Манинил

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Манинил

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Method of action: Hypoglycemic

Medically reviewed

Marina Burgos

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 Манинил

Quick Facts

Property Description
Active ingredient Glibenclamide (or Glyburide)
Form Tablet (Oral preparation)
Pharmacological class Oral Antidiabetic Agent (Sulfonylurea)
Common use Managing high blood sugar levels
Origin Synthetic compound

Манинил: Definition, Active Ingredient, and Origin

Манинил is a clinically recognized prescription-only medicine and a single-ingredient product whose identity is defined by its sole active ingredient, Glibenclamide, which is also identified as Glyburide in international nomenclature. This drug is a synthetic compound, manufactured and presented as a solid tablet, making it an oral preparation intended for systemic absorption and effect. The formulation consists of pure Glibenclamide integrated with a pharmaceutical base of inert excipients, a composition that supports consistent stability and reliable delivery of the active substance through oral administration. The established profile of Glibenclamide has been documented across pharmacological studies as a cornerstone therapy for metabolic control.

Pharmacological Classification and General Purpose

Манинил belongs to the sulfonylurea pharmacological class, specifically characterized as a second-generation sulfonylurea. As an antihyperglycemic drug, its general purpose is to assist in maintaining stable blood glucose levels for patients with Type 2 diabetes mellitus. This particular class of medicine is supported by clinical experience to achieve its effect by acting as an insulin secretagogue, meaning its mechanism is centered on promoting the release of pre-formed insulin from the pancreatic beta-cells. This action provides a glucose-lowering effect that helps control the hyperglycemia inherent in the condition, providing a systematic therapeutic option for long-term metabolic management.

What side effects are possible with Манинил?

Possible side effects and safety information

The safety profile for Glibenclamide (Манинил), as documented by regulatory authorities, is structured around several critical domains, with the most significant adverse event being hypoglycaemia (low blood sugar), which is classified as the most frequent and potentially serious risk.

Adverse reactions are officially categorized across several System-Organ Classes, including the Metabolism and Nutrition system for effects like hypoglycaemia and weight gain, Gastrointestinal disturbances (e.g., nausea, diarrhoea), and Skin and Subcutaneous Tissue disorders (e.g., allergic reactions, photosensitivity).

Documented Serious Adverse Reactions

Specific serious risks are highlighted in regulatory labeling:

  • Severe and Prolonged Hypoglycaemia: This is a serious, life-threatening risk requiring careful clinical monitoring.
  • Increased Cardiovascular Mortality: The FDA label notes an associated risk of increased cardiovascular mortality compared to treatment with diet alone or diet plus insulin.
  • Haemolytic Anaemia: A risk specifically noted in patients with G6PD deficiency.

Population-Specific Safety Considerations

The official labeling defines specific safety constraints for vulnerable groups. Older adults and patients with severe renal or hepatic impairment are at a heightened risk for severe, prolonged hypoglycaemia. Consequently, the drug is contraindicated in severe impairment of the liver or kidneys. Furthermore, the label notes that the risk of hypoglycaemia is more likely to occur at the beginning of treatment.

Safety-Related Restrictions

Regulatory documentation mandates that Манинил is contraindicated in conditions such as Type 1 Diabetes Mellitus, Diabetic Ketoacidosis, and when used concurrently with the medication Bosentan, due to the potential for hepatotoxicity.

Overdose and Emergency Response

Манинил Overdose and when to seek help

The defining characteristic of a Glibenclamide (Glyburide) overdose is the onset of profound and prolonged hypoglycemia (severely low blood sugar), which constitutes a life-threatening medical emergency documented in regulatory information. Documented clinical signs of overdose are direct manifestations of low blood sugar, including confusion, altered mental status, stupor, coma, and convulsions (seizures). Systemic signs may include tachycardia (rapid heartbeat), sweating, and anxiety.

When to Seek Urgent Help

Immediate emergency medical attention is strictly required for any suspected overdose. Regulator guidance mandates contacting a Poison Control Center or emergency services without delay, as uncorrected, severe hypoglycemia can lead to permanent brain damage or death. Official documents also note that ingestion of even a small number of tablets in infants and young children necessitates immediate referral to a healthcare facility.

Management and Monitoring Requirements

Treatment protocols are focused on correcting blood glucose. While no specific chemical antidote is known, supportive measures include the administration of intravenous glucose (dextrose). Due to the drug's long duration of action, which can cause hypoglycemia to recur, hospital monitoring for at least 24 hours is officially required even after initial symptoms are corrected. Official labeling notes an increased risk of severe, prolonged reactions in the elderly and patients with existing renal or hepatic insufficiency.

Therapeutic Uses of Манинил

What Манинил Treats: Main Uses and Benefits

The medication is commonly used to provide supportive relief and is relevant for easing symptoms related to chronic blood sugar dysregulation.

This medication is commonly used for managing Type 2 Diabetes Mellitus, which is a chronic condition where systemic imbalance prevents the body from properly controlling blood sugar. It is applied across domains where additional symptomatic support is needed, such as in cases of persistently high blood sugar levels (hyperglycemia) and related symptoms like excessive thirst and frequent urination.

The medication may assist with managing symptom clusters that may become disruptive, particularly when lifestyle modification has failed to bring glucose levels within therapeutic targets. It helps maintain a sense of stability when symptoms are more noticeable and contributes to improved day-to-day comfort during symptomatic periods.


Quick Fact: Support for Metabolic Strain

Context Benefit
Symptom Category Symptoms related to systemic imbalance
Relief Contributes to easing the overall symptom burden caused by chronic hyperglycemia
Clinical Scenario Used when additional pharmacological support is needed to achieve glycemic targets
Long-Term Role Supports the process of lowering the potential for developing serious diabetic complications

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Манинил (Glibenclamide) — Official Regulatory Information

Category Official Regulatory Statement
Populations for whom use is allowed Adults with Type 2 Diabetes Mellitus who respond inadequately to dietary measures alone.
Populations for whom use is contraindicated Patients with: Hypersensitivity to Glibenclamide, other sulfonylureas, or sulphonamides; Type 1 Diabetes Mellitus; Diabetic Ketoacidosis or Pre-Coma; Severe Renal Failure (e.g., GFR < 60 mL/min); Severe Hepatic Insufficiency; Acute Alcohol Intoxication; and Porphyria.
Age-related eligibility rules Paediatric Population (Children/Adolescents): Use is contraindicated by some regulators, and safety and effectiveness have not been established. Older Adults (Aged 65+): Requires careful dose adjustment, starting with the lowest available dose, due to increased hypoglycemia risk.
Condition-specific eligibility rules Severe Renal/Hepatic Impairment: Contraindicated (see above). Mild to Moderate Renal/Hepatic Impairment: Requires dose adjustment and use of the lowest dose levels. Must NOT be used in acute conditions with potential to alter renal function (e.g., severe infection, shock).
Pregnancy and lactation eligibility status Pregnancy: Contraindicated (patient must change over to insulin). Lactation (Breastfeeding): Contraindicated.
Eligibility-related restrictions Patients who are malnourished or debilitated or have irregular calorie intake require caution and treatment must start at the lowest dose. Patients undergoing major surgery or experiencing trauma/febrile infection should temporarily switch to insulin therapy.

Connection to the Overall Eligibility Profile

Official regulatory documents rigidly define the population eligible for Манинил by confining its use exclusively to adults with Type 2 Diabetes. These documents establish multiple absolute non-eligibility criteria, formally contraindicating the medicine for specific disease states (e.g., Type 1 diabetes, severe organ failure), physiological conditions (pregnancy, lactation), and age groups (children), thereby structuring the strict boundaries of its labeled use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This information details the officially documented interactions for Манинил (Glibenclamide) with other medicines and substances. The interactions are structured according to the mechanism or resulting effect, based on authoritative government regulatory documentation.

Documented Interaction Categories

Interaction Type Examples of Interacting Products Resulting Constraint/Requirement
Metabolic Inhibition (CYP2C9/3A4) Certain azole antifungals, cimetidine, sulfonamides, chloramphenicol Increases Манинил concentration; requires close monitoring and potential dose review.
Metabolic Induction (CYP2C9/3A4) Rifampicin Decreases Манинил concentration; reduces effectiveness and requires close monitoring.
Pharmacodynamic Enhancement Other anti-diabetic agents, high-dose salicylates, beta-blockers Increased risk of hypoglycemia (low blood sugar); necessitates careful monitoring.
Pharmacodynamic Reduction Corticosteroids, thiazide diuretics, thyroid products, estrogens Decreased glucose-lowering effect; may require intensified blood glucose monitoring.
Specific Avoidance Alcohol, Oral Miconazole Avoidance is required due to the risk of severe, prolonged hypoglycemia and/or disulfiram-like reactions.

Official Regulatory Constraint

Co-administration with Bosentan is explicitly contraindicated in official labeling due to the increased risk of liver toxicity and potential efficacy issues. All interactions require that blood glucose levels be monitored closely when co-administered medicines are started or stopped.

Mechanism of Action

How Манинил Works: Mechanism of Action

Манинил (Glibenclamide) exerts its action by selectively targeting the sulfonylurea receptor 1 ( SUR1), a regulatory subunit of the ATP-sensitive potassium ( K ATP) channel complex found primarily on pancreatic beta cells. The drug acts as an inhibitor, binding to SUR1 and forcing the K ATP channel to close.

This channel closure prevents the efflux of potassium ions ( K^+), causing the beta-cell membrane to depolarize. Depolarization activates voltage-dependent calcium channels ( VDCC), leading to a rapid influx of extracellular Ca^2+. The resulting increase in intracellular Ca^2+ concentration triggers the exocytosis of pre-formed insulin from secretory granules into the bloodstream.

This elevation in circulating insulin acts systemically, enhancing glucose uptake by peripheral tissues and suppressing hepatic glucose production. The physiological consequence of this mechanistic cascade is a decrease in the overall plasma glucose concentration.

Dosage and Administration Information

Манинил is an oral medication taken as a tablet, with available strengths distinguishing between regular and micronized formulations of glibenclamide. The administration is intended for long-term use and follows established procedural guidelines to ensure consistent intake. The required route of administration is oral, and the tablet is swallowed with breakfast or the first main meal of the day.

The initial dosing for standard adult regimens typically ranges from 2.5 mg to 5 mg once daily for the regular tablet, while the micronized formulation requires a lower initial dose. The maximum daily dose is set at 20 mg for the regular tablet and 12 mg for the micronized version. When the daily dose exceeds 10 mg (regular) or 6 mg (micronized), the total amount is administered in divided doses. Furthermore, the non-micronized and micronized forms are not bioequivalent, and a re-titration of dosage is required if switching between formulations.

Dose adjustment, or titration, is a gradual process undertaken at intervals of one week or longer based on the patient's metabolic response. Particular populations may require different approaches: a lower initial dose (e.g., 1.25 mg regular or 0.75 mg micronized) is utilized for older adults and those with hepatic impairment. In the event of a missed dose, the next scheduled dose is not doubled.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Манинил (Glibenclamide)

Evidence for Use in Type 2 Diabetes Mellitus

The majority of the research for Glibenclamide, the active ingredient in Манинил, was studied for the long-term management of Type 2 Diabetes Mellitus (T2DM). Research examined its effect on glycemic biomarkers, such as HbA1 c and daily blood glucose levels, in adult populations. Findings describe patterns observed in the studies where individuals receiving Glibenclamide experienced reductions in their HbA1 c measurements. The measurements tracked in these studies are central to managing this condition, which is characterized by functional limitations in glucose control.

In analyses comparing Glibenclamide to other pharmacological options, findings were mixed regarding patterns related to long-term outcomes such as serious cardiovascular events and mortality. Researchers have also noted that the drug's effect on lowering blood sugar may reach a non-linear dose-response point in some study groups.

Evidence for Use in Gestational Diabetes Mellitus

Glibenclamide was evaluated in women diagnosed with Gestational Diabetes Mellitus (GDM) in comparative randomized controlled trials. Researchers compared patterns in maternal blood glucose to those observed with insulin or other oral medications. Studies reported that administration of Glibenclamide was associated with achieving targeted blood glucose measurements in mothers. However, when examining neonatal outcomes in meta-analyses, findings were mixed regarding specific newborn health outcomes, with some data describing that Glibenclamide was associated with a higher rate of neonatal hypoglycemia than insulin, while other studies found similar patterns.

What Is Still Uncertain About Манинил

Research highlights what is known — and what is still uncertain — about the drug. Key research gaps and limitations include the inconsistency across systematic reviews concerning the comparative patterns for certain fetal outcomes in GDM and long-term macrovascular outcomes in T2DM. Furthermore, long-term effects are not fully established for children exposed to the drug in utero, and data for certain groups remain insufficient, such as older adults with multiple comorbidities. Subgroup findings are uncertain in areas such as use in individuals with significant kidney or liver issues.

Key Studies & References AMGLIDIA (Glibenclamide) Summary of Product Characteristics (European Medicines Agency - EMA)

Frequently Asked Questions (FAQ)

Common questions about Манинил (FAQ)

Q: Does Манинил contain lactose?

According to the official product information, Манинил tablets do contain lactose monohydrate as an excipient. This is an inactive ingredient that helps form the tablet. Official information notes that patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption are advised to discuss this ingredient with their healthcare provider.

Q: What is the active ingredient in Манинил?

The active ingredient in Манинил is glibenclamide. Glibenclamide is classified as an oral antidiabetic medicine, which is a substance that helps control high blood sugar (glucose) levels.

Q: What is the purpose of Манинил?

Манинил is an oral antidiabetic medicine indicated for the management of non-insulin-dependent (Type 2) diabetes mellitus in adults. Official information indicates it is used when diet, physical exercise, and weight reduction alone are not sufficient to effectively lower blood sugar levels.

Q: Can I drink alcohol while taking Манинил?

Regulatory documents state that consuming alcohol while taking glibenclamide (the active substance in Манинил) can intensify the blood sugar-lowering effect of the medicine. This interaction significantly increases the risk of hypoglycemia (dangerously low blood sugar). Official prescribing information strongly advises caution and typically recommends avoiding alcohol while taking this medication.

Q: Can I drive a car while taking Манинил?

According to the official product information, the ability to drive or operate machinery may be affected by fluctuations in blood sugar, specifically by hypoglycemia (low blood sugar) or, less often, hyperglycemia (high blood sugar). Official warnings advise patients to be particularly cautious about the risk of hypoglycemia and the effects it may have on concentration and reaction time.

Q: How long does it take for Манинил to take effect?

The official product information indicates that the active substance, glibenclamide, begins to lower blood sugar (glucose) levels approximately 60 to 90 minutes after ingestion. The blood sugar-lowering effect of a single dose generally persists for about 24 hours.

Q: What should I do if I forget to take a dose of Манинил?

Regulatory information advises against taking a double or larger than prescribed dose of Манинил to compensate for a missed dose. Taking an extra dose significantly increases the risk of dangerously low blood sugar (hypoglycemia). Instead, official guidance indicates that if a dose is missed, patients should continue with their regular dosing schedule.

Q: Can Манинил be used during pregnancy?

Studies and official information indicate that Манинил (glibenclamide) is contraindicated and should not be used during pregnancy. Regulatory information indicates that patients who are pregnant or planning to become pregnant are generally advised to switch to insulin therapy.

Q: Is Манинил available in different strengths?

Yes, official product information confirms that Манинил is available in tablet form in different strengths. These strengths contain either 3.5 mg or 5 mg of the active substance, glibenclamide. The appropriate strength is determined by a healthcare provider based on the patient's individual treatment requirements.

Q: Can children take Манинил?

According to the official product information, there is insufficient data available regarding the use of Манинил in children and adolescents. Consequently, the use of this medicine is not recommended for patients who are under 18 years of age.

How should Манинил be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal instructions for Манинил (Glibenclamide) are defined by regulatory labeling to maintain the product's quality and stability.

Storage Component Official Requirement
Temperature Store below 30 C or 25 C (check specific label).
Environment Protect from both light and moisture.
Packaging Keep the tablets in the original container and ensure the container is tightly closed.
Child Safety Must be stored out of the reach of children.
Shelf-Life Standard stability period (e.g., 36 months) applies when stored under the specified conditions.

For disposal, any unused or expired Манинил should be discarded in accordance with local pharmaceutical waste collection rules. The product does not require specific hazardous waste handling beyond these standard procedures.

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

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