at increased risk for hypoglycemia
The maximum recommended dose is mg once daily.
Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1?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, AMARYL should be administered at least hours prior to colesevelam.
3 DOSAGE FORMS AND STRENGTHS
AMARYL is formulated as tablets of:
1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with ?AMA RYL? on one side)
2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with ?AMA RYL? on one side)
4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with ?AMA RYL? on one side)
WARNINGS AND PRECAUTIONS
Hypoglycemia
Hypersensitivity Reactions
Hemolytic Anemia
Increased Risk of Cardiovascular Mortality with Sulfonylureas
A number of medications affect glucose metabolism and may require AMARYL dose adjustment and particularly close monitoring for hypoglycemia or worsening glycemic control.
The following are examples of medications that may increase the glucose-lowering effect of sulfonylureas including AMARYL, increasing the susceptibility to and/or intensity of hypoglycemia: oral anti-diabetic medications, pramlintide acetate, insulin, angiotensin converting enzyme (ACE) inhibitors, H2 receptor antagonists, fibrates, propoxyphene, pentoxifylline, somatostatin analogs, anabolic steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine oxidase inhibitors. When these medications are administered to patient receiving AMARYL, monitor the patient closely for hypoglycemia. When these medications are withdrawn from patient receiving AMARYL, monitor the patient closely for worsening glycemic control.
The following are examples of medications that may reduce the glucose-lowering effect of sulfonylureas including AMARYL, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid. When these medications are administered to patient receiving AMARYL, monitor the patient closely for worsening glycemic control. When these medications are withdrawn from patient receiving AMARYL, monitor the patient closely for hypoglycemia.
Beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of AMARYL?s glucose-lowering effect.
Both acute and chronic alcohol intake may potentiate or weaken the glucose-lowering action of AMARYL in an unpredictable fashion.
The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.
A potential interaction between oral miconazole and sulfonylureas leading to severe hypoglycemia has been reported. Whether this interaction also occurs with other dosage forms of miconazole is not known.
Colesevelam can reduce the maximum plasma concentration and total exposure of glimepiride when the two are coadministered.
There may be an interaction between glimepiride and inhibitors (e.g., fluconazole) and inducers (e.g., rifampin) of cytochrome P450 2C9.
HOW SUPPLIED/STORAGE AND HANDLING
AMARYL tablets are available in the following strengths and package sizes:
1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with
?AMA RYL? on one side) in bottles of 100 (NDC 0039-0221-10)
2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with
?AMA RYL? on one side) in bottles of 100 (NDC 0039-0222-10)
4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with
?AMA RYL? on one side) in bottles of 100 (NDC 0039-0223-10)
Store at 25?C (77?F); excursions permitted to 20 25?C (68 77?F) (see USP Controlled Room Temperature).
Dispense in well-closed containers with safety closures.
