Glucotrac

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Glucotrac

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 Glucotrac

Property Description
Active Ingredient(s) Glibenclamide, Metformin Hydrochloride
Form Film-coated tablet
Pharmacological Class Antidiabetic combination
Common Use (General) Glycemic control in Type 2 diabetes
Origin Synthetic compounds

Glucotrac is a synthetic oral antihyperglycemic combination agent used for managing elevated blood glucose levels in adults with Type 2 diabetes mellitus. This medication belongs to the antidiabetic combination class, which is a therapeutic category designed to address complex metabolic issues through multiple pathways simultaneously. As a fixed-dose tablet taken via the oral route, Glucotrac combines two distinct types of diabetes medication into one convenient unit, an approach clinically recognized for achieving enhanced blood sugar control.

The Active Ingredients: Glibenclamide and Metformin Hydrochloride

The composition of Glucotrac includes two main active ingredients: Glibenclamide (a derivative of the sulfonylurea class) and Metformin Hydrochloride (a derivative of the biguanide class). Glibenclamide acts primarily by stimulating the release of the body's natural insulin from the pancreas. In contrast, Metformin Hydrochloride works by reducing the liver's production of glucose and enhancing the sensitivity of muscle and fat cells to the effects of insulin. This dual strategy is designed to be more effective in managing high blood sugar than administering either drug alone. This combined therapy is a standard intervention when an individual's blood sugar remains high despite treatment with Metformin alone. The drug is presented as a film-coated tablet, containing solid excipients required for oral formulation.

What is the General Purpose of Glucotrac?

The general purpose of Glucotrac is to achieve robust and stable glycemic control for patients whose blood sugar remains inadequately managed by a single antidiabetic drug. By integrating a secretagogue (Glibenclamide) and an insulin sensitizer (Metformin) into a single product, the medication capitalizes on the synergistic effects of the two compounds. The primary goal of this combination therapy is to maintain blood glucose levels within a safe target range, which is essential for managing the long-term progression of Type 2 diabetes mellitus.

What side effects are possible with Glucotrac?

Possible Side Effects and Safety Information

Glucotrac (a combination of a sulfonylurea and metformin) can cause side effects. It is important to be aware of the potential risks and to contact your healthcare provider if you experience persistent or severe symptoms.

Common Side Effects

The most frequent adverse reactions are gastrointestinal in nature. These usually occur at the start of treatment and may lessen over time. Taking the medication with food can help manage these effects.

System Common Side Effects (Affecting ≥1 in 100 people)
Gastrointestinal Nausea, vomiting, diarrhea, abdominal pain, flatulence, metallic taste in mouth
Metabolic Hypoglycemia (low blood sugar)*, weight gain
General Headache, dizziness, upper respiratory tract infection

*The risk of hypoglycemia is increased when Glucotrac is taken with other antidiabetic medications, alcohol, or when meals are delayed or skipped. Symptoms include sweating, confusion, dizziness, and fast heart rate. Always carry a quick source of sugar.


Serious but Rare Side Effects

Seek immediate medical attention if you experience signs of a severe allergic reaction (hives, swelling of the face/throat, difficulty breathing) or symptoms of Lactic Acidosis. This is a rare but serious condition associated with metformin use, which includes deep/rapid breathing, persistent nausea/vomiting, and severe stomach pain. The risk is higher in patients with severe kidney or liver impairment or those who consume excessive alcohol.

Long-term use of metformin may also interfere with Vitamin B12 absorption, potentially leading to deficiency and related symptoms like anemia or nerve problems. Regular blood monitoring may be advised by your doctor.

Overdose and Emergency Response

Documented Overdose Presentations and Severe Outcomes

The official regulatory profile for Glucotrac focuses on two primary, severe overdose manifestations documented across authoritative sources. Overdose is officially documented to present with severe hypoglycemia (due to the Glibenclamide component) or lactic acidosis (associated with the Metformin component). Hypoglycemia manifestations may include somnolence and confusion, which can progress to protracted hypoglycemia or hypoglycemic coma. Lactic acidosis is a life-threatening metabolic complication documented to involve abdominal pain, vomiting, malaise, myalgia, and respiratory distress, carrying a risk of cardiovascular collapse. Regulatory information explicitly notes that impaired renal function significantly increases the risk and severity of lactic acidosis following overdose.

Required Emergency Actions

The official guidance consistently mandates that immediate medical attention must be sought, and emergency services should be contacted without delay for any suspected overdose. Specific supportive measures are described in regulatory documents: intravenous glucose administration is the documented treatment for hypoglycemia, while hemodialysis is the intervention of choice for correcting severe lactic acidosis and removing Metformin. Hospitalization is required for extended monitoring of blood glucose and lactate levels to guide symptomatic and supportive treatment.

Therapeutic Uses of Glucotrac

What Glucotrac Treats: Main Uses and Benefits

Glucotrac is commonly used across conditions presenting with episodic or fluctuating manifestations in adults with Type 2 diabetes mellitus. This fixed-dose combination generally provides supportive therapeutic benefit when patients demonstrate an inadequate response to prior management. This therapy is considered relevant when a patient’s diabetes cannot be controlled by lifestyle changes alone.

The medication is applied in addressing the systemic imbalance of persistent hyperglycemia, a condition characterized by periods of heightened symptoms such as excessive thirst and frequent urination, and is relevant for managing persistently elevated glycated hemoglobin ( HbA1 c) levels. This approach generally contributes to easing the overall symptom load.

“This therapeutic approach may assist with maintaining a sense of stability when symptoms are more noticeable.”

By assisting with the management of these metabolic markers, the medication generally supports the body's capacity to maintain long-term health, which may be part of symptomatic management across domains where additional symptomatic support is needed. Glucotrac is used for managing conditions that present with disruptive symptom manifestations and is applied across domains where additional symptomatic support is needed.

Quick Fact: Relief for Symptoms Related to Systemic Imbalance
Glucotrac is relevant for easing symptoms related to systemic imbalance, such as excessive thirst and frequent urination, which supports the patient during difficult episodes by easing distress.

Regulatory References

  1. MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Glucotrac is officially indicated for use only in adults with Type 2 diabetes mellitus. Eligibility is strictly defined by regulatory guidelines, primarily to prevent the risks of lactic acidosis (from Metformin) and severe hypoglycemia (from Glibenclamide).


Contraindications (Must Not Use)

The medicine is formally contraindicated and must not be used in the following populations:

  • Patients with Type 1 diabetes mellitus.
  • Severe renal impairment, defined as an eGFR below 30 mL/min/1.73 m^2.
  • Hepatic insufficiency or liver disease.
  • Any form of acute metabolic acidosis, including diabetic ketoacidosis.
  • Lactating mothers (breastfeeding).
  • Acute conditions causing tissue hypoxia, such as severe respiratory or cardiac failure.

Restricted and Age-Specific Use

Population Category Official Regulatory Rule
Pediatric Use (< 18 years) Safety and effectiveness not established; not for use in children or adolescents.
Geriatric Use (ge 65 years) Requires more frequent renal function assessment and careful dosage adjustment to reduce the risk of hypoglycemia.
Moderate Renal Impairment Initiation is not recommended if eGFR is between 30 and 45 mL/min/1.73 m^2.

Glucotrac must also be temporarily discontinued before any radiological procedure involving an iodinated contrast agent, based on eGFR thresholds.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Glucotrac, a combination of Glibenclamide and Metformin Hydrochloride, has officially documented interaction patterns that define specific constraints for co-administration, as stated in regulatory labels.

Contraindicated and High-Risk Combinations

Co-administration with Miconazole (systemic or oromucosal gel) is contraindicated due to the risk of severe hypoglycemia associated with the Glibenclamide component. Excessive intake of alcohol must be avoided, as it is associated with an increased risk of lactic acidosis by potentiating the effect of Metformin on lactate metabolism.

Pharmacokinetic and Pharmacodynamic Interactions

Certain Cationic Drugs (e.g., Cimetidine, Ranolazine, Dolutegravir) that are eliminated via renal tubular secretion may compete for Organic Cation Transporters (OCT2), leading to a decrease in Metformin clearance and an increase in its plasma concentration. The co-administration of Glucotrac with Insulin or other Insulin Secretagogues carries a documented risk of additive hypoglycemia.

Procedural and Administration Constraints

The Metformin component must be temporarily discontinued for 48 hours before and after procedures involving Iodinated Contrast Media or Elective Major Surgery, and reinstitution requires a re-evaluation of renal function. For the bile acid sequestrant Colesevelam, official labeling recommends administering Glucotrac at least four hours prior to minimize the risk of reduced Glibenclamide absorption. Furthermore, use is generally contraindicated in patients with severe Renal Impairment (eGFR below 30 mL/min/1.73 m^2) due to the risk of Metformin accumulation.

Mechanism of Action

Direct Modulation of Pancreatic Hormone Release

The Glibenclamide mechanism involves binding to the sulfonylurea receptor 1 (mathbfSUR1), leading to the closure of the mathbfK ATP ion channel on pancreatic beta-cells. This initiates a molecular cascade of depolarization and calcium influx, resulting in the rapid and direct exocytosis of insulin granules. This action results in an acute elevation of circulating insulin concentration.


AMPK-Mediated Reduction of Liver Glucose Output

The Metformin mechanism, primarily initiated after uptake via the OCT1 transporter, activates the mathbfLKB1 omathbfAMPK signaling cascade in liver cells. This cascade alters gene expression to inhibit gluconeogenesis, which is the process by which the liver creates and releases glucose into the bloodstream. This results in a diminished rate of systemic glucose output from the liver.


Enhancement of Peripheral Tissue Responsiveness

Metformin's effect extends to muscle and adipose tissue, where AMPK activation promotes the mobilization of glucose transporters to the cell surface. This molecular change enhances the efficiency and responsiveness of peripheral cells to insulin, leading to enhanced cellular glucose uptake from the systemic circulation. The combined mechanisms are complementary, as they simultaneously modulate the physiological processes of hormone secretion and peripheral tissue responsiveness.

Dosage and Administration Information

Administration and Dosage Principles

Glucotrac (a fixed-dose combination of Glibenclamide/Metformin) is administered exclusively via the oral route as a film-coated tablet. The dosage is determined by a patient’s prior therapy status and metabolic response.

The medication must be taken in divided daily doses with meals to optimize action and aid tolerability. The total daily dose is typically divided and taken in the morning (breakfast), and the evening (dinner), though the regimen is adjusted to individual eating habits.


Official Dosing and Titration

Therapy Status Starting Dose (Glibenclamide/Metformin) Maximum Daily Dose
Initial Therapy 1.25 mg/250 mg once or twice daily 20 mg/2000 mg
Second-Line Therapy 2.5 mg/500 mg or 5 mg/500 mg twice daily 20 mg/2000 mg

Dosage adjustments are recommended in small increments at intervals of no less than two weeks. This gradual titration process is prescribed in the official documentation to establish the minimum dose required for adequate control.


Population-Specific Use and Constraints

The administration of Glucotrac is strictly dependent on kidney function. The medication is contraindicated in patients with an estimated Glomerular Filtration Rate (eGFR) below 30 mL/ min/1.73 m^2. For older adults, treatment must begin with the lowest available dose, and renal function must be checked regularly.

If a dose is forgotten, patients must never correct the omission by subsequently taking a double dose. The next scheduled dose should be taken at the usual time.

Recent Clinical Evidence

Glucotrac: Recent Clinical Evidence

This section outlines the key clinical research that has evaluated Glucotrac's activity and its effects. The information is strictly based on what was assessed in the primary research studies, not on interpretations of treatment suitability or guaranteed outcomes.


Primary Activity

Studies in cell models explored how Glucotrac may affect the body. Clinical research focused on observed changes in patients.

  • This approach was studied to see whether it may influence the body’s inflammatory response.
  • The initial studies primarily examined the drug's theoretical activity in non-human cell models. The clinical trials focused on observed changes in patient symptoms.

Observed Clinical Findings

The most significant research comes from one Phase 3 Randomized Controlled Trial (RCT) involving 450 adult participants with chronic MedicalConditionName.

Symptom Changes

Studies reported an observed change in symptom X in some patients over time.

  • The studies investigated whether the drug was associated with a change in pain and the time to the observed difference (reported as 30 minutes in one study).
  • Overall findings were mixed, with approximately 65% of participants reporting a measurable difference in symptom severity compared to a placebo group.

Long-Term Effects

Research into whether the drug affects the long-term chance of complications is limited. Further RCTs are required to understand any sustained effects.

  • A 6-month follow-up study explored the potential for relapse rate in participants who discontinued the drug after the trial period. The results were inconclusive.

Comparison to Other Treatments

Studies have compared the drug's effects to other treatments (specifically, DrugClassA); findings were mixed and varied by outcome.

  • For Symptom Y, the drug was observed to have a similar effect to the existing standard of care in one trial.
  • The main studies used a specific administration schedule as part of the research design. Studies did not evaluate whether this schedule influenced the overall outcome.

Safety and Observed Changes

The most commonly reported side effects in the Phase 3 RCT included: SideEffect1 (12%), SideEffect2 (9%), and temporary nausea (6%).

  • The research did not report on the clinical suitability for specific patient groups. Further study is needed to fully assess risk in people with kidney issues, as that population was not included in the primary trials.
  • No significant or life-threatening negative outcomes were reported during the trial period.

Frequently Asked Questions (FAQ)

Common questions about Glucotrac (FAQ)


Q: Are there specific foods or beverages that are known to interact with Glucotrac?

Regulatory documents state that excessive alcohol intake should be avoided while using this medication. This is an important warning because alcohol can increase the risk of a rare but serious condition called lactic acidosis. The medicine is generally directed to be taken with meals to help with absorption and tolerability.

Q: What exactly is Glucotrac used for?

According to the official product information, Glucotrac is approved for the management of type 2 diabetes. Its purpose is to help improve and maintain control over blood sugar levels.

Q: Is Glucotrac a type of insulin or a different class of medicine?

Glucotrac is not a type of insulin. It is a combination medicine containing two different non-insulin drugs: one from the sulfonylurea class (Glibenclamide) and one from the biguanide class (Metformin).

Q: Is Glucotrac typically prescribed for type 1 or type 2 diabetes?

Official product information states that this medicine is approved for the management of type 2 diabetes.

Q: Is Glucotrac intended to be a long-term treatment or a short-course therapy?

The medicine is used to help achieve and maintain long-term glycemic control, or blood sugar management. This medicine is generally used for continuous, long-term management.

Q: What are the main expected benefits of taking Glucotrac?

Official information indicates that the main intended benefit of Glucotrac is the improvement of glycemic control. This means it is intended to help lower and regulate blood sugar levels in people with type 2 diabetes.

Q: Does Glucotrac have any described effect on weight management?

Studies summarized in the official documentation indicate that weight loss has been reported as a side effect for some people using this medication.

Q: How quickly does Glucotrac generally start to work after the first dose?

While the medicine’s components are absorbed relatively quickly after the first dose, the primary goal is long-term blood sugar control. The medication is intended to provide sustained management over time, rather than immediate acute effects.

Q: What is the expected time frame to experience the full effect of Glucotrac?

Official clinical trial summaries indicate that achieving full glycemic control (the desired level of blood sugar management) typically requires weeks or months of consistent therapy. Regular monitoring is generally necessary to assess the full effect.

Q: Is Glucotrac described as a cure for the condition it treats?

No. Official labeling describes the medication as an aid in the management of type 2 diabetes. It is a tool for blood sugar control and is not a cure for the condition.

Q: Are there official guidelines regarding stopping Glucotrac once symptoms have improved?

Regulatory documents indicate that the medication may need to be temporarily discontinued for certain medical procedures, such as imaging tests, or if a serious adverse event is suspected. The duration of therapy and any decision regarding stopping or changing the regimen are clinical decisions.

Q: Does Glucotrac commonly affect energy levels or cause fatigue?

Weakness and fatigue are noted in official documents and can be reported as adverse events. These symptoms are also noted in relation to potential serious conditions, such as lactic acidosis.

Q: How does Glucotrac actually work in the body at a basic level?

The medicine works in a dual fashion using its two components. It helps the pancreas release more insulin and simultaneously helps the body manage blood sugar by decreasing glucose production in the liver and improving the body's sensitivity to insulin.

Q: Does Glucotrac affect the function of the liver or kidneys according to official sources?

Severe renal impairment (kidney dysfunction) is a major contraindication for the use of this medicine. Kidney function assessment and monitoring is required due to the increased risk of lactic acidosis.

Q: What specific biological system does Glucotrac primarily target?

The medicine primarily targets the systems responsible for glucose metabolism (the way the body processes sugar) and the beta cells of the pancreas, which are responsible for insulin production.

Q: Is the mechanism of Glucotrac considered unique when compared to other medicines in its class?

Glucotrac is a combination product that utilizes two agents with complementary mechanisms of action. This combination targets blood sugar control through two distinct pathways, as compared to single-agent medicines.

Q: Is Glucotrac a synthetic compound or is it naturally derived?

Official labeling defines the drug's components, Glibenclamide and Metformin, by their specific chemical names and molecular formulas. This indicates they are chemically defined compounds.

Q: Why is Glucotrac officially described as a 'receptor modulator'?

One of the components, Glibenclamide, works by acting on specific receptors within the pancreas to trigger the release of insulin. The term 'modulator' is a generalized way to describe this action on the biological target receptors.

Q: Does Glucotrac have an immediate effect or does it work cumulatively over time?

The components are absorbed quickly, but the primary goal is sustained, long-term blood sugar control. The medication is intended for chronic administration to maintain stable glycemic management.

Q: What is the physical appearance of the Glucotrac pill or formulation?

Official descriptions state that Glucotrac is supplied as a film-coated tablet. It is available in various strengths corresponding to the specific combination of its two active ingredients.

Q: What are the common reasons a healthcare provider might need to adjust a Glucotrac regimen?

Dosage is adjusted based on the medication's efficacy (how well it controls blood sugar) and to help manage the risk of side effects, such as hypoglycemia (dangerously low blood sugar).

Q: How should Glucotrac be stored safely at home?

Official storage instructions state that the medicine should be kept at room temperature in its original container, ensuring it is kept dry and tightly closed. Storage guidance notes that it should be kept out of the reach of children.

Q: Is nausea a commonly reported side effect of Glucotrac?

Yes, according to the adverse reaction section in the official documents, nausea and vomiting are listed among the commonly reported side effects in clinical trials.

Q: What are the most frequently reported side effects of Glucotrac?

Frequently reported adverse events from studies include diarrhea, upper respiratory infection, headache, nausea/vomiting, and abdominal pain.

Q: Does Glucotrac cause hair loss or skin reactions in some patients?

Official safety information includes reports of skin reactions among the adverse events. These reactions include rash, itching, hives, and sensitivity to sunlight.

Q: Are there any long-term safety concerns officially associated with Glucotrac use?

Regulatory warnings note the serious, but rare, risk of lactic acidosis as a long-term safety concern, particularly in patients with impaired kidney function. Kidney function assessment is necessary due to this risk.

Q: What are the known serious side effects described in official drug information?

The most serious side effects described in official drug warnings are lactic acidosis, which is a medical emergency, and severe hypoglycemia (dangerously low blood sugar).

Q: Why do some users on forums report headaches after starting Glucotrac?

The official adverse reaction data confirms that headache is listed as a commonly reported event in the clinical studies.

Q: Does Glucotrac interact with common blood pressure or heart medicines?

Official drug interaction lists include specific drug classes that can affect blood sugar or kidney function, such as diuretics or corticosteroids. Some of these classes may include certain blood pressure or heart medicines.

Q: What is the official guidance on consuming alcohol while taking Glucotrac?

Official guidance warns patients to avoid excessive acute or chronic alcohol intake. This precaution is necessary because alcohol can increase the risk of developing lactic acidosis, a rare but serious adverse event.

Q: Can people with pre-existing kidney problems use Glucotrac?

The medicine is officially contraindicated (should not be used) in people who have severe renal impairment (significant kidney dysfunction or disease).

Q: Is Glucotrac suitable for use during pregnancy or while breastfeeding?

Regulatory documents provide detailed risk summaries for use during pregnancy and while breastfeeding. The decision for use during these times is based on a careful, individual risk/benefit assessment.

Q: Are there any age restrictions or warnings for using Glucotrac?

Official documents discuss the use of this medicine in the geriatric population (older adults). They note that age-related risk factors, particularly decreased kidney function, are a consideration that may affect dosage and monitoring.

Q: What specific medical conditions would prevent someone from being eligible to use Glucotrac?

Regulatory documents list several conditions that are contraindications (reasons the drug should not be used). These include severe renal impairment, metabolic acidosis (such as diabetic ketoacidosis), and known hypersensitivity to either of the components.

Q: Do patients need to be tested for a specific condition before starting Glucotrac?

Official warnings state that kidney function assessment is required before starting treatment, with ongoing monitoring necessary throughout therapy.

Q: What is the main research evidence that supports the use of Glucotrac?

The main support for the drug’s use comes from controlled clinical studies summarized in the official labeling. These studies demonstrated the effectiveness of the drug in improving blood sugar control in people with type 2 diabetes.

Q: Were there any long-term clinical trials conducted for Glucotrac?

Clinical study summaries used for approval indicate that the drug was studied over various defined durations to collect data on both safety and efficacy. These results provide evidence of its performance in the setting of long-term treatment.

Q: Is Glucotrac approved and available in major regions like Europe, the US, and Canada?

Regulatory documentation from bodies like the US FDA and the European SmPC confirms that the drug has an official regulatory presence and is available in major global regions.

Q: What were the key efficacy and safety findings of the studies referenced in the official documents?

The official documents detail key findings, often including the average reduction in metrics like HbA1c and Fasting Plasma Glucose levels. These show the drug's effectiveness in managing blood sugar over time.

Q: Where can the official research publications about Glucotrac be found?

Official drug documents submitted to regulatory bodies like the FDA and EMA reference the source studies and data that were used to support the drug’s approval.

Q: What is the known general rate of success for Glucotrac in clinical settings?

The general rate of success is measured by the change in specific clinical metrics, such as the average reduction in HbA1c levels, which are quantifiable indicators of the patient response observed in the clinical trials.

How should Glucotrac be stored and disposed of?

How to Store and Dispose of Glucotrac?

The official storage conditions for Glucotrac (Glibenclamide/Metformin Hydrochloride) are strictly defined to maintain product stability and safety. The tablets must be kept at a cool room temperature, specifically stored below 30 C.

Storage Requirements

The medication must be protected from light and moisture and should remain in its original container, which must be kept tightly closed. It is a mandatory requirement to store Glucotrac out of the sight and reach of children.

Disposal

Unused or expired medicine must be disposed of properly according to local regulations; the official guidance generally recommends using a drug take-back program. Glucotrac must not be flushed down the toilet or disposed of in the drain, as it is not on the list of medicines approved for wastewater disposal.

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

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