Engflag

Diamicron 80

Quick links to important sections

Diamicron 80

Diamicron 80_EN

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Diamicron 80

Quick Facts

Property Description
Active ingredient Gliclazide
Form Standard-release Tablet
Pharmacological class Oral Hypoglycemic Agent (Sulfonylurea)
Common use Management of Type 2 diabetes mellitus
Origin Synthetic

What Type of Medicine is Diamicron 80?

Diamicron 80 is a prescription-only pharmaceutical preparation classified as an Oral Hypoglycemic Agent, essential for treating Type 2 diabetes mellitus in adult patients. Its core identity is defined by the active ingredient, Gliclazide, a synthetic compound that belongs to the sulfonylurea agent chemical group. The Gliclazide compound is recognized as a second-generation sulfonylurea, reflecting its widespread clinical application in this therapeutic area. This distinction means its distribution is controlled, differentiating it from over-the-counter options.

Composition and Form: Gliclazide 80 mg Tablets

The medication is formulated for administration via the oral route as a standard-release tablet. It is a single-ingredient product, containing only the active compound, Gliclazide, in a strength of 80 mg. The tablet structure is created using a solid matrix of excipients that supports the compound’s uniform delivery. This specific 80 mg strength is a conventional formulation, chemically and kinetically distinct from the modified-release (MR) forms of Gliclazide.

General Purpose of Gliclazide

The general purpose of Gliclazide is to safely exert a beneficial hypoglycemic action, reducing elevated levels of glucose in the bloodstream. This benefit is achieved because the compound functions as an insulin secretagogue, meaning its primary physiological action is to stimulate the insulin-producing cells of the pancreas to enhance the output of natural insulin. By improving the dynamics of insulin secretion, the medication supports the necessary metabolic control for those managing Type 2 diabetes mellitus, such as maintaining target glucose levels during fasting periods.

Regulatory References

  1. WHO Essential Medicines List entry for Gliclazide

What side effects are possible with Diamicron 80?

Possible side effects and safety information

As an Oral Hypoglycemic Agent, the most frequent and expected adverse effect of Gliclazide (Diamicron 80) is hypoglycemia (low blood sugar), which is classified as a Common side effect in regulatory documents (affecting up to 1 in 10 people). Hypoglycemia is more likely to occur when meals are inadequate, following strenuous exercise, or with severe dietary restriction.

Adverse reactions are formally grouped by System-Organ Class in official labeling:

System-Organ-Classes and Frequency

System-Organ Class Common Adverse Effects Rare Adverse Effects
Metabolism and nutrition disorders Hypoglycemia —
Gastrointestinal disorders Abdominal pain, Nausea, Diarrhea, Constipation, Vomiting —
Hepatobiliary disorders — Hepatitis, Jaundice, Elevated liver enzymes
Blood and lymphatic system disorders — Agranulocytosis, Leukopenia, Thrombocytopenia
Skin and subcutaneous tissue disorders — Serious bullous reactions, Angioedema

Serious Adverse Reactions and Safety Constraints

Regulatory documents list several Serious Adverse Reactions. These include Severe Hypoglycemia (which can lead to coma), Hepatitis (potentially leading to liver failure), and severe changes in blood cell counts, such as Agranulocytosis.

Population-Specific Safety: Older adults are at an increased risk of severe hypoglycemia. Furthermore, the medicine is generally contraindicated in individuals with severe hepatic (liver) or renal (kidney) impairment, as these conditions significantly heighten the risk of severe and prolonged low blood sugar.

Time-Related Patterns: Transient visual disturbances may occur, particularly at the start of treatment, due to the body's adjustment to changes in blood glucose levels.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information for Diamicron 80

Overdose with Diamicron 80 (Gliclazide) is officially documented to lead to hypoglycemia (excessively low blood glucose) as the primary clinical manifestation. The severity is dose-dependent, progressing from mild signs to severe, life-threatening events.

Documented Overdose Manifestations

The initial presentation of an overdose can include sweating, pallor, hunger, and tremor. As the condition worsens, the central nervous system may be affected, with symptoms such as headache, confusion, difficulty concentrating, and disorientation. Severe, prolonged hypoglycemia can escalate to loss of consciousness (coma) and convulsions (seizures), which are listed as serious outcomes in regulatory documents.

Mandated Emergency Action

Immediate medical attention must be sought for any sign or symptom consistent with hypoglycemia or overdose. Emergency services should be contacted urgently if the patient experiences loss of consciousness or convulsions. Regulatory guidance mandates a specific management protocol in a hospital setting.

Management and Monitoring

For severe cases, the required management involves the administration of intravenous glucose (dextrose), as no specific antidote is known for Gliclazide. Due to the documented risk of hypoglycemia relapse, prolonged hospital monitoring for at least 24 to 48 hours is officially required. Patients with impaired liver or kidney function are noted to be at an increased risk of severe, sustained hypoglycemia following an overdose.

Therapeutic Uses of Diamicron 80

What Diamicron 80 Treats: Main Uses and Benefits

Diamicron 80 contains the active substance gliclazide, which belongs to a class of medicines known as sulfonylureas. The core therapeutic area is applied across conditions involving episodic or fluctuating manifestations related to blood sugar. Its main use is for Type II diabetes mellitus in adults. This condition is characterized by periods of heightened symptoms (hyperglycemia) when diet and exercise alone are not sufficient to manage blood glucose control.

Gliclazide contributes to managing blood sugar levels by addressing the systemic imbalance. This medicine is commonly used to help with the symptoms related to systemic imbalance that high blood sugar creates, particularly in situations where patients experience inadequate control from lifestyle measures alone. The primary indication is non-insulin-dependent diabetes mellitus.

“This action may assist with maintaining functional stability and supports the patient during difficult episodes by easing distress.”

Diamicron 80 is relevant when supportive symptom management is appropriate to help ease the overall symptom burden. It provides support that helps ease the overall symptom burden of non-insulin-dependent diabetes.

Quick Fact: Supportive management for Symptoms related to systemic imbalance

Regulatory References

  1. Therapeutic Goods Administration Product Information

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Diamicron 80 — Official Regulatory Information

The eligibility for Diamicron 80 (Gliclazide 80 mg) is strictly defined by government regulatory labeling, establishing rules for who can and cannot safely use the medicine.

Eligibility Scope

Populations for whom use is allowed (as stated in label):

  • Adults with Type 2 diabetes mellitus (non-insulin-dependent diabetes).

Populations for whom use is contraindicated:

  • Patients with Hypersensitivity to Gliclazide, other sulfonylureas, or sulfonamides.
  • Patients with Type 1 diabetes mellitus or acute complications like diabetic keto-acidosis.
  • Patients with Severe renal insufficiency or Severe hepatic insufficiency.
  • Pregnancy and Breast-feeding mothers.

Age-related eligibility rules:

  • Children and adolescents (pediatric population): Use is not recommended as safety and effectiveness have not been established.

Eligibility-related restrictions:

  • Patients over 65 years of age may require careful monitoring due to potential increased susceptibility to the drug's action.
  • Use is contraindicated during severe trauma, infection, or surgery.
  • Patients taking systemic Miconazole are contraindicated from use.

Connection to the Overall Eligibility Profile

Official regulatory documents establish clear absolute contraindications based on metabolic stability, organ function, known allergies, and reproductive status. Eligibility is strictly confined to the indicated population of adults with Type 2 diabetes who do not possess any of the explicit contraindications or serious physiological restrictions detailed in the product labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Diamicron 80 (Gliclazide) is defined by officially documented risks that primarily alter its blood glucose-lowering effect, as established in regulatory documents.

Formal Restrictions and Prohibited Combinations

Co-administration with Miconazole (systemic or oromucosal gel) is officially contraindicated due to the severe potentiation of the hypoglycaemic effect. Several other combinations are classified as not recommended due to significant interaction risk, including Alcohol and Phenylbutazone (systemic route).

Documented Exposure and Pharmacodynamic Effects

Interactions are categorized by their effect on blood glucose levels:

  • Potentiation of Hypoglycaemic Effect: Medicines such as Fluconazole, ACE Inhibitors (e.g., Captopril), and MAOIs can increase the blood glucose lowering effect. This potentiation is also noted with Beta-blockers, which may additionally officially mask the typical warning signs of low blood sugar.

  • Antagonistic Effects (Hyperglycaemia Risk): Co-administration with substances like Danazol, Glucocorticoids (systemic and local), and Sympathomimetic Agents (I.V.) may officially increase blood glucose levels, counteracting Gliclazide's action.

  • Exposure Reduction: The herbal preparation St. John’s Wort is noted to decrease Gliclazide exposure, which can impair blood glucose control and is a not-recommended combination.

Population-Specific Notes

The regulatory profile documents that the risk of blood glucose disturbances (dysglycaemia) with Fluoroquinolones is of particular relevance in elderly patients. Furthermore, any resulting hypoglycaemic episode may be prolonged in the presence of officially documented severe renal or hepatic impairment.

Mechanism of Action

How Diamicron 80 Works (Gliclazide Mechanism of Action)

Diamicron 80, containing the active substance Gliclazide, exerts its effect by acting as an insulin secretagogue. Its primary mechanism involves binding specifically to the sulfonylurea receptor 1 ( SUR1) subunit of the ATP-sensitive potassium ( K ATP) channels located on the membrane of pancreatic beta cells.

Binding to SUR1 leads directly to the closure of the K ATP channel. This closure prevents the efflux of potassium ions ( K^+), causing the electrical depolarization of the beta cell membrane. Depolarization, in turn, opens voltage-gated calcium channels, allowing a rapid influx of calcium ions ( Ca^2+) into the cell cytoplasm. This rise in intracellular Ca^2+ concentration triggers the exocytosis and subsequent release of stored insulin.

Gliclazide also demonstrates extrapancreatic properties by influencing systems related to oxidative stress and platelet adhesion, providing a mechanism that modulates vascular processes beyond the core insulin-releasing action.

Dosage and Administration Information

How to Use Diamicron 80 mg: Official Administration Guidelines

Diamicron 80 mg is a standard-release tablet intended for oral use, following strictly defined instructions. The proper use is closely tied to the patient's meal schedule and metabolic response, in accordance with established prescribing protocols.

Dosing Schedule and Administration

Parameter Official Instruction (Adults)
Route of Administration Oral
Starting Daily Dose 40 mg to 80 mg (one-half to one 80 mg tablet)
Maximum Daily Dose 320 mg
Single Dose Maximum 160 mg

Dosing Frequency: The total daily dose is typically taken once daily when the amount is 160 mg or less. Doses exceeding 160 mg must be divided and administered twice daily.

Administration Timing: The tablet must be taken with a meal, ideally with breakfast, to align with the body’s metabolic activity. It is prescribed with the prerequisite that the patient maintains a regular, adequate food intake.

Preparation: The tablet should be swallowed whole with water. It is explicitly instructed not to chew, crush, or break the tablet, as this could disrupt the intended release of the medication.

Procedural Rules

Dose Adjustment: Any increase in dosage must be performed gradually, with a minimum interval of at least 14 days between successive steps. The adjustment is determined solely by the physician based on the patient's individual metabolic response (blood glucose and HbA1 c levels).

Missed Dose: If a dose is forgotten, the patient must not increase the subsequent dose to compensate. The next scheduled dose should be taken at the usual time to maintain the prescribed pattern of use.

Recent Clinical Evidence

Recent Clinical Evidence

Drug Activity and Study Focus

Diamicron 80 (gliclazide) is an oral medication that belongs to the sulfonylurea class. Research investigated the drug’s activity at the beta-cell membrane in the pancreas. Studies have examined changes in levels of blood glucose and glycosylated hemoglobin (HbA1c) in relation to this activity. HbA1c provides an indication of average blood glucose levels over the preceding two to three months.

The primary research examined the drug’s activity in Randomized Controlled Trials (RCTs) conducted across numerous countries. These studies focused on patients with Type 2 Diabetes Mellitus. The trials investigated the drug's effect on the overall metabolic control of glucose.

Key Clinical Research Findings

Studies focused on measuring fasting plasma glucose (FPG) and postprandial glucose (PPG) levels and examined whether the drug was associated with maintaining stable blood sugar control over time.

Sub-group Research: Combination Therapy

Studies have explored the effect of combining gliclazide and metformin in patients who did not achieve target glycemic control with initial single-drug treatment. The study’s findings indicated an association between the combination and recorded endpoints, specifically concerning the HbA1c score. The findings involved an evaluation against standard care within the study's design. Research noted the risk profile for hypoglycemia appeared different when examining older patients using this combination.

Safety and Tolerability

Studies examined the safety profile of the drug in healthy adults. Studies documented the frequency of specific adverse events, including hypoglycemia and gastrointestinal discomfort.

Overall, trials evaluated the drug’s tolerability and the frequency of side effects compared to a placebo group and a comparator drug group. The trials reviewed data on safety and tolerability for up to two years of use.

Key Studies & References

  1. Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes (ADVANCE Trial)

Frequently Asked Questions (FAQ)

Common questions about Diamicron 80 (FAQ)

Q: What is the difference between Gliclazide and Diamicron 80?

A: Gliclazide is the active substance or generic name of the medicine. Diamicron 80 is one of the brand names for the 80 mg standard-release formulation of Gliclazide. According to official product information, they refer to the same drug compound used to manage Type 2 diabetes.

Q: Is Diamicron 80 the same type of medicine as Metformin?

A: No, regulatory documents classify them differently. Diamicron 80 (Gliclazide) belongs to the sulfonylurea class of medicines, while Metformin belongs to the biguanide class. They are classified differently based on how they influence the body's glucose management.

Q: What is the difference between Diamicron 80 and the MR (Modified Release) version?

A: Diamicron 80 is a standard-release tablet, meaning the active substance is released immediately upon use. The MR (Modified Release) version is designed to ensure the active substance is released slowly over a longer period. Official administration information differs between the standard and modified-release forms.

Q: How quickly does Diamicron 80 start working after the first use?

A: Official pharmacological data indicates that the active substance, Gliclazide, is rapidly and well absorbed after being taken by mouth. The concentration of the active substance in the blood typically reaches its peak within 4 to 6 hours after the tablet is taken, according to pharmacological data.

Q: Does Diamicron 80 cause weight gain?

A: According to official patient information leaflets and safety documentation, weight gain is listed as a potential side effect associated with the use of Gliclazide, the active substance in Diamicron 80.

Q: Can Diamicron 80 affect kidney function over time?

A: The medicine is generally contraindicated (should not be used) in patients who already have severe renal impairment (severe kidney issues), as this condition is associated with a significantly heightened risk of severe and prolonged low blood sugar. However, official documents indicate that the prescribed dosing can be used with careful monitoring in patients with mild to moderate kidney insufficiency.

Q: Are there specific foods that interact with Diamicron 80?

A: Official administration instructions emphasize that the tablet must be taken with a meal to align with the body's metabolism and help reduce the risk of low blood sugar. Regulatory documents list skipping meals or irregular mealtimes as conditions that may increase the risk of low blood sugar (hypoglycemia).

Q: What beverages or drinks should be limited while using Diamicron 80?

A: The official product information explicitly lists alcohol consumption as a combination that is not recommended with Diamicron 80. This is due to the potential for alcohol to cause severe blood glucose disturbances. There are no formal restrictions on other common non-alcoholic beverages.

Q: Can Diamicron 80 interact with common over-the-counter pain relievers?

A: The regulatory Interactions section lists a specific anti-inflammatory medicine, Phenylbutazone (systemic route), as a combination that is not recommended because it may dangerously increase the blood sugar-lowering effect. General guidance on other common over-the-counter pain relievers is not provided in the interaction tables.

Q: What are the official warnings about using Diamicron 80 with alcohol?

A: The combination of Diamicron 80 and alcohol is officially not recommended. Alcohol can significantly potentiate (increase the strength of) the blood sugar-lowering effect of the medicine, leading to severe hypoglycemia. Alcohol consumption may also hide the typical warning signs of low blood sugar.

Q: How does Diamicron 80 compare to other sulfonylurea medications?

A: Gliclazide is officially classified as a second-generation sulfonylurea medicine. While this places it within a specific pharmacological group, regulatory product information does not provide comparative claims of superiority or inferiority against other individual medications in this class.

Q: Is the risk of low blood sugar higher with Diamicron 80 than with other diabetes pills?

A: Hypoglycemia (low blood sugar) is listed as the most frequent and expected adverse effect of Gliclazide. Clinical studies have generally documented a low incidence of severe hypoglycemia when using this specific compound compared to certain other types of oral glucose-lowering medications.

Q: Can people with heart failure use Diamicron 80?

A: Heart failure is not listed among the absolute contraindications, such as severe liver or kidney failure. However, official regulatory documents note that the presence of severe vascular diseases, such as severe coronary heart disease, increases the potential risk of developing low blood sugar (hypoglycemia) with this medication.

Q: Is it necessary to carry sugar or candy when using Diamicron 80?

A: Official product information stresses the importance of understanding the risk of hypoglycemia (low blood sugar), which is common. Although the documents do not specifically mandate carrying sugar, they extensively detail how patients should be informed on the detection and management of a hypoglycemic episode.

Q: Is it safe to take Diamicron 80 if I have a sulfur allergy?

A: Gliclazide is formally contraindicated (not to be used) if a patient has a known hypersensitivity to Gliclazide, other sulfonylureas (the class of drug), or related drugs known as sulfonamides (often called sulfa drugs).

Q: Does Diamicron 80 interact with herbal supplements like ginseng?

A: The regulatory documents specifically warn against combining Diamicron 80 with St. John’s Wort. For other common herbal supplements like ginseng, general guidance states that there is not enough information to confirm their safety, and they may still affect blood sugar levels.

Q: What evidence is there about Diamicron 80 helping with blood sugar control?

A: The medicine is indicated for managing Type 2 diabetes when changes in diet and exercise alone are not sufficient. Studies often evaluate the drug’s activity based on maintaining target levels of glycosylated hemoglobin ( HbA1 c) in patients.

Q: What general expectations should a patient have when starting Diamicron 80?

A: Regulatory documents note that maintaining a regular, adequate food intake is a prerequisite for using the medication. Patients should also be aware of the high risk of hypoglycemia and the possibility of transient visual disturbances (temporary changes in vision) when first beginning treatment.

Q: Does Diamicron 80 have any known effects on vision?

A: Official safety labeling notes that transient visual disturbances (temporary changes in vision) may occur, particularly at the start of treatment. This is related to the body adjusting to changes in blood glucose levels, not typically a direct side effect on the eye's structure.

Q: Can Diamicron 80 be taken with hypertension (blood pressure) medication?

A: Yes, but official documents detail that some medicines for hypertension, such as ACE Inhibitors (a common class of blood pressure medication), are officially documented to potentiate (increase) the blood sugar-lowering effect of Gliclazide. Therefore, careful monitoring may be necessary.

Q: Is Diamicron 80 safe to use before driving or operating machinery?

A: Since Gliclazide can cause hypoglycemia (low blood sugar), which may result in reduced alertness, dizziness, or confusion, official product warnings advise individuals to avoid driving or operating machinery until they know how the medication affects them, due to the risk of hypoglycemia.

Q: Why do some people stop taking Diamicron 80?

A: Official documents indicate that the medicine must be stopped if a patient develops a contraindication, such as becoming pregnant or developing severe liver or kidney problems. Discontinuation can also occur due to an allergic reaction or if the hypoglycaemic efficacy of the drug naturally attenuates (wears off) over time.

Q: Are there any long-term research studies on the safety of Diamicron 80?

A: Clinical trials have investigated the drug's safety profile for periods of up to two years for specific endpoints. Furthermore, official information mentions that longer-term safety and cardiovascular outcomes have been investigated in systematic reviews and large meta-analyses.

Q: Is Diamicron 80 available in other strengths besides 80 mg?

A: Yes, official dosage and formulation information confirms that Gliclazide is available in a standard-release tablet of 40 mg, in addition to the 80 mg strength. It is also available in different strengths for the modified-release (MR) formulation.

How should Diamicron 80 be stored and disposed of?

Storage and Disposal Instructions for Diamicron 80 mg Tablets

Diamicron 80 mg tablets (Gliclazide) must be stored according to official regulatory specifications to maintain product integrity.

Storage Requirements

Condition Requirement
Temperature Store below 25°C or 30°C, as specified in the labeling.
Protection Store in a dry place and protected from light.
Packaging Keep the medicine in its original package.
Safety Store out of the sight and reach of children.

Disposal

Unused or expired tablets must not be thrown away via household refuse or wastewater (e.g., sink or toilet). The product must be disposed of safely through a designated pharmaceutical collection program or by consulting a pharmacist for guidance on proper local disposal protocols. The stated shelf life applies only when the product is stored under these required conditions.

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

Equivalent of Diamicron 80 found in:

A-Z Index: