GLIBIL 5/MG 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus (as monotherapy or adjunct to diet and exercise when diet alone is insufficient)

Dosage & Administration

Initial Dose

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

How to Take

Take orally once daily with breakfast or the first main meal; swallow with water. If a scored immediate‑release tablet, it may be split if needed; do not take on an empty stomach and do not skip meals after dosing.

Safety & Warnings

Warnings & Precautions

High risk of severe/prolonged hypoglycemia (especially elderly, renal/hepatic impairment, malnutrition, missed meals); counsel not to skip meals and to monitor glucose; caution/avoid in G6PD deficiency (hemolysis risk); may need temporary switch to insulin during acute illness/surgery/major stress; beta-blockers can mask hypoglycemia; monitor for hepatic dysfunction and discontinue if significant liver injury occurs.

Driving Warning

May impair ability to drive or operate machinery due to risk of hypoglycemia.

Drug Interactions

Drug Interactions

Major: bosentan (contraindicated). Increased hypoglycemia risk with azole antifungals (miconazole/fluconazole), sulfonamides, salicylates, phenylbutazone/NSAIDs, warfarin (variable), MAOIs, alcohol; beta-blockers may mask hypoglycemia. Reduced effect with rifampicin and hyperglycemia-inducing drugs (corticosteroids, thiazide diuretics).

Interaction Severity

MAJOR: Miconazole (especially systemic/oromucosal) - severe/prolonged hypoglycemia; Bosentan - avoid/contraindicated due to hepatotoxicity risk and reduced antidiabetic effect. MODERATE: Azole antifungals such as fluconazole (↑ hypoglycemia risk), clarithromycin, alcohol (↑ hypoglycemia; possible disulfiram-like reaction), NSAIDs/salicylates, sulfonamides, warfarin (variable; monitor), beta-blockers (mask symptoms), ACE inhibitors (↑ hypoglycemia), corticosteroids/thiazides (↓ glycemic control), rifampicin (↓ effect).

Alcohol Interaction

Dangerous

Special Populations

Breastfeeding

Contraindicated

Elderly

Start at lowest available dose (1.25-2.5 mg/day); titrate slowly with careful blood glucose monitoring; high risk of severe prolonged hypoglycemia; avoid if possible in patients over 65 with renal impairment

Liver Impairment

Mild-moderate hepatic impairment: use with caution and start low with close glucose monitoring; severe hepatic impairment: contraindicated/avoid.

Storage & Patient Advice

Storage Conditions

Store below 30°C, in a dry place, away from light

Missed Dose

If missed, take the dose with the next meal when remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule. Do not double the dose and do not take without eating.

Stopping the Medicine

Do not stop abruptly without clinician guidance; if discontinuing, arrange alternative glycemic therapy and monitor glucose closely to prevent hyperglycemia.

Overdose

Symptoms: severe, prolonged hypoglycemia (may cause seizures/coma/neurologic deficits). Management: immediate oral glucose if conscious; if severe/unconscious give IV dextrose bolus (e.g., 50% dextrose) followed by continuous dextrose infusion (e.g., 10%); consider glucagon; monitor for recurrence for 24-48 hours and seek emergency care.

Patient Counseling

Take with breakfast/first main meal and do not skip meals; know and treat hypoglycemia promptly (carry fast-acting glucose); avoid or limit alcohol; check glucose as directed and keep follow-up for HbA1c; tell clinicians about kidney/liver disease, planned surgery/acute illness, and all medicines (interaction risk).

Monitoring Requirements

Monitor capillary blood glucose (fasting and/or post‑prandial as individualized) and HbA1c about every 3 months until stable then at least twice yearly; monitor renal function (SCr/eGFR) and liver function periodically; monitor weight and assess for hypoglycemia; consider CBC if clinically indicated (rare hematologic effects).

Pharmacology

Bioavailability

Oral absorption is good but bioavailability is variable (commonly reported ~80-100%); it is highly protein bound and metabolized hepatically with active metabolites contributing to prolonged hypoglycemia in renal impairment.

Metabolism

Extensive hepatic metabolism primarily via CYP2C9 (minor CYP3A4), producing hydroxy metabolites (e.g., 4-trans-hydroxy and 3-cis-hydroxy) that retain some hypoglycemic activity.

Protein Binding

>99% protein bound, mainly to albumin.

Product Information

Available Dosage Forms

Tablet (immediate‑release) for this product (GLIBIL-5 TABS, 5 mg).

Composition per Dose

Each tablet: 5 mg glibenclamide

Generic Availability

Yes

Diabetes Type

Type 2

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 13-06-2026