Azukon MR Special Precautions

Gliclazide as other sulfonylureas, is capable of producing moderate to severe hypoglycemia, particularly in the following conditions; in patients controlled by diet alone; in case of accidental overdose; when calorie or glucose intake is deficient; in patients with hepatic and/or renal impairment, however, in long-term clinical trials, patients with renal insufficiency have been treated satisfactorily, using Gliclazide at reduced doses. Dosage adjustments may be necessary, on the occurrence of mild symptoms of hypoglycemia (sweating, pallor, hunger pangs, tachycardia, and sensation of malaise). Such findings should be treated with oral glucose and adjustments made in medicine dosage and/or meal patterns; on the occurrence of severe hypoglycemic reactions (coma or neurological impairment, see Overdosage), loss of control of blood glucose (hyperglycemia). When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control may occur. At such times it may be necessary to progressively increase the dosage of Gliclazide and if this is insufficient, discontinue the treatment of Gliclazide and to administer insulin.
Abnormalities of hepatic function may occur during Gliclazide therapy. There are less frequent reports of hepatic failure, hepatitis and jaundice following treatment with Gliclazide.
Care should be exercised in patients with hepatic and/or renal impairment and a small starting dose should be used with careful patient monitoring. As with other sulfonylureas, hypoglycemia will occur if the patient's dietary intake is reduced or if they are receiving a larger dose of Gliclazide than what is required.
Patients should be informed that their concentration might be affected if their diabetes is not satisfactorily controlled, especially at the beginning of treatment.
Use in Pregnancy & Lactation: If patient is pregnant, diabetes should be treated with insulin. Inform the doctor if the patient wishes to become pregnant. Some sulfonylureas are distributed into breast milk and the class of drugs should be avoided during breast feeding.