AMARYL 2/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 mg once daily with the first main meal; usual maintenance 1-4 mg once daily; maximum 8 mg/day (some references note limited added benefit above 6 mg/day).

Initial Dose

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

Maintenance Dose

1-4 mg once daily.

Maximum Dose

8 mg once daily.

Children's Dosage

Data are insufficient to recommend pediatric use of AMARYL.

Dose Adjustment Notes

Titrate based on SMBG/HbA1c in small increments (typically 1 mg) at 1-2 week intervals; use lower starting doses and cautious titration in elderly and in renal or hepatic impairment due to increased hypoglycemia risk.

How to Take

Oral: take once daily with water immediately before or with the first main meal (usually breakfast); tablets should be swallowed whole (do not crush/chew unless the specific product is scored and the label allows splitting).

Side Effects

Common Side Effects

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

Side Effect Frequency

Most important/common: hypoglycemia (frequency varies by population and concomitant therapy); other common effects include headache, dizziness, nausea/GI upset, and weight gain; rare but serious: hematologic dyscrasias (e.g., thrombocytopenia/leukopenia), hepatic injury (elevated enzymes/jaundice), and hypersensitivity/skin reactions.

Safety & Warnings

Contraindications

Known hypersensitivity to the drug; diabetic ketoacidosis, with or without coma.

Warnings & Precautions

Major warnings/precautions: hypoglycemia risk (missed meals, alcohol, exercise, elderly, renal/hepatic impairment) and need for SMBG; beta-blockers may mask symptoms; G6PD deficiency-risk of hemolysis (consider non-sulfonylurea); stress/illness/surgery may require temporary insulin; possible cross-hypersensitivity with sulfonamides; cardiovascular risk warning associated with sulfonylurea class; secondary failure over time.

Age Restriction

Data are insufficient to recommend pediatric use of AMARYL.

Driving Warning

Use caution when driving or operating machinery; hypoglycemia may impair ability to drive or operate machinery.

Drug Interactions

Drug Interactions

Key interactions: CYP2C9 inhibitors (e.g., fluconazole, miconazole-especially oral) increase hypoglycemia risk; CYP inducers (e.g., rifampicin) reduce effect; other glucose-lowering drugs (insulin, metformin, GLP-1 RA, etc.) increase hypoglycemia risk; NSAIDs/salicylates and ACE inhibitors can potentiate hypoglycemia; beta-blockers can mask hypoglycemia symptoms; quinolones may cause dysglycemia; corticosteroids and thiazide diuretics can raise glucose (reduce efficacy); warfarin effect may be altered.

Interaction Severity

MAJOR: miconazole (especially oral/systemic) and azole antifungals such as fluconazole (CYP2C9 inhibition) → increased glimepiride exposure and severe hypoglycemia; concomitant insulin/other secretagogues can also markedly increase hypoglycemia risk. MODERATE: rifampicin (reduced effect), quinolones, NSAIDs, ACE inhibitors, beta-blockers (may potentiate/mask hypoglycemia), corticosteroids and thiazides (hyperglycemia), warfarin (variable effect).

Food Interaction

Take with (or immediately before) the first main meal; do not skip or delay meals after dosing to reduce hypoglycemia risk.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Data are insufficient to recommend pediatric use of AMARYL.

Elderly

Start at 1 mg once daily, titrate slowly with careful 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 cautiously with close glucose monitoring; severe renal impairment-avoid or use only with extreme caution (higher risk of prolonged hypoglycemia).

Liver Impairment

Hepatic impairment: use with caution and start low/titrate slowly; severe hepatic impairment-avoid/contraindicated.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without prescriber advice; stopping can worsen glycemic control and may require alternative therapy/monitoring.

Overdose

Overdose causes potentially prolonged severe hypoglycemia (confusion, seizures, coma); treat immediately with oral fast-acting carbohydrate if conscious, or IV dextrose (bolus then infusion) if impaired consciousness; consider glucagon if IV access unavailable; monitor for recurrent hypoglycemia for 24-48+ hours and seek emergency care.

Patient Counseling

Take once daily with (or just before) the first main meal and do not skip meals; recognize and treat hypoglycemia (carry fast-acting glucose); avoid or limit alcohol; use caution driving/operating machinery if hypoglycemia occurs; check glucose as directed and keep follow-ups for HbA1c and kidney function; report severe/recurrent hypoglycemia or signs of allergy, jaundice, or unusual bruising/bleeding.

Monitoring Requirements

Monitor capillary blood glucose (SMBG) as clinically indicated and HbA1c about every 3 months until stable then at least twice yearly; monitor for hypoglycemia; assess renal function periodically (and consider liver function/CBC if clinically indicated or if symptoms suggest hepatic/hematologic adverse effects).

Pharmacology

Mechanism of Action

Sulfonylurea: stimulates insulin release by binding SUR1 on pancreatic beta-cell ATP-sensitive K+ channels, closing the channel → depolarization → Ca2+ influx → insulin secretion; may also improve peripheral insulin sensitivity.

Onset of Action

2-3 hours.

Duration of Effect

24 hours.

Half-Life

5-9 hours

Bioavailability

100%.

Metabolism

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

Excretion

Eliminated mainly as metabolites: ~60% in urine and ~40% in feces.

Protein Binding

Very highly protein bound (approximately >99%).

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 2 mg glimepiride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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