GLIM 4/MG TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults as monotherapy or in combination with metformin or insulin

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (oral): Start 1-2 mg once daily with breakfast/first main meal (1 mg if high hypoglycemia risk); usual maintenance 1-4 mg once daily; maximum 8 mg/day. Combination with insulin: continue glimepiride at a low dose and titrate insulin per glucose response (no fixed insulin starting dose is universally recommended).

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.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Titrate in 1-2 mg increments no more frequently than every 1-2 weeks based on glucose; use conservative initiation/titration (e.g., start 1 mg daily) in elderly, renal impairment, hepatic impairment, or other high hypoglycemia-risk patients; when switching from longer-acting sulfonylureas, consider a washout or lower starting dose to reduce hypoglycemia risk.

How to Take

Swallow whole with water; take with breakfast or the first main meal of the day; do not crush or chew

Side Effects

Common Side Effects

Hypoglycemia; dizziness; headache; nausea (± vomiting); abdominal pain/dyspepsia; diarrhea; weight gain; asthenia (weakness).

Side Effect Frequency

Common: hypoglycemia; dizziness; headache; nausea (± other GI upset); weight gain; asthenia. Less common/rare but clinically important: hypersensitivity skin reactions, elevated liver enzymes/hepatitis/cholestasis, and hematologic dyscrasias (e.g., leukopenia, thrombocytopenia).

Safety & Warnings

Contraindications

Hypersensitivity to glimepiride/other sulfonylureas (or excipients); type 1 diabetes mellitus; diabetic ketoacidosis (with or without coma).

Warnings & Precautions

High hypoglycemia risk (elderly, malnourished, renal/hepatic impairment; missed meals/exercise); educate/monitor glucose; beta-blockers may mask symptoms; caution in G6PD deficiency (hemolysis); possible cross-reactivity with sulfonamides; during stress/illness/surgery may need temporary insulin; class warning: possible increased cardiovascular mortality (based on older sulfonylurea data).

Age Restriction

Pediatric use: safety and efficacy not established; generally not recommended under 18 years.

Driving Warning

Use caution when driving or operating machinery; risk of hypoglycemia may impair ability to drive

Drug Interactions

Drug Interactions

Key interactions: CYP2C9 inhibitors (e.g., fluconazole) and miconazole increase hypoglycemia risk; NSAIDs/salicylates, ACE inhibitors, MAOIs, warfarin and alcohol may potentiate hypoglycemia; CYP2C9 inducers (e.g., rifampin) and hyperglycemic agents (corticosteroids, thiazides, thyroid hormones) may reduce effect; beta-blockers can mask hypoglycemia symptoms.

Interaction Severity

MAJOR: Miconazole (especially oral/systemic) and other strong CYP2C9 inhibitors (e.g., fluconazole) → markedly increased hypoglycemia risk; Concomitant insulin/other hypoglycemics → additive hypoglycemia. MODERATE: Beta-blockers (mask/prolong hypoglycemia); NSAIDs and some ACE inhibitors/MAOIs (may enhance hypoglycemia); CYP2C9 inducers such as rifampin (reduced effect); corticosteroids and thiazide diuretics (hyperglycemia/reduced control). MINOR/variable: Alcohol (unpredictable glycemic effect; may worsen hypoglycemia).

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

Not approved for children.

Elderly

Initiate at 1 mg once daily; titrate slowly with close blood glucose monitoring due to increased risk of hypoglycemia; renal function should be assessed before and during treatment

Kidney Impairment

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

Liver Impairment

Use with caution in hepatic impairment; start low (e.g., 1 mg once daily) and titrate carefully; avoid/use alternative therapy in severe hepatic impairment.

Storage & Patient Advice

Missed Dose

Take as soon as remembered with food. If it is almost time for the next dose, skip the missed dose. Do not take a double dose.

Stopping the Medicine

Do not stop abruptly without prescriber advice; stopping can worsen glycemic control-consult your doctor before discontinuation.

Overdose

Overdose causes potentially prolonged severe hypoglycemia (confusion, seizures, coma); treat with rapid glucose (oral if conscious, IV dextrose if not), consider glucagon if IV access unavailable, and monitor/continue dextrose as needed for 24-48 hours with urgent medical care.

Patient Counseling

Take once daily with breakfast/first main meal at the same time each day; do not skip meals after dosing; recognize and treat hypoglycemia (carry fast-acting glucose); monitor glucose as directed; avoid/limit alcohol; use caution driving/operating machinery if hypoglycemia occurs; tell clinicians about all medicines (notably azole antifungals, beta-blockers, NSAIDs, steroids); seek care for severe/recurrent hypoglycemia or signs of allergy, jaundice, or unusual bruising/infection.

Monitoring Requirements

Monitor capillary/SMBG (or CGM) and HbA1c (about every 3 months until stable, then every 3-6 months); monitor for hypoglycemia; assess renal function periodically; consider liver enzymes and CBC if clinically indicated (e.g., symptoms of hepatic dysfunction or blood dyscrasia).

Pharmacology

Mechanism of Action

Sulfonylurea: stimulates insulin release by closing ATP-sensitive K+ channels (SUR1) on pancreatic beta cells causing depolarization and Ca2+ influx; also has minor extrapancreatic effects improving insulin sensitivity.

Onset of Action

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

Duration of Effect

24 hours.

Half-Life

5-9 hours.

Bioavailability

High/near-complete oral bioavailability (often cited as ~100%).

Metabolism

Hepatic metabolism primarily via CYP2C9 to M1 (active) and M2 (inactive) metabolites.

Protein Binding

>99.5%.

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 4 mg glimepiride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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