Engflag

Glitisol 5mg

Quick links to important sections

Glitisol 5mg

Glitisol 5mg_EN

Treatment option:

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 Glitisol 5mg

Quick Facts

Property Description
Active Ingredient Glibenclamide (also known as Glyburide)
Form 5 mg Tablet
Pharmacological Class Oral Hypoglycemic Agent, Sulfonylurea (Second Generation)
Common Use Management of Type 2 Diabetes Mellitus
Origin Synthetic, Organic compound

What is Glitisol 5mg and What Class of Drug Is It?

Glitisol 5mg is a pharmaceutical product containing the synthetic active ingredient Glibenclamide, which is classified as an Oral Hypoglycemic Agent. This drug is utilized to manage elevated blood sugar levels, a characteristic feature of Type 2 Diabetes Mellitus. Glibenclamide belongs specifically to the sulfonylurea class of antidiabetic medications. Its role in the management of non-insulin dependent diabetes mellitus is established within global healthcare, supported by long-standing clinical use.

Composition, Form, and General Purpose

Glitisol is supplied as a single-ingredient 5 mg tablet intended for oral administration, composed of Glibenclamide along with pharmaceutical excipients. While Glitisol is a specific brand name, its active component, Glibenclamide, is the same substance found in other formulations across the market, where it is also known as Glyburide. The primary purpose of this medication is to achieve and maintain better glycemic control in adult patients with Type 2 Diabetes, representing a recognized standard of care for this condition.

How Does Glitisol 5mg Generally Work? (High-Level Action)

Glitisol generally works by acting as an insulin secretagogue, meaning it directly stimulates the pancreas to release more of the body’s own insulin. This action is achieved by targeting specific receptors on the pancreatic beta cells, thereby increasing the amount of insulin available in the bloodstream. The overall benefit of this action is the accelerated movement of glucose from the bloodstream into the body's cells, effectively lowering the concentration of sugar in the blood and helping patients manage their metabolic health.

Regulatory References

  1. WHO Model List of Essential Medicines
  2. WHO Essential Medicines List for Type 2 Diabetes

What side effects are possible with Glitisol 5mg?

Glitisol (Glibenclamide) is associated with a range of officially documented adverse reactions, which are classified by frequency and affected body system in regulatory documentation.

Adverse Reaction Classifications

The most critical and frequent adverse reaction is hypoglycemia (low blood sugar), which is classified as Very Common in regulatory documents. This risk is inherent to its pharmacological action. Other adverse effects are grouped by the affected System-Organ Class (SOC).

Frequency Classification Examples (as per official regulatory documents)
Very Common Hypoglycemia
Common Gastrointestinal disturbances (e.g., nausea, vomiting), Allergic skin reactions (e.g., pruritus, rash)
Rare Changes in blood cell count (e.g., Leukopenia, Thrombocytopenia)
Very Rare Severe hepatic dysfunction (e.g., cholestatic jaundice), Serious blood disorders (e.g., Agranulocytosis)

Serious Adverse Reactions and Safety Patterns

Serious adverse reactions officially listed in prescribing information include severe and prolonged hypoglycemia, severe hepatic dysfunction, and serious hematologic disorders.

Safety notes specify that hypoglycemia is documented as being more likely to occur during the initial treatment period or when the dosage is being adjusted. Additionally, transient visual impairment may be observed at the start of treatment.

Population-Specific Safety Considerations

Official labels detail that the risk of severe and prolonged hypoglycemia is increased in specific groups, including older adults and patients with severe renal or hepatic impairment. Due to this heightened risk, use is generally restricted or contraindicated in cases of severe renal or hepatic dysfunction, as defined in regulatory texts.

Overdose and Emergency Response

An overdose of Glitisol 5mg (Glibenclamide) is officially documented by health regulators as resulting in manifestations of hypoglycaemia, or abnormally low blood sugar. This primary metabolic effect may range from mild, self-limiting symptoms to severe, life-threatening clinical presentations. The physiological systems primarily affected are the metabolic system and the central nervous system.

Recognized Severe Outcomes

Outcome Regulator Classification
Severe Hypoglycaemia Requires immediate, specific intervention.
Hypoglycaemic Coma Life-threatening neurological sequelae.
Seizure Serious clinical manifestation of overdosage.

The key official risk is the potential for prolonged hypoglycaemic reactions, which necessitates extended monitoring. Regulatory documents affirm that no specific antidote is known for Glibenclamide overdose; management is therefore strictly symptomatic and supportive.

When to Seek Immediate Medical Help

Authorities mandate that individuals who have taken an excessive dose must seek immediate medical attention and contact a Poison Control Center immediately. Immediate hospitalisation is required for severe reactions, particularly if there is loss of consciousness or a seizure. Treatment protocols involve the administration of oral glucose for mild cases, or a rapid IV injection of glucose 50% solution for severe neurological compromise. This required action confirms the critical nature of Glibenclamide overdose.

Therapeutic Uses of Glitisol 5mg

Quick Facts: Glitisol 5mg Uses

  • Type 2 Diabetes: Used as an intervention to support appropriate blood sugar levels.
  • Adjunct Therapy: Intended for use in conjunction with dietary planning and appropriate physical activity.
  • Glycemic Control: Helps achieve and maintain appropriate blood glucose management in adults.

Glitisol (glibenclamide), available in a 5mg tablet form, is prescribed to adults with type 2 diabetes mellitus. The primary role of this medication is to serve as an adjunct to professional medical recommendations concerning dietary intake and physical activity. It is used in individuals whose blood sugar levels have not achieved adequate balance through changes in diet and exercise alone.

The medication's benefit lies in its contribution to improving glycemic control—that is, the management of blood glucose levels over time. It is a therapeutic intervention intended to help stabilize and lower the amount of glucose in the bloodstream. This form of intervention is considered part of a comprehensive strategy to manage the condition.

Its use in managing blood sugar is aimed at maintaining appropriate levels. In clinical practice, this medication is a well-established resource in the therapeutic domain of type 2 diabetes, often used when initial lifestyle measures prove insufficient for managing the condition. This medication is not indicated for the management of type 1 diabetes.

Eligibility and Restrictions for Use

Who Can and Cannot Use Glitisol 5mg?

Glitisol 5mg (Glibenclamide) is approved for use in adult patients aged 18 years and older with Type 2 Diabetes Mellitus. Eligibility is strictly defined by regulatory authorities based on a patient's medical history, other conditions, and physiological status.

Contraindicated Populations and Restrictions

Glitisol is absolutely contraindicated and must not be used in the following populations, as stated in official labeling:

  • Type 1 Diabetes Mellitus or Diabetic Ketoacidosis (with or without coma).
  • Known hypersensitivity to Glibenclamide, other sulfonylurea drugs, or sulfonamide derivatives.
  • Patients with severe hepatic insufficiency or severe renal failure.
  • Individuals diagnosed with acute porphyria.
  • Patients concurrently receiving bosentan.

Age and Reproductive Status

Category Eligibility Status (Regulatory Wording)
Pediatric Use Safety and efficacy have NOT BEEN ESTABLISHED in children and adolescents.
Older Adults Use requires CAUTION and specific consideration due to increased susceptibility to effects.
Pregnancy/Lactation CONTRAINDICATED; use is not recommended during either pregnancy or breastfeeding.

These constraints ensure that the medicine is reserved for the population where its use is officially established and documented.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Glitisol 5mg (Glibenclamide) focuses on substances that can alter the drug's metabolic clearance or modify its blood-glucose-lowering effect, as documented in regulatory information.

Formally Contraindicated and Restricted Combinations

Classification Interacting Substance Documented Outcome and Restriction
Contraindicated Bosentan Prohibited co-administration due to documented risk of elevated liver enzymes and hepatotoxicity.
Contraindicated Miconazole (systemic or oromucosal) Prohibited co-administration due to high risk of significantly potentiated hypoglycemic effects, possibly leading to coma.
Restriction Alcohol (Ethanol) Not recommended due to documented increase in the hypoglycaemic reaction.

Pharmacokinetic and Pharmacodynamic Interactions

Glitisol is primarily metabolized by the CYP2C9 enzyme. Substances that inhibit this enzyme (e.g., Fluconazole) or displace Glibenclamide from plasma protein binding sites (e.g., Phenylbutazone) can increase the drug's plasma exposure, enhancing its hypoglycemic effect. Conversely, inducers like Rifampicin can diminish the blood-glucose-lowering action.

Pharmacodynamic interactions are significant, as co-administration with other blood-glucose-lowering agents (e.g., NSAIDs, ACE inhibitors) can potentiate the hypoglycemic effect. Conversely, drugs that raise blood glucose (e.g., corticosteroids, thiazide diuretics) can lead to a diminution of Glitisol's effect. Additionally, Glitisol may increase the plasma concentration of Cyclosporine.

The risk of serious, prolonged hypoglycemic reactions resulting from interactions is officially heightened in cases of severe hepatic or renal impairment due to documented elevated blood levels of Glibenclamide.

Mechanism of Action

Targeting the SGLT2 Protein for Glucose Excretion

Glitisol 5mg operates by acting as a selective inhibitor of the Sodium-Glucose Cotransporter 2 (SGLT2) protein, which is found primarily in the proximal tubules of the kidneys. By blocking this specific transport mechanism, the drug prevents the reabsorption of most of the filtered glucose back into the bloodstream, initiating the urinary excretion of glucose (glucosuria).

Modulating Fluid and Electrolyte Homeostasis

The mechanistic action on SGLT2, which cotransports sodium with glucose, inherently influences volume regulation. The drug causes an increase in the excretion of both sodium and water (natriuresis and diuresis) through the urine. This secondary effect produces a reduction in intravascular fluid volume and alters the systemic vascular load, leading to changes in plasma volume and systemic pressure dynamics.

Dosage and Administration Information

Glitisol 5mg is administered orally as a standard tablet and is taken daily. The starting dose for adults typically ranges from 2.5 mg to 5 mg once daily. The total daily dosage may be increased up to a maximum of 20 mg for regular tablets, though lower maximums are common across different regions. Dosage adjustments are made in increments of 1.25 mg to 2.5 mg, which are performed at intervals of approximately one week, based on the patient’s metabolic response.

The timing of administration is strictly tied to food intake: the tablet must be taken with a meal, most commonly breakfast or the first main meal of the day. For total daily doses greater than 10 mg, the administration must be divided and typically taken with both the morning and evening meals. It is a procedural constraint that a missed dose must never be corrected by subsequently taking a larger dose.

Administration principles are modified for certain patient groups. For older adults, treatment is initiated with a lower daily dose (e.g., 1.25 mg to 2.5 mg) and adjusted with caution. A conservative initial and maintenance dosing strategy is also required for patients with hepatic or renal impairment. Usage in the pediatric population is not established.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research Evidence Summary

Initial research on the active components suggests the compound, a blend of Glucosamine and Chondroitin, is an extensively studied non-prescription agent for joint health. Studies have evaluated whether it affects markers of joint health, such as cartilage degradation indicators, and have reported on its tolerability within the context of the trial conditions.

Key Findings from Human Trials

Clinical trials investigated whether the combination could influence pain and discomfort in patients with mild to moderate knee discomfort. These studies primarily focused on individuals experiencing discomfort during activity. Some studies collected data related to changes in stiffness over a 12-week period.

A meta-analysis of randomized controlled trials (RCTs) examined the combined use of Glucosamine and Chondroitin compared to a placebo. The analysis reported varied effects on pain severity and joint function across the included studies. Some research collected data on changes in symptoms across different time points, with the most pronounced observations typically occurring after 8 weeks.

Efficacy and Tolerability

Research continues to evaluate the formulation's role in managing early-stage osteoarthritis symptoms, and it is sometimes included in research examining alternative therapies. Long-term studies have investigated whether the formulation affects the maintenance of joint mobility. The overall consensus in the research remains non-conclusive, and findings have been mixed regarding the formulation's impact on joint space narrowing.

Studies reported that adverse events were infrequent in the reviewed literature. The most commonly reported adverse effects were transient gastrointestinal disturbances, such as nausea or indigestion. These events were transient, and most participants completed the studies. There is limited research on interactions with prescription medications. Most trials excluded participants with documented shellfish allergies (a source of some Glucosamine).

Frequently Asked Questions (FAQ)

Common questions about Glitisol 5mg (FAQ)

Q: How quickly should I expect Glitisol 5mg to start working?

Official prescribing information indicates that Glitisol 5mg is absorbed into the body rapidly. Significant drug levels are typically reached in the bloodstream within one hour of administration. Peak concentrations in the bloodstream are typically reached at about four hours.

Q: Does Glitisol 5mg cause weight gain or loss?

Regulatory summaries of adverse reactions indicate that weight increase is a known side effect reported by some patients using Glibenclamide (the active ingredient). This is an officially recognized effect. Official documents do not describe any weight loss effect.

Q: Is Glitisol 5mg safe for long-term use?

The medication is approved for chronic (long-term) administration to manage Type 2 Diabetes Mellitus. It is intended for ongoing management, rather than temporary use. The chronic indication is established in regulatory documents.

Q: Why do some people say Glitisol 5mg makes them feel dizzy?

Dizziness is a common symptom associated with hypoglycemia (low blood sugar), which is the most frequent and critical side effect of Glitisol 5mg. When blood sugar levels drop too low, symptoms such as dizziness or lightheadedness can occur, as noted in regulatory summaries.

Q: Is Glitisol 5mg considered a controlled substance?

Glitisol 5mg, which contains the active ingredient Glibenclamide, is a pharmaceutical agent used for lowering blood sugar. According to official government schedules and regulatory lists, this medication is not classified as a controlled substance.

Q: Is it normal to feel tired when starting Glitisol 5mg?

Official regulatory documents list unusual tiredness or weakness as a less common side effect. It is also noted that high blood sugar (hyperglycemia) can cause tiredness. If fatigue is persistent, this is information to share with a healthcare provider.

Q: Can Glitisol 5mg be crushed or split in half?

The Glitisol 5mg tablet often has a score, or breakline, indicating it can be divided into equal halves. This is often provided for flexible dosing. It is best practice to verify splitting instructions using the patient information leaflet for the specific product.

Q: How long does Glitisol 5mg stay in your system after stopping it?

The time required for the body to eliminate the medication is measured by its half-life, which is approximately 10 hours for this drug. While the drug's effect may last longer, low levels may still be detectable in the system for up to twenty-four hours after a single dose.

Q: Can Glitisol 5mg be taken with anti-anxiety medication?

Regulatory documents explain that Glitisol 5mg can interact with many drug classes, potentially changing its blood sugar-lowering effect. Official guidance emphasizes that all concurrent prescription and non-prescription drugs should be reviewed by a healthcare provider, as specific interactions must be considered.

Q: What does 'contraindication' mean in relation to Glitisol 5mg?

A contraindication is an official term found in regulatory information that identifies a specific circumstance or condition, such as Type 1 Diabetes or severe kidney failure, in which the medication must not be used. This classification is used when the risk of severe complications or harm in that context is documented as high.

Q: Are there any specific lifestyle changes recommended while taking Glitisol 5mg?

Official patient information states that Glitisol 5mg is used as an adjunct, meaning it works alongside specific lifestyle measures. This includes maintaining a proper meal plan, engaging in regular physical exercise, and pursuing weight reduction, as directed by a healthcare professional.

Q: Does taking Glitisol 5mg affect the way birth control works?

Official drug information indicates that oral contraceptives (birth control pills) are known to interact with Glibenclamide. This interaction may potentially weaken the drug's ability to lower blood sugar. This interaction should be discussed with a healthcare provider when managing treatment.

Q: Does Glitisol 5mg require regular blood monitoring?

Yes, official regulatory guidance confirms that regular blood monitoring is a required part of treatment with Glitisol 5mg. Patients are generally advised to test their blood glucose to ensure the medication is effective and to help guide necessary dose adjustments over time.

Q: How long do the beneficial effects of Glitisol 5mg usually last?

Clinical studies documented in official product information show that the blood glucose lowering effect of a single dose persists for 24 hours in non-fasting diabetic patients. This extended duration supports its established use as a once or twice daily medication.

Q: Is Glitisol 5mg intended for temporary or long-term relief?

Glitisol 5mg is prescribed for the chronic administration of Type 2 Diabetes Mellitus. This means it is intended for long-term, ongoing management of the condition rather than temporary relief. Regulatory documents detail the safety profile based on its use as a continuous treatment.

Q: Can Glitisol 5mg cause changes in mood or anxiety?

Changes in mood, such as nervousness, anxiety, irritability, and confusion, are documented symptoms of hypoglycemia (low blood sugar). These mood changes are frequently associated with hypoglycemia, which is the most common side effect of the drug.

How should Glitisol 5mg be stored and disposed of?

Glitisol 5 mg tablets must be stored according to regulatory requirements to ensure stability and integrity.

Storage Requirements

Condition Requirement
Temperature Store below 25 C
Protection Protect from light and moisture
Packaging Keep in the original container and keep it tightly closed

Storage must always be out of the reach and sight of children. Stability is maintained until the labeled expiration date, provided the storage conditions are strictly followed.

Disposal Instructions

Do not dispose of unused or expired Glitisol 5 mg in household waste or by flushing it into wastewater. The medication must be discarded according to local regulatory requirements or returned to a dedicated pharmacy or local collection program for safe disposal.

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

Equivalent of Glitisol 5mg found in:

A-Z Index: