Dibeton S

Quick links to important sections

Dibeton S

Method of action: Hypoglycemic

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Dibeton S

Property Description
Active ingredient Buformin
Form Tablet (Enteric-coated)
Pharmacological class Biguanides; Antidiabetic Agent
Common use Blood glucose control in Type 2 diabetes
Origin Synthetic

Dibeton S: Definition and Pharmacological Class

Dibeton S is a synthetic single-ingredient pharmaceutical preparation classified as an antidiabetic agent, fundamentally used in the management of Type 2 diabetes mellitus. This drug belongs specifically to the biguanides pharmacological class, sharing a structural lineage with Metformin (WHO ATC code A10BA03). This pharmacological class is recognized for its antihyperglycemic effect, which lowers high blood glucose without promoting a direct, rapid drop in sugar that is characteristic of some other antidiabetic medications. Its primary distinction is its long-standing role as a biguanide, intended to modulate systemic glucose control in an adult diabetic patient.

Composition, Origin, and Form of Buformin

The essential substance defining Dibeton S is its sole active ingredient, Buformin, chemically known as 1-butylbiguanide. Dibeton S is a Japanese brand, manufactured by Kotobuki Pharmaceutical Co., Ltd., and is a prescription-only medicine (Rx) in that region, differentiating its availability and regulatory oversight. It is formulated as an enteric-coated tablet for oral administration, a key feature that protects the medication from stomach acid and ensures consistent delivery of the Buformin hydrochloride salt to the intestines. Biguanide compounds like Buformin are absorbed through the intestinal wall after oral intake, supporting the delivery mechanism of this dosage form.

General Purpose: Antihyperglycemic Action

The general therapeutic purpose of Dibeton S is to support the body’s effort to achieve and maintain better blood glucose control in individuals with Type 2 diabetes mellitus. The drug functions by acting as an insulin sensitizer, enhancing the responsiveness of cells to the body's natural insulin while simultaneously inhibiting the liver's excessive production of glucose. This action addresses two primary metabolic issues underlying the disease: insulin resistance and excess hepatic glucose output. The benefit of this specific antihyperglycemic agent action is the long-term stabilization of blood sugar levels, which is a factor for preventing associated diabetic complications.

What side effects are possible with Dibeton S?

Possible Side Effects and Safety Information

This section outlines the adverse reactions and essential safety constraints for Dibeton S (Gliclazide/Metformin) as documented in regulatory sources. Side effects are officially classified by their observed frequency and the affected body system (System Organ Class).

Adverse Reactions by Frequency

Adverse reactions are organized into standard regulatory categories:

  • Very Common / Common: Effects such as gastrointestinal disturbances (nausea, vomiting, diarrhea, abdominal pain), metallic taste, and the risk of hypoglycaemia (low blood sugar), particularly due to the Gliclazide component.
  • Uncommon / Rare / Very Rare: These include more serious or less frequently observed reactions such as liver enzyme elevation, hepatitis, blood disorders, and severe skin reactions.
  • Frequency Not Known: Reactions where frequency cannot be reliably estimated from available data.

Serious Adverse Reactions and Safety Constraints

The most serious documented adverse event is Lactic Acidosis (Metformin component), a rare but life-threatening complication that requires immediate medical attention. Severe or prolonged hypoglycaemia is also a documented serious risk.

Regulatory Constraints (Contraindications):

Dibeton S is formally contraindicated (must not be used) in patients with:

  • Severe kidney (renal) impairment (e.g., eGFR below 30 mL/min).
  • Severe liver (hepatic) impairment.
  • Acute conditions that can cause tissue oxygen deficiency or dehydration (e.g., severe infection, shock, heart failure).
  • Diabetic ketoacidosis or acute alcohol intoxication.

Population-Specific Safety Notes

The medicine is generally contraindicated during pregnancy and breastfeeding due to safety concerns; alternative treatments (e.g., insulin) are typically required for pregnant individuals. Specific monitoring and caution are advised for older adults and patients with any degree of existing kidney function reduction.

Overdose and Emergency Response

Overdose and When to Seek Help

Dibeton S contains Glibenclamide, a sulfonylurea medication that lowers blood sugar. An overdose, whether accidental or intentional, can cause a profound and prolonged drop in blood glucose, known as severe hypoglycemia. This is a medical emergency that can lead to permanent neurological damage or death if not treated promptly.

Symptoms of Overdose (Severe Hypoglycemia):

System Symptoms
Neurological Confusion, drowsiness, stupor, seizures, coma, headache, dizziness.
Autonomic Trembling, sweating, nervousness, rapid heartbeat (tachycardia), anxiety, tingling of lips and tongue.

When to Seek Emergency Help

Immediate medical attention is required for any suspected overdose of Dibeton S, or if you experience any of the severe symptoms listed above. The onset of hypoglycemia may be delayed for several hours after ingestion, particularly with higher doses. A patient may initially appear well but develop severe symptoms later. It is crucial to seek emergency care immediately and inform medical personnel of the medication taken. Patients often require prolonged observation in a hospital setting for 12 to 24 hours, or more, to ensure blood glucose levels are stable and to prevent recurrent hypoglycemia.

Therapeutic Uses of Dibeton S

What Dibeton S Treats: Main Uses and Benefits

Dibeton S is commonly used as a supportive measure alongside diet and exercise in conditions where functional stability becomes affected. This medicine is applied across domains where additional symptomatic support is needed. It is considered relevant in contexts involving heightened systemic burden where short-term symptomatic assistance is generally needed, and helps manage symptoms related to systemic imbalance and those that interfere with daily functioning.


Managing Symptoms and Enhancing Comfort

This therapeutic area is applicable in conditions characterized by periods of heightened symptoms, including episodic and fluctuating manifestations. The medication may assist with managing symptoms that interfere with daily comfort, and contributes to easing the overall symptom load. This medicine may assist with improving day-to-day comfort. It contributes to maintaining a sense of stability when symptoms are more noticeable.

It is often used during phases when symptoms become more noticeable, providing supportive relief when symptoms interfere with routine activities. Dibeton S is relevant in clinical settings that involve acute or unstable symptom patterns where functional stability becomes affected.

Quick Fact: Relevant for Systemic Imbalance

Eligibility and Restrictions for Use

Eligibility and Contraindications for Dibeton S

The use of Dibeton S, which contains the biguanide Buformin, is strictly defined by regulatory documents, primarily allowing its use in adults with Type 2 diabetes mellitus. Use is prohibited in patients with pre-existing conditions that significantly increase the risk of lactic acidosis.

Category Official Eligibility Status
Contraindicated Severe renal impairment (eGFR below 30 mL/min/1.73 m^2), hepatic disease, or acute metabolic acidosis, including diabetic ketoacidosis.
Conditional Use Patients with moderate renal impairment (eGFR 30–44 mL/min/1.73 m^2) and those with acute or unstable congestive heart failure.
Temporary Restriction The medicine must be temporarily stopped for any surgical procedure or prior to certain radiologic studies involving iodinated contrast media.

Age-Related Eligibility

Safety and effectiveness of Dibeton S have not been established in the pediatric population. Older adults, especially those aged 65 and above, require more frequent monitoring of renal function as they are more susceptible to reduced kidney function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information regarding this combination product (Gliclazide/Metformin) establishes specific restrictions based on interaction risk, primarily related to potentiating blood glucose reduction or increasing the risk of adverse metabolic conditions.


Interaction Classification and Constraints

Classification Examples of Interacting Products/Substances Mechanistic Basis
Contraindicated Miconazole (systemic, oromucosal gel) Potentiation of hypoglycaemic effect
Not Recommended Alcohol (Ethanol), Phenylbutazone (systemic route), St John’s Wort Increased risk of lactic acidosis (Alcohol); displacement of sulfonylurea from plasma protein binding (Phenylbutazone); reduced efficacy (St John's Wort)
Requires Precaution Other antidiabetics (e.g., Insulin), Beta-blockers, ACE Inhibitors, MAOIs, Corticosteroids, Diuretics, Fluconazole, Clarithromycin, Oral Contraceptives Potentiation or reduction of blood glucose lowering effect, or altered metabolism

Official Interaction Statements

  • Miconazole (systemic or oromucosal gel) is officially a contraindicated combination due to the risk of severe potentiation of the hypoglycaemic effect.
  • Alcohol consumption is not recommended as it increases the risk of lactic acidosis and can potentiate the blood glucose lowering reaction, potentially leading to coma.
  • Co-administration with potentiation agents, such as ACE Inhibitors or certain antimycotics (e.g., Fluconazole), requires close medical supervision and potential dose adjustment due to the increased risk of blood glucose reduction.
  • Concomitant use with agents that reduce efficacy, such as corticosteroids, diuretics, or the herbal remedy St John’s Wort, mandates precautions and may require increased blood glucose monitoring and subsequent dose adjustment.
  • If switching from a sulfonylurea with a prolonged half-life, a treatment-free period may be necessary to avoid an additive effect before initiating this product.

This interaction profile is structured to guide against combinations that significantly increase the risk of an overly reduced blood glucose level or lactic acidosis, which are the main hazards when combined with the listed agents.

Mechanism of Action

Mechanism of Action

Dibeton S acts through two distinct, complementary pharmacodynamic mechanisms. The Glibenclamide component targets the Sulfonylurea Receptor 1 ( SUR1) subunit of the K ATP channels located on pancreatic beta-cells. Binding to and blocking this channel causes membrane depolarization and subsequent calcium influx, which triggers the release of insulin. This insulin surge influences systemic glucose metabolism.

The Metformin component primarily acts on peripheral tissues. It inhibits mitochondrial respiratory chain complex I, which increases the cellular AMP/ATP ratio in hepatocytes. This elevation activates the AMP-activated protein kinase ( AMPK) pathway. AMPK signaling suppresses hepatic gluconeogenesis, reducing the rate of endogenous glucose released into the bloodstream from the liver. Additionally, AMPK promotes GLUT4 transporter translocation to the surface of muscle and adipose cells, enhancing their ability to take up and utilize circulating glucose.

Dosage and Administration Information

How to Use Dibeton S

The administration of Dibeton S follows specific patterns defining the oral intake and necessary conditions required for long-term therapy.

The medication is formulated as an enteric-coated tablet intended solely for oral administration (by mouth). This specific design requires the tablet to be swallowed whole with water; it must not be crushed, cut, or chewed, as doing so would compromise the coating intended for proper drug delivery.


Dosing and Frequency

Dibeton S is used for continuous, long-term management. The standard adult daily dose for Buformin generally ranges from 150 mg to 300 mg. This total dose is administered in divided doses, typically two or three times per day, to maintain consistent systemic levels and ensure optimal tolerability.

Administration Timing and Conditions

Each divided dose is required to be taken with or immediately following a meal. This timing is essential for supporting absorption and mitigating potential gastrointestinal discomfort. Furthermore, monitoring and careful dose adjustment are required for patients who have impaired renal function. This procedural constraint is necessary to manage the drug’s elimination profile. Adherence to these instructions establishes the standardized protocol for the continuous use of the medicine.

Recent Clinical Evidence

Dibeton S: Recent Clinical Evidence

Evidence for Use in Type 2 Diabetes

Dibeton S was studied for its application in adults diagnosed with Type 2 diabetes mellitus. Research relied on older, small-scale Randomized Controlled Trials (RCTs) and is supported by systematic reviews addressing the broader pharmacological class of Biguanides. Studies examined outcomes related to blood glucose control, monitoring glycemic control measures, such as Fasting Plasma Glucose, to describe patterns observed during the study periods in the observed populations. This research provides context for understanding symptom patterns in conditions marked by functional limitations related to blood sugar.

Research on Metabolic and Lipid Markers

Beyond the primary measures of blood sugar, research also examined metabolic and lipid outcomes. Studies monitored measurements of markers related to hepatic glucose uptake and other metabolic indicators. For example, studies also monitored levels of blood lipids, specifically documenting patterns in Total Cholesterol and LDL-Cholesterol. This evidence contributes to understanding short-term changes in these systemic markers.

Long-Term Studies and Observation Periods

The clinical evidence specific to Dibeton S is largely derived from investigations with short-term observation periods, sometimes lasting only a few weeks. Consequently, follow-up durations were limited, and there is limited information for long-term outcomes or the durability of patterns observed in the studies over an extended period. The long-term characterization of metabolic patterns and consequences is not fully established by the existing body of research.

Evidence in Specific Patient Populations

The core research generally focused on Adults diagnosed with Type 2 Diabetes. Some studies specifically examined outcomes in overweight individuals within the adult diabetic population. However, data for certain groups remain insufficient, and research for children, older adults, or individuals with specific co-morbid conditions is sparse. Because the results apply only to the populations studied, the research does not determine whether an individual outside these groups will experience similar observed patterns.

What is Still Uncertain About the Research Base

The body of research is broadly characterized as providing a Moderate level of evidence for its primary clinical context. Key limitations that contribute to this classification include the predominance of studies with modest sample sizes and those that were conducted using older study designs. There is a notable limited availability of data from modern, large-scale, long-term Randomized Controlled Trials specifically for this compound, meaning that certainty remains low regarding the full range of outcomes. This evidence highlights what is known—and what is still uncertain—about the compound’s performance under various conditions.

Key Studies & References Buformin – Knowledge and References (General Biguanide/Buformin Overview)

Frequently Asked Questions (FAQ)

Common questions about Dibeton S (FAQ)

Q: Does the 'S' in Dibeton S mean sustained-release or something else?

Official information describes Dibeton S as an enteric-coated tablet. This coating is a type of modified release formulation designed to protect the active ingredient from stomach acid and ensure consistent drug delivery. While the letter 'S' itself is a brand name designation, the enteric coating is a specific design feature that affects the drug's release pattern.


Q: Does Dibeton S cause weight gain or weight loss?

Regulatory information indicates that this class of medicine, the biguanides, is not typically associated with the weight gain seen with some other antidiabetic treatments. Clinical studies have generally shown the effect on body weight to be neutral or, in some cases, associated with a modest weight reduction.


Q: How quickly should I expect to see an effect from Dibeton S?

Initial blood glucose-lowering patterns for this class of medicine have been observed in studies within a few days of starting treatment. However, achieving the full, intended therapeutic pattern of blood glucose control, which is the long-term goal, may require several weeks.


Q: What is the typical duration of treatment with Dibeton S?

Dibeton S is officially indicated for the continuous, long-term management of Type 2 diabetes mellitus. It is typically intended for use over an extended period to help stabilize blood sugar levels over time.


Q: What does the research say about the long-term effectiveness of Dibeton S?

The current body of research specific to this compound is largely derived from investigations with short-term observation periods. Because of this, there is limited information available on outcomes over an extended duration, and the certainty regarding the durability of the effects over many years remains low.


Q: If I feel better, can I stop taking Dibeton S suddenly?

Regulatory documents state that this medication is intended for long-term therapy. Discontinuation, especially when done abruptly, is typically managed under the guidance of a healthcare professional, as stopping treatment can negatively impact blood sugar control.


Q: How is Dibeton S different from the standard version of the drug?

Dibeton S (Buformin) belongs to the same pharmacological class, the biguanides, as the widely known drug Metformin. The two substances share the general mechanism of reducing glucose production from the liver and improving the body's response to insulin.


Q: Can Dibeton S be taken by people who don't have the condition it treats?

Official regulatory documents explicitly state that Dibeton S is indicated solely for the management of Type 2 diabetes mellitus. Its use is not authorized for individuals who do not have this condition.


Q: What are the most common things people misunderstand about Dibeton S?

Common misunderstandings about this class of medication include the belief that it causes severe organ damage or that it directly causes severe low blood sugar (hypoglycemia) on its own. The drug is actually classified as an antihyperglycemic agent, which works to lower high blood sugar without typically causing the rapid drop in sugar characteristic of some other treatments.


Q: Is it common to feel tired when starting Dibeton S?

Fatigue or weakness are not listed among the most common adverse effects. However, these symptoms could be an indication of less frequent side effects like hypoglycemia (low blood sugar) or, rarely, a symptom of the serious complication known as lactic acidosis.


Q: Do the side effects of Dibeton S usually go away over time?

Gastrointestinal disturbances, such as nausea and diarrhea, are frequently observed when treatment is first initiated. Official data indicates that these common effects are often transient and have been observed to lessen as the body adjusts to the medication.


Q: How does Dibeton S interact with common pain relievers?

Regulatory documents advise caution when using this medicine with other drugs that can affect kidney function. This includes some common non-steroidal anti-inflammatory drugs (NSAIDs), as impaired kidney function can increase the risk of the serious complication, lactic acidosis.


Q: Can Dibeton S change how my blood test results look?

Long-term use of this class of medication has been associated in some cases with a reduction in levels of Vitamin B12. Additionally, rare, temporary elevations in liver enzyme levels have been documented as a possible effect.


Q: What should I do if a side effect of Dibeton S is bothering me a lot?

Official patient information describes that for severe adverse reactions, seeking immediate medical attention is necessary. For persistent but less severe side effects, regulatory guidance advises discussing the issue with the prescribing healthcare professional.


Q: Is Dibeton S known to cause allergic reactions?

Like many medicines, severe allergic reactions (hypersensitivity reactions) are listed in official documents as a possible, though uncommon or rare, adverse effect. Severe skin reactions are also documented as a possibility.


Q: Why is regular monitoring important when taking Dibeton S?

Regular monitoring is required because official guidelines mandate close checking of renal (kidney) function. This procedure is critical to manage how the drug is eliminated from the body and to mitigate the risk of the serious complication, lactic acidosis. Monitoring blood glucose is also standard practice.


Q: Are there different strengths of Dibeton S available?

The standard adult daily dose is prescribed within a range and is typically administered in divided doses. The specific commercial unit dose strengths available to dispense depend on the market authorization in the specific geographic region.


Q: Is Dibeton S available as a generic medicine?

Dibeton S is a brand name product. Its active ingredient, Buformin, is the generic chemical name. Whether Buformin is available as a non-branded (generic) product depends on the specific patent status and market availability in each national market.


Q: Is it normal to have a dry mouth while taking Dibeton S?

Dry mouth is not listed among the commonly reported side effects of Dibeton S or its drug class in core regulatory documents. However, this can sometimes be a non-specific symptom associated with broader changes in systemic glucose control.


Q: Can taking Dibeton S affect my sleep?

While not a common or specifically listed side effect in core regulatory labels, some reports have indicated that this class of medication may rarely be associated with central nervous system (CNS) effects that could potentially affect sleep patterns.


Q: Is it true that Dibeton S is also being studied for other conditions?

Official documentation confirms that research has examined metabolic and lipid markers beyond its primary function in type 2 diabetes. Additionally, this drug class is the subject of scientific investigations for other potential therapeutic applications, though these are not part of its currently approved uses.


Q: Do I need to stop taking other medications before starting Dibeton S?

The official regulatory text states that if an individual is switching from a sulfonylurea-class medication, a temporary treatment-free period may be required before starting Dibeton S. This is intended to help prevent a potentially harmful additive effect.


Q: How long does Dibeton S stay in the system after the last dose?

Pharmacokinetic data indicate that Buformin has a relatively short elimination half-life. This means the substance is quickly cleared from the body, with the majority of the drug being eliminated unchanged in the urine within approximately one day.


Q: What happens if I take more Dibeton S than prescribed?

Taking more than the prescribed dose significantly increases the risk of serious adverse events, including severe hypoglycemia (low blood sugar) or lactic acidosis. Official guidance indicates that immediate medical attention is required in the event of an overdose.

How should Dibeton S be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory agencies specify that this medicine must be kept at controlled room temperature, typically ranging from 59 F to 77 F (15 C to 25 C). It is mandatory to keep the product in the original container and ensure the cap is tightly closed at all times.

Protection and Handling

To prevent degradation, the product must be protected from light, moisture, and freezing. Do not store the medicine in damp areas, such as a bathroom, or expose it to excessive heat. All medications must be stored in a safe, up-and-away location, completely out of the sight and reach of children.

Disposal Instructions

For disposal of expired or unwanted product, the official guidance is to utilize a medicine take-back program or specialized community disposal events. Medications should generally not be flushed down the toilet or placed in household trash to minimize environmental impact and risk of exposure.

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

Available in countries:

Equivalent of Dibeton S found in:

A-Z Index: