| a) Generic Name |
Gliclazide USP.
|
| b) Trade/Brand Name |
To be submitted at the time of inclusion.
|
| a) Presentation |
Tablet (Film Coated).
Each tablet contains Gliclazide USP 80 mg.
|
| b) Indications |
Non insulin dependent (type-II) diabetes mellitus, diabetes mellitus which is not controlled adequately by diet.
|
| c) Dosage & administration |
The total dose ranges from 1 to 4 tablets, which is taken in equal divided doses before breakfast and dinner. Usually the treatment is started with 1-2 tablets daily and is increased until adequate control is achieved. Beyond the dose of 1-2 tablets, a twice daily split dosage is advised and should be divided according to the main meals of the day. For the elderly diabetic, the starting dose should be 1/2 tablet in the morning and 1/2 tablet in the evening.
|
| d) Contraindications |
Domperidone is contraindicated to patients who have known hypersensitivity to this drug and in case of neonates.
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| d) Side effects |
Gliclazide is generally well tolerated. Nausea, headache and gastrointestinal disturbances have been reported.
|
| e) Precautions and
Warnings
|
It should be used with caution in hepatic and renal impairment. Food must be taken after a dose is administered and periodic blood sugar monitoring should be done.
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| e) Contraindications |
DGliclazide should not be used in juvenile onset diabetes, diabetes complicated by ketosis and acidosis, diabetics undergoing surgery, after severe trauma or during infections, patients known to have hypersensitivity to other sulphonylureas and related drugs, diabetic pre-coma and coma, and severe renal or hepatic insufficiency.
|
| Use in Pregnancy & Lactation |
Gliclazide is contraindicated in pregnancy and the patient must change over to insulin during pregnancy. It should not be used in lactation also.
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| k) Storage Conditions |
• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.
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| l) Package Quantity |
To be submitted at the time of inclusion.
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