Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Non insulin dependent diabetes mellitus.
The total daily dose may vary from 40-320mg. The dose should be adjusted according to the individual’s response, commencing with 40-80mg daily and increasing until adequate control is achieved. A single dose should not exceed 160mg. When higher doses are required, gliclazide should be taken twice daily and according to the main meals of the day.
In obese patients or those not showing adequate response to gliclazide alone, additional therapy may be required.
Plasma clearance of gliclazide is not altered in the elderly and steady state plasma levels can therefore be expected to be similar to those in adults under 65 years. Clinical experience in the elderly to date shows that gliclazide is effective and well tolerated. Care should be exercised however, when prescribing sulfonylureas in the elderly due to a possible age-related increased risk of hypoglycaemia.
Gliclazide, as with other sulfonylureas, is not indicated for the treatment of juvenile onset diabetes mellitus.
For oral use.
An overdose of sulfonylureas may cause hypoglycaemia.
Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.
Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalisation.
If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 ml of concentrated glucose solution (20 to 30%). This should be followed by continuous infusion of a more dilute glucose solution (10%) at a rate that will maintain blood glucose levels above 1 g/l. Patients should be monitored closely and, depending on the patient’s condition after this time, the doctor will decide if further monitoring is necessary.
Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins.
Shelf life: 2 years.
This medicinal product does not require any special storage conditions.
Blister packs of PVC with Aluminium foil containing 20, 28, 56, 60 84, 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
