DAONIL M TAB 5

Indications

Approved Uses

Type 2 diabetes mellitus in adults when diet and exercise alone are insufficient

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adjunct to diet/exercise): Initial 2.5-5 mg once daily with breakfast/first main meal; titrate by ~2.5 mg at ~weekly intervals based on glucose; usual maintenance ~5-15 mg/day; doses >10 mg/day may be divided; maximum 20 mg/day.

Initial Dose

2.5mg to 5mg once daily with breakfast or the first main meal.

Maintenance Dose

5-15 mg/day as a single morning dose or in divided doses

Maximum Dose

20mg per day.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Individualize and titrate based on glucose; start low and titrate gradually (e.g., 2.5 mg increments at ~weekly intervals); consider dividing doses when >10 mg/day; use lower starting doses and cautious titration in elderly/debilitated/malnourished and in renal/hepatic impairment due to hypoglycemia risk (avoid/use extreme caution in severe impairment per labeling/guidelines).

How to Take

Swallow whole with water; take with breakfast or the first main meal of the day; maintain consistent meal timing

Side Effects

Common Side Effects

Hypoglycemia; weight gain; gastrointestinal upset (nausea, vomiting, diarrhea, abdominal/epigastric discomfort/heartburn, feeling of fullness)

Safety & Warnings

Contraindications

Hypersensitivity to glibenclamide/sulfonylureas; type 1 diabetes; diabetic ketoacidosis; diabetic coma/pre-coma; severe renal impairment; severe hepatic impairment; pregnancy (generally avoid-insulin preferred); concomitant bosentan (contraindicated).

Age Restriction

Not recommended/Not indicated in children and adolescents (<18 years); use only under specialist direction if ever considered.

Drug Interactions

Food Interaction

Take with food (with breakfast or the first main meal).

Special Populations

Children

Not approved for children.

Elderly

Start at 2.5 mg/day; titrate slowly with close blood glucose monitoring; increased risk of prolonged hypoglycemia; avoid if possible in patients over 65 with renal impairment

Storage & Patient Advice

Overdose

Overdose causes potentially prolonged severe hypoglycemia (confusion, seizures, coma); treat with rapid glucose (oral if conscious) and IV dextrose if severe/unconscious, with prolonged monitoring (often 24-48+ hours) and repeat dextrose as needed.

Pharmacology

Mechanism of Action

Stimulates insulin secretion by closing pancreatic beta-cell ATP-sensitive K+ channels (SUR1), causing depolarization, Ca2+ influx, and insulin release.

Onset of Action

Insulin response begins within ~15-60 minutes; clinical glucose-lowering onset is about ~1 hour.

Duration of Effect

Up to ~24 hours (commonly ~16-24 hours)

Half-Life

Approximately 10 hours (variable; commonly reported range ~5-16 hours).

Bioavailability

Rapidly and nearly completely absorbed (high oral bioavailability).

Metabolism

Extensively hepatic metabolism, primarily via CYP2C9 (minor CYP3A4), to hydroxy metabolites (4-trans-hydroxy and 3-cis-hydroxy) that have reduced/weak hypoglycemic activity; metabolites are eliminated in urine and bile.

Protein Binding

>99% protein bound (mainly to albumin).

Product Information

Available Dosage Forms

Tablet (oral)

Composition per Dose

Each tablet: 5 mg glibenclamide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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