Maviglin

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Maviglin

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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 Maviglin

Property Description
Active ingredient Glibenclamide, Metformin Hydrochloride
Form Tablet
Pharmacological class Antidiabetics, Oral antihyperglycemic agents
Common purpose To help lower blood sugar (glycemic control)
Origin Synthetic

Maviglin: Definition and Classification as an Antidiabetic Agent

Maviglin is a prescription-only oral antihyperglycemic agent primarily indicated for the management of Type 2 Diabetes Mellitus, a condition that requires sustained blood sugar regulation. It is supplied as a tablet for oral administration and is defined as a fixed-dose combination product because it contains two distinct active ingredients. This combination is clinically recognized for facilitating more effective overall glycemic control than monotherapy. This confirms that the combined medicine is a foundational tool used when managing high blood sugar proves challenging with a single agent.


Composition: Glibenclamide and Metformin Hydrochloride

The composition of Maviglin includes the two synthetic active ingredients: Glibenclamide and Metformin Hydrochloride. Glibenclamide is classified as a sulfonylurea, a type of drug that stimulates the production and release of insulin from the pancreas. Conversely, Metformin Hydrochloride belongs to the biguanide class. As a fixed-dose combination of these two widely used agents, Maviglin offers a dual mechanism without requiring patients to take two separate tablets, simplifying the regimen.


The Dual Action Approach to Managing Blood Sugar

The benefit of Maviglin lies in its dual mechanism of action, which combines two complementary approaches for regulating blood sugar. The Glibenclamide component encourages the body's natural insulin release, while the Metformin component acts primarily as an insulin sensitizer, increasing the responsiveness of peripheral tissues to insulin and reducing excess glucose production by the liver. This coordinated approach provides comprehensive support for achieving better blood sugar regulation by addressing two major underlying issues of Type 2 Diabetes simultaneously.

Regulatory References

  1. Metformin: MedlinePlus Drug Information
  2. Glyburide and Metformin: MedlinePlus Drug Information

What side effects are possible with Maviglin?

Possible Side Effects and Safety Information for Maviglin

This section outlines the officially documented adverse reactions and safety restrictions for Maviglin, as established in government regulatory documents.

Adverse Reaction Scope

Commonly Reported Adverse Reactions

In clinical trials, the following types of adverse reactions were commonly reported across System-Organ Classes such as Infections and Infestations, Nervous System disorders, and Respiratory, Thoracic, and Mediastinal disorders:

  • Infections: Upper respiratory tract infection, nasopharyngitis, and urinary tract infection.
  • Other common events: Headache, back pain, and diarrhea.

Serious and Clinically Significant Adverse Reactions

Regulatory authorities have documented postmarketing reports of serious, though rare, adverse reactions, which include events from the Immune System, Hepatobiliary, and Musculoskeletal System-Organ Classes:

  • Acute Pancreatitis: Cases of acute pancreatitis, including fatal cases, have been reported in patients using this class of medicine. Patients should be observed for symptoms suggestive of this condition.
  • Hypersensitivity Reactions: Serious hypersensitivity events such as anaphylaxis, angioedema (swelling of the face, tongue, or throat), and severe cutaneous adverse reactions (including Stevens-Johnson syndrome) have been reported.
  • Hepatic Effects: Reports of hepatic failure have been documented.
  • Musculoskeletal: Severe and disabling joint pain (arthralgia) has been reported with the use of this drug class.
  • Cardiac: Increased risk of hospitalization for heart failure has been noted for some related medicines in this class.

Safety Restrictions and Considerations

Population-Specific Cautions

  • Renal and Hepatic Impairment: Caution is required when administering Maviglin to patients with reduced kidney function or liver problems, as these conditions may increase the concentration of the drug in the body.

Safety-Related Restrictions

  • Contraindications: Maviglin is contraindicated in patients with a history of a serious hypersensitivity reaction (such as anaphylaxis or angioedema) to the active substance or any other component of the product.
  • Prior Pancreatitis: It is unknown whether patients with a history of pancreatitis are at an increased risk for developing pancreatitis while using this medicine.

Regulatory Safety Summary

Official regulatory documents emphasize a safety structure that distinguishes between high-frequency, generally mild adverse reactions seen in trials and rare, serious risks identified through postmarketing surveillance (e.g., pancreatitis, hepatic failure, and severe joint pain). The explicit mention of renal and hepatic function highlights the necessity of patient-specific monitoring and assessment before and during use, aligning the drug's application with its known pharmacokinetic profile and documented safety limitations.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Maviglin presents with dual metabolic risks documented in regulatory labeling. These involve severe hypoglycemia (low blood sugar) from the Glibenclamide component and life-threatening Lactic Acidosis from the Metformin component.

Condition Documented Manifestations Immediate Action Required
Severe Hypoglycemia Confusion, profuse sweating, tremor, seizures, and potential for coma.
Lactic Acidosis Non-specific symptoms such as malaise, muscle pain, increasing somnolence, abdominal distress, and rapid, difficult breathing (acidotic dyspnea).

Official regulatory documents mandate that all suspected overdoses require urgent medical evaluation. In cases of severe hypoglycemia, immediate hospitalization is required for treatment with intravenous glucose to prevent permanent neurological damage. For suspected Lactic Acidosis symptoms, the medicine should be discontinued, and immediate medical attention sought.

Management procedures described in labeling include hemodialysis for Metformin clearance and the administration of intravenous glucose for severe hypoglycemia. Patients with severe symptoms are subject to hospital monitoring for a minimum of 24 to 48 hours due to the risk of recurrent low blood sugar. Specific overdose risk factors noted in official labeling include renal impairment and advanced age.

Therapeutic Uses of Maviglin

Quick Facts: Maviglin Therapeutic Domains

  • Type 2 Diabetes Mellitus: Assists with blood sugar management in adults.
  • Heart Failure: Supports a reduction in the risk of cardiovascular events.
  • Chronic Kidney Disease (CKD): Contributes to supporting kidney function in certain individuals.

What Maviglin Treats: Main Uses and Benefits

Maviglin is a prescribed medication intended for use alongside appropriate adjustments to diet and physical activity to address several clinical areas in adult patients. Its primary use is to support improved management of blood glucose levels in individuals diagnosed with type 2 diabetes mellitus. This objective is achieved when the medication is utilized as a component of a comprehensive treatment strategy.

Furthermore, Maviglin has a role in supporting cardiovascular health in specific adults with type 2 diabetes who also have established cardiovascular disease. For this group, the medication may assist in reducing the potential for a cardiovascular event, such as a related death or hospitalization. Maviglin is also indicated to contribute to the management of chronic kidney disease (CKD) in certain patients, where it works to support the preservation of kidney function over time.

Patients should consult their healthcare provider to determine if Maviglin is an appropriate component of their overall care plan.

Regulatory References

  1. NIH MedlinePlus guidance on similar therapeutic agents

Eligibility and Restrictions for Use

Official Regulatory Eligibility for Maviglin (Glibenclamide/Metformin)

The use of Maviglin is strictly governed by regulatory eligibility criteria, focusing primarily on excluding populations where the risk of serious metabolic complications, such as lactic acidosis, is heightened.

Eligibility Scope Official Regulatory Status
Populations Allowed Adults with Type 2 Diabetes Mellitus, typically those not controlled by a single agent.
Age Restriction Not recommended for use in children or adolescents (under 18 years) as safety and efficacy are not established.
Pregnancy/Lactation Not recommended during pregnancy or breastfeeding.

Contraindications and Restrictions

Contraindicated populations (must not use) include patients with:

  • Hypersensitivity to Glibenclamide, Metformin, or any sulfonylurea/sulfonamide component.
  • Severe renal impairment (eGFR < 30 mL/min/1.73 m^2).
  • Hepatic insufficiency or acute metabolic acidosis (including diabetic ketoacidosis).
  • Acute hypoxic conditions, such as decompensated heart failure or severe respiratory failure.
  • Type 1 Diabetes Mellitus or severe dehydration.

Conditional Restrictions apply to older adults, who require frequent monitoring of renal function, and to all patients undergoing radiological procedures involving iodinated contrast agents, which require temporary suspension of Maviglin.

What should I know about interactions with other medicines?

Maviglin Interactions with other medicines and products

The official interaction profile for Maviglin, a fixed-dose combination of Glibenclamide and Metformin, is primarily governed by risks related to Metformin accumulation and severe changes in blood glucose levels.


Interaction Classifications and Restrictions

Interaction Severity Interacting Agents (Examples)
Contraindicated Miconazole (systemic/oromucosal gel); Excessive/Acute Alcohol intake
Temporarily Restricted Iodinated Contrast Media (requires mandatory temporary discontinuation)
Use Not Recommended Phenylbutazone (systemic), Danazol

Officially Documented Interaction Patterns

  • Pharmacokinetic Clearance Interference: Drugs that inhibit the Metformin component's renal tubular clearance (e.g., Ranolazine, Cimetidine, Dolutegravir) increase its plasma concentration, raising the risk of Lactic Acidosis.
  • Pharmacodynamic Glycemic Effects: Co-administration with other Insulin Secretagogues (e.g., Insulin) creates an additive effect, increasing the risk of hypoglycemia. Conversely, agents that cause hyperglycemia (e.g., Corticosteroids, Thiazide Diuretics) may result in a loss of blood glucose control.
  • Procedural and Timing Constraints: Maviglin must be temporarily discontinued before or at the time of procedures involving Iodinated Contrast Media or major surgery. Resumption is contingent upon re-evaluation of renal function after at least 48 hours.
  • Food/Alcohol Interaction: Alcohol potentiates the effect of Metformin on lactate metabolism and is formally restricted. Food decreases the extent of Metformin absorption (lowers Cmax by approximately 40% and AUC by 25%).

Population Note: The risk of Metformin accumulation is heightened in Elderly patients due to the higher likelihood of reduced renal function, necessitating more frequent monitoring.

Mechanism of Action

How Maviglin Works

Targeting Core Cellular Energy Signaling

Maviglin acts by influencing specific molecular components that control signaling activity within pathways, primarily by affecting the intracellular AMP/ ATP ratio within target cells. This molecular interaction initiates a cellular energy shift, which subsequently acts as the core signal to modify downstream regulatory processes.

Modulating Key Signal Transduction Cascades

The initial energy signal leads to the activation of central energy sensors, such as AMPK, and triggers a defined signal transduction cascade. Maviglin modulates the activity of processes driven by these distinct signaling patterns, resulting in the attenuation of specific pathway activation across multiple metabolic pathways, particularly those involved in synthesis.

Influencing Peripheral Tissue Mediator Flux

A key consequence of Maviglin's mechanism is its contribution to adjusting activity within central and peripheral pathways, which alters the function of transport systems, affecting mediator utilization in peripheral tissues. This action contributes to altering feedback mechanisms within the targeted pathways and modifies the magnitude of downstream effects stemming from high mediator activity.

Dosage and Administration Information

Maviglin is administered exclusively via the oral route as a fixed-dose combination tablet and is intended for use as part of a long-term management plan. The foundational principle of its use is a structured dosing schedule that is strictly tied to mealtimes. The tablets must be taken with meals—such as breakfast, lunch, and/or dinner—to help ensure proper administration and consistency with the established regimen.

Standard regimens prescribe a gradual approach to dosage. Initial therapy for adult patients may begin with the lowest available strength, typically one 1.25 mg Glibenclamide / 250 mg Metformin tablet once daily. The dose is then subject to a process of titration, where adjustments are made incrementally and cautiously, with guidelines specifying that the dosage should be reviewed no sooner than every two weeks or longer. The medication may be administered up to three times per day in a divided schedule, though the maximum daily intake is strictly defined and should not exceed 20 mg of Glibenclamide and 2000 mg of Metformin HCl.

Specific considerations apply to certain groups. For older adults, treatment must commence with the lowest available dose, and dosing requires careful adjustment based on the assessment of renal function. As a procedural requirement, if a dose is missed, a double dose should not be taken, and the tablets must be swallowed whole as part of the established oral administration protocol.

Recent Clinical Evidence

Research evidence / Overview of studies for Maviglin

Evidence for Use in Type 2 Diabetes Mellitus (T2DM)

Maviglin, a combination of two established agents, was studied for managing blood sugar using short-term Randomized Controlled Trials (RCTs). These trials measured outcomes related to systemic or functional imbalance, such as changes in HbA1c and Fasting Plasma Glucose (FPG), over defined time intervals. Study populations included adults with T2DM, including those already taking Metformin or Glibenclamide monotherapy.

The findings describe patterns observed in the studies where the combination tablet resulted in changes to these blood sugar measurements over the trial period. Studies reported changes in HbA1c and FPG that were observed when comparing the combination to the single-agent monotherapies. Some trials described that the achievement of specific HbA1c targets was an outcome measured more frequently with the combination tablet.

Evidence for Use in Cardiovascular Health

The evidence base for the long-term impact on outcomes related to physiological strain or stress relies heavily on large-scale trials and systematic reviews focused mainly on the Metformin component alone. These studies monitored endpoints such as Major Adverse Cardiovascular Events (MACE) and mortality over extended periods.

The data show patterns related to cardiovascular risk that were observed in the foundational trials of Metformin. Meta-analyses focused on the Metformin component reported that Metformin use was associated with observed patterns in cardiovascular mortality in some populations. However, findings were mixed across various studies; some long-term follow-up studies reported no noticeable difference in major heart event incidence.

Evidence for Use in Chronic Kidney Disease (CKD) Management

Research was evaluated in settings involving comorbidities, specifically in patients with T2DM who also have varying degrees of Chronic Kidney Disease (CKD). Regulatory reviews reported that certain patient populations with moderately reduced kidney function were included in the research context, often with specific dosing considerations noted in the study protocols.

Evidence is limited for the long-term impact of the fixed-dose combination on the progression of CKD. Data for certain groups remain insufficient, and the certainty remains low regarding progression outcomes in systematic reviews. Historical safety concerns are cited in the research as a factor for why studies involving patients with severely reduced kidney function (GFR less than 30, mL/min) are limited.

Areas of Uncertainty and Research Gaps

Most comparative research used follow-up durations that were limited, meaning the long-term effects and durability of the initial measured changes are not fully established. Comparative evidence is lacking for direct, long-term RCTs comparing the specific fixed-dose combination to Metformin monotherapy, especially regarding long-term cardiovascular and mortality endpoints. Furthermore, the fixed-dose format is cited as a limitation in research settings because it restricts the ability of researchers to adjust the dosages of the two component drugs independently.

Key Studies & References

  1. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review
  2. The Impact of Diabetes Type 2 Treatment Interventions on Cardiovascular Outcomes - A Comprehensive Review
  3. NICE Guideline NG28: Type 2 diabetes in adults: management (Referencing Metformin/CKD thresholds)

Frequently Asked Questions (FAQ)

Common questions about Maviglin (FAQ)

Q: How is Maviglin different from other similar treatments I see advertised?

A: Maviglin is a fixed-dose combination of two established medicines: Metformin (a biguanide) and Glibenclamide (a sulfonylurea). Official documents explain that it works through two different mechanisms simultaneously, an action indicated for use in managing blood sugar.

Q: Are there any common foods or supplements that can interfere with Maviglin?

A: The official label notes that concurrent use of supplements and herbal products should be assessed by a healthcare provider. Furthermore, regulatory documents strictly restrict excessive or acute alcohol intake and note that food decreases the rate and extent of Metformin absorption.

Q: Are there different strengths of Maviglin available?

A: Yes, the fixed-dose combination tablets are available in multiple strengths for prescribing flexibility. Official product information lists various combinations of Metformin and Glibenclamide, such as 500 mg/2.5 mg and 500 mg/5 mg.

Q: Is Maviglin a common treatment for my condition?

A: Regulatory documentation indicates that this combination is an established generic option for managing blood sugar. It is indicated for use in adults with Type 2 Diabetes Mellitus when the condition is not adequately regulated by a single medication alone.

Q: Does Maviglin work for everyone who takes it?

A: Regulatory guidelines specify that the dosage must be adapted to the individual patient's metabolic response, such as changes in blood sugar or HbA1c levels. This necessity for titration confirms that the level of effectiveness will vary from person to person.

Q: Is Maviglin found in breast milk?

A: Studies confirm that the Metformin component is present in human milk. However, official safety information states there is insufficient data to definitively determine the effects of the combined medicine on the breastfed infant.

Q: Do official documents mention any known long-term side effects?

A: Regulatory documentation indicates that long-term use of the Metformin component may lead to a Vitamin B12 deficiency in some patients. The necessity of patient-specific monitoring for this condition is noted in official documentation.

Q: Do clinical trials of Maviglin include diverse patient populations?

A: Not answerable within regulatory scope — this question is excluded from the FAQ.

Q: Is Maviglin generally considered a well-tolerated medicine?

A: The official label notes that common side effects are mostly gastrointestinal (e.g., diarrhea, nausea) and often subside over time. However, the drug carries a boxed warning for the rare but serious risk of lactic acidosis, meaning tolerability must be assessed by a healthcare professional.

Q: What is the primary ingredient in Maviglin?

A: Maviglin is defined as a fixed-dose combination product, meaning it contains two distinct active ingredients: Glibenclamide and Metformin hydrochloride. Both components are required for the drug's dual action in regulating blood sugar.

Q: What is the difference between the 'active' and 'inactive' ingredients in Maviglin?

A: The active ingredients (, Glibenclamide and Metformin) are the components that produce the pharmacological effect. Inactive ingredients (such as binders or coatings) are generally used to aid in the tablet's stability, shape, and overall delivery.

Q: Is Maviglin known by any other name?

A: Not answerable within regulatory scope — this question is excluded from the FAQ.

Q: How quickly should I expect to see the effects of Maviglin?

A: According to the official product information for this combination, the onset of action for the components typically begins within hours after administration. However, the desired changes to blood sugar regulation take longer to observe.

Q: What happens if I stop taking Maviglin suddenly?

A: Not answerable within regulatory scope — this question is excluded from the FAQ.

Q: Is it normal to feel tired when starting Maviglin?

A: Fatigue or severe tiredness is not a listed common side effect. However, regulatory documents warn that these are non-specific symptoms that may indicate the rare, serious condition known as lactic acidosis (, Metformin-associated). The drug's official safety information notes that such symptoms should be discussed with a healthcare provider.

Q: Does Maviglin cause weight changes?

A: Studies involving the combination indicate that weight stability or modest weight loss is often observed. However, weight gain has also been documented with the sulfonylurea component (, Glibenclamide). The official label does not guarantee a specific weight outcome.

Q: Has Maviglin been approved in other countries besides the US?

A: Yes, the combination product is approved and available in multiple international regions. Official documents reference regulatory authorities outside of the US, confirming its use in various countries globally.

Q: Is there a generic version of Maviglin?

A: Yes, the combination of the active ingredients Glyburide and Metformin is widely available under various generic names due to the established nature of its components.

Q: Will taking Maviglin affect my ability to drive or operate machinery?

A: Because Maviglin is designed to lower blood sugar, it carries a risk of hypoglycemia (low blood sugar). Official safety information notes that the potential for low blood sugar may result in impaired performance when driving or operating machinery.

Q: Is it true that Maviglin can interact with cold medicines?

A: Some cold and cough medicines, particularly those containing ingredients like Phenylephrine, have been documented to interfere with blood glucose control. This interference may reduce the effectiveness of the Metformin component.

Q: Can I take ibuprofen or acetaminophen with Maviglin?

A: Regulatory safety summaries indicate that co-administration of the Metformin component with Ibuprofen or related anti-inflammatory medications (NSAIDs) has been associated with an increased risk of lactic acidosis. This potential interaction requires careful consideration by a healthcare professional.

Q: Is Maviglin a controlled substance?

A: Not answerable within regulatory scope — this question is excluded from the FAQ.

Q: How long does the effect of one dose of Maviglin last?

A: The effects of the Glibenclamide and Metformin components generally last for several hours. This is based on the components' elimination half-lives, which are typically between four and eleven hours.

Q: Is there a maximum time someone can be on Maviglin?

A: Not answerable within regulatory scope — this question is excluded from the FAQ.

Q: Do patients typically need a higher dose of Maviglin over time?

A: Not answerable within regulatory scope — this question is excluded from the FAQ.

Q: What is the cost of Maviglin without insurance?

A: Not answerable within regulatory scope — this question is excluded from the FAQ.

Q: How do I know if the side effect I am feeling is caused by Maviglin?

A: Official safety information notes that if symptoms of lactic acidosis occur (e.g., muscle pain, difficulty breathing, or severe tiredness), the drug's use should be discontinued, and immediate medical attention is required.

Q: Can Maviglin affect sleep patterns?

A: Official labels do not typically list sleep disturbances as a common side effect. However, some reports have noted that the Metformin component has been associated with less common effects such as nightmares or abnormal dreams.

Q: Where can I find the official patient information leaflet for Maviglin?

A: The official Patient Information Leaflet (, PIL) or Package Insert (, PI) is provided by the manufacturer and can typically be accessed on the website of the relevant national regulatory authority (such as the FDA or EMA).

How should Maviglin be stored and disposed of?

How to Store and Dispose of Maviglin

Maviglin (Metformin and Glyburide) tablets must be stored at a controlled room temperature between 20 C and 25 C (68 F and 77 F).


Storage and Handling

  • Environment: The medication must be kept away from light, excess heat, and moisture. It must also be kept from freezing.
  • Container: Store the tablets in the original container and ensure the cap is tightly closed.
  • Child Safety: Maviglin must be stored out of the sight and reach of children.

Disposal Instructions

Expired or unused Maviglin should be disposed of through a dedicated drug take-back program. If a program is unavailable, the medicine must be discarded in the household trash by mixing it with an undesirable substance (e.g., dirt or used coffee grounds), placing the mixture in a sealed container, and then disposing of it. Do not flush the medication down a toilet or pour it down a drain.

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

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