AMARYL 1/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 and/or insulin) when appropriate.

Dosage & Administration

Dosing by Condition

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

Initial Dose

1 mg once daily with breakfast or first main meal

Maintenance Dose

1-4mg once daily; most patients are controlled on 4mg or less.

Maximum Dose

8 mg once daily.

Children's Dosage

Data are insufficient to recommend pediatric use of AMARYL.

Dose Adjustment Notes

Start low and titrate based on glycemic response; increase by 1 mg (some references allow 1-2 mg) no more frequently than every 1-2 weeks; use conservative dosing and close monitoring in renal or hepatic impairment and when switching from other sulfonylureas.

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, asthenia (weakness), and weight gain.

Safety & Warnings

Contraindications

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

Warnings & Precautions

High hypoglycemia risk (elderly, malnourished, irregular meals, renal/hepatic impairment); educate on recognition/management and monitor glucose; caution in G6PD deficiency (hemolysis risk); beta-blockers may mask symptoms; intercurrent illness/surgery/stress may require therapy adjustment (often temporary insulin); possible weight gain; consider class warning regarding cardiovascular risk and use individualized risk-benefit.

Age Restriction

Pediatric use: Data are insufficient to recommend pediatric use of AMARYL.

Driving Warning

Hypoglycemia may impair ability to drive or operate machinery; patients should be advised accordingly.

Drug Interactions

Drug Interactions

Increased hypoglycemia risk with CYP2C9 inhibitors (e.g., fluconazole/miconazole), NSAIDs/salicylates, sulfonamides, MAOIs, ACE inhibitors; decreased effect with enzyme inducers (e.g., rifampicin) and hyperglycemia-inducing drugs (e.g., corticosteroids, thiazides, thyroid hormones, phenytoin); beta-blockers may mask hypoglycemia; alcohol may potentiate hypoglycemia; warfarin effect may be altered.

Interaction Severity

MAJOR: Miconazole (especially systemic/oromucosal) and other strong CYP2C9 inhibitors (e.g., fluconazole) and concomitant insulin/other secretagogues due to severe/additive hypoglycemia risk. MODERATE: NSAIDs/salicylates, sulfonamides, MAOIs, ACE inhibitors, beta-blockers (may potentiate or mask hypoglycemia); corticosteroids and thiazide diuretics (may reduce glycemic control); rifampicin (may reduce effect). MINOR: H2 blockers (cimetidine/ranitidine) and alcohol (variable glycemic effects).

Food Interaction

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

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Contraindicated

Children

Data are insufficient to recommend pediatric use of AMARYL.

Elderly

Start with 1mg once daily and titrate slowly due to increased risk of hypoglycemia. Monitor renal function.

Kidney Impairment

Renal impairment: start at 1 mg once daily and titrate cautiously with close glucose monitoring; severe renal impairment (e.g., eGFR <30 mL/min/1.73 m²) generally avoid/not recommended due to hypoglycemia risk.

Liver Impairment

Mild-moderate hepatic impairment: use with caution and start low (e.g., 1 mg daily) with careful titration; severe hepatic impairment: avoid/not recommended (often treated as contraindicated).

Storage & Patient Advice

Stopping the Medicine

Do not stop without prescriber advice; if discontinuing, ensure close glucose monitoring and timely transition to alternative therapy to avoid hyperglycemia.

Overdose

Overdose causes potentially prolonged severe hypoglycemia (seizures/coma); treat immediately with oral glucose if conscious, and IV dextrose (bolus then infusion) if severe/unconscious, with prolonged monitoring (often 24-48 hours) due to recurrence risk.

Patient Counseling

Take once daily with breakfast/first main meal at the same time each day; do not skip meals after taking it; recognize and treat hypoglycemia (carry fast-acting glucose); monitor glucose as directed; avoid/limit alcohol; inform clinicians about illness, surgery, or new medications due to interaction and hypoglycemia risks.

Monitoring Requirements

Monitor capillary/SMBG (or CGM) as clinically indicated and HbA1c about every 3 months until stable then at least twice yearly; monitor for hypoglycemia and weight; consider periodic renal function and liver tests based on comorbidity/risk and when clinically indicated.

Pharmacology

Mechanism of Action

Stimulates insulin release from pancreatic beta cells by closing ATP-sensitive potassium (KATP) channels via SUR1 binding, leading to depolarization and calcium influx; may also improve peripheral insulin sensitivity.

Duration of Effect

24 hours.

Half-Life

Approximately 5-9 hours.

Bioavailability

100%.

Metabolism

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

Excretion

Approximately 60% excreted in urine and 40% in feces, primarily as metabolites.

Protein Binding

>99% (very 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.

Insulin Type

Not an insulin

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.