Product Description

Gliclazide Extended-Release Tablets IP 60 mg is an oral antidiabetic medication from the sulfonylurea class, used to control high blood sugar levels in adults with Type 2 diabetes mellitus (T2DM, non-insulin-dependent diabetes). It stimulates the pancreas to produce more insulin, helping cells absorb glucose for energy. 

It is an adjunct to diet, exercise, and weight management; suitable for monotherapy or combination with other agents (e.g., metformin, DPP-4 inhibitors). The XR formulation releases the drug gradually over 24 hours, providing stable glycemic control with once-daily dosing and a lower risk of hypoglycemia than immediate-release versions.

It does not cure diabetes and requires lifelong use to prevent complications like neuropathy, retinopathy, or cardiovascular disease. Not for Type 1 diabetes or diabetic ketoacidosis (DKA).

Avoid it if you have Type 1 DM, DKA, sulfa allergy, or severe kidney/liver disease. Baseline HbA1c and renal function tests are recommended.

Uses

Gliclazide XR 60 mg Tablets IP are indicated for:

• Glycemic control in adults with Type 2 diabetes mellitus as an adjunct to diet and exercise (monotherapy or in combination with metformin, pioglitazone, or insulin)

• Prevention of long-term complications such as kidney damage (nephropathy), blindness (retinopathy), nerve damage (neuropathy), and cardiovascular events

Not for gestational diabetes, Type 1 DM, or acute hyperglycemia (use insulin). Target HbA1c <7% with monitoring every 3–6 months per ADA guidelines.

How it works

Gliclazide XR 60 mg Tablets contain gliclazide, which binds to the sulfonylurea receptor 1 (SUR1) on ATP-sensitive potassium (K-ATP) channels in pancreatic beta cells. This inhibits K+ efflux, depolarizing the cell membrane and opening voltage-gated calcium channels. The resulting calcium influx triggers insulin granule exocytosis (secretion), increasing insulin release in a glucose-dependent manner (though less so at low glucose, risking hypo). The XR matrix ensures slow dissolution in the GI tract, providing steady plasma levels (t½ 10–12 hours extended) for 24-hour coverage. It may also have mild extrapancreatic effects, like improving insulin sensitivity and reducing platelet aggregation, but the primary action is insulin stimulation.

Benefits

Gliclazide XR 60 mg Tablets provide effective, once-daily control of blood sugar (HbA1c reduction of 1–1.5% in trials), reducing postprandial spikes and fasting hyperglycemia while minimizing hypoglycemia risk (lower than glibenclamide). The steady release supports better adherence and stable levels throughout the day, helping prevent diabetes complications (e.g., 20–30% lower microvascular risk with good control). It is weight-neutral or causes minimal gain compared to insulin, and the formulation is convenient for elderly patients, improving quality of life without the need for multiple doses.

How to use

Swallow the whole tablet. Do not crush, break, or chew it unless explicitly instructed by a healthcare professional. With Meals: Taking gliclazide with food can help mitigate gastrointestinal discomfort. Some guidance suggests taking it before breakfast or approximately 30 minutes before the first meal.

Side Effects

Most side effects are related to hypoglycemia or GI effects and are dose-dependent. Common side effects (affecting 1–10% of patients) include:

• Hypoglycemia (low blood sugar: dizziness, weakness, sweating, confusion, hunger, tremors—treat with 15 g fast carbs like glucose tablets or juice)

• Nausea, vomiting, diarrhea, or constipation

• Weight gain (1–2 kg average)

• Headache or dizziness

Less common but notable side effects:

• Rash, itching, or hives (allergic)

• Fatigue

Safety Advice

• Alcohol: Avoid or limit, as it can unpredictably cause hypoglycemia (e.g., delayed onset) or hyperglycemia (binge drinking), plus GI irritation.

• Pregnancy: Category C (crosses placenta; animal studies show no teratogenicity, but human data limited—increased neonatal hypo risk). Stop at least 2 weeks before delivery; switch to insulin (preferred for tight control). Consult your doctor if planning pregnancy—use contraception.

• Breastfeeding: Avoid, as gliclazide passes into milk and may cause infant hypoglycemia. Use insulin or metformin alternatives; monitor if unavoidable.

• Driving/Operating Machinery: Hypoglycemia may impair judgment; do not drive until stable (e.g., after meals) and carry glucose/ID. Inform the licensing authority of frequent hypoglycemia.

Storage Conditions

• Store at a temperature below 30°C (86°F), in a cool, dry place away from direct sunlight, heat, and excessive moisture.

FAQs

What are gliclazide extended-release tablets 60 mg IP used for?

Gliclazide extended-release tablets are used to manage blood sugar levels in adults with type 2 diabetes mellitus. It is prescribed when diet and exercise alone haven't been sufficient to control blood glucose, and it can be used either as a stand-alone medication or in combination with other diabetes medications like metformin.

How does gliclazide work?

Gliclazide is a sulfonylurea medication that works by stimulating the pancreas to release more insulin. This increase in insulin helps lower blood sugar levels. It also improves insulin sensitivity and might help improve microvascular complications and offer vascular protection.

When should gliclazide be taken?

Gliclazide extended release is typically taken once daily with breakfast or the first meal of the day. Take it around the same time each day for best results.

What if a dose is missed?

If you miss a dose, take it as soon as you remember. However, if it's almost time for the next scheduled dose, skip the missed dose and