CLAZ MR 30/MG MR TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults when diet and exercise (and weight control) alone are insufficient to achieve glycemic control.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): Start 30 mg once daily with breakfast; increase by 30 mg steps every ≥2-4 weeks according to blood glucose/HbA1c; usual maintenance 30-120 mg once daily; maximum 120 mg once daily.

Initial Dose

30 mg once daily, taken with breakfast.

Maintenance Dose

30 mg to 120 mg once daily.

Maximum Dose

120 mg once daily for the modified-release formulation.

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 based on glycemic response at intervals of at least 2-4 weeks (often ~4 weeks). Start at 30 mg and titrate cautiously in older adults and in mild-moderate renal impairment; avoid/use specialist advice in severe renal/hepatic impairment. When switching from immediate-release gliclazide, use clinical judgment (commonly 80 mg IR daily ≈ 30 mg MR daily) with close glucose monitoring.

How to Take

Swallow the modified-release tablet whole with water; do not crush or chew. Take once daily in a single intake with breakfast (or the first main meal) at the same time each day.

Side Effects

Common Side Effects

Hypoglycemia; gastrointestinal disturbances (nausea, vomiting, abdominal pain, dyspepsia, diarrhea, constipation); weight gain.

Safety & Warnings

Contraindications

Hypersensitivity to gliclazide/other sulfonylureas/sulfonamides; type 1 diabetes; diabetic ketoacidosis; diabetic pre-coma/coma; severe renal impairment; severe hepatic impairment; concomitant miconazole (especially systemic/oromucosal); pregnancy; breastfeeding.

Warnings & Precautions

High hypoglycemia risk with missed/irregular meals, calorie restriction, strenuous exercise, alcohol, elderly/frail, and renal/hepatic impairment; counsel not to skip meals and to monitor glucose (and HbA1c). Beta-blockers can mask adrenergic symptoms; consider G6PD deficiency risk (hemolysis); intercurrent illness/surgery/stress may require temporary insulin; review interacting drugs and educate on hypoglycemia recognition/management.

Age Restriction

Not recommended/insufficient data in children and adolescents (<18 years); use is generally restricted to adults.

Driving Warning

Avoid Driving

Drug Interactions

Interaction Severity

MAJOR/Contraindicated: miconazole (especially systemic/oromucosal) due to severe hypoglycemia risk. MODERATE: other agents that increase hypoglycemia risk (e.g., fluconazole/azole antifungals, clarithromycin, sulfonamides, MAOIs, NSAIDs, ACE inhibitors, alcohol) and agents that raise glucose/antagonize effect (e.g., systemic corticosteroids, thiazide diuretics, sympathomimetics). MODERATE: warfarin (possible potentiation of anticoagulant effect-monitor INR). MINOR/Clinical note: beta-blockers may mask hypoglycemia symptoms (risk is clinical rather than purely pharmacokinetic).

Food Interaction

Take with food-preferably with breakfast/first main meal; do not skip or delay meals after dosing to reduce hypoglycemia 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.

Elderly

Start at 30 mg once daily; titrate slowly with careful blood glucose monitoring due to increased risk of hypoglycemia; avoid prolonged or severe hypoglycemia

Kidney Impairment

Mild-moderate renal impairment (eGFR/CrCl ≥30 mL/min): generally no formal dose adjustment but start low and titrate cautiously with close monitoring; severe renal impairment (CrCl <30 mL/min): avoid/contraindicated.

Liver Impairment

Mild-moderate hepatic impairment: use with caution and start at the lowest dose (e.g., 30 mg MR) with close glucose monitoring; severe hepatic impairment: contraindicated/avoid.

Storage & Patient Advice

Stopping the Medicine

Do not stop gliclazide MR without medical advice; stopping can worsen glycemic control and cause hyperglycemia.

Overdose

Overdose causes potentially prolonged severe hypoglycemia (neuroglycopenia, seizures, coma). Treat with rapid carbohydrates if conscious; if severe/unconscious give IV dextrose (bolus then infusion) and monitor for recurrent hypoglycemia for 24-48 hours; hospital/urgent care is required for severe cases.

Patient Counseling

Take once daily with breakfast/first main meal and swallow whole (do not crush/chew). Do not skip meals; know and treat hypoglycemia (carry fast-acting glucose). Monitor glucose as directed and keep follow-up for HbA1c. Avoid/limit alcohol and check before starting new medicines (notably azole antifungals like miconazole/fluconazole, some antibiotics, NSAIDs). Report recurrent hypoglycemia, severe rash, jaundice, or unusual bruising/bleeding.

Monitoring Requirements

Monitor capillary blood glucose as clinically indicated (especially during initiation/titration and with interacting drugs), and HbA1c about every 3 months until controlled then every ~6 months. Assess renal function at baseline and periodically; consider liver function periodically; monitor for hypoglycemia and weight changes.

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 minor extrapancreatic effects (improved peripheral insulin sensitivity/reduced hepatic glucose output).

Duration of Effect

Approximately 24 hours.

Protein Binding

Approximately 95% (primarily albumin)

Product Information

Available Dosage Forms

Modified-release tablet, Immediate-release tablet.

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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