Gliclazide 

(gly-claz-ide)

PCI / LCI Contraindication for pregnancy & lactation (breast feeding)

Molecule Info

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Indication(s) & Dosage

Gliclazide is indicated for:

Control of hyperglycemia in gliclazide responsive diabetes mellitus of stable, mild, non-ketosis prone, maturity onset or adult type which cannot be controlled by proper dietary management and exercise, or when insulin therapy is not appropriate.

Geriatrics (>65 years of age):
No significant differences in efficacy and tolerance were observed between patients over 65 years of age and younger patients, however greater sensitivity of some older individuals cannot be ruled out.

Children (<18 years of age):
Safety and effectiveness of Gliclazide in children have not been established. Gliclazide is therefore not recommended for use in children and adolescents.

Dosage & Administration

Dosing Considerations
Determination of the proper dosage for Gliclazide MR (modified release) for each patient should be made on the basis of frequent determinations of blood glucose during dose titration and throughout maintenance.

The daily dose of Gliclazide MR* may vary from 30 to 120 mg once daily (i.e., one half tablet to 2 tablets of Gliclazide MR 60 mg, or 1 to 4 tablets of Gliclazide MR 30 mg).

Recommended Dose and Dosage Adjustment
The recommended starting dose of Gliclazide MR is 30 mg daily, i.e. one half tablet of Gliclazide MR 60 mg or one tablet of Gliclazide MR 30 mg, even in elderly patients
(over 65 years old). A single daily dose provides effective blood glucose control. The single daily dose may be between 30 mg and 90 mg, or even 120 mg. The daily dose should not exceed 120 mg.

Dose adjustment should be carried out in steps of 30 mg, according to the blood glucose response. Each step should last for at least two weeks.

For Gliclazide 80mg plain formulation: Initially, 40-80 mg daily gradually increased to 320 mg daily if necessary. Doses >160 mg daily may be given in 2 divided doses.

Missed Dose

If a dose is forgotten, the patient should be advised to skip the missed dose and take his or her usual dose at the regular time the next day. The dose taken on the next day should not be increased to account for the missed dose.

Administration
It is recommended that the medication be taken at breakfast time. The 30 mg tablets cannot be split in half and should be swallowed whole. The 60 mg tablets (when available) can be halved. Both the 30 mg and 60 mg tablets must not be chewed or crushed.
- Previously untreated patients should commence with a dose of 30 mg and will benefit from dose adjustment until the appropriate dose is reached.
- One Gliclazide MR 60 mg tablet is equivalent to two Gliclazide MR 30 mg tablets.
The breakability of the Gliclazide modified-release 60 mg tablet allows the use of a dose of 30 mg as a half tablet and of 90 mg as one and a half tablets.
- Half a tablet of Gliclazide MR 60 mg or one tablet of Gliclazide MR 30 mg corresponds to one tablet of Gliclazide 80 mg.
- Gliclazide MR can replace an antidiabetic treatment without any transitional period. If a patient is switched from a hypoglycemic sulfonylurea with a prolonged half-life (i.e.
chlorpropamide) he/she should be carefully monitored (for 1 to 2 weeks) in order to avoid hypoglycemia due to possible residual effects of the previous therapy.

Geriatrics
No significant differences in efficacy and tolerance were observed between patients over 65 years of age and younger patients, however greater sensitivity of some older individuals cannot be ruled out. Patients over 65 years of age should be started with Gliclazide MR 30 mg with dosage adjustments being made cautiously.

Hepatic or Renal Impairment
Patients with renal or hepatic impairment should be started with Gliclazide MR 30 mg with dosage adjustments being made cautiously.

Patients receiving Insulin
Maturity onset diabetics with no ketoacidosis or history of metabolic decompensation and whose insulin requirements are less than 40 units per day may be considered for Gliclazide MR therapy after cessation of insulin.

If a change from insulin to Gliclazide MR is contemplated in such a patient, discontinue insulin for a period of 2 or 3 days to determine whether any therapy other than dietary regulation and exercise is needed. During this insulin-free interval, test the patient's urine at least 3 times daily for glucose and ketone bodies and monitor the results carefully. The appearance of significant ketonuria accompanied by glucosuria within 12 to 24 hours after the withdrawal of insulin, strongly suggests that the patient is ketosis prone, and precludes the change from insulin to sulfonylurea therapy.

Overdosage

Symptoms
Overdosage with sulfonylureas may result in hypoglycemia but it should be noted that the dosage which causes such hypoglycemia varies widely and may be within the accepted therapeutic range in sensitive individuals.

The manifestations of hypoglycemia include sweating, flushing or pallor, numbness, chilliness, hunger, trembling, headache, dizziness, increased pulse rate, palpitations, increased blood pressure and apprehensiveness in mild cases. In more severe cases, coma appears.

However, symptoms of hypoglycemia are not necessarily as typical as those described above and sulfonylureas may cause insidious development of symptoms mimicking cerebrovascular insufficiency.

Treatment of Overdosage
Discontinue medication and treat hypoglycemia by giving dextrose promptly and in sufficient quantity.

Some sulfonylurea-induced hypoglycemias may be refractory to treatment and susceptible to relapse especially in elderly or malnourished patients. Continuous dextrose infusions for hours or days have been necessary. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.

Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalization. Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins.

Contraindications Type 1 DM, diabetes complicated with ketoacidosis; hypersensitivity; severe renal and hepatic impairment. Pregnancy and lactation.
Special Precautions Monitor blood glucose concentration. May require insulin during metabolic stress. Care when transferring from combination therapy. Increased risk of severe hypoglycaemia in elderly, debilitated patients, patients with hepatic or renal impairment. Risk of hypogylcaemia when caloric intake is deficient, after strenuous exercise, when taken with ethanol or when >1 antidiabetic drug is used.
Adverse Drug Reaction(s) GI disturbances, skin reaction, leucopenia, thrombocytopenia, agranulocytosis, haemolytic anaemia, cholestatic jaundice, vomiting, diarrhoea, gastritis, increased transaminases.
Drug Interactions Nausea and flushing with alcohol. Hypoglycaemic effect increased by salicylates, phenylbutazone, clofibrate, sulphonamides, oral anticoagulants and MAOIs. Hypoglycaemic effect diminished by rifampicin, barbiturates, alcohol, diuretics, diazoxide, corticosteroids, β-blockers, oestrogens and sympathomimetic drugs; dose adjustment may be required.
Pharmacology Gliclazide stimulates insulin secretion from pancreatic β-cells, reduces hepatic gluconeogenesis, and lowers blood glucose concentrations. It also inhibits platelet aggregation at therapeutic doses.
Duration: >12 hr.
Absorption: Readily absorbed from the GI tract (oral).
Distribution: Protein-binding: 94%.
Metabolism: Extensively hepatic; converted to inactive metabolites.
Excretion: Urine (60-70% metabolites and small amounts of unchanged drug); faeces (10-20%); 10-12 hr (elimination half-life).
ATC Classification A10BB09 - gliclazide; Belongs to the class of sulfonamides, urea derivatives. Used in the treatment of diabetes.

*MR: Modified Release

Brand/Product Info


Total Products : 54                                                      
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ADMIRA MR Unimed & Unihealth Manufacturers Ltd. Gliclazide 30mg Tablet (Modified Release) 30's: 180.00 MRP
ADMIRA-80 Unimed & Unihealth Manufacturers Ltd. Gliclazide 80mg Tablet 30's: 180.00 MRP
COMPRID XR 30 Square Pharmaceuticals Ltd. Gliclazide 30mg Tablet 3x10's: 181.20 MRP
COMPRID XR 60 Square Pharmaceuticals Ltd. Gliclazide 60mg Tablet 3x10's: 330.90 MRP
COMPRID, Square Pharmaceuticals Ltd. Gliclazide 80mg Tablet 6x10's: 421.20 MRP
Consucon Incepta Pharmaceuticals Limited Gliclazide 80mg Tablet Tablet 10x5's :MRP 300 Tk
Consucon MR Incepta Pharmaceuticals Limited Gliclazide 30mg Tablet Tablet 10x5's:MRP 350 Tk
DIACON Apex Pharmaceuticals Ltd. Gliclazide 80mg Tablet 50's: 225.00 MRP
DIACON-80 Millat Pharmaceuticals Ltd Gliclazide 80mg Tablet 50's: 300.00 MRP
DIAGLE Aexim Pharmaceutical Ltd. Gliclazide 80mg Tablet 50's: 225.00 MRP
DIAMICRON MR Servier Bangladesh Operation Gliclazide 30mg & 60mg modified release tablets Tablet 30's each: 345.90 & 541.50 IP
DIAPRID Alco Pharma Ltd Gliclazide 80mg Tablet 30's: 150.00 MRP
DIAPRO Beximco Pharmaceuticals Ltd Gliclazide 80mg tablet Tablet 50's: 350.00 MRP
DIAPRO MR Beximco Pharmaceuticals Ltd Gliclazide 30mg MR tablet Tablet (Modified Release) 30's: 210.00 MRP
DIATROL Pacific Pharmaceuticals Ltd. Gliclazide 80mg Tablet 50's, 100's: 400.00 & 800.00 MRP
DIATROL MR Pacific Pharmaceuticals Ltd. Gliclazide 30mg Tablet (Modified Release) 50's: 400.00 MRP
DIGREEN Nipa Pharmaceuticals Ltd. Gliclazide 80mg Tablet 50's: 225.00 MRP
DIMEROL Drug International Ltd Gliclazide 80mg Tablet 50's: 350.00 MRP
DIMEROL-MR Drug International Ltd Gliclazide 30mg Tablet (Modified Release) 50's: 300.00 MRP
EUCRON Euro Pharma Ltd. Gliclazide 80mg Tablet 50's: 300.00 MRP
EZIDE Edruc Limited Gliclazide 80mg Tablet 50's: 300.00 IP
GIDE Medicon Laboratories Ltd Gliclazide 80mg Tablet 50's: 300.00 MRP
GLAD Sandoz/Novartis Gliclazide 80mg Tablet 5x10's, MRP 350.00
GLAZID Techno Drugs Gliclazide 80mg Tablet 30's, 60's: 180.00 & 360.00 MRP
GLICA Modern Pharmaceuticals Ltd Gliclazide 80mg Tablet 40's: 200.00 MRP
GLICASIL Silva Pharmaceuticals Limited Gliclazide 80mg Tablet 50's: 250.94 MRP
GLICLID The Acme Laboratories Ltd. Gliclazide 80mg Tablet 40's: 144.00 MRP
GLICRON Renata Limited Gliclazide 80mg Tablet 30's: 150.00 MRP
GLICRON CR Renata Limited Gliclazide 30mg Capsule(controlled release) 30's: 180.60 MRP
GLIMICRON The White Horse Pharma Gliclazide 80mg Tablet 50's: 350.00 MRP
GLIMICRON MR The White Horse Pharma Gliclazide 30mg Tablet (Modified Release) 50's: 300.00 MRP
GLITAB Hudson Pharmaceuticals Ltd Gliclazide 80mg Tablet 100's: 450.00 MRP
GLITZ Sharif Pharmaceuticals Ltd. Gliclazide 80mg Tablet 30's: 210.00 MRP
GLIZID Opsonin Pharma Limited Gliclazide 80mg Tablet 30's: 180.00 MRP
GLIZID MR Opsonin Pharma Limited Gliclazide 30mg Tablet (Modified Release) 30's: 180.00 MRP
GLUCOSTAT Biopharma Laboratories Ltd Gliclazide 80mg Tablet 50's: 301.00 MRP
GLUCOZID Aristopharma Ltd. Gliclazide 80mg Tablet 50's: 300.00 MRP
GLUZIT Popular Pharmaceuticals Ltd. Gliclazide 80mg Tablet 50's: 276.00 MRP
GORED General Pharmaceuticals Ltd Gliclazide 80mg Tablet 50's: 301.00 MRP
GORED MR General Pharmaceuticals Ltd Gliclazide 30mg Tablet (Modified Release) 28's: 247.24 MRP
KEZID Kemiko Pharmaceuticals Ltd Gliclazide 80mg Tablet 50's: 300.00 MRP
LOZIDE ACI Ltd. Gliclazide 80mg Tablet 40's: 240.80 MRP
OCLAZID Orion Pharma Ltd. Gliclazide 80mg Tablet 50's: 301.00 MRP
OCLAZID MR Orion Pharma Ltd. Gliclazide 30mg Tablet (Modified Release) 30's: 180.60 MRP
ORAZID Somatec Pharmaceuticals Ltd. Gliclazide 80mg Tablet 30's: 150.60 MRP
PROGLID Supreme Pharmaceuticals Ltd. Gliclazide 80mg Tablet 30's: 150.00 MRP
SINAZID IBN SINA Pharmaceutical Industry Ltd. Gliclazide 80mg Tablet 50's: 325.00 IP
SUCLEER R A K Pharmaceuticals Pvt. Ltd. Gliclazide 80mg Tablet 50's: 300.00 MRP
SUCLEER MR R A K Pharmaceuticals Pvt. Ltd. Gliclazide 30mg Tablet (Modified Release) 30's: 180.00 MRP
SUCOTAB Globe Pharmaceuticals Ltd Gliclazide 80mg Tablet 50's: 250.00 MRP
SUGRED Ad-din pharmaceuticals Ltd. Gliclazide 80mg Tablet 30's: 180.00 MRP
XIDO Delta Pharma Limited Gliclazide 80mg Tablet 50's: 250.00 MRP
ZENZIDE Zenith Pharmaceuticals Ltd. Gliclazide 80mg Tablet 30's: 150.00 MRP
ZIDE Pharmadesh Laboratories Limited Gliclazide 80mg Tablet 50's: 300.00 MRP

Gen. MedInfo

Why is Gliclazide prescribed?

Gliclazide is used along with diet and exercise, and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Gliclazide lowers blood sugar by causing the pancreas to produce insulin (a natural substance that is needed to break down sugar in the body) and helping the body use insulin efficiently. Gliclazide will only help lower blood sugar in people whose bodies produce insulin naturally. Gliclazide is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may occur if high blood sugar is not treated).

The information in this section for gliclazide varies according to the condition being treated and the particular preparation used.

How should Gliclazide be used?

Gliclazide comes as a tablet to take by mouth. It is usually taken once a day with breakfast or the first main meal of the day. To help you remember to take gliclazide, take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take gliclazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

In diabetes, the body may not be able to produce enough insulin or the insulin that it produces may not have the full effect. In some instances, the body may not be able to produce any insulin at all. These can all lead to problems controlling the blood sugar level.

It is very important that your blood sugar level is well controlled. Blood sugar levels which are too high or too low can be dangerous. Your prescriber or a member of your diabetes team will be able to give you information on how to recognise the warning signs of high and low blood sugar levels. They will also be able to inform you what to do if either of these occurs.

Warning signs can vary from person to person. If the usual warning signs of poorly controlled blood sugar levels change or disappear, you should contact your prescriber or a member of your diabetes team.

The amount of Gliclazide you need to control your blood sugar levels will be worked out by your prescriber or your diabetes team. They may also advise you to measure your blood sugar regularly & they will show you how to do this. If you are having problems controlling or measuring your blood sugar, you should contact your prescriber or a member of your diabetes team.

Other information about Gliclazide:

  • your doctor may start you on a low dose of Gliclazide and then increase the dose depending on how you respond to treatment
  • your prescriber may vary the dose of your medicine to find what is best for controlling your blood sugar level, especially if your circumstances change. These circumstances may include: if you have a high temperature; if you have an infection; changes to your health during periods of illness, trauma or emotional stress; if you are about to have surgery; changes to your diet and timing of your meals; or changes to the amount of physical activity that you are doing

Do not share your medicine with other people. It may not be suitable for them and may harm them.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Whether Gliclazide is suitable for you

Gliclazide is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing Gliclazide knows your full medical history.

Your prescriber may only prescribe Gliclazide with special care or may not prescribe it at all if you:

  • are allergic or sensitive to or have had a bad reaction to sulphonylureas or sulphonamides in the past
  • are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
  • are breast-feeding
  • are elderly
  • have certain types of heart and circulation or metabolic problems such as thyroid problems, adrenal or pituitary gland problems that increase the risk of having hypoglycaemia
  • have glucose-6-phosphate dehydrogenase deficiency
  • have ketoacidosis or are at risk of going into a coma
  • have kidney problems
  • have liver problems
  • have type-1 diabetes
  • you are at risk of developing hypoglycaemia because of having an inadequate diet. This includes being malnourished, having a low-calorie diet, eating at irregular intervals, skipping meals, fasting, or exercising excessively

Furthermore, the prescriber may only prescribe Gliclazide with special care or may not prescribe it at all for a child, an adolescent or for someone who is in a coma.

As part of the process of assessing suitability to take Gliclazide a prescriber may also arrange tests:

  • to check that Gliclazide is having the desired effect
  • to check that Gliclazide is not having any undesired effects

Over time it is possible that Gliclazide can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Gliclazide has become unsuitable, it is important that the prescriber is contacted immediately.

Alcohol

Alcohol can interact with certain medicines.

In the case of Gliclazide:

  • Gliclazideinteracts with alcohol

It is best to avoid drinking alcohol and medicines containing alcohol while you are taking Gliclazide.

Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Gliclazide:

  • Gliclazide is not known to interact with food. You should continue on the diet advised by your dietician or prescriber

For more advice speak to your prescriber, nutritionist or pharmacist.

Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Gliclazide:

  • your ability to drive or operate machinery may be affected if your blood sugar levels are low

You should see how Gliclazide affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Gliclazide:

  • do not take Gliclazide during pregnancy
  • if you become pregnant, or think you have become pregnant while taking Gliclazide, you must contact your prescriber

People with diabetes may start to have insulin instead of Gliclazide to control their blood sugar during pregnancy. If you are taking Gliclazide and are planning to become pregnant, become pregnant or think that you are pregnant, talk to a member of your diabetes team. For more information on managing your diet and your diabetes during your pregnancy, talk to your prescriber or a member of your diabetes or antenatal team.

Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Gliclazide:

  • it is not known whether Gliclazide passes into breast milk
  • women who are breast-feeding must not take Gliclazide

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with Gliclazide. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop Gliclazide without taking advice from your doctor.

Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

inform your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also inform your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Gliclazide:

  • acarbose
  • captopril
  • chlorpromazine
  • clarithromycin
  • danazol
  • enalapril
  • fluconazole
  • insulin
  • metformin
  • miconazole
  • phenylbutazone
  • ritodrine when injected into a vein
  • salbutamol when injected into a vein
  • terbutaline when injected into a vein
  • tetracosactide
  • warfarin

The following types of medicine may interact with Gliclazide:

  • ACE inhibitors
  • anticoagulants
  • beta-blockers
  • dipeptidyl peptidase-4 inhibitors
  • GLP-1 receptor agonists
  • glucocorticosteroids
  • H2 antagonists
  • monoamine oxidase inhibitors
  • non-steroidal anti-inflammatories
  • other antidiabetics
  • sulphonamides
  • thiazolidinediones

If you are taking Gliclazide and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Gliclazide.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking Gliclazide in combination with complementary preparations and vitamins, you tonform your prescriber.

What other information to know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Gliclazide.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

 Ref: MedlinePlus, U.S. Natl. Library of Medicine


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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*Trademark name & prescribing information are the property of their respective Manufacturers.