Oclazid-MR
Generic Name
Gliclazide Modified Release 30 mg Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| oclazid mr 30 mg tablet | ৳ 6.04 | ৳ 60.40 |
Description
Overview of the medicine
Oclazid-MR 30 mg Tablet contains Gliclazide, a sulfonylurea antidiabetic drug used to manage blood glucose levels in adults with Type 2 Diabetes Mellitus, when diet, exercise, and weight reduction alone are insufficient.
Uses & Indications
Dosage
Adults
The usual initial dose is 30 mg once daily, taken at breakfast. The dose may be increased to 60 mg, 90 mg, or 120 mg once daily, in successive steps, allowing at least a 1-month interval between each dose increment, except in patients whose blood glucose has not reduced after 2 weeks. The maximum recommended daily dose is 120 mg.
Elderly
The same dosing regimen as for adults is recommended, with careful titration and blood glucose monitoring. Initial dose 30 mg once daily.
Renal_impairment
In mild to moderate renal impairment (creatinine clearance 30-60 mL/min), the recommended initial dose is 30 mg once daily with careful monitoring. Severe renal impairment (creatinine clearance <30 mL/min): Not recommended.
How to Take
Take orally once daily with breakfast. The tablet should be swallowed whole; do not chew or crush it.
Mechanism of Action
Gliclazide primarily stimulates the insulin secretion from the pancreatic β-cells by binding to sulfonylurea receptors, leading to closure of ATP-sensitive potassium channels. This depolarization of the β-cell membrane opens voltage-dependent calcium channels, increasing calcium influx and subsequently increasing insulin release.
Pharmacokinetics
Onset
Onset of action within 2-4 hours.
Excretion
Mainly excreted in urine as metabolites (60-70%) and approximately 10-20% in feces.
Half life
Approximately 10-12 hours for the modified-release formulation.
Absorption
Rapidly and completely absorbed from the gastrointestinal tract. Plasma concentrations increase progressively over the first 6 hours, reaching a plateau from the 6th to the 12th hour.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C9, into inactive metabolites. Less than 1% of the unchanged drug is found in urine.
Side Effects
Contraindications
- Hypersensitivity to gliclazide, other sulfonylureas, or sulfonamides.
- Type 1 Diabetes Mellitus.
- Diabetic ketoacidosis, diabetic pre-coma and coma.
- Severe renal or hepatic insufficiency (use of insulin is recommended in these cases).
- Concomitant use with systemic miconazole.
Drug Interactions
Miconazole (systemic, oral gel)
Potentiates the hypoglycemic effect, possibly leading to coma.
Danazol, Chlorpromazine (high doses), Glucocorticoids (systemic), Diuretics (e.g., thiazides), Barbiturates
May reduce the hypoglycemic effect, leading to elevated blood glucose levels.
Phenylbutazone, Alcohol, other antidiabetic agents (e.g., metformin, insulin), Beta-blockers, ACE inhibitors, Fluconazole, H2-receptor antagonists
May potentiate the hypoglycemic effect of gliclazide.
Storage
Store in a cool, 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. Symptoms include sweating, pallor, intense hunger, tremor, nausea, headache, dizziness, and in severe cases, seizures and coma. Management involves prompt administration of glucose (oral if conscious, intravenous if unconscious) and monitoring blood glucose levels.
Pregnancy & Lactation
Not recommended during pregnancy. Insulin is the preferred treatment for diabetes in pregnant women. Avoid during lactation as gliclazide may be excreted in breast milk, posing a risk of neonatal hypoglycemia.
Side Effects
Contraindications
- Hypersensitivity to gliclazide, other sulfonylureas, or sulfonamides.
- Type 1 Diabetes Mellitus.
- Diabetic ketoacidosis, diabetic pre-coma and coma.
- Severe renal or hepatic insufficiency (use of insulin is recommended in these cases).
- Concomitant use with systemic miconazole.
Drug Interactions
Miconazole (systemic, oral gel)
Potentiates the hypoglycemic effect, possibly leading to coma.
Danazol, Chlorpromazine (high doses), Glucocorticoids (systemic), Diuretics (e.g., thiazides), Barbiturates
May reduce the hypoglycemic effect, leading to elevated blood glucose levels.
Phenylbutazone, Alcohol, other antidiabetic agents (e.g., metformin, insulin), Beta-blockers, ACE inhibitors, Fluconazole, H2-receptor antagonists
May potentiate the hypoglycemic effect of gliclazide.
Storage
Store in a cool, 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. Symptoms include sweating, pallor, intense hunger, tremor, nausea, headache, dizziness, and in severe cases, seizures and coma. Management involves prompt administration of glucose (oral if conscious, intravenous if unconscious) and monitoring blood glucose levels.
Pregnancy & Lactation
Not recommended during pregnancy. Insulin is the preferred treatment for diabetes in pregnant women. Avoid during lactation as gliclazide may be excreted in breast milk, posing a risk of neonatal hypoglycemia.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by national regulatory bodies (e.g., DGDA in Bangladesh)
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Gliclazide MR has been extensively studied in clinical trials demonstrating its efficacy and safety in achieving glycemic control in patients with Type 2 Diabetes Mellitus, with a low risk of severe hypoglycemia compared to some other sulfonylureas.
Lab Monitoring
- Regular monitoring of blood glucose levels (fasting and post-prandial).
- Periodic monitoring of glycated hemoglobin (HbA1c).
- Monitoring of renal and hepatic function, especially in patients with pre-existing conditions.
Doctor Notes
- Emphasize patient education on hypoglycemia symptoms and management strategies.
- Consider starting with a low dose and titrating carefully, especially in elderly patients or those with mild to moderate renal impairment.
- Advise patients about the importance of adherence to diet and exercise alongside medication.
- Regularly monitor HbA1c, fasting blood glucose, and post-prandial blood glucose levels.
Patient Guidelines
- Always take this medicine exactly as prescribed by your doctor. Do not change the dose or stop treatment without consulting your doctor.
- Take Oclazid-MR with your breakfast every morning. Swallow the tablet whole; do not chew or crush it.
- Be aware of the symptoms of hypoglycemia (e.g., sweating, trembling, dizziness, confusion, intense hunger) and know how to treat it (e.g., consume a quick-acting source of sugar like fruit juice, glucose tablets, or candy).
- Do not skip meals, as this can increase the risk of hypoglycemia.
Missed Dose Advice
If a dose is missed, do not take a double dose to compensate. Take the next dose at the usual time. Contact your doctor if you are unsure.
Driving Precautions
Patients should be aware of the symptoms of hypoglycemia and exercise caution while driving or operating machinery, especially when starting treatment or after dose changes. If you experience hypoglycemia, you should not drive.
Lifestyle Advice
- Adhere to a healthy, balanced diet plan recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Maintain a healthy weight.
- Monitor your blood glucose levels regularly as advised by your doctor.
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