CLAZ MR 60/MG MR TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults when diet, exercise, and weight reduction alone are insufficient to achieve adequate glycemic control.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): start 30 mg once daily with breakfast; titrate by 30 mg based on glucose/HbA1c at intervals of about 2-4 weeks (often ≥1 month); maintenance 30-120 mg once daily; maximum 120 mg/day.

Initial Dose

The recommended starting dose is 30 mg once daily.

Maintenance Dose

30mg to 120mg once daily.

Maximum Dose

120mg per day for modified-release formulation.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Adjust dose based on glycemic response; increase in 30 mg increments. Usual titration interval is at least 2-4 weeks (often ~1 month), but may be increased after 2 weeks if response is inadequate. Use cautious titration in older adults and in renal/hepatic impairment; consider lower starting dose (e.g., 30 mg daily) and close monitoring. When switching from immediate‑release gliclazide, convert to the nearest total daily dose and monitor closely.

How to Take

Take once daily with breakfast (or the first main meal). Swallow the modified‑release tablet whole with water; do not crush or chew. If the tablet is scored, it may be split only to aid swallowing (not to change the dose) and both halves should be taken together.

Side Effects

Common Side Effects

Hypoglycemia; gastrointestinal upset (nausea, dyspepsia/abdominal pain, diarrhea, constipation); weight gain; headache/dizziness.

Side Effect Frequency

Common: hypoglycemia; gastrointestinal disturbances (nausea, dyspepsia, diarrhea, constipation) and skin reactions (rash, pruritus, urticaria). Rare/very rare: blood dyscrasias (e.g., leukopenia, thrombocytopenia, agranulocytosis, hemolytic/aplastic anemia) and hepatic effects (elevated liver enzymes, hepatitis/cholestatic jaundice).

Safety & Warnings

Contraindications

Hypersensitivity to gliclazide/other sulfonylureas/sulfonamides; type 1 diabetes; diabetic ketoacidosis; diabetic pre-coma/coma; severe renal impairment; severe hepatic impairment; concomitant miconazole (systemic/oromucosal); pregnancy; breastfeeding.

Warnings & Precautions

High hypoglycemia risk with missed/irregular meals, low-calorie intake, strenuous exercise, alcohol, elderly/frail patients; educate on recognition/management of hypoglycemia and ensure regular meals; caution in G6PD deficiency; caution in renal/hepatic impairment; monitor glucose and HbA1c; consider temporary insulin during acute stress (infection, surgery, trauma).

Age Restriction

Not recommended for use in children and adolescents (<18 years) due to insufficient safety/efficacy data.

Driving Warning

May cause hypoglycemia which can impair driving ability; patients should be cautious when driving or operating machinery, particularly if experiencing hypoglycemic symptoms

Drug Interactions

Drug Interactions

Key interactions: miconazole (contraindicated-marked hypoglycemia); other potentiators of hypoglycemia include fluconazole/other azoles, NSAIDs/salicylates, alcohol, and ACE inhibitors; beta-blockers may both potentiate and mask hypoglycemia; reducers of effect (hyperglycemia) include systemic corticosteroids, danazol, chlorpromazine (high dose), and enzyme inducers such as rifampicin and St John’s wort.

Interaction Severity

MAJOR/Contraindicated: miconazole (systemic and often oral gel) due to severe hypoglycemia. MODERATE/Clinically significant: other azole antifungals (e.g., fluconazole), phenylbutazone/NSAIDs, alcohol, beta‑blockers (mask hypoglycemia), ACE inhibitors (may enhance hypoglycemia), fluoroquinolones (dysglycemia), rifampicin (reduced effect), corticosteroids and chlorpromazine (hyperglycemia/antagonize effect), danazol (hyperglycemia).

Food Interaction

Take with food-preferably with breakfast/first main meal-and do not skip or delay meals after dosing to reduce hypoglycemia risk.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Not approved for children.

Elderly

Start at 30 mg once daily; titrate slowly with careful blood glucose monitoring due to increased risk of hypoglycemia; avoid prolonged or severe hypoglycemia

Kidney Impairment

Severe renal impairment: avoid/contraindicated; mild-to-moderate renal impairment: may use usual dosing with careful titration and close hypoglycemia monitoring (consider lower starting dose in frail/elderly).

Liver Impairment

Severe hepatic impairment: contraindicated/avoid; mild-to-moderate hepatic impairment: use with caution, start low and monitor closely for hypoglycemia.

Storage & Patient Advice

Storage Conditions

Store below 30°C

Missed Dose

If you miss a dose, take it as soon as you remember the same day with food; if it is the next day or close to the next dose, skip the missed dose and take the next dose at the usual time-do not double the dose.

Stopping the Medicine

Do not stop without clinician guidance; if discontinued, ensure close glucose monitoring and timely initiation/adjustment of alternative antihyperglycemic therapy.

Overdose

Expected toxicity is severe, potentially prolonged hypoglycemia; treat immediately with rapid glucose (oral if conscious; IV dextrose if impaired consciousness), consider glucagon if IV access delayed, and monitor for recurrent hypoglycemia for at least 24-48 hours (often requires hospitalization).

Patient Counseling

Take once daily with breakfast/first main meal; swallow whole with water (do not crush/chew). Do not skip meals; know and treat hypoglycemia (carry fast sugar). Avoid or limit alcohol. Tell clinicians about all medicines (notably azoles, NSAIDs, beta‑blockers, steroids). Monitor glucose as directed and attend HbA1c checks. Store below 30°C.

Monitoring Requirements

Monitor capillary blood glucose (especially during initiation/titration and with intercurrent illness), HbA1c about every 3 months until stable then at least twice yearly; monitor for hypoglycemia; assess renal and hepatic function periodically and when clinically indicated.

Pharmacology

Mechanism of Action

Binds to the sulfonylurea receptor (SUR1) on pancreatic β‑cell ATP‑sensitive K+ channels, closing the channel, causing depolarization, Ca2+ influx, and insulin release; may also have minor extrapancreatic effects.

Onset of Action

Glucose‑lowering begins within the first day of dosing; for MR formulations, peak effect typically occurs several hours after dosing (often ~6-12 hours), with full titration effect assessed over 1-2 weeks or longer.

Duration of Effect

24 hours (once-daily modified-release formulation)

Half-Life

Approximately 12-20 hours (effective half‑life may vary by MR formulation).

Bioavailability

High oral bioavailability (approximately near-complete; commonly cited ~95-100% for gliclazide).

Metabolism

Extensively hepatic metabolism, primarily via CYP2C9 to inactive metabolites (CYP2C19 is not a primary pathway).

Excretion

Extensively metabolized hepatically; excreted mainly in urine as metabolites, with a smaller fraction in feces; negligible unchanged drug in urine.

Protein Binding

Approximately 95% protein bound (mainly to albumin).

Product Information

Available Dosage Forms

Modified-release tablet, Immediate-release tablet.

Composition per Dose

Each modified-release tablet: 60 mg gliclazide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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