sb-glic-xr
Generic Name
Gliclazide 30 mg Modified Release Tablet
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sb glic xr 30 mg tablet | ৳ 6.00 | N/A |
Description
Overview of the medicine
sb-glic-xr 30 mg Tablet is an oral anti-diabetic medicine used to lower blood sugar levels in adults with type 2 diabetes mellitus. It belongs to the sulfonylurea class of drugs, stimulating insulin release from the pancreatic beta cells. The extended-release formulation allows for once-daily dosing.
Uses & Indications
Dosage
Adults
Initial dose is 30 mg once daily, taken at breakfast. Dose may be increased in increments of 30 mg every 2-4 weeks, depending on blood glucose response, up to a maximum of 120 mg once daily.
Elderly
Similar to adult dosage, but caution should be exercised and a lower initial dose may be considered due to potential for impaired renal function and increased sensitivity to hypoglycemic effects. Start with 30 mg once daily.
Renal_impairment
Mild to moderate renal impairment: 30 mg once daily. Severe renal impairment: Not recommended. Close monitoring of blood glucose is required.
How to Take
Take the tablet orally once daily with breakfast. Swallow the tablet whole with a glass of water; do not crush, chew, or divide it.
Mechanism of Action
Gliclazide primarily acts by stimulating insulin release from the pancreatic beta cells, particularly in the presence of glucose. It binds to the sulfonylurea receptor 1 (SUR1) on the beta-cell membrane, leading to closure of ATP-sensitive potassium channels, depolarization, calcium influx, and subsequent insulin exocytosis. It also has extrapancreatic effects and may improve insulin sensitivity in peripheral tissues and reduce hepatic glucose production.
Pharmacokinetics
Onset
Within 2-4 hours, peak effect is usually 4-12 hours after a single dose.
Excretion
Mainly through urine (60-70%) as metabolites, with a small portion excreted in feces (10-20%).
Half life
Approximately 12-20 hours for the XR formulation.
Absorption
Well absorbed orally. The extended-release formulation ensures a gradual and sustained absorption. Bioavailability is approximately 97%.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 enzyme CYP2C9, into inactive metabolites.
Side Effects
Contraindications
- Type 1 diabetes mellitus
- Diabetic pre-coma and coma
- Diabetic ketoacidosis
- Severe renal or hepatic insufficiency
- Hypersensitivity to gliclazide or other sulfonylureas or to any of the excipients
- Concomitant use with miconazole (oral systemically active formulation)
Drug Interactions
Rifampicin, Barbiturates
Can decrease the hypoglycemic effect.
Miconazole (oral gel, systemic)
Potentiates the hypoglycemic effect, possibly leading to coma.
Phenylbutazone, Danazol, Chlorpromazine, Glucocorticoids
Can affect blood glucose levels; dose adjustments may be needed.
Beta-blockers, ACE inhibitors, Fluconazole, H2-receptor antagonists
Can 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
Symptoms include severe hypoglycemia. Management involves immediate administration of glucose (oral if conscious, intravenous if unconscious) and careful monitoring. Hospitalization may be required for severe cases.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for fetal harm; insulin therapy is generally preferred. Avoid during lactation as it is unknown if gliclazide is excreted in breast milk and can cause neonatal hypoglycemia.
Side Effects
Contraindications
- Type 1 diabetes mellitus
- Diabetic pre-coma and coma
- Diabetic ketoacidosis
- Severe renal or hepatic insufficiency
- Hypersensitivity to gliclazide or other sulfonylureas or to any of the excipients
- Concomitant use with miconazole (oral systemically active formulation)
Drug Interactions
Rifampicin, Barbiturates
Can decrease the hypoglycemic effect.
Miconazole (oral gel, systemic)
Potentiates the hypoglycemic effect, possibly leading to coma.
Phenylbutazone, Danazol, Chlorpromazine, Glucocorticoids
Can affect blood glucose levels; dose adjustments may be needed.
Beta-blockers, ACE inhibitors, Fluconazole, H2-receptor antagonists
Can 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
Symptoms include severe hypoglycemia. Management involves immediate administration of glucose (oral if conscious, intravenous if unconscious) and careful monitoring. Hospitalization may be required for severe cases.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for fetal harm; insulin therapy is generally preferred. Avoid during lactation as it is unknown if gliclazide is excreted in breast milk and can cause neonatal hypoglycemia.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA (Directorate General of Drug Administration, Bangladesh)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of Gliclazide MR in type 2 diabetes, demonstrating its ability to reduce HbA1c with a relatively low risk of hypoglycemia compared to some other sulfonylureas. Studies have also investigated its cardiovascular benefits.
Lab Monitoring
- Fasting and postprandial blood glucose levels
- HbA1c levels (every 3-6 months)
- Renal function (creatinine, GFR)
- Liver function tests (ALT, AST) periodically
Doctor Notes
- Emphasize patient education on hypoglycemia recognition and management.
- Monitor renal and hepatic function, especially in elderly patients.
- Consider combination therapy if monotherapy is insufficient for glycemic control.
- Review patient's diet and exercise regimen regularly.
Patient Guidelines
- Take medicine consistently at the same time each day with breakfast.
- Do not skip meals to avoid hypoglycemia.
- Be aware of symptoms of hypoglycemia and how to manage them (e.g., consume sugary drinks/food).
- Regularly monitor blood sugar as advised by your doctor.
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
If you miss a dose, do not take a double dose to make up for it. Take the next dose at the usual time. Consult your doctor if you frequently miss doses.
Driving Precautions
Caution is advised, especially at the start of treatment or during dose changes, due to the risk of hypoglycemia which can impair ability to drive or operate machinery. Patients should be aware of hypoglycemia symptoms.
Lifestyle Advice
- Maintain a balanced diet suitable for diabetes.
- Engage in regular physical activity as advised by your doctor.
- Monitor weight and strive for a healthy BMI.
- Avoid smoking and limit alcohol intake.
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