Gliclazide (Clinect)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Gliclazide 80mg

Available from:

Clinect NZ Pty Limited

INN (International Name):

Gliclazide 80 mg

Dosage:

80 mg

Pharmaceutical form:

Tablet

Composition:

Active: Gliclazide 80mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, 10 tabs/strip; 30 tabs/pack, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bal Pharma Ltd

Therapeutic indications:

Gliclazide is indicated for diabetes mellitus of the maturity onset type, which cannot be controlled by diet alone

Product summary:

Package - Contents - Shelf Life: Blister pack, 10 tabs/strip - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, 10 tabs/strip - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with white or blue PP screw cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with white or blue PP screw cap - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

2000-11-09

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-GLICLAZIDE
Gliclazide 80mg Tablets
Please refer to Medsafe website (
www.medsafe.govt.nz
) for the most recent datasheet
Page 1
PRESENTATION
APO-GLICLAZIDE 80mg tablets are white, round, flat with bevelled edge tablets, 7.9mm in
diameter, identified APO over 80 on one side and cross-scored on the other. Each tablet contains
80mg gliclazide and typically weighs 160mg.
USES
ACTIONS
Gliclazide is a hypoglycaemic agent of the sulphonylurea group. It stimulates insulin secretion
from functional pancreatic beta-cells and increases the sensitivity of the beta-cells to a glucose
stimulus. Some residual beta-cell function is therefore necessary. Gliclazide restores the
diminished first-phase of insulin secretion noted in non-insulin dependant diabetes mellitus.
Any long-term hypoglycaemic activity of gliclazide can be attributed to an ability to maintain its
effect on insulin secretion. Extrapancreatic effects may also be involved in the long-term efficacy
of gliclazide. These effects include improvement in insulin mediated glucose utilisation and
potentiation of postreceptor insulin sensitive pathways.
At normal therapeutic levels in man, gliclazide reduces platelet adhesiveness and aggregation.
PHARMACOKINETICS
Gliclazide is readily absorbed from the gastrointestinal tract with peak plasma concentration
occurring within 4 to 6 hours. Single dose studies demonstrate that maximal falls in blood glucose
levels occur approximately 5 hours after drug administration. With a 160mg dose a 20% reduction
in blood glucose levels was still in evidence. It is extensively bound to plasma proteins
(approximately 94%). The half-life is approximately 10 to 12 hours.
Gliclazide is distributed to the extracellular fluid. In animals, high concentrations of gliclazide were
found in the liver,