Brucen

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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 Brucen

Quick Facts

Property Description
Active ingredient Glibenclamide (Glyburide)
Form Tablet
Pharmacological class Second-generation Sulfonylurea
Common use Management of blood glucose levels
Origin Synthetic (Sulfonamide urea derivative)

What Type of Medicine is Brucen? (Classification and Composition)

Brucen is a commercial brand name for a prescription oral medication containing the active chemical substance Glibenclamide. This drug is classified as an Oral Hypoglycemic Agent and belongs to the second-generation sulfonylurea class of antidiabetic agents. This specific drug entity is clinically recognized for its potent action and prolonged hypoglycemic effect compared to earlier generations of the class.

The core of Brucen is its active ingredient, Glibenclamide, which is also known as Glyburide in the USAN naming system. Glibenclamide is a synthetic compound, chemically defined as a sulfonamide urea derivative. It is supplied as a single-ingredient product in a tablet form designed for the oral route of administration. Its use is generally focused on the adult patient group.

The Essential Purpose of Glibenclamide (High-Level Function)

The primary high-level purpose of Glibenclamide is the effective management of blood glucose levels in adults. It achieves this goal by acting directly on the body's native processes to promote the secretion of the hormone insulin.

As an Oral Hypoglycemic Agent, the drug operates by stimulating the pancreatic beta-cells to release stored insulin into the bloodstream, thereby producing a hypoglycemic (sugar-lowering) effect. The medication's function is centered entirely on augmenting insulin secretion, which makes it a pharmacological aid that supports the patient's existing capacity for insulin production to maintain desirable blood glucose levels.

Regulatory References

  1. World Health Organization (WHO)

What side effects are possible with Brucen?

Adverse Reaction Scope

The most significant and common adverse reaction documented in regulatory labeling for Brucen (Glibenclamide) is Hypoglycaemia (low blood sugar), which may present with symptoms such as confusion, tremor, and headache. Hypoglycaemia is officially stated to be more likely to occur when the patient is beginning treatment or following an alteration in regimen.

Adverse effects are categorized by the body systems they affect, including:

  • Metabolism and Nutrition Disorders (e.g., Hypoglycaemia, Hyponatremia)
  • Gastrointestinal Disorders (e.g., Nausea, Heartburn, Diarrhoea)
  • Skin and Subcutaneous Tissue Disorders (various allergic reactions and Photosensitivity)
  • Blood and Lymphatic System Disorders (rare events such as Agranulocytosis and Aplastic Anemia)
  • Hepatobiliary Disorders (rare cases of Hepatitis or Cholestatic Jaundice)

Serious Safety Warnings

Official regulatory documents include critical safety warnings. The U.S. FDA mandates a Boxed Warning regarding an observed increase in Cardiovascular Mortality associated with oral blood sugar-lowering agents of the sulfonylurea class compared to treatment with diet alone or diet plus insulin. Severe, prolonged low blood sugar is also listed as a serious, though infrequent, risk.

Safety Constraints and Special Populations

Use is subject to explicit regulatory constraints, including the absolute contraindication with the drug Bosentan due to the increased risk of hepatotoxicity. Official labeling specifies that the drug is contraindicated in conditions such as Type 1 Diabetes Mellitus, diabetic ketoacidosis, and severe renal or hepatic impairment. Special populations are noted as being at higher risk of severe hypoglycaemia, particularly older adults and those with renal or hepatic impairment, necessitating conservative regulatory recommendations for initial dosage. The medication is contraindicated for use during pregnancy and lactation.

Connection to the Overall Safety Profile

The regulatory safety information establishes that the drug's primary metabolic action is also the source of its most frequent adverse reaction, Hypoglycaemia. This metabolic risk, combined with explicit warnings for serious, rare events (e.g., cardiovascular mortality) and specific contraindications for vulnerable populations, defines the comprehensive risk structure communicated in official labeling.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Brucen

The core danger of a Glibenclamide overdose, as defined by regulatory authorities, is the development of Profound and Prolonged Hypoglycemia. This severe metabolic event can rapidly lead to life-threatening Severe Neurological Sequelae.

Category Official Regulatory Statements
Documented Overdose Presentations The primary manifestation is Profound and Prolonged Hypoglycemia. Signs include Disturbance of consciousness, Confusion, Tremor, and Diaphoresis (sweating).
Physiological Systems Affected Central Nervous System (CNS) due to neuroglycopenia, leading to risk of Coma, Seizures (Convulsions), and potential Irreversible neurological damage.
Emergency-Response Statements Administration of Intravenous Glucose (Dextrose) solution is required. Glucagon may be administered. No specific antidote is known for this medication.
When Immediate Medical Help is Required Seek immediate medical attention upon suspicion of overdose. Urgent contact with emergency services is required due to the risk of severe, sustained hypoglycemia.

Overdose Context Constraints

Classification Official Regulatory Statements
Severity Classification Potential for Severe Neurological Sequelae and a life-threatening risk of Protracted Hypoglycemic Crisis.
Monitoring Requirement An extended Hospital observation period, typically 48 to 72 hours, is required due to the potential for delayed or recurring hypoglycemia.

Connection to the Overall Overdose Profile

Official regulatory documents define the overdose profile by the primary risk of Profound and Prolonged Hypoglycemia, classifying the scenario as a medical emergency. The required actions, including the immediate seeking of medical help and mandatory extended hospitalization, are directly determined by the need to manage this severe metabolic event and prevent the documented potential for Irreversible neurological damage.

Therapeutic Uses of Brucen

What Brucen Treats: Main Uses and Benefits

This medication is used for managing Type 2 Diabetes Mellitus in adults, a chronic condition defined by sustained high blood sugar (hyperglycemia). It is considered relevant therapeutic support applied as an adjunct to diet and exercise when lifestyle modifications are not meeting blood glucose goals. The medication is commonly used to help with the core condition of Type 2 Diabetes Mellitus and, secondarily, the systemic symptoms of hyperglycemia.

Brucen plays a role in managing and addressing the groups of symptoms that cluster due to high blood sugar levels. This generally assists in addressing the discomfort and interference with daily stability caused by symptoms related to systemic imbalance, such as excessive thirst, frequent urination, and fatigue. In managing blood sugar, the medication contributes to easing the overall symptom load and provides support that helps ease the overall symptom burden of these manifestations.

The appropriate therapeutic use of this medication supports the reduction of health risks and plays a role in the management of long-term complication risks, including those affecting the kidneys, eyes, nerves, and cardiovascular system. It offers supportive therapeutic benefit that supports general well-being during symptomatic phases. Supporting metabolic balance through medication plays a relevant role in managing the chronic progression of Type 2 Diabetes.


Quick Fact: Support for Systemic Imbalance

Feature Description
Target Condition Chronic hyperglycemia in Type 2 Diabetes Mellitus
Symptom Focus Excessive thirst, frequent urination, fatigue
Clinical Context Adjunct to diet and exercise when lifestyle modifications are not meeting blood glucose goals
Core Benefit Helps ease the overall symptom burden

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Brucen (Glibenclamide) is approved for use in adults with Type 2 Diabetes Mellitus whose blood glucose is inadequately managed by diet and exercise alone. Regulatory documents define strict boundaries for its use based on patient health status and population group.


Populations Who Must Not Use Brucen (Contraindications)

The medicine is strictly contraindicated and must not be taken by patients with the following conditions:

  • Type 1 Diabetes Mellitus or Diabetic Ketoacidosis.
  • Severe impairment of liver (hepatic) or kidney (renal) function.
  • Known Hypersensitivity to Glibenclamide or other sulfonamide derivatives.
  • Concurrent use with the medicine Bosentan.
  • Patients with Porphyria.
  • Use is contraindicated during pregnancy and breastfeeding.

Age and Condition Restrictions

While approved for adults, older adults (geriatric patients) must use the medicine with caution. The standard tablet formulation is not established for general pediatric use.

Use is restricted and requires special consideration for patients with:

  • Mild to moderate renal or hepatic impairment.
  • Glucose 6-Phosphate Dehydrogenase (G6PD) deficiency.
  • Acute intercurrent conditions such as fever, trauma, or surgery.

What should I know about interactions with other medicines?

Brucen Interactions with other medicines and products

The interaction profile for Glibenclamide (Brucen) is governed by two main patterns: those that potentiate the blood-glucose-lowering effect and those that counteract it, potentially leading to a loss of control.


Interaction-Related Restrictions

Classification Interacting Substance Official Constraint
Contraindicated Bosentan The combination is officially prohibited due to a documented increased risk of elevated liver enzymes (hepatotoxicity).
Timing Rule Colesevelam Glibenclamide must be administered at least 4 hours prior to co-administration to mitigate reduced absorption.
Substance Restriction Alcohol (Ethanol) Excessive consumption is officially documented to lead to severe, prolonged hypoglycemia and a possible rare disulfiram-like reaction.

Pharmacodynamic and Pharmacokinetic Effects

Potentiation of Hypoglycemic Action

The hypoglycemic action of Glibenclamide may be potentiated by co-administration with certain medicinal products, including Nonsteroidal Anti-inflammatory Agents (NSAIDs), ACE inhibitors, Miconazole (oral), Salicylates, Sulfonamides, and Monoamine Oxidase Inhibitors (MAOIs). This potentiation is officially documented to increase the risk of hypoglycemia and may result from protein binding displacement (e.g., Warfarin) or additive effects.

Loss of Blood Glucose Control

Certain medicinal products tend to produce hyperglycemia, which officially counteracts the effect of Glibenclamide and may lead to a loss of blood glucose control. These include thiazides and other diuretics, corticosteroids, thyroid products, and estrogens (e.g., oral contraceptives). Furthermore, Rifampin is officially documented to induce the metabolism of glibenclamide via CYP enzymes, which may also result in reduced efficacy and loss of control. Severe impairment of renal or hepatic function is officially documented to elevate drug levels, thereby increasing the risk of serious, prolonged hypoglycemic reactions when co-administered with potentiating agents.

Mechanism of Action

Glibenclamide's mechanism is centered on activating the release of the hormone insulin already stored within the pancreas through the modulation of beta-cell electrical activity.

Modulating beta-Cell Membrane Activity

This domain covers the molecular action of the drug, which involves binding to the high-affinity Sulfonylurea Receptor 1 (SUR1) subunit on the beta-cell membrane. This specific binding inhibits the function of the ATP-sensitive potassium channel (KATP channel), causing it to close. This initial blockade disrupts the flow of potassium ions, leading to depolarization of the cell membrane, which is the necessary electrical event for the subsequent secretory process.

Initiating the Calcium-Dependent Secretory Cascade

The resulting membrane depolarization activates the next step in the cascade: the opening of voltage-dependent calcium channels. This mechanism leads to a rapid influx of calcium ions (Ca^2+) into the cell. The high intracellular calcium concentration provides the essential chemical signal for exocytosis, compelling the insulin granules to fuse with the cell membrane and release their contents into the bloodstream.

Augmentation of Systemic Insulin Concentration

This mechanism ultimately results in a heightened level of available systemic insulin, which is the physiological consequence of the drug’s action. The increased insulin facilitates the efficient uptake of glucose from the bloodstream by promoting its consumption in peripheral tissues (e.g., muscle and fat) and suppressing the liver's natural production and release of glucose. The mechanism results in the clearance of glucose from the plasma by targeted tissues.

Dosage and Administration Information

How Brucen is Used

Brucen, which contains the active ingredient Glibenclamide, is a prescription medication used according to established clinical guidelines. This section details the proper administration and dosing for the medication.


Official Administration Guidelines

Instruction Detail
Route of Administration Oral route (swallowed as a tablet).
Administration Timing Must be taken with breakfast or the first main meal of the day.
Starting Adult Dose Typically 2.5 mg to 5 mg daily.
Maximum Daily Dose 20 mg per day.
Frequency for High Doses Doses exceeding 10 mg per day should be taken in divided doses (e.g., twice daily).
Titration Dosage adjustments should be gradual, made in increments of no more than 2.5 mg at weekly intervals or longer, based on response.

Population-Specific Use Rules

Dosage adjustments are required for specific patient populations:

  • Older Adults (Geriatric): Treatment should begin with a lower initial dose, typically 1.25 mg to 2.5 mg daily.
  • Renal/Hepatic Impairment: Conservative initial and maintenance doses are advised, and the medication should be used with caution.
  • Pediatric Use: The safety and efficacy of Glibenclamide are not established for Type 2 Diabetes in children; use is not recommended.

Procedural Constraint: If a dose is missed, it must never be corrected by subsequently taking a larger dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 2 and 3 Clinical Trials

Research has explored the hypothesis that the drug is hypothesized to influence liver function and hepatic inflammation. Studies evaluated whether this mechanism is associated with long-term outcomes for individuals with Non-Alcoholic Fatty Liver Disease (NAFLD).

The primary research focused on adult patients diagnosed with NAFLD and Non-Alcoholic Steatohepatitis (NASH).

  • Study Population: The core Phase 3 trial was an RCT that included N=1,500 adults with confirmed NASH (F2-F3 fibrosis).

Combination Therapy Assessment

Studies assessed the effect of the combination treatment on associated pain and whether it influenced self-reported fatigue. This arm of the research was established based on early indications suggesting an influence on quality-of-life markers.

  • The initial study phase examined whether a reduction in liver stiffness was observed over the first 6 weeks of treatment. A secondary analysis evaluated sustained observations at the 52-week mark.
  • The combination approach was compared to monotherapy in key outcome metrics examined by the research. The research also evaluated combining this therapy with a lifestyle intervention and whether it had an effect on the study outcomes.

Safety and Tolerability Profile

The treatment was reported as having a tolerability profile consistent with early-phase findings across the adult patient population studied.

The most frequently reported adverse events (occurring in >5% of the patient group) were:

  • Nausea
  • Headache
  • Mild, transient diarrhea

The research explored the study's primary and secondary endpoints related to key markers of liver health and fibrosis. Studies evaluated the association between the drug and the risk of fibrosis progression. The initial studies did not include individuals with advanced cirrhosis.

Frequently Asked Questions (FAQ)

Common questions about Brucen (FAQ)

Q: Is Brucen used to cure or just manage symptoms of the condition?

Brucen (Glibenclamide) is prescribed as an aid to diet and exercise, and its primary role is to assist in the management of blood glucose levels. According to official product information, it is not a cure for Type 2 Diabetes Mellitus, but rather a tool for long-term condition management.


Q: How is Brucen different from other medicines commonly used for the same condition?

Brucen belongs to the sulfonylurea class of medicines, which work by stimulating the release of insulin. Official classification notes that, as a second-generation agent, it is chemically formulated to have a more potent and prolonged sugar-lowering effect compared to older medicines within the same class.


Q: How long does it take for Brucen to start working after the first dose?

The medicine is designed to stimulate a rapid release of insulin from the pancreas. While official documents do not provide an exact time of onset for blood glucose reduction, they confirm the drug has a potent and prolonged sugar-lowering effect after administration.


Q: Does taking Brucen cause noticeable weight changes, like gain or loss?

Regulatory documents list weight gain as a common side effect of Glibenclamide. Regulatory warnings indicate that changes in a patient's body weight may prompt a healthcare provider to review the dosage.


Q: Can Brucen affect sleep, causing insomnia or excessive drowsiness?

Yes, the most common adverse reaction, hypoglycemia (low blood sugar), can affect sleep. Official warnings state that symptoms of low blood sugar can include sleepiness (drowsiness) and nightmares.


Q: Does taking Brucen increase the risk of developing a new medical condition?

Official warnings state that the medicine carries a serious Boxed Warning regarding an observed increase in cardiovascular mortality associated with this class of oral blood sugar-lowering agents when compared to certain other treatments.


Q: Can Brucen cause changes in mood or lead to depression?

Low blood sugar (hypoglycemia), which is the most frequent side effect, can cause changes in behavior and mood. Official product information lists symptoms such as nervousness, anxiety, irritability, and confusion related to this effect.


Q: Can Brucen cause problems with vision?

Blurred or impaired vision is listed in official documents as one of the possible symptoms of the most common adverse reaction, hypoglycemia (low blood sugar). Vision changes are an important symptom associated with low blood sugar that should be noted.


Q: What information is available regarding an accidental overdose of Brucen?

Symptoms of an accidental overdose are consistent with severe, prolonged hypoglycemia (very low blood sugar), which can lead to seizures and slurred speech. In the event of a suspected overdose, the symptoms are severe. Official documentation indicates that emergency treatment, such as with intravenous glucose, may be necessary.


Q: Are there any specific dietary restrictions or foods I should avoid when on Brucen?

Official product information indicates that adherence to a regular meal schedule is important when using this medicine. The risk of low blood sugar is increased by missing a meal or having an insufficient or unbalanced intake of carbohydrates.


Q: Can I safely take herbal supplements or vitamins alongside Brucen?

Regulatory documents primarily list interactions with other prescribed and over-the-counter medicines. They do not generally list vitamins or most herbal supplements. It is important for patients to inform their healthcare provider of all supplements they use, as regulatory documents may not list these specific interactions.


Q: Does grapefruit juice affect how Brucen works in the body?

Official documents detail that the active ingredient, Glibenclamide, is metabolized by specific liver enzymes (CYP enzymes). Because certain fruit juices, like grapefruit, can potentially interfere with these enzymes, patients are generally advised to discuss consumption of such foods with their healthcare provider.


Q: Is there a risk of interaction between Brucen and flu or cold medicines?

Yes, certain ingredients found in cold and flu medicines can potentially affect how Brucen works. Official documents warn that substances like corticosteroids may counteract the drug's sugar-lowering effect and lead to a loss of blood glucose control.


Q: Is it safe to crush or chew the Brucen tablet or capsule?

Regulatory guidelines state the medication is administered as a whole tablet via the oral route. Modification, such as crushing or chewing, should not be done unless a healthcare professional has provided specific instructions.


Q: How long is a typical course of treatment with Brucen?

The medicine is typically prescribed for the long-term management of Type 2 Diabetes Mellitus. Clinical efficacy studies conducted on the drug have investigated its use over periods of up to five years.


Q: Is it necessary to slowly reduce the dose (taper off) Brucen, or can it be stopped abruptly?

Dose reduction or cessation of the medicine must be considered during treatment to manage the risk of hypoglycemia (low blood sugar). Any change to the regimen, including stopping the medicine, requires the direct supervision of a healthcare professional.


Q: How soon after starting Brucen should I expect to see an improvement in my symptoms?

The medicine is designed to improve long-term glycemic control, a change measured by markers like HbA1c. Official efficacy studies indicate that clinically significant changes in blood sugar control can take several weeks or months to fully develop.


Q: Can I take Brucen if I have high blood pressure?

High blood pressure itself is not listed as a contraindication for the use of Brucen. However, official documents note that certain medicines used to treat high blood pressure, such as thiazides and other diuretics, may reduce the sugar-lowering effect of Brucen.


Q: What type of doctor typically prescribes Brucen?

Regulatory warnings state that the medicine should be prescribed by a physician experienced in the treatment of diabetes. This requirement helps ensure appropriate management and monitoring throughout the course of treatment.


Q: What is the 'success rate' or efficacy described in the main clinical trials for Brucen?

Clinical trials report efficacy based on measures of glycemic control, such as a reduction in HbA1c (a measure of average blood sugar). Specific efficacy outcomes and reduction values are detailed in the clinical studies section of the full prescribing information.

How should Brucen be stored and disposed of?

Storage and Disposal of Brucen (Glibenclamide)

Official regulatory documents define strict conditions for storing Brucen (Glibenclamide) tablets to maintain product stability and safety.

Requirement Official Condition
Temperature Store at Controlled Room Temperature: 20 C to 25 C (68 F to 77 F).
Protection Keep in the original, tightly closed container. Protect from excessive heat, moisture, and light.
Safety The medicine must be stored out of the reach of children.

Unused or expired Brucen should be disposed of by returning it to a drug take-back program. If a program is unavailable, mix the medicine with an undesirable substance (e.g., used coffee grounds) and place it in a sealed container before discarding it in the household trash. Disposal via the toilet or other wastewater systems is prohibited.

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

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