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Gliclazida Dinive

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Gliclazida Dinive

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Gliclazida Dinive_EN
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Method of action: Antiadhesive, Drugs Used In Diabets, Hypoglycemic

Treatment option: Insulin Dependent Diabetes, Cerebrovascular Accident, Nephropathy, Retinopathy, Diabetes Mellitus

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.

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Overview of Gliclazida Dinive

Property Description
Active ingredient Gliclazide
Form Oral Tablet (Modified Release/SR)
Pharmacological class Sulfonylurea, Oral Hypoglycemic Agent
Common use Management of Type 2 Diabetes Mellitus
Origin Synthetic, Second-Generation Derivative

1. Identity and Pharmaceutical Classification

Gliclazida Dinive is a synthetic, prescription-only medication whose active ingredient is Gliclazide, classified as an Oral Hypoglycemic Agent. The chemical substance Gliclazide belongs to the Sulfonylureas pharmacological class, a category of drugs specifically developed to lower blood sugar levels. This classification establishes the drug as a targeted intervention for chronic metabolic regulation. As a Second-Generation Sulfonylurea Derivative, Gliclazide is recognized in clinical practice for assisting patients in the long-term management of high blood sugar characteristic of Type 2 Diabetes Mellitus.

2. Composition, Form, and General Therapeutic Goal

The medication is typically presented as an Oral Tablet, often using a Modified Release (MR) or Sustained Release (SR) Formulation, intended to help manage Type 2 Diabetes Mellitus. This Modified Release characteristic is a crucial design feature, distinguishing it from immediate-release forms and promoting a more consistent therapeutic effect. The composition is a single-ingredient product containing only the active ingredient, Gliclazide, combined with necessary excipients for the oral dosage form. As the medication assists in achieving glycemic control, its primary objective is mitigating the damaging effects of prolonged hyperglycemia.

3. The High-Level Action Principle

Gliclazide functions by acting directly on the pancreas to encourage the release of the body’s own insulin into the bloodstream. This action principle—that of a Pancreatic beta-cell Secretagogue—means the drug specifically targets the cells responsible for producing and storing insulin. By prompting the pancreas to release more of this hormone, Gliclazide helps facilitate the necessary reduction of plasma glucose levels, which is the immediate functional purpose of the medication in diabetes management.

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What side effects are possible with Gliclazida Dinive?

Possible side effects and safety information

The safety profile for Gliclazide, the active ingredient in Gliclazida Dinive, is documented based on classifications and reports from official government regulatory sources.

Adverse Reaction Classifications

Consistent with its function as an oral hypoglycemic agent, the most characteristic adverse reaction is Hypoglycaemia (low blood sugar), which is classified as Common in regulatory documentation. This is often more likely to occur at the beginning of treatment or during changes in dosage.

Other adverse reactions are grouped by the physiological system affected (System-Organ Classes):

  • Gastrointestinal Disorders: Disturbances such as abdominal pain, nausea, vomiting, dyspepsia, diarrhoea, and constipation are documented as Common.
  • Skin and Subcutaneous Tissue Disorders: Reactions including rash, pruritus (itching), urticaria, and angioedema are listed.
  • Blood and Lymphatic System Disorders: Rare haematological changes, such as leucopoenia or thrombocytopenia, have been documented.

Serious Safety Considerations

While uncommon, certain serious adverse reactions are listed in regulatory safety information:

  • Severe Hypoglycaemia: Episodes can be severe, prolonged, and may lead to coma or neurological impairment.
  • Hepatobiliary Disorders: Rare reports exist of hepatic impairment, including hepatitis and cholestatic jaundice.
  • Serious Skin Reactions: Rare, severe bullous reactions, such as Stevens-Johnson syndrome, have been documented.

Contraindications and Restrictions

Official labeling defines specific restrictions for use. Gliclazide is formally contraindicated in individuals with severe renal or hepatic insufficiency due to the significantly increased risk of severe, prolonged hypoglycaemia. It is also contraindicated during pregnancy and lactation, and in those with known hypersensitivity to Gliclazide or other sulfonylureas. These restrictions define the formal limits of the drug's approved safety profile.

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Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — official regulatory information for Gliclazida Dinive

Overdose scope

Documented overdose presentations: The principal manifestation is severe hypoglycemia, which may present with physical symptoms such as sweating, tremors, and palpitations. More profound signs include confusion, slurred speech, drowsiness, and vomiting.

Physiological systems affected (as stated in label): Metabolic System, Central Nervous System.

Dose-related or exposure-related factors (if applicable): The Modified-Release (MR) formulation is specifically associated with an increased risk of prolonged and recurrent hypoglycemia following an overdose.

Population-specific overdose notes (if applicable): The elderly and patients with hepatic or severe renal impairment are documented as being at a heightened risk for severe and persistent effects.

Emergency-response statements (as written in official documents): Treatment requires symptomatic and supportive therapy, including immediate glucose administration (oral or intravenous). Gastric decontamination may be considered after recent ingestion.

When immediate medical help is required (label-derived phrasing only): Seek immediate medical attention for any suspected overdose. Contact emergency services immediately for symptoms of severe hypoglycemia, loss of consciousness, or seizures. Prolonged clinical and biochemical monitoring in a hospital setting is mandatory.

Overdose classifications (high-level)

Severity classification (as defined in official documents): Overdose can lead to severe or life-threatening outcomes, including hypoglycemic coma and the possibility of permanent neurological damage.

Regulatory basis (EMA / FDA / etc.): The information is consistent with regulatory texts provided by national and intergovernmental health authorities.

Overdose-context constraints (as defined in official documents): No specific antidote is known for Gliclazide itself, and monitoring must be prolonged due to the sustained-release property of the formulation.

Resulting overdose structure

Official overdose statements:

  • Overdose leads to severe hypoglycemia that can progress to life-threatening seizures and coma.
  • Immediate medical attention and hospitalization are required for suspected overdose due to the risk of prolonged, recurrent hypoglycemia.
  • Treatment focuses on glucose administration and continuous blood glucose monitoring.
  • The elderly and those with hepatic/renal impairment face increased risk of severe effects.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the Gliclazida Dinive overdose profile based on the risk of profound and prolonged low blood glucose, which necessitates immediate emergency care. The required management centers on symptomatic support, glucose replacement, and mandatory prolonged observation to mitigate the danger posed by the modified-release formulation.

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Therapeutic Uses of Gliclazida Dinive

Gliclazida Dinive is primarily used for managing Type 2 Diabetes Mellitus, addressing the symptoms related to systemic imbalance caused by persistently high blood sugar levels. The medication is indicated for the treatment of non-insulin dependent diabetes when initial measures, such as dietary changes and physical exercise, are insufficient to control blood glucose. The medication is applied across domains where additional symptomatic support is needed to achieve long-term glycemic stability.

The therapeutic benefit is a sustained reduction in blood glucose and improved HbA1 c control, which supports patients by helping to manage the risks associated with prolonged high blood sugar. The medication is commonly used in adult patient groups who require additional symptomatic support for ongoing metabolic management. This therapy may assist with supporting functional stability and contributes to easing the overall symptom burden associated with chronic high blood sugar.

Quick Fact: Relief for Chronic Hyperglycemia The medication is relevant for easing symptoms related to systemic imbalance and is commonly used in conditions presenting with chronic manifestations that interfere with daily comfort. It plays a role in managing the long-term HbA1 c levels.

Regulatory References

  1. Australian Therapeutic Goods Administration
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Eligibility and Restrictions for Use

Gliclazide is an oral antidiabetic medication for use in Adults with Type 2 diabetes. Regulatory labeling defines specific populations and conditions where use is prohibited or restricted.

Formal Contraindications (Must Not Use)

Contraindicated Group Rationale
Type 1 Diabetes The drug is ineffective and potentially harmful in insulin-dependent diabetes.
Pregnancy and Breastfeeding Contraindicated due to risk of fetal/neonatal hypoglycemia; insulin is the recommended therapy.
Severe Organ Impairment Prohibited in severe renal or severe hepatic insufficiency (insulin is recommended).
Acute States Contraindicated in diabetic ketoacidosis, pre-coma, or coma and during acute stress conditions (e.g., severe infection, surgery).
Allergy Prohibited if hypersensitive to gliclazide, other sulfonylureas, or sulfonamides.

Eligibility Restrictions and Caution

Restricted Group Requirement
Pediatric Population Use in children and adolescents (under 18) is not established and generally not recommended.
Elderly Use is allowed, but close monitoring is required due to increased susceptibility to hypoglycemia.
G6PD-Deficiency Caution is advised due to the risk of hemolytic anemia; a non-sulfonylurea alternative should be considered.
Mild-to-Moderate Impairment Mild-to-moderate renal or hepatic impairment requires careful patient monitoring.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Gliclazide details specific combinations that may alter its blood glucose-lowering effect. These interactions are strictly classified based on the formal constraints required by health authorities.

Interaction Classification and Restrictions

Classification Examples of Interacting Agent/Substance
Formally Contraindicated Miconazole (systemic or oromucosal gel)
Combinations Not Recommended Alcohol (Ethanol), Phenylbutazone (systemic route), Danazol
Requiring Precaution Beta-Blockers, ACE Inhibitors, Glucocorticoids, Fluoroquinolones

Documented Outcomes and Specific Notes

Co-administration with certain medicinal products, such as ACE Inhibitors and other Antidiabetic Agents, is documented to result in a potentiation of the blood glucose lowering effect. Conversely, agents such as Glucocorticoids and high-dose Chlorpromazine are noted to cause a counteraction, potentially elevating blood glucose levels.

Regulatory documentation specifies that the herbal product St. John’s Wort can lead to decreased Gliclazide systemic exposure, which may result in a loss of blood glucose control. The potential for prolonged, severe hypoglycemic episodes is highlighted in patients with severe hepatic or renal impairment due to altered pharmacokinetics. Furthermore, the risk of dysglycemia when combined with Fluoroquinolones is specifically noted in elderly patients.

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Mechanism of Action

Ontology: How Gliclazida Dinive Works

The drug's mechanism of action focuses on modulating key processes in the pancreas and the circulatory system to modulate pathways affecting systemic glucose concentration.

Insulin Release via Pancreatic K ATP Channel Blockade

This domain describes the primary molecular event: Gliclazide binds to the Sulfonylurea Receptor 1 ( SUR1) on pancreatic beta cells. This binding causes the ATP-sensitive Potassium Channel ( K ATP channel) to close, initiating a cellular depolarization cascade that leads to an increase in insulin secretion.

Cellular Signaling and Glucose Modulation

The downstream effect of the K ATP channel block is the opening of voltage-dependent calcium channels, allowing Ca^2+ to rush into the cell, which directly triggers the release of pre-formed insulin. The resulting rise in circulating insulin promotes the uptake and utilization of glucose by the body's tissues and suppresses the liver's glucose production, thereby resulting in the modulation of glucose concentration.

Modulation of Microvascular Components

Gliclazide also engages an extrapancreatic mechanism that influences vascular and hemostatic processes. This involves the drug modulating platelet aggregation and activity, as well as enhancing the natural fibrinolytic activity of the vascular lining (endothelium). This pathway adjustment results in changes to platelet aggregation and fibrinolytic activity.

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Dosage and Administration Information

How to Use Gliclazida Dinive

Gliclazida Dinive (Gliclazide Modified Release/SR) is a prescription medication intended strictly for oral administration in adults to manage Type 2 Diabetes Mellitus. The instructions below summarize the standard usage protocols.

Administration Protocol and Dosage

Parameter Official Instruction
Route of Administration Oral route only
Dose Form Modified Release (MR) Tablet
Dosing Frequency Once daily, as a single intake
Timing & Food Taken at breakfast time and with a regular food intake
Physical Handling Tablet must be swallowed whole; do not crush or chew

Standard Adult Dosing and Adjustments

The standard adult dosing is governed by a defined titration schedule, with doses adjusted by a healthcare provider based on the patient's metabolic response.

  • Starting Dose: The treatment is initiated with 30 mg once daily.
  • Maintenance Dose: The typical maintenance range is 30 mg to 120 mg daily.
  • Maximum Dose: The maximum recommended daily dose is 120 mg.

Dose Titration: Dose increments (in 30 mg steps) generally require an interval of at least one month. If a dose is missed, the next day's dose should not be increased.

Population-Specific Guidance: The same starting dose is used for older adults and patients with mild-to-moderate renal impairment, requiring careful monitoring. Use is generally not recommended for the pediatric population, as efficacy and safety are not established in children and adolescents.

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Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Combination Therapy

Research has explored the potential effect of the combination of Drug A and Drug B on pain and inflammation in patients with chronic osteoarthritis. Studies have examined this approach, which involves the use of two agents.

  • Drug A (Analgesic): Studies investigated the impact of Drug A on the severity of acute episodes.
  • Drug B (Anti-inflammatory): Drug B has been the subject of research to examine its role regarding markers of systemic inflammation.

Key Findings from Clinical Trials

Efficacy and Outcome Measures

Clinical trials evaluated outcomes in patients with moderate to severe chronic pain. Studies examined the use of this agent across various dosages. Pain scores were assessed during the trial period in studies evaluating this dosage.

Onset of Action In some trials, the onset of action was a measured endpoint.

Long-term Use Research compared outcomes from combination therapy and monotherapy for long-term management. Evidence remains limited on the relative long-term profiles of the two approaches.

Safety and Tolerability Profile

Clinical trials documented the incidence of adverse events in the studied populations. The most commonly reported adverse events were documented across the studies.

Cardiovascular Considerations Studies reported an association between Drug B and an elevated incidence of cardiovascular events in certain patient groups. Studies have also explored research on prevention of resistance.

The delivery method was evaluated for its effect on absorption.

Important Note: This information is not a substitute for professional medical advice.

Key Studies & References New Trends in Pharmacological Treatments for Osteoarthritis

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Frequently Asked Questions (FAQ)

Common questions about Gliclazida Dinive (FAQ)

Q: What is the primary function of Gliclazida Dinive?

Gliclazida Dinive is an oral medicine that belongs to a class of drugs called sulfonylureas. According to official product information, its primary function is to help lower high blood sugar levels. It achieves this by stimulating the pancreas to release more insulin.

Q: For what medical condition is Gliclazida Dinive used?

Regulatory documents state that Gliclazida Dinive is used to treat Type 2 diabetes mellitus. This is the form of diabetes where the body either doesn't produce enough insulin or doesn't use the insulin it produces effectively. The medicine is indicated for use when lifestyle measures like diet, exercise, and weight reduction have not sufficiently controlled blood sugar levels.

Q: Can I take Gliclazida Dinive if I am pregnant or planning to become pregnant?

Official information indicates that Gliclazida Dinive is not recommended for use during pregnancy. This is because its safety has not been fully established, and a healthcare professional will review the necessary alternative treatment options. It is necessary to consult with a healthcare professional to review treatment options when planning or suspecting pregnancy.

Q: Is Gliclazida Dinive associated with weight gain?

Studies and official product information indicate that weight gain is listed as a possible side effect associated with Gliclazida Dinive. This is a recognized effect for medications in the sulfonylurea class. Concerns about changes in weight should be addressed with a healthcare professional.

Q: What is the risk of low blood sugar (hypoglycemia) with this medicine?

According to the official product information, hypoglycemia (low blood sugar) is a very common side effect of Gliclazida Dinive. This outcome reflects how the medication helps the body release more insulin. Patients should be familiar with the signs of low blood sugar, which may include sweating, dizziness, and confusion.

Q: Is Gliclazida Dinive safe for use in children or adolescents?

Regulatory documents indicate that Gliclazida Dinive is not recommended for use in children and adolescents under 18 years of age. This non-recommendation is due to insufficient regulatory data on safety and effectiveness in that age group.

Q: Can I take Gliclazida Dinive if I have kidney problems?

The official product information specifies that Gliclazida Dinive is contraindicated (should not be used) if you have severe kidney failure. For less severe kidney issues, the medication may still be used, but close monitoring is required. A healthcare professional must determine if this treatment is appropriate based on the degree of kidney impairment.

Q: Can I take Gliclazida Dinive if I am breastfeeding?

According to the official product information, Gliclazida Dinive is contraindicated (not to be used) while breastfeeding. It is currently unknown if the drug passes into breast milk, which could pose a risk to the nursing infant. Reviewing alternative treatment options or ceasing breastfeeding should be done in consultation with a healthcare professional.

Q: What should I do if I miss a dose of Gliclazida Dinive?

Official regulatory documents state that a missed dose should be followed by taking the next dose at the regular scheduled time. It is specified that a double dose should not be taken to compensate for a missed one. Consistency in taking the medication is important for effective blood sugar management.

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How should Gliclazida Dinive be stored and disposed of?

How to Store and Dispose of Gliclazide

Official regulatory guidelines strictly define the necessary storage and disposal requirements for Gliclazide tablets to ensure stability and safety.

Required Storage Conditions

Condition Regulatory Requirement
Temperature Store below 25 C or 30 C, depending on the formulation. Some modified-release tablets do not require special conditions.
Protection Must be protected from moisture and light and stored in the original container/package.
Safety The medicine must always be kept out of the sight and reach of children (a mandatory requirement).
Stability Do not use the tablets after the labeled expiry date printed on the carton.

Official Disposal Instructions

Any unused or expired Gliclazide must be disposed of in accordance with local requirements.

Regulators recommend that if a drug take-back program is unavailable, most non-flushable medicines like Gliclazide should be mixed with an undesirable substance (such as dirt) and placed in a sealed container before discarding in the household trash.

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

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