Diatrol MR
Generic Name
Gliclazide Modified Release 60 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| diatrol mr 60 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Diatrol MR 60 mg Tablet contains Gliclazide, a sulfonylurea antidiabetic drug used to lower blood glucose levels in patients with type 2 diabetes mellitus. The modified-release formulation allows for once-daily dosing.
Uses & Indications
Dosage
Adults
Initial dose 30 mg or 60 mg once daily with breakfast. Dosage can be titrated up to a maximum of 120 mg once daily, depending on blood glucose response.
Elderly
No specific dose adjustment is generally required, but close monitoring is advised due to increased risk of hypoglycemia.
Renal_impairment
Mild to moderate renal impairment: Usually no dose adjustment needed. Severe renal impairment: Not recommended. Close monitoring for hypoglycemia is essential.
How to Take
Take orally once daily with breakfast. Swallow the tablet whole; do not chew, crush, or divide.
Mechanism of Action
Gliclazide stimulates insulin secretion from pancreatic beta cells by binding to sulfonylurea receptors (SUR1) on the cell surface, leading to closure of ATP-sensitive potassium channels and depolarization, which opens voltage-gated calcium channels, causing calcium influx and subsequent insulin release. It also has extrapancreatic effects and may improve peripheral insulin sensitivity and reduce hepatic glucose production.
Pharmacokinetics
Onset
Plasma concentrations reach steady-state within 2 days of dosing. Onset of hypoglycemic action is gradual due to MR formulation.
Excretion
Mainly excreted in urine (60-70%) as metabolites, with a small portion excreted in feces.
Half life
Approximately 12-20 hours for the modified-release formulation, allowing once-daily administration.
Absorption
Well absorbed from the gastrointestinal tract. The modified-release formulation provides sustained plasma concentrations over 24 hours.
Metabolism
Extensively metabolized in the liver by CYP2C9, primarily to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Gliclazide or other sulfonylureas
- Type 1 Diabetes Mellitus
- Diabetic ketoacidosis
- Severe renal or hepatic impairment
- Concomitant use of Miconazole
Drug Interactions
NSAIDs
May potentiate hypoglycemic effect.
Miconazole
Potentiates hypoglycemic effect, leading to severe hypoglycemia.
Beta-blockers
May mask symptoms of hypoglycemia and inhibit recovery.
ACE inhibitors
May enhance blood glucose lowering effect.
Corticosteroids
May increase blood glucose levels, requiring dose adjustment.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms include severe hypoglycemia. Management involves oral or intravenous glucose administration, monitoring blood glucose, and supportive care.
Pregnancy & Lactation
Not recommended during pregnancy. Use only if potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to Gliclazide or other sulfonylureas
- Type 1 Diabetes Mellitus
- Diabetic ketoacidosis
- Severe renal or hepatic impairment
- Concomitant use of Miconazole
Drug Interactions
NSAIDs
May potentiate hypoglycemic effect.
Miconazole
Potentiates hypoglycemic effect, leading to severe hypoglycemia.
Beta-blockers
May mask symptoms of hypoglycemia and inhibit recovery.
ACE inhibitors
May enhance blood glucose lowering effect.
Corticosteroids
May increase blood glucose levels, requiring dose adjustment.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms include severe hypoglycemia. Management involves oral or intravenous glucose administration, monitoring blood glucose, and supportive care.
Pregnancy & Lactation
Not recommended during pregnancy. Use only if potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies (e.g., DGDA, FDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Gliclazide, including its modified-release formulation, has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in the management of Type 2 Diabetes Mellitus.
Lab Monitoring
- Fasting and postprandial blood glucose levels
- HbA1c levels (every 3-6 months)
- Renal function tests (e.g., serum creatinine)
- Liver function tests
Doctor Notes
- Educate patients thoroughly on hypoglycemia recognition, prevention, and immediate management.
- Regularly assess renal and hepatic function, especially in elderly patients.
- Consider potential drug interactions, particularly with Miconazole, beta-blockers, and NSAIDs.
- Emphasize the importance of diet, exercise, and blood glucose monitoring as adjuncts to pharmacotherapy.
Patient Guidelines
- Take with breakfast daily.
- Do not skip meals.
- Monitor blood glucose regularly as advised by your doctor.
- Be aware of hypoglycemia symptoms (e.g., sweating, trembling, confusion) and carry sugar/glucose to treat it.
- Inform your doctor about all other medications and medical conditions.
Missed Dose Advice
If a dose is missed, do not take a double dose to make up for it. Take the next dose at the usual time. If it's close to the next dose, skip the missed dose.
Driving Precautions
May cause hypoglycemia, leading to dizziness, impaired concentration, or blurred vision. Advise caution when driving or operating machinery, especially if symptoms of hypoglycemia occur.
Lifestyle Advice
- Maintain a balanced diet and follow a meal plan.
- Engage in regular physical activity appropriate for your health condition.
- Achieve and maintain a healthy weight.
- Avoid excessive alcohol consumption.
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