Medicine Information

Glucostat-MR

Name: Glucostat-MR
Brand: Glucostat-MR
Rating: 4.5 (117 reviews)

Tablet (Modified Release)60 mgOral Hypoglycemic AgentATC: A10BB09

Generic Name

Gliclazide (Modified Release) 60 mg tablet

Manufacturer

Incepta Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
glucostat mr 60 mg tablet	৳ 12.00	৳ 120.00

Description

Overview of the medicine

Glucostat-MR 60 mg Tablet is an oral anti-diabetic medicine containing Gliclazide (modified release). It is used to lower blood glucose levels in adults with type 2 diabetes mellitus.

Uses & Indications

Treatment of type 2 diabetes mellitus in adults, particularly when dietary management, physical exercise, and weight reduction alone are insufficient to control blood glucose levels.

As monotherapy or in combination with other anti-diabetic agents like metformin.

Dosage

Adults

Initial dose: 30 mg once daily, preferably with breakfast. Can be increased to 60 mg, 90 mg, or 120 mg once daily, depending on blood glucose response. Maximum daily dose is 120 mg.

Elderly

No specific dose adjustment is required in elderly patients, but careful monitoring is advised due to increased risk of hypoglycemia.

Renal_impairment

In mild to moderate renal impairment, no dose adjustment is typically needed, but careful monitoring is essential. Contraindicated in severe renal impairment.

How to Take

Take orally, once daily with breakfast. Swallow the tablet whole with water; do not chew, crush, or break it.

Mechanism of Action

Gliclazide primarily stimulates insulin secretion from the beta cells of the pancreatic islets. It binds to the sulfonylurea receptor on the beta-cell membrane, leading to closure of ATP-sensitive potassium channels, membrane depolarization, and calcium influx, which triggers insulin release. It also has some extrapancreatic effects.

Pharmacokinetics

Onset

Onset of action is typically within 1-2 hours for immediate release, but for MR, effects are sustained over time.

Excretion

Mainly excreted in urine (60-70%) and feces (10-20%) as metabolites.

Half life

Approximately 12-20 hours for the modified release formulation, allowing for once-daily dosing.

Absorption

Well absorbed after oral administration. Modified release formulation ensures sustained plasma concentrations. Bioavailability is high (approx. 97%).

Metabolism

Extensively metabolized in the liver, primarily by CYP2C9, into inactive metabolites.

Side Effects

Contraindications

Type 1 diabetes mellitus
Diabetic ketoacidosis
Severe renal or hepatic impairment
Hypersensitivity to gliclazide or other sulfonylureas
Concomitant use with miconazole (systemic formulation)
Pregnancy and lactation

Drug Interactions

Miconazole (systemic)

Potentiates hypoglycemic effect, leading to severe hypoglycemia.

Corticosteroids, Diuretics, Danazol, Chlorpromazine

May reduce the hypoglycemic effect (increase blood glucose).

Phenylbutazone, Alcohol, Beta-blockers, ACE inhibitors

May increase the hypoglycemic effect.

Storage

Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.

Overdose

Overdose can lead to severe hypoglycemia. Management includes immediate administration of glucose (oral if conscious, intravenous if unconscious) and careful monitoring. Hospitalization may be required.

Pregnancy & Lactation

Not recommended during pregnancy and lactation. Insulin therapy is generally preferred for diabetes management during pregnancy. It is unknown if gliclazide is excreted in breast milk.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 tablets30 tablets

Shelf Life

24 months

Availability

Pharmacies, Hospitals

Approval Status

Approved (local regulatory bodies likely, e.g., DGDA)

Patent Status

Expired (for generic gliclazide)

WHO Essential Medicine

Yes

Clinical Trials

Gliclazide MR has been studied in various clinical trials demonstrating its efficacy and safety in managing type 2 diabetes, showing sustained glycemic control with a relatively low risk of severe hypoglycemia compared to some other sulfonylureas.

Lab Monitoring

Blood glucose levels (fasting and postprandial)
HbA1c (every 3-6 months)
Renal function tests (e.g., serum creatinine)
Liver function tests (periodically)

Doctor Notes

Emphasize patient education on hypoglycemia recognition and management.
Consider renal and hepatic function before initiating and during therapy.
Advise patients on lifestyle modifications alongside medication for optimal control.

Patient Guidelines

Take your medicine exactly as prescribed by your doctor.
Do not skip meals, especially breakfast, as this can increase the risk of hypoglycemia.
Carry a source of fast-acting glucose (e.g., sugar candies, glucose tablets) to treat mild hypoglycemia.
Regularly monitor your blood glucose levels as advised by your doctor.

Missed Dose Advice

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.

Driving Precautions

Patients should be aware of the risk of hypoglycemia, which can impair concentration and reaction time. Drive with caution, especially at the start of treatment or during dose adjustments.