Introduction

AMARYL is an oral sulfonylurea drug containing the active ingredient glimepiride.

Glimepiride is chemically identified as 1-[[p- [2- (3-ethyl-4-methyl-2-oxo-3-pyrroliline-1-
carboxamido) ethyl] benzene Group] sulfonyl] -3- (trans-4-methylcyclohexyl) urea
(C24H34N4O5S), the molecular weight is 490.62. Glimepiride is a white to yellow-white
crystal, odorless to almost odorless powder, and hardly soluble in water. The structural
formula is:

Zh

AMARYL tablets contain the active ingredient glimepiride and the following inactive
ingredients: lactose (aqueous), sodium starch glycolate, povidone, microcrystalline cellulose
and magnesium stearate. In addition, the AMARYL 1 mg tablet contains iron oxide red, the
AMARYL 2 mg tablet contains iron oxide yellow and FD & C blue # 2 aluminum lake, and the
AMARYL 4 mg tablet contains FD & C blue # 2 aluminum lake.

Chemical Name

The chemical name of Glimepiride is as follows:

1-[[4- [2- (3-ethyl-4-methyl-2-oxo-3-pyrroliline-1-carboxamido) -ethyl] phenyl] sulfonyl] -3-

trans -(4-methylcyclohexyl) urea or

1-({p- [2- (3-ethyl-4-methyl-2-oxo-3-pyrroliline-1-carboxamido) -ethyl] phenyl} sulfonyl] -3-

trans (4-methylcyclohexyl) urea or

3-ethyl-2,5-dihydro-4-methyl-N- [2- [4-[[[[trans-4-methylcyclohexyl) -amino] carbonyl] -

amino] sulfonyl] Phenyl] ethyl] 2-oxo-1H-pyrrole-1-carboxamide, or

1H-pyrrole-1-carboxamide, 3-ethyl-2,5-dihydro-4-methyl-N- [2- [4-[[[[[((4-methylcyclohexyl)

-amino ] Carbonyl] amino] sulfonyl] phenyl] ethyl] -2-oxo, trans [5]

Glimepiride has another name, N- [4- [2- (3-ethyl-4-methyl-2-oxo-3-pyrroliline-1-

carboxamido) -ethyl] -Benzenesulfonyl] -N'-4-methylcyclohexylurea.

common name

Glimepiride is the generic name for the prescription drug Amaryl, which is used to treat
patients with type 2 diabetes. Glimepiride belongs to a class of drugs called sulfonylureas. It
stimulates the pancreas to produce insulin and helps the body use insulin more efficiently.
The drug can also reduce someone's chance of developing life-threatening type 2 diabetes
complications. The drug was approved by the FDA in 1995 and is manufactured by Sanofi-
Aventis.
Glimepiride is in tablet form and is usually taken once a day. It can be used alone or in
combination with insulin or other oral medications such as metformin. Your doctor may
start treatment with a low dose of the drug and gradually increase the dose when needed.

Product name (brand name)

AMARYL® (glimepiride tablet) is an oral hypoglycemic drug of the sulfonylurea type.

Glimepiride is a white to yellow-white crystal, odorless to almost odorless powder,
formulated in 1 mg, 2 mg, and 4 mg concentrations for oral use. AMARYL tablets contain
the active ingredient glimepiride and the following inactive ingredients: lactose (aqueous),
sodium starch glycolate, povidone, microcrystalline cellulose and magnesium stearate. In
addition, 1 mg AMARYL tablets contain iron oxide red, 2 mg AMARYL tablets contain iron
oxide yellow and FD & C Blue No. 2 aluminum lake, and 4 mg AMARYL tablets contain FD &
C Blue No. 2 aluminum lake.

Indication

Indications and clinical uses

AMARYL is suitable for:

• AMARYL (glimepiride) can be used as an aid to proper diet management, exercise and
weight loss to reduce blood sugar in patients with type 2 diabetes who cannot control high
blood sugar through diet and exercise.

• AMARYL can be used in combination with metformin during diet and exercise, while
AMARYL or metformin alone cannot effectively control blood sugar.

• AMARYL has also been instructed to be used in combination with insulin to reduce
patients with type 2 diabetes who cannot control high blood sugar through diet and
exercise, only in combination with oral hypoglycemic agents.

Pediatrics (<18 years): The safety and effectiveness of children with type 2 diabetes have
not been determined.

Geriatrics (> 65 years): There is no significant difference in the pharmacokinetics of

glimepiride 65 years or older. Elderly patients are particularly susceptible to the
hypoglycemic effects of hypoglycemic drugs (see "Warnings and Precautions", "Endocrine
and Metabolism", "Hyperglycemia and Effects and Clinical Pharmacology", "Special
Populations and Conditions", " Geriatrics "section).

Contraindications

Disabled in patients with AMARYL

• Type 1 diabetes (formerly known as insulin-dependent diabetes mellitus or IDDM).

• Known allergies or allergies to AMARYL, any sulfonylurea or sulfonamide or any other
component of the formulation. For a complete list, see the Dosage Form, Composition, and
Packaging section of the product monograph.

• Diabetic ketoacidosis with or without coma. This condition should be treated with insulin.

• Pregnant or lactating women.

There is no experience with AMARYL in patients with severe liver impairment and dialysis
patients. In patients with severe kidney or liver damage