AMARYL 3/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

initial: 1 mg orally once daily with breakfast/first main meal (some patients may start at 2 mg if low hypoglycemia risk).
titration: Increase by 1 mg (up to 2 mg per step in some references) no more frequently than every 1-2 weeks based on SMBG/HbA1c.
maintenance: 1-4 mg once daily.
max: 8 mg once daily.

Initial Dose

1 mg once daily (regardless of this SKU strength; dose is titrated from 1 mg)

Maintenance Dose

1-4 mg once daily; titrated based on glycemic response.

Maximum Dose

8 mg once daily

Children's Dosage

Not recommended for use in pediatric patients due to adverse effects on body weight and hypoglycemia.

Dose Adjustment Notes

Titrate based on glucose response at 1-2 week intervals; increase by 1 mg (some references allow 1-2 mg) per step; use conservative titration in elderly/renal impairment or other high hypoglycemia-risk patients; when switching from long-acting sulfonylureas consider a washout or lower starting dose; when used with insulin or other agents, consider lowering the concomitant agent to reduce hypoglycemia.

How to Take

Take orally once daily with breakfast or the first main meal; swallow the tablet whole with water (do not crush/chew unless the product is scored and the prescriber/pharmacist advises splitting).

Side Effects

Common Side Effects

Hypoglycemia; dizziness; headache; nausea (GI upset such as abdominal pain/diarrhea can occur); weight gain.

Side Effect Frequency

"Very common/most clinically important: Hypoglycemia (frequency varies by population and concomitant therapy; it is the key expected adverse effect).
Common: Dizziness, headache, nausea and other GI upset; weight gain.
Uncommon/Rare: Blood dyscrasias (e.g., thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia), hypersensitivity reactions, elevated liver enzymes/hepatitis/cholestasis, severe cutaneous reactions (e.g., SJS/TEN), hyponatremia, visual disturbances."

Safety & Warnings

Contraindications

Hypersensitivity to glimepiride or other sulfonylureas/sulfonamides; type 1 diabetes; diabetic ketoacidosis (± coma/precoma); pregnancy; severe hepatic impairment; severe renal impairment

Warnings & Precautions

Risk of hypoglycemia (higher in 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; stress/illness/surgery may require switching to insulin; not for type 1 diabetes or DKA; class warning: possible increased cardiovascular mortality vs diet alone

Age Restriction

Safety and efficacy evaluated in pediatric patients 8-17 years with type 2 diabetes; not recommended for use in pediatric patients due to adverse effects on body weight and hypoglycemia risk; data insufficient to recommend pediatric use

Driving Warning

Hypoglycemia may impair ability to drive or operate machinery

Drug Interactions

Drug Interactions

Potentiates hypoglycemia with other antidiabetics (incl. insulin), NSAIDs/salicylates, sulfonamides, azole antifungals (e.g., fluconazole/miconazole), MAOIs, ACE inhibitors; reduced effect with rifampicin and other enzyme inducers, thiazide diuretics, corticosteroids; beta-blockers may mask hypoglycemia; alcohol may cause unpredictable glycemic effects; may alter anticoagulant effect of warfarin

Interaction Severity

"MAJOR: Miconazole (especially systemic/oromucosal) and other strong CYP2C9 inhibitors (e.g., fluconazole) due to markedly increased hypoglycemia risk; concomitant insulin/secretagogues can also cause severe additive hypoglycemia.
MODERATE: NSAIDs, sulfonamides, quinolones, MAOIs, ACE inhibitors (may enhance hypoglycemia); beta-blockers (may mask hypoglycemia symptoms); rifampicin (reduced effect via enzyme induction); corticosteroids/thiazides (may worsen glycemic control).
MINOR: Alcohol (unpredictable effect on glycemia; may increase hypoglycemia risk)."

Food Interaction

Administer with food-preferably breakfast or the first main meal; skipping/delaying meals increases hypoglycemia risk.

Special Populations

Pregnancy

Not recommended for use in pregnancy or nursing mothers; data insufficient to establish pregnancy category per FDA system

Breastfeeding

Consult Doctor

Children

Not recommended for use in pediatric patients 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; 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/ESRD: avoid or use only with specialist oversight (insulin often preferred)

Liver Impairment

Mild-moderate hepatic impairment: use with caution, start low (e.g., 1 mg daily) and titrate slowly; severe hepatic impairment: avoid/contraindicated

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without medical advice; consult prescriber before discontinuing

Overdose

May cause prolonged, severe hypoglycemia (sweating, tremor, confusion, seizures, coma); treat immediately with oral glucose if conscious, IV dextrose if severe/unconscious (± glucagon), and monitor for recurrent hypoglycemia for 24-48 hours; 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 symptoms occur; limit/avoid alcohol; inform clinicians about all medicines (notably azole antifungals like fluconazole/miconazole) and report severe/recurrent hypoglycemia or signs of liver/blood problems (jaundice, dark urine, unusual bruising/fever).

Monitoring Requirements

Monitor blood glucose (SMBG) regularly and HbA1c about every 3 months until stable then at least twice yearly; monitor for hypoglycemia; consider periodic renal function and liver enzymes, and CBC if clinically indicated (e.g., symptoms of blood dyscrasia).

Pharmacology

Mechanism of Action

Sulfonylurea that stimulates insulin release by closing ATP-sensitive K+ channels (SUR1) on pancreatic beta cells, leading to depolarization and Ca2+ influx; may also modestly improve peripheral insulin sensitivity.

Bioavailability

100%.

Metabolism

Hepatic metabolism primarily via CYP2C9 to metabolites (including an active hydroxy metabolite and a less active/inactive carboxy metabolite).

Protein Binding

>99% (approximately 99.5%).

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 3 mg glimepiride

Generic Availability

Yes

Diabetes Type

Type 2

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