GLIM 1/MG TAB 30/TAB

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): Initial 1 mg once daily with breakfast/first main meal; titrate by 1 mg at 1-2 week intervals based on glucose; usual maintenance 1-4 mg once daily; maximum 8 mg once daily.

Initial Dose

1 mg once daily with the first main meal

Maintenance Dose

1-4 mg once daily

Maximum Dose

8 mg once daily

Children's Dosage

Not recommended for children due to adverse effects on body weight and hypoglycemia.

Dose Adjustment Notes

Start 1 mg once daily in patients at increased hypoglycemia risk (elderly, renal impairment, debilitated/malnourished) and titrate conservatively (generally every 1-2 weeks); use caution in hepatic impairment and when switching from longer-acting sulfonylureas.

How to Take

Swallow tablet whole with water once daily with breakfast or the first main meal of the day; do not crush or chew.

Side Effects

Common Side Effects

Hypoglycemia, weight gain, dizziness, headache, nausea.

Safety & Warnings

Contraindications

Hypersensitivity to glimepiride or other sulfonylureas/sulfonamides; type 1 diabetes; diabetic ketoacidosis (with or without coma); pregnancy (avoid-insulin preferred); breastfeeding (avoid)

Warnings & Precautions

Major precautions: hypoglycemia risk (higher in elderly, malnourished, renal/hepatic impairment, irregular meals); educate on recognition/management and monitor glucose; beta-blockers may mask symptoms; caution in G6PD deficiency (hemolysis); during stress/illness/surgery may need temporary insulin; possible weight gain; caution with alcohol; monitor for hepatic dysfunction and blood dyscrasias

Age Restriction

Not recommended under 18 years.

Drug Interactions

Drug Interactions

Key clinically relevant interactions: other antidiabetics/insulin (↑ hypoglycemia); CYP2C9 inhibitors (e.g., fluconazole) and miconazole (↑ hypoglycemia); CYP inducers (e.g., rifampicin) (↓ effect); NSAIDs/salicylates, ACE inhibitors, some antibiotics (e.g., quinolones, clarithromycin/chloramphenicol) (↑ hypoglycemia); corticosteroids and thiazide diuretics (↑ glucose/↓ effect); beta-blockers (mask hypoglycemia); alcohol (↑ hypoglycemia); warfarin (may alter anticoagulant effect)

Food Interaction

Take with breakfast or the first main meal; avoid taking on an empty stomach and do not skip meals after dosing due to increased hypoglycemia risk.

Special Populations

Pregnancy

Consult Doctor

Children

Not recommended for children due to adverse effects on body weight and hypoglycemia.

Elderly

Start at 1mg once daily and titrate slowly and conservatively to avoid hypoglycemia.

Kidney Impairment

Renal impairment: start at 1 mg once daily and titrate cautiously with close glucose monitoring; severe CKD: use extreme caution/consider alternative (often insulin) rather than declaring an absolute contraindication

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; limit/avoid alcohol; tell clinicians about all medicines (notably azole antifungals, rifampin, beta-blockers, NSAIDs); use caution driving if hypoglycemia occurs.

Monitoring Requirements

Monitor capillary blood glucose (as clinically indicated) and HbA1c about every 3 months until stable then periodically; monitor for hypoglycemia; assess renal function periodically and consider liver function tests if clinically indicated.

Pharmacology

Mechanism of Action

Sulfonylurea that stimulates insulin release by closing ATP-sensitive K+ channels on pancreatic beta cells (depolarization → Ca2+ influx); may also have extrapancreatic effects improving insulin sensitivity.

Onset of Action

Peak glucose-lowering effect occurs about 2-3 hours after an oral dose.

Duration of Effect

24 hours.

Half-Life

Approximately 5-9 hours.

Metabolism

Hepatic metabolism primarily via CYP2C9 to two main metabolites (M1 active hydroxy metabolite and M2 inactive carboxy metabolite).

Excretion

Renal (60% as metabolites), fecal (40% as metabolites)

Protein Binding

>99% (highly protein bound).

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 1 mg glimepiride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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