Arrow Gliclazide

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Arrow Gliclazide

Gliclazide: Quick Overview

Gliclazide is an oral prescription medication, classified as a second-generation sulfonylurea, primarily used to manage high blood sugar levels in adults diagnosed with type 2 diabetes mellitus. It is typically prescribed by a healthcare provider when diet, exercise, and lifestyle changes alone have proven insufficient for effective blood glucose control.

Quick Facts

Property Description
Active ingredient Gliclazide
Form Tablet (Immediate-Release and Modified-Release)
Pharmacological class Sulfonylurea (second-generation)
Common use Management of Type 2 Diabetes
Status Prescription Only (Rx)

Gliclazide is the active ingredient in many generic and brand-name medications, and its distinguishing feature is its availability in a Modified-Release (MR) tablet. This formulation is designed to provide a gradual, sustained release of the drug, which often allows for convenient once-daily dosing.

Its action is defined by its pharmacological class. This class of drugs is characterized by its ability to stimulate the pancreatic beta-cells to increase insulin production. This establishes Gliclazide's role in helping the body produce more of its own insulin to lower blood glucose.

Furthermore, Gliclazide is recognized internationally for its established efficacy and safety. It is included on the List of Essential Medicines, confirming its importance for global health systems.

What side effects are possible with Arrow Gliclazide?

Possible Side Effects and Safety Information

Gliclazide's safety profile is defined by officially documented adverse reactions and specific regulatory limitations. The primary and most frequent safety risk associated with Gliclazide, consistent with its drug class (sulfonylureas), is hypoglycemia (low blood sugar), which may range from mild to severe, potentially requiring medical attention.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized by frequency:

Classification Examples of Reactions
Common (1 in 10 to 1 in 100 people) Hypoglycemia, gastrointestinal disturbances (e.g., abdominal pain, nausea, vomiting, diarrhea, dyspepsia, constipation).
Uncommon (1 in 100 to 1 in 1,000 people) Nervous system disturbances.
Very Rare (less than 1 in 10,000 people) Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), hepatic dysfunction (e.g., hepatitis).

Clinically Significant and Systemic Safety Concerns

Serious Adverse Reactions documented in official sources include severe, prolonged hypoglycemia, severe allergic reactions, and significant changes in blood cell counts (hematological disorders) such as agranulocytosis and thrombocytopenia. Liver enzyme elevations may also occur, indicating potential hepatobiliary issues.

Regulatory Restrictions and Cautions

Gliclazide is contraindicated for use in patients with severe kidney or liver failure, Type 1 diabetes, diabetic keto-acidosis, or known hypersensitivity to the drug or related sulfonamides. It is also contraindicated during pregnancy and breast-feeding. Regulatory documents highlight that the risk of hypoglycemia is increased in certain populations, notably the elderly, and when combined with specific medications (e.g., miconazole, alcohol) that can intensify its blood-glucose-lowering effect.

Overdose and Emergency Response

The documented manifestation of Gliclazide overdose is a severe and prolonged drop in blood sugar, known as hypoglycaemia. This condition constitutes a medical emergency and may progress to severe and life-threatening outcomes.

Documented Manifestations

Overdose-induced hypoglycaemia typically presents with two main symptom clusters. Adrenergic signs may include sweating, rapid heart rate (tachycardia), anxiety, and palpitations. Neuroglycopenic signs, resulting from compromised brain function, may involve headache, intense hunger, confusion, agitation, poor concentration, and visual or speech disturbances. Severe outcomes can include the progression of symptoms to convulsions (seizures), loss of consciousness, and coma. Severe cerebral hypoglycaemia poses a risk of permanent neurological injury.

Required Emergency Actions

Immediate medical treatment or hospitalisation are required if the hypoglycaemic episode is classified as severe or prolonged, even if symptoms are temporarily resolved by sugar intake. If a patient is found to be unconscious, emergency services must be called immediately.

Supportive measures documented in regulatory information include the initial consumption of sugar. For severe cases, management requires hospitalisation and continuous intravenous glucose administration, which may need to be continued for several days due to the medication's prolonged action. It is noted that the hypoglycaemic episode may be significantly prolonged in patients with severe hepatic or renal impairment.

Therapeutic Uses of Arrow Gliclazide

What Gliclazide Treats: Main Uses and Benefits

Gliclazide is primarily indicated for adult patients with Type 2 Diabetes Mellitus, a condition characterized by systemic hyperglycemia—the chronic, persistent elevation of blood sugar. Gliclazide is used when dietary measures, physical exercise, and weight loss alone are not sufficient to achieve blood glucose control.

The core therapeutic domains include managing persistent high blood sugar, supporting sustained glycemic control as adjunctive therapy, and addressing long-term vascular risk. This medication is commonly applied as a second-line intervention when patients experience persistent glycemic imbalance, and its use is relevant for long-term management, which includes supporting efforts to address potential diabetes-related vascular damage, including issues affecting the heart, eyes, and kidneys.

“By sustaining effective sugar control, it supports overall patient comfort and contributes to supporting functional stability of organs by easing the damaging impact of prolonged high glucose exposure.”

This supportive treatment may assist with maintaining a more predictable and manageable experience of day-to-day metabolic health, helping patients achieve and maintain target blood glucose and HbA1c levels.


Quick Fact: Relief for Persistent Glycemic Imbalance

Gliclazide is commonly used to help stabilize fluctuating sugar levels in adults whose long-term glucose indicators remain elevated despite lifestyle efforts.

Regulatory References

  1. Therapeutic Goods Administration (TGA) product information

Eligibility and Restrictions for Use

Gliclazide is a prescription medication used to manage blood sugar in adults with Type 2 diabetes. Its use is strictly defined by regulatory documents, which include clear rules on who is ineligible to take the medicine.

Contraindications and Restrictions

Classification Populations Who Must Not Use Gliclazide
Absolute Contraindications Type 1 diabetes, diabetic ketoacidosis, diabetic pre-coma or coma, and hypersensitivity to gliclazide or other sulfonamides.
Severe Organ Impairment Severe renal insufficiency and severe hepatic insufficiency (insulin is recommended instead).
Physiological States Pregnancy and Lactation (breast-feeding).
Drug-Specific Concomitant treatment with miconazole (systemic or oromucosal gel).
Special Consideration Groups for Whom Use is Limited or Not Recommended
Age Children and adolescents (use not established).
Condition Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency (risk of hemolytic anemia); patients with rare hereditary galactose intolerance disorders.
Clinical Risk Individuals with malnutrition or irregular food intake due to increased hypoglycemia risk.

Official labeling mandates that treatment is only prescribed if the patient is likely to have a regular food intake, emphasizing that the drug is for non-insulin-dependent diabetes management in adults.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Gliclazide's interaction profile is officially categorized by regulatory bodies based on the resulting effect on blood glucose and drug exposure. The overall regulatory structure defines combinations that are contraindicated, not recommended, or require precautions for use.


Contraindicated and Not Recommended Combinations

Classification Interacting Entity Interaction Description
Contraindicated Miconazole (systemic/gel) Officially documented to increase the hypoglycaemic effect, carrying a risk of coma.
Not Recommended Phenylbutazone (systemic) Increases the hypoglycaemic effect by reducing Gliclazide elimination and displacing plasma protein binding.
Not Recommended Alcohol (Ethanol) Increases the hypoglycaemic reaction by inhibiting compensatory mechanisms and may cause a disulfiram-like reaction.

Exposure and Pharmacodynamic Effects

Interactions primarily result in either potentiation (increased blood glucose lowering) or antagonism (reduced blood glucose lowering) of Gliclazide's effect. Potentiators that may increase the risk of hypoglycemia include other antidiabetic agents, certain antibiotics (Clarithromycin, Fluconazole), NSAIDs, Beta-blockers, ACE inhibitors, and MAOIs. Antagonists that may cause a loss of glycemic control (hyperglycemia) include Glucocorticoids, Danazol, and certain diuretics. Additionally, Gliclazide may potentiate the effect of oral anticoagulant therapy, such as Warfarin.

The use of the herbal product St. John's Wort is officially documented to affect blood glucose control by potentially reducing Gliclazide exposure. A specific population consideration notes that the risk of dysglycemia (hypo- and hyperglycemia) with Fluoroquinolones is especially reported in elderly patients. Severe hepatic or renal impairment may also prolong a hypoglycemic episode due to altered pharmacokinetics.

Mechanism of Action

Stimulating Insulin Secretion via K ATP Channel Inhibition

Gliclazide's primary mechanism is to promote the release of insulin from the pancreatic beta-cells. It achieves this by binding to and inhibiting the sulfonylurea receptor ( SUR1 subunit) on the ATP-sensitive potassium channel ( K ATP). This targeted interaction blocks the normal efflux of potassium ions ( K^+) from the beta-cell, initiating the cell signaling cascade.

The Ca^2+ Dependent Signaling Cascade

Inhibition of the K ATP channel causes the cell membrane to depolarize. This depolarization immediately opens voltage-dependent calcium channels, triggering a rapid influx of calcium ions ( Ca^2+). The resulting increase in intracellular Ca^2+ is the final signal that compels insulin-containing vesicles to fuse with the cell membrane, leading to the exocytosis (release) of endogenous insulin.

Resulting Systemic Glucose Modulation

The physiological consequence of this mechanism is a significant, targeted increase in circulating endogenous insulin. This action enhances the utilization of glucose by peripheral tissues (muscle and fat) and suppresses glucose production by the liver. The net effect of this enhanced glucose clearance is a net shift in circulating glucose concentration, which modulates the systemic glucose-processing pathway.

Dosage and Administration Information

Official Dosing and Administration Guidelines

Gliclazide is administered via the oral route and is available in both Immediate-Release (IR) and Modified-Release (MR) tablet formulations, each following a specific dosing regimen.

Administration Scope

Instruction Detail
Dosing Schedule MR Tablets: The starting dose is typically 30 mg once daily, with a maximum daily dose of 120 mg. IR Tablets: Starting doses are typically 40 mg to 80 mg daily, with a maximum daily dose of 320 mg.
Frequency MR Tablets are taken as a single daily dose. IR Tablets are taken once daily for doses up to 160 mg; doses above 160 mg must be administered in divided doses.
Timing The tablets must be taken with a meal, specifically with breakfast. Use is only recommended if the patient is likely to maintain a regular food intake, including breakfast.
Handling Missed Doses If a dose is missed, it should be skipped entirely. The next dose must be taken at the usual time, and the dose on the subsequent day must not be doubled.

Procedural and Population Rules

For administration, tablets must be swallowed whole with water; they must not be crushed or chewed (particularly the MR form) to maintain the integrity of the release mechanism. The dose adjustment process, or titration, is typically carried out gradually, often with intervals of at least one month between dose increases.

In specific populations, the medication is not recommended for the paediatric population due to a lack of established safety data. In cases of mild to moderate renal impairment, the standard dosing regimen may be used, provided there is careful patient monitoring.

Recent Clinical Evidence

Research evidence / Overview of studies for Gliclazide


Evidence for Glycemic Control and Comparative Studies

Research has extensively examined Gliclazide through controlled trials and comprehensive reviews. These studies have primarily explored the use of the medication in adults diagnosed with Type 2 Diabetes, focusing on outcomes related to systemic or functional imbalance, which is a way to describe blood sugar control (measured by the marker HbA1c). Comparisons were studied for how they differed against other oral treatments. When Gliclazide was evaluated in comparisons with other similar oral treatments, findings describe patterns observed in the studies regarding the degree of change in blood sugar markers. Studies report observations related to body weight when comparing Gliclazide to some other medications in the same class.


Research on Long-Term Vascular Outcomes

A large, multinational controlled trial examined Gliclazide Modified-Release as a component of an intensive treatment strategy. This research explored the use of Gliclazide, as part of an intensive strategy, and whether it was associated with differences in the rates of serious macrovascular (e.g., heart) and microvascular (e.g., kidney) events. This involved monitoring patients over several years, documenting event rates in treatment groups aiming for different blood sugar target ranges. A key point is that the research examined Gliclazide within the context of an overall multi-drug intensive control regimen. The findings describe group patterns, not personal outcomes related to Gliclazide as a single agent. Data for certain groups remain insufficient regarding the use of Gliclazide monotherapy specifically for macrovascular outcomes.


Areas of Ongoing Research and Evidence Gaps

While extensive research was observed in the populations studied, long-term effects are not fully established for periods extending far beyond the key trials. Subgroup findings are uncertain in cases where sample sizes were modest or when researchers measured outcomes differently. Comparative evidence is lacking in direct head-to-head comparisons against some of the newer treatment options currently used for diabetes. Research is ongoing to continue to explore questions related to the variability of clinical markers.

Frequently Asked Questions (FAQ)

Common questions about Gliclazide (FAQ)


Q: Does Gliclazide typically cause weight gain?

Official product information indicates that weight gain is a potential side effect associated with Gliclazide therapy. Official product information suggests following prescribed diet and exercise recommendations as part of the overall treatment plan.


Q: Is Gliclazide the same kind of medication as Metformin?

Gliclazide and Metformin are not the same kind of medication. Gliclazide is a sulfonylurea, which stimulates the pancreas to release insulin. Metformin is a biguanide, which primarily works by decreasing glucose production in the liver. These medications have different mechanisms and are often used together.


Q: How quickly does Gliclazide start to work after starting treatment?

Gliclazide is rapidly absorbed after being taken orally. According to pharmacokinetic data, the highest concentration of the drug in the blood is generally expected to occur within four to six hours after administration.


Q: Is Gliclazide intended for short-term or long-term medication use?

Treatment for Type 2 diabetes usually requires ongoing management. Gliclazide is generally prescribed for the long-term management of blood sugar levels as part of a chronic care plan.


Q: What signs indicate that Gliclazide is having its intended effect?

The primary way to assess the intended effect is through laboratory tests. These include regular measurement of fasting blood glucose levels and glycated haemoglobin (HbA1c), which gives an average measure of blood sugar control over the previous months.


Q: Are there any specific safety warnings regarding Gliclazide use and operating machinery or driving?

Gliclazide can cause dizziness or drowsiness, especially if a patient experiences low blood sugar (hypoglycemia). Official warnings note that caution is required when driving or operating machinery until the effects of the medication are known.


Q: Are there any specific foods or supplements to avoid while taking Gliclazide?

Regulatory documents specifically advise avoiding alcohol and the herbal product St. John’s Wort, as these can affect the medication's blood glucose-lowering effects. Interactions with other specific foods or common vitamins have not been established in regulatory information.


Q: What is the difference between standard Gliclazide and the modified-release (MR) version?

The key difference is in the release mechanism. The Modified-Release (MR) tablets are formulated using a special matrix to release the drug slowly over 24 hours, which allows for convenient once-daily dosing. The Immediate-Release (IR) tablets release the drug quickly and may require administration in divided doses.


Q: Can Gliclazide cause skin reactions, rashes, or increased sun sensitivity?

Rashes, redness, itching, and blistering are among the reported skin reactions. Because Gliclazide belongs to the sulfonylurea class of drugs, official warnings also note that increased sensitivity to the sun is a potential risk.


Q: What is the basis for the concern that Gliclazide may affect the pancreas over time?

Over time, the blood sugar-lowering effectiveness of Gliclazide may gradually lessen. Regulatory information indicates this attenuation is associated with either the natural progression of Type 2 diabetes or a reduced response to the medication, known as secondary failure.


Q: Can Gliclazide interact with commonly used vitamins or herbal supplements?

Regulatory documents mention that the herbal product St. John’s Wort may interfere with blood glucose control. Interactions with other commonly used vitamins or specific supplements are generally not established in the official product information.


Q: What kind of medical monitoring (e.g., blood tests) is typically necessary when taking Gliclazide?

Regular medical monitoring is necessary. This includes standard tests to check blood glucose levels and glycated haemoglobin (HbA1c). In addition, regulatory documents state that periodic assessment of the heart, eyes, kidney, and liver status may be necessary.


Q: Is Gliclazide considered appropriate for older adult patients?

Gliclazide can be prescribed for older adults, often starting at a minimum dose. However, regulatory information specifically notes that the risk of low blood sugar (hypoglycemia) is increased in the elderly population, requiring that patients and caregivers are aware of the increased risk.


Q: Does taking Gliclazide have the potential to cause dizziness or lightheadedness?

Dizziness and drowsiness are reported side effects. Furthermore, because Gliclazide lowers blood sugar, common symptoms of hypoglycemia (low blood sugar) include dizziness, tiredness, and a lack of energy.


Q: Can Gliclazide be taken alongside other medications used for diabetes?

Gliclazide may be added to a treatment plan. Regulatory documents indicate that Gliclazide is used in combination with other anti-diabetic agents, which may include biguanides (like Metformin), alpha-glucosidase inhibitors, or insulin therapy.


Q: Does Gliclazide have any known effect on blood pressure?

Gliclazide is a diabetes treatment and is not primarily used to affect blood pressure. However, in rare instances, symptoms associated with a rapid drop in blood sugar (hypoglycemia) can include an irregular or fast heart rate.


Q: Are there differences in expected outcomes between the immediate and modified release forms of Gliclazide?

Studies comparing the two formulations have shown similar efficacy in achieving blood glucose control (measured by HbA1c levels). The main difference in outcomes relates to the practical aspect of the MR formulation allowing for convenient once-daily dosing.


Q: What might happen if a patient stops taking Gliclazide suddenly?

Regulatory warnings note that suddenly stopping Gliclazide is not recommended. Discontinuance without guidance may result in a loss of blood glucose control, which could cause the underlying diabetes condition to worsen.


Q: What should a patient know if they feel ill or unwell shortly after taking Gliclazide?

Digestive disorders such as nausea, vomiting, or abdominal pain are common side effects, but official information notes these may be reduced by ensuring the medication is taken with a meal. Official guidance indicates that urgent medical attention is required if patients experience any symptoms of a severe allergic reaction.


Q: Can Gliclazide be safely used by patients who are also taking thyroid hormone medication?

Official regulatory information indicates that thyroid hormone medications may interfere with blood sugar control. Regulatory information states that close monitoring of blood glucose levels may be necessary, as the dose may require adjustment to maintain glycemic control.


Q: What are general recommendations for managing the onset of low blood sugar while on Gliclazide?

Official patient information suggests consuming a form of fast-acting sugar, such as glucose tablets or sweet juice, for mild symptoms of low blood sugar. Urgent medical attention is required if symptoms persist, recur, or lead to unconsciousness.


Q: Can Gliclazide be used for people who are insulin resistant?

Gliclazide works mainly by stimulating the pancreas to release more insulin. Additionally, regulatory documents note that it has extra-pancreatic actions that have been demonstrated to help increase the body’s peripheral sensitivity to insulin.


Q: What kind of diet and exercise changes are often mentioned in research studies alongside Gliclazide use?

Gliclazide is prescribed as an addition to, not a replacement for, lifestyle changes. Official regulatory information notes that patients should follow prescribed dietary advice, maintain a regular food intake (including breakfast), and engage in regular exercise.


Q: What is the typical time frame in which the full effect of Gliclazide might be observed?

The dose adjustment process is typically carried out gradually. Official prescribing information notes that dose adjustments are typically made with intervals of at least one month to allow adequate time for the blood sugar-lowering effect of the previous dose to stabilize and be accurately assessed.


How should Arrow Gliclazide be stored and disposed of?

Storage and Disposal Requirements

Storage Conditions

Gliclazide tablets must be stored at room temperature, generally between 20 C to 25 C (68 F to 77 F). To maintain the medicine's stability, it is essential to keep the tablets in their original container, tightly closed. The medication must be protected from excessive heat and moisture and stored out of the reach of children.

Disposal Instructions

Unused or expired gliclazide should be disposed of properly to protect the environment. Do not dispose of this medicine by flushing it down a toilet or pouring it into a drain unless specifically instructed by a healthcare professional or regulatory body. The recommended method is to use a medicine take-back program available in your community or follow local guidelines for proper disposal of unused medication.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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