Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Amaryl should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

The maximum recommended dose is 8 mg once daily.

Glimepiride is substantially excreted by the kidney. Elderly patients are more likely to have renal impairment. In addition, hypoglycemia may be difficult to recognize in the elderly.

All sulfonylureas, including glimepiride tablets, can cause severe hypoglycemia.

Glimepiride tablets, like all sulfonylureas, can cause weight gain.

Reported liver function impairment (e.g., with cholestasis and jaundice), as well as hepatitis, which may progress to liver failure.

Reported hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH), most often in patients who are on other medications or who have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone.

Reports of alopecia.

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with glimepiride tablets or any other anti-diabetic drug.

Sulfonylureas can cause hemolytic anemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency. Because glimepiride tablets are a sulfonylurea, use caution in patients with G6PD deficiency and consider the use of a non sulfonylurea alternative. There are also postmarketing reports of hemolytic anemia in patients receiving glimepiride tablets who did not have known G6PD deficiency.

There have been postmarketing reports of hypersensitivity reactions in patients treated with glimepiride tablets, including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome.

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.

The following are examples of medications that may increase the glucose-lowering effect of sulfonylureas including glimepiride tablets, increasing the susceptibility to and/or intensity of hypoglycemia: oral antidiabetic 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 a patient receiving glimepiride tablets, monitor the patient closely for hypoglycemia. When these medications are withdrawn from a patient receiving glimepiride tablets, monitor the patient closely for worsening glycemic control.

The following are examples of medications that may reduce the glucose-lowering effect of sulfonylureas including glimepiride tablets, 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 a patient receiving glimepiride tablets, monitor the patient closely for worsening glycemic control. When these medications are withdrawn from a patient receiving glimepiride tablets, monitor the patient closely for hypoglycemia.

Beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of glimepiride tablet’s glucose-lowering effect.

Both acute and chronic alcohol intake may potentiate or weaken the glucose lowering action of glimepiride tablets in an unpredictable fashion.

A potential interaction between oral miconazole and sulfonylureas leading to severe hypoglycemia has been reported.

There may be an interaction between glimepiride and inhibitors (e.g., fluconazole) and inducers (e.g., rifampin) of cytochrome P450 2C9. Fluconazole may inhibit the metabolism of glimepiride, causing increased plasma concentrations of glimepiride which may lead to hypoglycemia. Rifampin may induce the metabolism of glimepiride, causing decreased plasma concentrations of glimepiride which may lead to worsening glycemic control.

Colesevelam can reduce the maximum plasma concentration and total exposure of glimepiride when the two are coadministered. However, absorption is not reduced when glimepiride is administered 4 hours prior to colesevelam. Therefore, glimepiride tablets should be administered at least 4 hours prior to colesevelam.

There are no adequate and well-controlled studies of glimepiride tablets in pregnant women. Based on on animal data, may cause fetal harm.

Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery.

Based on these animal data and the potential for hypoglycemia in a nursing infant, a decision should be made whether to discontinue nursing or discontinue glimepiride tablets, taking into account the importance of glimepiride tablets to the mother.

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• Maintenance dosage greater than 8 mg once daily. GoToSource

• Type 1 diabetes mellitus. GoToSource

Increased risk of myocardial infarction, stroke and cardiovascular mortality. GoToSource

Leukocytoclastic vasculitis (inflammation of small blood vessels). GoToSource

Liver injury. GoToSource

Erythema multiforme, exfoliative dermatitis (severe skin reaction) and photosensitivity (abnormal skin response to light). GoToSource

Hypoglycemia (low blood sugar). GoToSource

Lawsuits filed for myocardial infarction, ischaemic stroke, hypoglycaemia, and cardiovascular death.