gored-mr
Generic Name
Gliclazide Modified Release 30 mg
Manufacturer
Renata Limited
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
gored mr 30 mg tablet | ৳ 8.86 | ৳ 124.00 |
Description
Overview of the medicine
Gliclazide Modified Release 30 mg tablet is an oral antidiabetic drug used for the management of type 2 diabetes mellitus in adults, when diet, exercise, and weight reduction alone are not sufficient to control blood glucose levels.
Uses & Indications
Dosage
Adults
Initial dose 30 mg once daily, preferably with breakfast. Dose can be increased in steps of 30 mg at intervals of at least 1 month, up to a maximum of 120 mg once daily.
Elderly
Same as adult dose, but careful titration and monitoring recommended due to increased sensitivity to hypoglycemia.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment (creatinine clearance 30-60 mL/min). Not recommended for severe renal impairment (creatinine clearance < 30 mL/min).
How to Take
Oral. Take once daily with breakfast. Swallow the tablet whole with a glass of water, do not chew, crush, or divide it.
Mechanism of Action
Gliclazide stimulates insulin release from pancreatic β-cells by blocking ATP-sensitive potassium channels, leading to depolarization and calcium influx, thereby increasing insulin secretion.
Pharmacokinetics
Onset
Onset of action within 2-3 hours.
Excretion
Primarily excreted in the urine as metabolites (60-70%), with a small amount excreted in feces.
Half life
Approximately 12-20 hours for the MR formulation.
Absorption
Well absorbed from the gastrointestinal tract. Modified release formulation ensures sustained absorption over 24 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C9, into inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to gliclazide, other sulfonylureas, or any excipients.
- Type 1 diabetes mellitus.
- Diabetic precoma and coma, diabetic ketoacidosis.
- Severe renal or hepatic insufficiency.
- Concomitant treatment with miconazole.
- Pregnancy and lactation.
Drug Interactions
Miconazole
Potentiates the hypoglycemic effect of gliclazide, potentially leading to severe hypoglycemia.
Phenylbutazone, Alcohol
May enhance the hypoglycemic effect of gliclazide.
Beta-blockers, ACE inhibitors
May mask or enhance the symptoms of hypoglycemia.
Corticosteroids, Diuretics, Danazol
May reduce the hypoglycemic effect of gliclazide, leading to hyperglycemia.
Storage
Store in a dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of gliclazide may lead to severe hypoglycemia, which can manifest as sweating, pallor, hunger, tremors, confusion, and in severe cases, seizures or coma. Management involves prompt administration of oral glucose (e.g., sugar, fruit juice) for conscious patients, or intravenous glucose (e.g., 20-30% dextrose solution) for unconscious patients. Close monitoring of blood glucose is essential for at least 24-48 hours.
Pregnancy & Lactation
Gliclazide is contraindicated during pregnancy and breastfeeding. Insulin is the preferred treatment for glycemic control in pregnant women. Consult a doctor immediately if pregnancy occurs during treatment.
Side Effects
Contraindications
- Hypersensitivity to gliclazide, other sulfonylureas, or any excipients.
- Type 1 diabetes mellitus.
- Diabetic precoma and coma, diabetic ketoacidosis.
- Severe renal or hepatic insufficiency.
- Concomitant treatment with miconazole.
- Pregnancy and lactation.
Drug Interactions
Miconazole
Potentiates the hypoglycemic effect of gliclazide, potentially leading to severe hypoglycemia.
Phenylbutazone, Alcohol
May enhance the hypoglycemic effect of gliclazide.
Beta-blockers, ACE inhibitors
May mask or enhance the symptoms of hypoglycemia.
Corticosteroids, Diuretics, Danazol
May reduce the hypoglycemic effect of gliclazide, leading to hyperglycemia.
Storage
Store in a dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of gliclazide may lead to severe hypoglycemia, which can manifest as sweating, pallor, hunger, tremors, confusion, and in severe cases, seizures or coma. Management involves prompt administration of oral glucose (e.g., sugar, fruit juice) for conscious patients, or intravenous glucose (e.g., 20-30% dextrose solution) for unconscious patients. Close monitoring of blood glucose is essential for at least 24-48 hours.
Pregnancy & Lactation
Gliclazide is contraindicated during pregnancy and breastfeeding. Insulin is the preferred treatment for glycemic control in pregnant women. Consult a doctor immediately if pregnancy occurs during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, depending on storage conditions.
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Gliclazide Modified Release has been extensively studied in various clinical trials, demonstrating its efficacy and safety in achieving glycemic control in patients with type 2 diabetes mellitus, including studies like ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation).
Lab Monitoring
- Fasting and post-prandial blood glucose levels (regularly).
- HbA1c levels (every 3-6 months) to assess long-term glycemic control.
- Renal and hepatic function tests (periodically).
- Complete blood count (periodically, especially if blood dyscrasias are suspected).
Doctor Notes
- Educate patients thoroughly on recognizing and managing hypoglycemia.
- Emphasize the importance of adherence to diet, exercise, and regular blood glucose monitoring.
- Consider renal and hepatic function before initiating and during treatment, although dose adjustment may not be strictly necessary for mild to moderate impairment.
- Counsel patients on potential drug interactions, especially with alcohol and miconazole.
Patient Guidelines
- Take Gored-MR 30 mg tablet exactly as prescribed by your doctor, preferably with breakfast.
- Do not skip meals and follow a consistent meal schedule.
- Be aware of the symptoms of hypoglycemia (e.g., sweating, dizziness, confusion) and know how to treat them.
- Do not stop taking the medicine without consulting your doctor, even if you feel well.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it's almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Gliclazide may cause hypoglycemia, which can impair your ability to concentrate or react, affecting your ability to drive or operate machinery. Patients should be informed about the symptoms of hypoglycemia and should take precautions, especially at the start of treatment or during dose changes. If you experience symptoms of hypoglycemia, do not drive or operate machinery.
Lifestyle Advice
- Maintain a healthy, balanced diet as recommended by your healthcare provider.
- Engage in regular physical activity suitable for your condition.
- Avoid excessive alcohol consumption as it can increase the risk of hypoglycemia.
- Monitor your blood glucose levels regularly and keep a record.
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