DIAMICRON MR 60/MG 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults when diet and exercise (and weight reduction when appropriate) alone are insufficient.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults), modified-release: start 30 mg once daily with breakfast; increase in 30 mg steps to 60, 90, or 120 mg once daily as needed; maximum 120 mg/day.

Initial Dose

30mg once daily, taken with breakfast.

Maintenance Dose

30mg to 120mg once daily, adjusted according to blood glucose response.

Maximum Dose

120 mg once daily

Children's Dosage

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

Dose Adjustment Notes

Titrate based on glycemic response in 30 mg increments; usual titration interval is about 4 weeks, but may be shortened to ~2 weeks if inadequate control; in elderly or higher hypoglycemia-risk patients consider starting at 30 mg daily; in mild-moderate renal impairment generally no dose change is required but close monitoring is advised; switching from other sulfonylureas may require careful transition/monitoring.

How to Take

Take once daily at breakfast (preferably at the start of the meal); swallow the modified-release tablet whole with water-do not crush or chew; the tablet may be split only if it has a score line and the product labeling allows splitting to aid swallowing, but do not crush/chew.

Side Effects

Common Side Effects

Hypoglycemia; gastrointestinal upset (nausea, abdominal pain, dyspepsia, diarrhea/constipation); weight gain can occur; headache and dizziness may occur.

Safety & Warnings

Warnings & Precautions

Hypoglycemia risk (higher in elderly, malnourished/irregular meals, renal/hepatic impairment); symptoms may be masked by beta-blockers; caution in G6PD deficiency (hemolysis risk); caution in adrenal/pituitary insufficiency; monitor glucose/HbA1c and renal/hepatic function; during intercurrent illness/surgery/stress may need temporary insulin; avoid alcohol and review interacting drugs.

Age Restriction

Not recommended for use in children and adolescents under 18 years (safety/efficacy not established).

Drug Interactions

Food Interaction

Take with breakfast/with food; do not skip or delay meals after dosing to reduce hypoglycemia risk; alcohol should be avoided or minimized due to increased hypoglycemia risk.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

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

Elderly

Start at 30 mg once daily; titrate cautiously with close blood glucose monitoring due to increased risk of hypoglycemia; standard maximum dose of 120 mg applies

Storage & Patient Advice

Stopping the Medicine

Do not stop taking without consulting a doctor, as stopping can worsen glycemic control and cause hyperglycemia.

Overdose

Overdose causes potentially prolonged severe hypoglycemia (confusion, seizures, coma). Treat with rapid carbohydrates if conscious; if severe/unconscious give IV dextrose (e.g., bolus followed by infusion) and monitor for recurrent hypoglycemia for 24-48 hours; urgent medical care required.

Patient Counseling

Take once daily with breakfast; swallow whole (do not crush/chew). Do not skip meals; know and treat hypoglycemia (carry fast-acting glucose). Avoid/minimize alcohol. Check glucose as advised and keep follow-up for HbA1c. Tell your clinician about new medicines/illness, reduced food intake, or planned surgery; use caution with driving/operating machinery until you know your response.

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), but the primary effect is increased insulin secretion.

Onset of Action

Glucose-lowering begins within hours after a dose (peak effect typically within ~6-12 hours for MR), while full effect of a given dose level is assessed after titration over ~2-4 weeks.

Duration of Effect

Approximately 24 hours (once-daily coverage) for the modified-release formulation.

Half-Life

Approximately 12-20 hours (MR formulation; effective half-life may be longer than IR)

Bioavailability

>90% (high oral bioavailability; often cited ~97%)

Product Information

Available Dosage Forms

Modified-release tablet (this product); gliclazide is also available in some markets as an immediate-release tablet.

Composition per Dose

Each modified-release tablet: 60 mg gliclazide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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