DIAMICRON MR 30/MG 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults when diet and exercise (and weight reduction where appropriate) alone are insufficient to achieve adequate glycaemic control.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (modified-release): start 30 mg once daily with breakfast; increase by 30 mg steps at ≥1-month intervals; usual range 30-120 mg once daily; maximum 120 mg/day.

Initial Dose

30 mg once daily with breakfast

Maintenance Dose

30mg to 120mg once daily.

Maximum Dose

120mg per day for modified-release tablets.

Children's Dosage

Not approved for children. The safety and efficacy in children and adolescents have not been established.

Dose Adjustment Notes

Titrate in 30 mg increments at intervals of at least 1 month based on glucose/HbA1c; use the same regimen in mild-moderate renal impairment with careful monitoring; avoid/contraindicated in severe renal or severe hepatic impairment; in elderly or higher hypoglycaemia risk start low and titrate cautiously.

How to Take

Swallow the tablet whole with a glass of water. Do not crush or chew the modified-release tablet. Take once daily with breakfast.

Side Effects

Common Side Effects

Hypoglycaemia; gastrointestinal disturbances (nausea, dyspepsia/abdominal pain, diarrhoea, constipation); weight gain; headache/dizziness.

Safety & Warnings

Driving Warning

Hypoglycaemia may impair ability to drive or operate machinery; patients should be advised accordingly.

Drug Interactions

Food Interaction

Take once daily with breakfast/food; do not skip meals and maintain regular carbohydrate intake to reduce hypoglycaemia risk.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Not approved for children. The safety and efficacy in children and adolescents have not been established.

Storage & Patient Advice

Stopping the Medicine

Do not stop taking unless advised by your doctor; stopping may worsen glycemic control.

Patient Counseling

Take once daily with breakfast; swallow MR tablet whole (do not crush/chew); do not skip meals and keep regular carbohydrate intake; recognize and treat hypoglycaemia and carry fast-acting glucose; avoid or limit alcohol; check glucose as advised and attend HbA1c follow-up; inform clinicians about all medicines (notably miconazole/azole antifungals, antibiotics like fluoroquinolones, NSAIDs, beta-blockers) and report recurrent lows.

Pharmacology

Mechanism of Action

Sulfonylurea: binds SUR1 on pancreatic β-cells to close ATP-sensitive K+ channels, causing depolarization, Ca2+ influx and insulin release; may have additional extrapancreatic effects (e.g., improved insulin sensitivity/hemovascular effects), but the primary effect is insulin secretagogue activity.

Onset of Action

Glucose-lowering begins within the first day of dosing; peak plasma concentrations occur roughly 6-12 hours after MR dosing (clinical effect is sustained over 24 hours).

Duration of Effect

Approximately 24 hours (modified-release formulation).

Half-Life

Approximately 12-20 hours (modified-release gliclazide)

Bioavailability

Oral bioavailability: not reliably established/commonly reported as a single definitive value for gliclazide MR (do not state ~97% as a confirmed value).

Product Information

Available Dosage Forms

Modified-release tablet (this product: 30 mg MR).

Composition per Dose

Each modified-release tablet: 30 mg gliclazide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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