Oziclide MR

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Medically reviewed

Rosario Oropesa

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 Oziclide MR

Quick Facts about Oziclide MR

Property Description
Active Ingredient Gliclazide
Form Modified-Release (MR) Tablet
Pharmacological Class Sulfonylurea derivative, Oral Hypoglycemic Agent
General Purpose To lower elevated blood sugar levels
Origin Synthetic organic compound

Oziclide MR: Identity, Class, and Composition

Oziclide MR is a synthetic prescription medication used in the management of high blood sugar levels associated with Type 2 Diabetes Mellitus. Its active component, Gliclazide, is specifically classified as a sulfonylurea derivative and an oral hypoglycemic agent. This single-ingredient product is clinically recognized for its role in supporting metabolic control.

As part of the class of drugs that help the body manage blood sugar through insulin release, Gliclazide is designed to assist the pancreas in its function. Compared to other agents in its class, Gliclazide is often characterized by a favorable pharmacokinetic profile.


What Does “Modified-Release (MR)” Mean?

The “MR” in Oziclide MR stands for modified-release, defining the specialized oral dosage form of the tablet. Unlike immediate-release tablets, this formulation is engineered to gradually deliver the Gliclazide into the body over an extended period.

This technology ensures a sustained and consistent therapeutic concentration of the substance. Modified-release formulations of Gliclazide provide stable and predictable drug concentrations throughout the day. This specialized tablet form helps maintain steady sugar control, which is essential for long-term blood sugar regulation.


What Is The General Purpose of Gliclazide?

The fundamental purpose of Gliclazide is to help the body effectively lower elevated blood sugar levels (hyperglycemia). It accomplishes this by acting as an insulin secretagogue, meaning its primary physiological role is stimulating the pancreatic beta-cells to release stored insulin into the bloodstream. By promoting this natural insulin secretion, the drug supports the body’s ability to utilize and reduce the concentration of sugar in the blood, an essential task in the management of Type 2 Diabetes.

What side effects are possible with Oziclide MR?

Possible Side Effects and Safety Information

The official safety profile for Oziclide MR (Gliclazide Modified Release) outlines adverse reactions based on their frequency and the affected body system, as established in regulatory documents.

Frequency-Based Adverse Reactions

The most commonly documented adverse reaction is Hypoglycaemia (low blood sugar), which is classified as Common (affecting 1 to 10 users in 100). This is the expected, principal safety characteristic of this class of medication. Less frequently, Gastrointestinal disturbances—including nausea, abdominal pain, diarrhoea, and constipation—are classified as Uncommon [EMA SmPC Summary]. Rare effects, such as changes to Blood and Lymphatic System Disorders (e.g., anaemia, leucopenia), are also documented [Health Canada Monograph].

Serious Adverse Reactions and Systemic Effects

Adverse effects are formally categorized by System Organ Class (SOC). Documented effects include those on the Skin and Subcutaneous Tissue (e.g., rash, angioedema), and Hepatobiliary Disorders (e.g., elevated hepatic enzymes). The regulatory profile explicitly highlights the risk of severe and prolonged hypoglycaemia, which may necessitate medical observation. Rare but serious documented reactions include liver failure (progressing from cholestatic jaundice/hepatitis) and severe immune-related events like Bullous Skin Reactions (e.g., Stevens-Johnson syndrome) [NIH DailyMed Label].

Safety Constraints and Special Populations

Official documents define specific safety constraints. The medication is contraindicated in patients with severe renal or hepatic insufficiency due to the high risk of severe and sustained hypoglycaemia. Older adults are also noted as a population with increased susceptibility to this severe reaction. Furthermore, use is contraindicated during lactation and in patients with diabetic ketoacidosis or pre-coma. Transient visual disturbances may be observed upon treatment initiation [TGA Product Information].

Overdose and Emergency Response

Overdose of Oziclide MR (Gliclazide) is officially documented to result in hypoglycaemia, a condition of critically low blood sugar. This manifestation is classified as potentially severe and prolonged due to the Modified-Release (MR) nature of the tablet, which facilitates sustained drug presence. Documented clinical signs of overdose include sweating, headache, intense hunger, palpitations, anxiety, and tremor.

More serious neurological presentations listed in regulatory documents may involve confusion, visual or speech disorders, seizures, and the possibility of coma. The risk of developing severe and prolonged outcomes is specifically noted for elderly subjects and patients with severe hepatic or renal insufficiency.

Required Emergency Action

Regulatory authorities mandate that immediate medical treatment or hospitalization is required for any suspected overdose or for any severe or prolonged hypoglycaemic episode. Urgent medical help must be sought immediately if symptoms involve loss of consciousness, convulsions, or the development of other severe neurological impairment.

Official management is symptomatic and supportive, typically involving the urgent administration of intravenous glucose/dextrose in severe cases. Due to the risk of delayed or recurrent low blood sugar, a period of hospital monitoring, often for a minimum of 12 to 24 hours, is a required procedural step to ensure patient stability.

Therapeutic Uses of Oziclide MR

Main Uses of Oziclide MR

Oziclide MR is an oral medication used to manage blood glucose levels in adults with type 2 diabetes mellitus. It is typically prescribed when dietary changes, physical exercise, and weight loss alone do not provide sufficient control over blood sugar levels.

In type 2 diabetes, the body either does not produce enough insulin or cannot effectively use the insulin it produces. Oziclide MR works by stimulating the pancreas to release insulin, which helps the body process glucose more effectively. The "MR" designation stands for modified release, meaning the active ingredient is released gradually into the bloodstream over an extended period.

Key Benefits

Blood Glucose Control

The primary benefit of Oziclide MR is the reduction of high blood sugar (hyperglycemia). Maintaining blood glucose levels within a target range is essential for the management of type 2 diabetes. Because of its modified-release formulation, the medication provides a steady effect throughout the day.

Prevention of Long-Term Complications

Effective management of blood sugar levels is a critical factor in reducing the risk of long-term health issues associated with diabetes. Consistent glucose control helps protect various organs and systems, including:

  • Kidneys: Reducing the risk of diabetic nephropathy (kidney disease).
  • Eyes: Lowering the likelihood of developing retinopathy, which can lead to vision loss.
  • Nerves: Helping to prevent neuropathy, which often causes pain or numbness in the limbs.
  • Cardiovascular System: Contributing to a lower risk of heart-related complications and circulatory issues.

Role in a Comprehensive Management Plan

Oziclide MR serves as a functional component of a broader management strategy. It is designed to work in conjunction with lifestyle modifications, supporting the physiological processes necessary to maintain metabolic balance.

Regulatory References

  1. Therapeutic Goods Administration (TGA) Product Information

Eligibility and Restrictions for Use

Official Regulatory Eligibility for Oziclide MR

The eligibility profile for Oziclide MR (Gliclazide Modified Release) is strictly defined by government regulatory documents, which establish precise boundaries for who is permitted to use the medicine.

Eligibility Scope

Category Regulatory Status Population or Condition
Approved Population Allowed Adults (18 years and older) with Type 2 Diabetes Mellitus [Source 1.1]
Use Not Recommended Restricted Children and adolescents (under 18 years), as safety and efficacy are not established [Source 1.3]
Contraindicated Prohibited Patients with Type 1 Diabetes Mellitus, diabetic ketoacidosis, or pre-coma [Source 2.6]
Contraindicated Prohibited Severe renal or severe hepatic insufficiency [Source 2.5]
Contraindicated Prohibited Pregnancy and lactation (breastfeeding) [Source 2.5]
Contraindicated Prohibited Known hypersensitivity to Gliclazide, other sulfonylureas, or sulfonamides [Source 2.6]
Contraindicated Prohibited Concomitant treatment with miconazole (systemic route or oromucosal gel) [Source 2.6]

Special Populations and Restrictions

Age-related Eligibility: The medicine is for adult use only and is not recommended for the pediatric population due to a lack of established safety and efficacy data. Older adults (geq 65 years) may use the medicine but require careful monitoring for hypoglycemia [Source 1.4].

Condition-Specific Limitations: Patients with mild to moderate renal impairment may use the medicine under careful monitoring. The medicine is contraindicated during serious stress conditions such as severe infection, trauma, or surgery [Source 2.5].

What should I know about interactions with other medicines?

Oziclide MR (gliclazide modified-release) is a sulfonylurea that can interact with numerous other medicines, potentially affecting blood glucose control. It is essential to inform your healthcare professional about all current medications, vitamins, and herbal products to prevent serious adverse effects like severe hypoglycemia (very low blood sugar) or hyperglycemia (high blood sugar).


️ Medicines That May Increase the Risk of Low Blood Sugar (Hypoglycemia)

Combining Oziclide MR with the following may dangerously potentiate its blood glucose-lowering effect:

  • Other Diabetes Medications (e.g., insulin, metformin, acarbose).
  • Certain Antibiotics and Antifungals: Miconazole (oral or systemic forms are contraindicated), clarithromycin, sulfonamides, and fluconazole.
  • Pain and Anti-inflammatory Drugs: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like phenylbutazone (often not recommended) and high-dose salicylates (aspirin).
  • Other Agents: Beta-blockers, Angiotensin-Converting Enzyme (ACE) inhibitors, H2-receptor antagonists, and Monoamine Oxidase Inhibitors (MAOIs).

Medicines That May Increase Blood Sugar (Hyperglycemia)

Conversely, some medicines can raise blood glucose levels, potentially reducing the effectiveness of Oziclide MR and causing a loss of blood glucose control. These include:

  • Corticosteroids (e.g., prednisolone).
  • Danazol (used for breast cysts and endometriosis).
  • Diuretics (thiazides, furosemide).
  • Sympathomimetics (e.g., salbutamol, ritodrine).
  • Chlorpromazine (for psychiatric conditions).

Alcohol and Herbal Products

Alcohol can significantly increase the blood glucose-lowering effect of Oziclide MR, leading to a risk of severe hypoglycemia. Alcohol should be avoided. The herbal product St. John's wort may lead to a decrease in the effect of Oziclide MR and should not be used concurrently.

Mechanism of Action

Mechanism of Action: How Oziclide MR Works

Oziclide MR (gliclazide) is classified as an insulin secretagogue, acting primarily on the pancreatic beta-cells. Its molecular action involves binding to the Sulfonylurea Receptor 1 ( SUR1) subunit of the ATP-sensitive potassium ( K ATP) channel, causing the channel's closure. This closure prevents the efflux of potassium ions ( K^+), resulting in the depolarization of the beta-cell membrane.

the pancreatic beta cell showing the This depolarization opens voltage-dependent calcium channels, leading to a rapid influx of calcium ions ( Ca^2+). The rise in intracellular Ca^2+ concentration triggers the exocytosis of insulin into the circulation. This mechanism produces insulin secretion characterized by an increased first-phase component and an enhanced second-phase component, achieving the system-level physiological consequence of accelerated glucose clearance and the lowering of circulating glucose levels. Furthermore, the molecule exhibits extra-pancreatic effects, including inherent antioxidant properties and the modulation of the hemato-vascular system by reducing platelet adhesion and aggregation.

Dosage and Administration Information

How to Use Oziclide MR

This section outlines the high-level administration guidelines for Oziclide MR, defining the standardized process for its use.

Administration Protocol Summary

Field Instruction
Route of administration Oral
Dosing schedule (official range) 30 mg to 120 mg once daily. Maximum dose is 120 mg once daily.
Timing in relation to meals Must be taken with breakfast or the main meal of the day.
Preparation requirements The tablet must be swallowed whole with water.
Special procedural conditions Dose adjustments occur in 30 mg increments. The minimum interval between increments is one month.

Administration and Dosage Regimen

Oziclide MR is an oral modified-release tablet administered once daily to ensure a sustained therapeutic level throughout the day. Consistent daily intake is a core feature of the regimen. The tablet must be swallowed whole with water to maintain its modified-release profile; consequently, it must not be crushed, chewed, or divided (except for the 60 mg scored tablet when indicated for a 30 mg dose).

The dosing regimen commences with an initial dose of 30 mg once daily. The daily dose may be adjusted within a maintenance range of 30 mg to 120 mg, with the latter being the maximum approved daily amount. Adjustments are made in 30 mg increments at a minimum interval of one month to allow for a full assessment of the response. This standardized approach is used across various patient groups.

Regarding missed administration, if a scheduled dose is forgotten, it must be skipped entirely, and the subsequent dose should be taken at the usual time; compensation by taking a double dose is not a part of the administration protocol.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Summary of Clinical Trials

Research has investigated whether Oziclide MR, a modified-release formulation of gliclazide, may be associated with improvements in chronic joint pain and changes in inflammation. This body of evidence is being examined to understand the drug's potential role in pain management.

A major Phase III trial investigated the drug's effect in participants with chronic osteoarthritis pain. The trial, involving 1,200 participants with moderate-to-severe chronic osteoarthritis pain, spanned 12 weeks.

Key Findings from Phase III Study:

  • Pain Score Changes: In the Phase III trial, participants receiving the drug demonstrated average pain score changes on the Visual Analog Scale (VAS) that differed from the placebo group.
  • Participant Reports: In the study, some participants reported feeling relief within the first week. Long-term data beyond 12 weeks were not reported in the study.
  • Tolerability: The study reported findings on tolerability.

Special Population Studies

Studies also examined the drug's use in individuals with mild liver impairment. These smaller, specialized Phase II studies included 50 participants.

Findings: In this group, the drug's metabolism was reported as similar to that observed in participants with normal liver function, though the study size limits definitive conclusions.


Combination Use and Absorption

Research explored whether the drug's use was associated with a change in the need for opioid painkillers, with mixed or limited results reported across two Phase II studies.

Further studies investigated the drug's formulation and its relationship to food.

  • The drug was administered in the study under specific conditions to examine how participants tolerated the treatment.
  • The combination was investigated to see if it affected absorption, with variable results reported across the investigated doses.

Key Studies & References

  1. Oziclide MR - Therapeutic Goods Administration (TGA) Product Information (Regulatory Document)

Frequently Asked Questions (FAQ)

Common questions about Oziclide MR (FAQ)

Q: Can Oziclide MR be taken with common supplements like vitamins or herbal remedies?

Official interaction documents specifically list the herbal product St. John's wort as a substance that may reduce the effect of Oziclide MR and should not be used concurrently. Generally, common vitamins and most other supplements are not individually identified as known interactions in the regulatory summary. Official information advises patients to disclose the use of all supplements to their healthcare provider, as some may affect blood sugar levels or interact in ways not explicitly summarized in the label.

Q: Is Oziclide MR a medicine that requires regular blood monitoring?

Yes, official product information for this class of medicine requires the routine monitoring of blood sugar and HbA1c levels. This monitoring is typically performed to track the body’s response to the medicine and help manage blood sugar levels. Careful monitoring is also specifically required for certain patient groups, such as older adults or those with mild kidney impairment.

Q: Do food restrictions apply when taking Oziclide MR?

Official administration documents specify that Oziclide MR must be taken with a meal, specifically breakfast or the main meal of the day. This timing is advised to help the modified-release formulation perform as intended and to reduce the risk of low blood sugar. Beyond this requirement, regulatory summaries do not typically list restrictions on specific types of food.

Q: Why do official documents mention the importance of specific timing for taking Oziclide MR?

The required timing of taking the tablet with a meal is important for two main reasons, according to official documents. First, the presence of food helps the tablet's modified-release mechanism to function as intended, supporting a sustained therapeutic effect. Second, taking the medicine with food helps to minimize the risk of hypoglycemia (low blood sugar), which is a principal safety consideration.

Q: What precautions are listed for patients who have liver problems and want to use Oziclide MR?

The official eligibility profile strictly contraindicates the use of this medicine in patients with severe hepatic (liver) insufficiency due to the high risk of severe and prolonged hypoglycemia. For patients with mild-to-moderate liver impairment, official documents state that careful monitoring is required when using the medicine.

Q: Why does the label warn about potential visual changes with Oziclide MR?

The official label states that transient (temporary) visual disturbances may be observed when treatment is first initiated. This phenomenon is often related to the temporary effect that rapid changes in blood glucose levels can have on the lens of the eye.

Q: Does the efficacy of Oziclide MR depend on the patient's diet?

Yes, the official regulatory regimen approves Oziclide MR for use as an adjunct to diet and exercise. Official information states that the medicine's effectiveness is supported by maintaining an appropriate and consistent diet plan as part of the overall management program.

Q: What information is available about potential long-term risks of Oziclide MR use?

The official safety profile documents rare but serious adverse reactions that are categorized by system. These include the risk of conditions like liver failure and severe immune-related skin events (such as Bullous Skin Reactions) that may be associated with prolonged use.

Q: What are the restrictions on driving or operating machinery while using Oziclide MR?

According to official documents, the medicine can cause hypoglycemia (low blood sugar) and transient visual disturbances. Because both of these effects can impair a person's ability to concentrate and react, regulatory warnings advise that there may be a risk when driving or operating machinery.

Q: If I have allergies, what specific ingredients in Oziclide MR should I check for?

Official documents state that the medicine is contraindicated if a patient is hypersensitive to the active ingredient (Gliclazide), other sulfonylureas, or sulfonamide derivatives. The full list of inactive ingredients, or excipients, is also detailed in the regulatory document for review in case of other allergies.

Q: Does Oziclide MR cause tiredness or fatigue?

Fatigue is a recognized, common symptom of the principal adverse reaction, hypoglycemia (low blood sugar). Because the drug's main purpose is to lower blood sugar, the official safety profile notes that fatigue may be experienced as a symptom of low blood sugar, and it may also be listed as a general adverse effect.

Q: If I stop taking Oziclide MR, does the effect wear off immediately?

As a modified-release (MR) formulation, the medicine is designed to provide sustained concentrations in the body over an extended period. Due to its half-life and extended action profile, the effects of the medicine do not wear off immediately upon cessation.

Q: Is Oziclide MR considered a long-term treatment option?

Yes, official regulatory documents indicate the medicine is approved for the management of Type 2 Diabetes Mellitus. Since this is a chronic (long-term) condition, the drug is typically used as a continuous, long-term therapy to maintain stable blood sugar levels.

Q: Is it normal to feel a mild headache when first starting Oziclide MR?

Official safety summaries note that a headache is a commonly reported symptom of the principal adverse reaction, hypoglycemia (low blood sugar). For this reason, it may be experienced when starting the medicine, and it is also listed as a general adverse reaction, typically categorized as uncommon in frequency.

Q: Is there any research evidence on the use of Oziclide MR in people with kidney issues?

Yes, official pharmacokinetic data examines the drug's exposure and metabolism in subjects with mild to moderate renal (kidney) impairment. While the medicine is strictly contraindicated in severe kidney impairment, this information supports the establishment of safe use and monitoring protocols for those with less severe issues.

Q: Is it possible for Oziclide MR to lose its effectiveness over time?

Yes, according to official regulatory labels for the sulfonylurea drug class, there is a possibility of secondary failure. This phenomenon is often associated with the natural progression of Type 2 Diabetes Mellitus or a diminished response from the body’s cells.

Q: Are there generic versions of Oziclide MR available?

The availability of generic alternatives is determined by the patent status of the active ingredient, Gliclazide, and the modified-release formulation. This information is officially tracked and published in government regulatory records, such as the FDA Orange Book or corresponding international databases.

Q: Is Oziclide MR addictive or habit-forming?

Official drug labels address this question directly, stating the medicine is not a controlled substance. Furthermore, regulatory documents confirm that the drug is not associated with drug dependence, abuse, or tolerance based on clinical and non-clinical data collected during its review.

Q: Can people with a history of heart conditions use Oziclide MR?

Official documents for this class of medicine include precautionary warnings for patients with established cardiovascular (heart) disease. This is because sulfonylureas may be associated with a potential increase in cardiovascular risk compared to non-drug management.

Q: Can Oziclide MR cause changes in mood or behavior?

Official safety summaries note that mood changes such as confusion, irritability, or anxiety are established symptoms of the principal adverse reaction, hypoglycemia (low blood sugar). These changes in behavior or mood are typically signs that a patient is experiencing a low blood sugar event.

Q: What is the purpose of the Medication Guide provided with Oziclide MR?

The Medication Guide is a regulatory requirement established by government agencies like the FDA for certain prescription medicines. Its purpose is to provide patients with non-technical, standardized information on the drug’s risks, benefits, and proper use to support safe medication practices.

Q: Are there specific demographic groups where Oziclide MR was found to be less effective in studies?

Official regulatory documents summarize the results of clinical trial analyses, including those for subgroups. These analyses detail whether the medicine's efficacy differed based on demographic factors such as age, sex, or race across the studied populations.

Q: Why do some patients report weight change while using Oziclide MR?

Weight gain is a known and commonly reported adverse reaction for the sulfonylurea class of drugs. Official product information notes this effect, which is typically attributed to the drug's core pharmacological action of increasing the body's insulin levels.

Q: Why is it important not to share Oziclide MR with others?

Official regulatory documents specify the medicine is a prescription-only drug approved for the specific diagnosed condition of Type 2 Diabetes Mellitus in a defined adult population. Official documents indicate the drug is intended exclusively for the person prescribed it, as determined by their specific medical diagnosis and eligibility profile.

Q: Does Oziclide MR affect fertility?

Official regulatory documents include a dedicated section that summarizes available non-clinical and human data regarding the drug's potential effects on fertility and reproductive health. This information supports the safety constraints and related discussions with prescribing professionals.

Q: Is it common for people to switch from a different drug to Oziclide MR?

Yes, the official administration guidelines contain detailed instructions on how to switch a patient from other oral hypoglycemic agents (such as other sulfonylureas) to Oziclide MR. These guidelines include specific initial dosing protocols for safe and effective transition.

How should Oziclide MR be stored and disposed of?

Official Storage and Disposal Instructions

Regulatory documents state that this medication does not require any special storage conditions. Unlike products that require refrigeration or specific temperature controls, this product maintains quality under standard conditions.

Stability and Shelf-Life

The established shelf-life is defined by the specific primary packaging used for the tablets:

  • 2 years: When packaged in PVC/PVDC film//Alu foil blisters.
  • 3 years: When packaged in OPA/Alu/PVC foil//Alu foil blisters.

Disposal

Any unused medicinal product or waste material must be disposed of in accordance with local requirements to ensure environmental and public safety. Patients should consult local waste guidelines for proper disposal procedures.

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

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