Gliclazide

Drug Approvals

(British Approved Name, rINN)

International Nonproprietary Names (INNs) in main languages (French, Latin, and Spanish):

Synonyms: Gliclazida; Gliclazidum; Gliklatsidi; Gliklazid; Gliklazidas; Glyclazide; SE-1702
INN: Gliclazide [rINN (en)]
INN: Gliclazida [rINN (es)]
INN: Gliclazide [rINN (fr)]
INN: Gliclazidum [rINN (la)]
INN: Гликлазид [rINN (ru)]
Chemical name: 1-(3-Azabicyclo[3.3.0]oct-3-yl)-3-tosylurea; 1-(3-Azabicyclo[3.3.0]oct-3-yl)-3-p-tolylsulphonylurea
Molecular formula: C15H21N3O3S =323.4
CAS: 21187-98-4
ATC code: A10BB09
Read code: y02XY

Pharmacopoeias. In China, and Europe.

European Pharmacopoeia, 6th ed. (Gliclazide). A white or almost white powder. Practically insoluble in water slightly soluble in alcohol sparingly soluble in acetone freely soluble in dichloromethane.

Adverse Effects, Treatment, and Precautions

As for sulfonylureas in general. The BNF suggests that gliclazide may be suitable for use in patients with renal impairment, but that careful monitoring of blood-glucose concentration is essential. UK licensed product information recommends that it should not be used in patients with severe renal impairment.

Interactions

As for sulfonylureas in general.

Pharmacokinetics

Gliclazide is readily absorbed from the gastrointestinal tract. It is extensively bound to plasma proteins. The half-life is about 10 to 12 hours. Gliclazide is extensively metabolised in the liver to metabolites that have no significant hypoglycaemic activity. Metabolites and a small amount of unchanged drug are excreted in the urine.

Uses and Administration

Gliclazide is a sulfonylurea antidiabetic. It is given orally in the treatment of type 2 diabetes mellitus and has a duration of action of 12 to 24 hours. Because its effects are less prolonged than those of chlorpropamide or glibenclamide it may be more suitable for elderly patients, who are prone to hypoglycaemia with longer-acting sulfonylureas. The usual initial dose is 40 to 80 mg daily, gradually increased, if necessary, up to 320 mg daily. Doses of more than 160 mg daily are given in 2 divided doses. A modified-release tablet is also available: the usual initial dose is 30 mg once daily, increased if necessary up to a maximum of 120 mg daily.

Preparations

British Pharmacopoeia 2008: Gliclazide Tablets.

Proprietary Preparations

Argentina: Aglucide Diamicron Unava

Australia: Diamicron Glyade Nidem Oziclide

Austria: Diamicron

Belgium: Diamicron Uni Diamicron

Brazil: Azukon Diamicron Glicaron

Canada: Diamicron

Chile: Dianormax

Czech Republic: Diabrezide Diaprel

Denmark: Diamicron

France: Diamicron

Germany: Diamicron

Greece: Diamicron

Hong Kong: CP-Gliz Diamicron Diamitex Dianorm Glimicron Glucozide Glupozide Glyzyl Licla Marclazide Nidem Qualizide Suclear Sun-Glizide

Hungary: Diaprel Gluctam

India: Diamicron Gliza Glizid Glycigon Glycinorm Glygard Lycazid Semi-Glycigon

Indonesia: Diamicron Fredam Glicab Glidabet Glucodex Glucored Glukolos Glycafor Linodiab Meltika Nufamicron Pedab Tiaglib Xepabet Zumadiac

Ireland: Diabrezide Diaclide Diamicron

Italy: Cronemet Diabrezide Diamicron Dramion Galtes Glucobloc

Malaysia: Diacron † Diamicron Dianid Glimicron Glucozide Glyade Medoclazide Melicron † Opglucon Reclide Sun-Glizide

Mexico: Diamicron

The Netherlands: Diamicron

New Zealand: Diamicron Glizon

Philippines: Clibite Glizid Diaclid Diamicron Dianorm Glubitor Gluconil Glucoprime

Poland: Diabezidum Diabrezide Diaprel Diazidan Glazide Glinormax Norsulin

Portugal: Diamicron

South Africa: Diaglucide Diamicron Glucomed Glycron Glygard Ziclin

Singapore: Diamicron Dianorm Glimicron Glizide Glucozide Medoclazide Melicron †

Spain: Diamicron Uni Diamicron

Switzerland: Diamicron

Thailand: Cadicon Diabeside Diaclaron † Diamaze † Diamexon Diamicron Dianid Glicron Glucocron Glucozide Glycon Medoclazide Serviclazide

Turkey: Betanorm Diamicron Glazid Glumikron Oramikron

United Arab Emirates: Glyzide

UK: Diaglyk Diamicron

Venezuela: Diamicron Glidan Reclide †

Multi-ingredient:

India: Exermet GZ Gliclamet Glizid-M Glycigon-M Glycinorm M Glygard M Glyroz.

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