Glimepiride

Drug Approvals

(British Approved Name, US Adopted Name, rINN)

INNs in other languages (French, Latin, and Spanish):

Synonyms: Glimepirid; Glimepirida; Glimepiridi; Glimepiridum; Hoe-490
INN: Glimepiride [rINN (en)]
INN: Glimepirida [rINN (es)]
INN: Glimépiride [rINN (fr)]
INN: Glimepiridum [rINN (la)]
INN: Глимепирид [rINN (ru)]
Chemical name: 1-({p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl}sulfonyl)-3-(trans-4-methylcyclohexyl)urea
Molecular formula: C24H34N4O5S =490.6
CAS: 93479-97-1
ATC code: A10BB12
Read code: y0ASD

Pharmacopoeias. In Europe and US.

European Pharmacopoeia, 6th ed. (Glimepiride). A white to almost white powder. It exhibits polymorphism. Practically insoluble in water slightly soluble in dichloromethane soluble in dimethylformamide very slightly soluble in methyl alcohol.

The United States Pharmacopeia 31, 2008 (Glimepiride). A white to almost white powder. Practically insoluble in water sparingly soluble in dichloromethane soluble in dimethylformamide slightly soluble in methyl alcohol. It dissolves in dilute alkali hydroxides and in dilute acids. Store at a temperature not exceeding 25°.

Adverse Effects, Treatment, and Precautions

As for sulfonylureas in general. In some countries hepatic and haematological monitoring is recommended in patients receiving glimepiride in the UK the BNF considers the practical value of such monitoring unproven.

Fasting. Glimepiride, given in unchanged doses but with the time of the single daily dose switched from morning to just before breaking fast after sunset, was used in Muslim patients during Ramadan without causing an increased incidence of hypoglycaemic episodes.

For further advice on the management of diabetes mellitus in fasting Muslim patients during Ramadan see under Precautions of Insulin.

Interactions

As for sulfonylureas in general.

Pharmacokinetics

Glimepiride is completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur in 2 to 3 hours, and it is highly protein bound. The drug is extensively metabolised to two main metabolites, a hydroxy derivative and a carboxy derivative. The half-life after multiple doses is about 9 hours. About 60% of a dose is eliminated in the urine and 40% in the faeces.

Uses and Administration

Glimepiride is a sulfonylurea antidiabetic. It is given orally for the treatment of type 2 diabetes mellitus. Initial doses of 1 to 2 mg daily may be increased if necessary to 4 mg daily for maintenance. The maximum recommended dose is 6 mg in the UK and 8 mg in the USA.

Preparations

The United States Pharmacopeia 31, 2008: Glimepiride Tablets.

Proprietary Preparations

Argentina: Adiuvan Amaryl Endial Glemaz Gluceride Glucopirida Islopir Lomet Next Step

Australia: Amaryl Aylide Diapride Dimirel

Austria: Amaryl

Belgium: Amarylle

Brazil: Amaryl Azulix Bioglic Diamellitis Glimepibal Glimepil Glimeprid † Glimeran Glimesec † Hipomeril

Canada: Amaryl

Chile: Amaryl Glemaz Glucomet

Czech Republic: Amarwin Amaryl Amyx Apo-Glimep Eglymad Glemid GlimTek Glymexan Melyd Metis Oltar

Denmark: Amaryl

Finland: Amaryl

France: Amarel

Germany: Amaryl Glimegamma Glimerid

Greece: Dialosa Glimepiron Glimespes Glimexin Gliperin Mepirid Penoza Pharlecon Saccharofar Solosa Sucryl Tipo II Toremol

Hong Kong: Amaryl Diapride

Hungary: Amaryl Dialosa Glempid GlimeWin Gl

India Gliprex Limeral Meglimid Melyd Sintecal

India: Amaryl Betaglim Diaglim Euglim Glimcip Glimiprex Glimitab Glimulin Glyree Glyree M Karmelitos

Indonesia: Amadiab Amaryl Anpiride Glamarol Glimexal Gluvas Mapryl Metrix Relide

Ireland: Amaryl

Israel: Amaryl

Italy: Amaryl Solosa

Malaysia: Amaryl Diapride Glimaryl Glimin Glimulin Miaryl

Mexico: Amaryl Glupropan Zukedib

The Netherlands: Amaryl

Norway: Amaryl

New Zealand: Amaryl

Philippines: Imerid Norizec Solosa

Poland: Amaryl Amyx Avaron Betaglid Diaril Glemid Glibetic Glibezid Glidiamid Glimehexal Glimesan Glipid Limeral Melyd Oltar Pemidal Symglic

Portugal: Amaryl Diapiride Glimial Gludon

Russia: Amaryl Glemaz

South Africa: Amaryl Glamaryl

Singapore: Amaryl Diapride

Spain: Amaryl Roname

Sweden: Amaryl

Switzerland: Amaryl

Thailand: Amaryl

Turkey: Amaryl Diameprid Glimax

UK: Amaryl Niddaryl

USA: Amaryl

Venezuela: Amaryl Dimavyl Glimerid.

Multi-ingredient

Czech Republic: Avaglim Tandemact

France: Avaglim Tandemact

Greece: Avaglim

Hungary: Avaglim

India: Betaglim Mf Exermet GM Glimiprex M † Glimulin-MF †

Indonesia: Avandaryl

Portugal: Avaglim Tandemact

USA: Avandaryl Duetact.

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