AMAGLIME 2/MG TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults, as an adjunct to diet and exercise; may be used as monotherapy or in combination with other antidiabetic agents (e.g., metformin, insulin) when appropriate.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): initial 1 mg once daily with breakfast/first main meal (or 1-2 mg in some patients), titrate by 1-2 mg at 1-2 week intervals; usual maintenance 1-4 mg once daily; maximum 8 mg once daily.

Initial Dose

1-2 mg once daily with breakfast or first main meal

Maintenance Dose

1-4 mg once daily, titrated at 1-2 mg increments every 1-2 weeks based on blood glucose response

Maximum Dose

8 mg once daily (maximum recommended daily dose).

Dose Adjustment Notes

Start low and titrate cautiously: typically initiate 1 mg once daily in elderly and/or renal impairment; titrate by 1-2 mg no more frequently than every 1-2 weeks based on glucose; consider lower starting dose and careful monitoring when switching from longer-acting sulfonylureas to reduce hypoglycemia risk.

Side Effects

Common Side Effects

Hypoglycemia, weight gain, dizziness, headache, nausea; less commonly gastrointestinal upset (e.g., abdominal pain, diarrhea, vomiting) and asthenia.

Safety & Warnings

Warnings & Precautions

Hypoglycemia risk (higher in elderly, malnourished, irregular meals, renal/hepatic impairment); educate on recognition/management and monitor glucose; beta-blockers may mask symptoms; consider G6PD deficiency (risk of hemolysis); during stress (infection, surgery, trauma) may need temporary switch to insulin; potential weight gain; caution with alcohol and interacting drugs; cardiovascular risk signal exists for older sulfonylureas-use individualized risk-benefit and guideline-directed therapy.

Drug Interactions

Food Interaction

Take once daily with breakfast or the first main meal; skipping or delaying meals after dosing increases the risk of hypoglycemia.

Alcohol Interaction

Avoid

Special Populations

Elderly

Initiate at 1 mg once daily; titrate slowly with careful blood glucose monitoring due to increased risk of hypoglycemia

Kidney Impairment

Renal impairment: start at 1 mg once daily and titrate cautiously with close glucose monitoring; avoid or use extreme caution in severe renal impairment/dialysis due to higher and prolonged hypoglycemia risk.

Storage & Patient Advice

Patient Counseling

Take once daily with breakfast/first main meal; do not skip meals after dosing; recognize and treat hypoglycemia (carry fast-acting glucose); monitor glucose as directed; avoid or limit alcohol; inform clinicians about all medicines and before surgery/acute illness; do not double doses if missed.

Pharmacology

Mechanism of Action

Stimulates insulin secretion by closing ATP-sensitive potassium (KATP) channels in pancreatic beta cells (leading to depolarization and calcium influx); also has extrapancreatic effects that may improve insulin sensitivity.

Onset of Action

Approximately 2-3 hours to peak effect after an oral dose (with glucose-lowering effect beginning within hours).

Duration of Effect

24 hours.

Bioavailability

100%.

Metabolism

Hepatic metabolism primarily via CYP2C9 to two main metabolites (M1 active, M2 inactive).

Protein Binding

Very highly protein bound (approximately >99%).

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 2 mg glimepiride

Diabetes Type

Type 2

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