GLIM 6/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

initial: 1-2 mg orally once daily with breakfast/first main meal (1 mg if elderly or renal impairment/high hypoglycemia risk)
titration: Increase by 1-2 mg no more often than every 1-2 weeks
maintenance: 1-4 mg once daily
max: 8 mg once daily

Initial Dose

1-2 mg once daily, administered with breakfast or the first main meal.

Maintenance Dose

1-4 mg once daily. Dose is titrated up in increments of 1-2 mg every 1-2 weeks based on glycemic response.

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

Titrate upward in 1-2 mg increments no more frequently than every 1-2 weeks based on glucose response; start 1 mg once daily in patients at higher hypoglycemia risk (e.g., elderly, renal impairment) and titrate cautiously; use caution when switching from longer-acting sulfonylureas (may need lower initial dose/monitoring); avoid/use extreme caution in severe hepatic impairment and use caution in significant renal impairment.

How to Take

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

Side Effects

Common Side Effects

Hypoglycemia, dizziness, headache, nausea, weakness/asthenia, weight gain

Side Effect Frequency

Common: hypoglycemia; dizziness, headache, nausea, asthenia/weakness, weight gain. Less common/rare: visual disturbances, hypersensitivity/skin reactions, hematologic effects (e.g., thrombocytopenia/leukopenia), and hepatic enzyme elevations.

Safety & Warnings

Contraindications

Hypersensitivity to glimepiride/sulfonylureas (or excipients); Type 1 diabetes; diabetic ketoacidosis (± coma); pregnancy (generally avoid-use insulin); breastfeeding (generally avoid)

Warnings & Precautions

High hypoglycemia risk (elderly, malnourished, irregular meals, renal/hepatic impairment); 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; not for T1DM or DKA; possible weight gain; caution with driving/operating machinery if hypoglycemia occurs

Age Restriction

Not recommended under 18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: other glucose-lowering drugs (incl. insulin) ↑ hypoglycemia; CYP2C9 inhibitors (e.g., fluconazole) ↑ effect; enzyme inducers (e.g., rifampicin) ↓ effect; miconazole (systemic/oromucosal) ↑ severe hypoglycemia; NSAIDs/salicylates, sulfonamides, MAOIs, quinolones, ACE inhibitors can ↑ hypoglycemia; beta-blockers can mask hypoglycemia; thiazide diuretics/corticosteroids/sympathomimetics can ↑ glucose and reduce effect; bile-acid sequestrants (e.g., colesevelam) can ↓ absorption-separate dosing; warfarin effect may be altered; alcohol can ↑ hypoglycemia

Interaction Severity

"MAJOR: ["Miconazole (especially systemic/oromucosal): markedly increases hypoglycemia risk
Insulin or other insulin secretagogues: additive hypoglycemia risk"], "MODERATE: ["Fluconazole (CYP2C9 inhibition) and other strong CYP2C9 inhibitors: increased glimepiride exposure/hypoglycemia
Rifampin (CYP2C9 induction): reduced glimepiride effect/hyperglycemia
Quinolone antibiotics: dysglycemia (including hypoglycemia) risk
NSAIDs and salicylates: may potentiate hypoglycemia
ACE inhibitors: may enhance glucose-lowering/hypoglycemia
Beta-blockers: may mask hypoglycemia symptoms
Warfarin: possible alteration of anticoagulant effect/INR-monitor
Bile acid sequestrants (e.g., colesevelam): may reduce absorption-separate dosing"], "MINOR: ["Thiazide diuretics and corticosteroids: may antagonize glucose-lowering effect (hyperglycemia risk)"]

Food Interaction

Take once daily with breakfast or the first main meal; taking without food increases hypoglycemia risk.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category C

Breastfeeding

Use is not recommended

Children

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

Elderly

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

Kidney Impairment

Start 1 mg once daily and titrate cautiously in renal impairment; avoid/not recommended in severe renal impairment due to high hypoglycemia risk

Liver Impairment

Use with caution in hepatic impairment; start at 1 mg daily and titrate carefully; avoid/not recommended in severe hepatic impairment

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without prescriber advice; if switching from another long half-life sulfonylurea, a washout/transition may be needed

Overdose

Severe/prolonged hypoglycemia (sweating, tremor, palpitations, confusion → seizures/coma); treat immediately with fast-acting carbohydrate if conscious; if severe/unconscious give IV dextrose (bolus then infusion) and/or glucagon, with prolonged monitoring and repeat glucose as needed; seek emergency care

Patient Counseling

Take once daily with breakfast/first main meal and do not skip meals; recognize and treat hypoglycemia (carry fast-acting glucose), and use caution with driving/operating machinery if symptomatic; avoid or limit alcohol due to hypoglycemia risk; monitor glucose as directed and keep follow-up for HbA1c; inform clinicians about intercurrent illness, surgery, or medication changes that can affect glucose control.

Pharmacology

Mechanism of Action

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

Onset of Action

Approximately 2-3 hours after oral administration (peak effect).

Duration of Effect

24 hours.

Bioavailability

100%.

Metabolism

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

Excretion

Renal (60%), fecal (40%)

Protein Binding

>99% (highly protein bound).

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 6 mg glimepiride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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