Glucostat-MR
Generic Name
Gliclazide (Modified Release)
Manufacturer
ACI Limited
Country
Bangladesh
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Description
Overview of the medicine
Glucostat-MR contains Gliclazide, a sulfonylurea anti-diabetic agent used to lower blood glucose levels in adults with Type 2 Diabetes Mellitus. The modified-release formulation allows for once-daily dosing.
Uses & Indications
Dosage
Adults
Initial dose is 30 mg once daily, taken at breakfast. Dose can be adjusted in steps of 30 mg, according to blood glucose response, up to a maximum of 120 mg once daily.
Elderly
No special dose adjustment is required in elderly patients. Start with 30 mg once daily and titrate carefully.
Renal_impairment
In mild to moderate renal impairment, the same dosing regimen can be used with careful monitoring. In severe renal impairment, it is generally not recommended.
How to Take
Take orally, once daily with breakfast. The tablet should be swallowed whole and not crushed or chewed.
Mechanism of Action
Gliclazide primarily works by stimulating the beta cells of the pancreas to release more insulin. It also has some extra-pancreatic effects, including improving peripheral insulin sensitivity and reducing hepatic glucose production. Its modified release formulation provides sustained plasma concentrations.
Pharmacokinetics
Onset
Within 1-2 hours (effects on blood glucose).
Excretion
Mainly excreted in the urine (less than 1% as unchanged drug) and faeces.
Half life
Approximately 10-12 hours for the modified release formulation.
Absorption
Well absorbed after oral administration. Modified release formulation ensures sustained absorption.
Metabolism
Extensively metabolized in the liver to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to gliclazide or other sulfonylureas
- Type 1 Diabetes Mellitus
- Diabetic pre-coma and ketoacidosis
- Severe renal or hepatic insufficiency
- Concomitant treatment with miconazole
- Lactation
Drug Interactions
Phenylbutazone, Alcohol
Potentiate the hypoglycemic effect of sulfonylureas.
Miconazole (systemic, oral gel)
Increases the hypoglycemic effect with possible onset of hypoglycemia (may lead to coma). Contraindicated.
Beta-blockers, Fluconazole, Cimetidine
May increase the hypoglycemic effect.
Corticosteroids, Diuretics, Barbiturates
May reduce 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 of Gliclazide can lead to hypoglycemia. Symptoms include sweating, pallor, hunger, trembling, headache, and confusion. Management involves immediate administration of glucose (oral or intravenous depending on severity) and close monitoring.
Pregnancy & Lactation
Glucostat-MR is contraindicated during pregnancy and breastfeeding. Insulin is the preferred treatment for diabetes during pregnancy.
Side Effects
Contraindications
- Hypersensitivity to gliclazide or other sulfonylureas
- Type 1 Diabetes Mellitus
- Diabetic pre-coma and ketoacidosis
- Severe renal or hepatic insufficiency
- Concomitant treatment with miconazole
- Lactation
Drug Interactions
Phenylbutazone, Alcohol
Potentiate the hypoglycemic effect of sulfonylureas.
Miconazole (systemic, oral gel)
Increases the hypoglycemic effect with possible onset of hypoglycemia (may lead to coma). Contraindicated.
Beta-blockers, Fluconazole, Cimetidine
May increase the hypoglycemic effect.
Corticosteroids, Diuretics, Barbiturates
May reduce 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 of Gliclazide can lead to hypoglycemia. Symptoms include sweating, pallor, hunger, trembling, headache, and confusion. Management involves immediate administration of glucose (oral or intravenous depending on severity) and close monitoring.
Pregnancy & Lactation
Glucostat-MR is contraindicated during pregnancy and breastfeeding. Insulin is the preferred treatment for diabetes during pregnancy.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Gliclazide MR has been extensively studied, including in major trials like the ADVANCE trial, which confirmed its cardiovascular safety and efficacy in reducing macrovascular and microvascular complications in Type 2 Diabetes.
Lab Monitoring
- Regular monitoring of blood glucose levels
- HbA1c levels
- Renal function tests (e.g., serum creatinine, eGFR)
- Liver function tests (periodically)
Doctor Notes
- Emphasize patient education on hypoglycemia recognition and management.
- Advise patients on the importance of diet, exercise, and regular blood glucose monitoring.
- Consider renal and hepatic function before initiating and during therapy.
Patient Guidelines
- Take medicine exactly as prescribed by your doctor.
- Monitor your blood glucose levels regularly as instructed.
- Be aware of symptoms of hypoglycemia and know how to manage them.
- Maintain a balanced diet and engage in regular physical activity.
- Do not crush or chew the tablet; swallow it whole.
Missed Dose Advice
If you miss a dose, do not take a double dose to make up for the forgotten one. Take your next dose at the usual time.
Driving Precautions
Patients should be aware of the symptoms of hypoglycemia, especially at the beginning of treatment or after dose adjustments. If hypoglycemia occurs, driving or operating machinery should be avoided.
Lifestyle Advice
- Follow a diabetic diet plan, controlling carbohydrate and sugar intake.
- Engage in regular moderate exercise (e.g., brisk walking, swimming).
- Maintain a healthy body weight.
- Limit or avoid alcohol consumption.
- Quit smoking if applicable.
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