Gliclazide 80 mg (Plain) & 30/60 mg (MR/XR)
Generic Name: Gliclazide 80 mg (Plain) & 30/60 mg (MR/XR)
Therapeutic Class: Sulfonylureas (Antidiabetic)
Indications
Gliclazide is indicated for the treatment of:
- Type 2 Diabetes Mellitus: Management of non-insulin-dependent diabetes in adults when dietary measures, physical exercise, and weight loss alone are insufficient to control blood glucose levels.
- Microvascular Complications: It is often chosen for its potential benefits in reducing the progression of diabetic retinopathy and nephropathy in Type 2 patients.
Presentation
Standard Tablet: 80 mg plain tablets.
Modified Release (MR/XR) Tablet: 30 mg and 60 mg tablets designed for once-daily dosing with a sustained release profile.
Modified Release (MR/XR) Tablet: 30 mg and 60 mg tablets designed for once-daily dosing with a sustained release profile.
Description
Gliclazide is a second-generation sulfonylurea that lowers blood glucose by stimulating insulin secretion from the Beta cells of the islets of Langerhans in the pancreas. It binds to the sulfonylurea receptor (SUR1) on the beta-cell membrane, closing ATP-sensitive potassium channels. This leads to cell depolarization, opening of calcium channels, and subsequent insulin release. Additionally, Gliclazide has unique extrapancreatic effects, such as increasing peripheral insulin sensitivity and exhibiting antioxidant properties that protect vascular endothelium.
Dosage & Administration
Administration: Should be taken 30 minutes before breakfast for optimal absorption.
- 80 mg Tablet: Initial dose is 40–80 mg daily. Maintenance dose is 80–160 mg. Maximum dose is 320 mg/day (divided into two doses).
- 30/60 mg MR Tablet: 30 mg to 120 mg as a single daily dose at breakfast. 60 mg MR is equivalent to two 30 mg MR tablets.
- Missed Dose: If a dose is missed, the next dose should be taken at the usual time. Do not double the dose.
Side Effects
- Hypoglycemia: Most common, especially if meals are skipped or after heavy exercise.
- Gastrointestinal: Nausea, dyspepsia, diarrhea, and constipation (minimized if taken with food).
- Dermatological: Rash, pruritus, erythema, and bullous reactions (rare).
- Hepatic: Rare increases in liver enzymes or cholestatic jaundice.
Pregnancy & Lactation
Pregnancy: Not recommended. Insulin is the preferred agent for managing diabetes during pregnancy.
Lactation: Contraindicated as it is unknown if Gliclazide is excreted in human milk, and there is a risk of neonatal hypoglycemia.
Lactation: Contraindicated as it is unknown if Gliclazide is excreted in human milk, and there is a risk of neonatal hypoglycemia.
Precautions & Interactions
Precautions: Use with caution in patients with **G6PD deficiency** (risk of hemolytic anemia) and severe renal or hepatic impairment.
Drug Interactions:
Drug Interactions:
- Potentiators (Increased Hypoglycemia risk): NSAIDs, Salicylates, Sulfonamides, Phenylbutazone, and MAOIs.
- Antagonists (Reduced Efficacy): Corticosteroids, Thiazide diuretics, and Danazol.
- Alcohol: May increase the hypoglycemic effect and lead to a disulfiram-like reaction.
Storage
Store in a dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.