Maizar

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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 Maizar

Quick Facts

Property Description
Active Ingredients Fluticasone Propionate, Salmeterol
Form Inhalation Powder, Metered-Dose Inhaler
Pharmacological Class Inhaled Corticosteroid / Long-Acting Beta Agonist Combination (ICS/LABA)
Common Use Maintenance of respiratory function
Origin Synthetic

What is Maizar and What Are Its Core Components?

Maizar is a synthetic fixed-dose combination (FDC) medicine intended for delivery via the inhalation route, serving as a controller medication for chronic airway support. The core identity of this product is defined by its two co-formulated active ingredients: Fluticasone Propionate and Salmeterol. This FDC strategy is recognized for its role in maintenance therapy.

This combination drug is a prescription-only medicine, formulated to integrate both essential therapeutic compounds into a single system, ensuring coordinated delivery. Fluticasone Propionate is structurally classified as a corticosteroid, and Salmeterol belongs to the beta2-adrenergic agonist group.

The Pharmacological Identity: An ICS/LABA Combination

Maizar is formally classified as an Inhaled Corticosteroid / Long-Acting Beta Agonist Combination (ICS/LABA), a foundational pharmacological class that utilizes a dual-action therapeutic approach. This classification establishes that the drug simultaneously addresses two core physiological elements: underlying tissue irritation and prolonged muscular constriction.

The Fluticasone Propionate component provides necessary local anti-inflammatory action, while the Salmeterol component facilitates sustained bronchodilation. There is a recognized long-term benefit of the ICS/LABA combination class for foundational respiratory support. This fixed-dose approach is utilized for maintaining stable airway function in patients requiring continuous maintenance.

Maizar's Delivery Form and General Purpose

The delivery system for Maizar is confined to the inhalation route, typically via a dry powder device or a metered-dose device, ensuring the active ingredients are distributed locally within the pulmonary system. The base or vehicle can include powder excipients like lactose, or propellant systems.

The overall therapeutic purpose of this inhaled therapy is to serve as a reliable, preventative controller medication for chronic airway management. By delivering the fixed-dose combination of the anti-inflammatory Fluticasone Propionate and the long-acting beta agonist Salmeterol on a continuous basis, the medicine offers foundational support aimed at maintaining stable, open airways and reducing airway sensitivity.

Regulatory References

  1. NIH DailyMed Drug Label for Fluticasone/Salmeterol

What side effects are possible with Maizar?

Official Safety Profile and Adverse Reactions

The safety profile of the Fluticasone Propionate/Salmeterol combination is organized by government regulatory bodies, classifying possible adverse reactions by the System-Organ Class affected and the observed frequency.

Very Common reactions (affecting more than 1 in 10 individuals) consistently documented in regulatory labels include Headache and Nasopharyngitis. Common reactions (affecting up to 1 in 10) documented in official sources include Oral Candidiasis (thrush), Bronchitis, Pharyngitis, Muscle cramps, and Pneumonia (specifically in patients with COPD).

Uncommon effects (up to 1 in 100) are associated with the beta-agonist component and corticosteroid systemic exposure, including Tremor, Palpitations, Tachycardia, Anxiety, and Hyperglycemia. Rare reactions (up to 1 in 1,000) include severe Anaphylactic reactions and certain Arrhythmias.


Serious Adverse Reactions and Safety Constraints

Regulatory documentation highlights several serious safety concerns. Paradoxical bronchospasm, a rapid and unexpected worsening of breathing, is documented as a potential immediate adverse reaction. Systemic effects of the inhaled corticosteroid component can occur with prolonged use or high doses, including Adrenal suppression and risk of Bone Mineral Density reduction.

Population-specific safety notes are also outlined. For pediatric patients, monitoring for Reduction in growth velocity is warranted. Patients with COPD have a documented increased risk of Pneumonia. Additionally, the label notes caution for patients with pre-existing Cardiovascular disorders, due to the effects of the Salmeterol component. The medicine should not be used concurrently with strong Cytochrome P450 3A4 inhibitors due to the potential for increased systemic exposure.

Overdose and Emergency Response

The official regulatory documentation on Maizar overdose describes two primary risk profiles. Acute overdose is primarily associated with the long-acting beta agonist component, manifesting as signs of excessive sympathomimetic stimulation, including tachycardia, palpitations, and tremor. Physiological changes documented in regulatory sources also include hypokalemia (low potassium) and hyperglycemia (high blood sugar). Severe acute outcomes listed in the labeling include seizures, severe cardiac arrhythmias, and paradoxical bronchospasm.

In contrast, long-term prolonged high-dose exposure to the inhaled corticosteroid component may lead to adrenal suppression or hypercorticism, with acute adrenal crisis being a rare, severe outcome. Acute adrenal crisis has been very rarely reported in children exposed to prolonged higher-than-approved doses.

Emergency Action: The prescribing information mandates that if an overdose is suspected, or if an individual experiences severe acute symptoms such as collapse, trouble breathing, or a seizure, emergency services must be called immediately. An urgent medical assessment is also required for sudden, progressive deterioration in respiratory control.

Management: There is no specific treatment or antidote documented for this combination. Management is strictly symptomatic and supportive, requiring procedures such as continuous cardiac monitoring, correction of metabolic imbalances, and consideration of specific pharmacological interventions with extreme caution.

Therapeutic Uses of Maizar

What Maizar Treats: Main Uses and Benefits

Maizar is a foundational controller therapy commonly used for the long-term management of major chronic respiratory conditions, primarily persistent asthma and Chronic Obstructive Pulmonary Disease (COPD). This combination is relevant when a patient's condition is not fully controlled by a single inhaled corticosteroid, applying to adults and children aged four years and older with persistent asthma, as well as adults with COPD, including chronic bronchitis and emphysema.

The medicine is relevant for easing symptoms related to airway obstruction and chronic inflammation. This includes addressing symptoms such as wheezing, chronic coughing, chest tightness, and recurring shortness of breath. The medication provides support that helps ease the overall symptom burden.

The sustained support assists with maintaining functional stability, which is key for managing chronic conditions.

The therapeutic benefit supports the goal of improved asthma control and may assist with reducing the frequency of debilitating exacerbations in COPD patients. This supports the patient during difficult episodes and contributes to improved comfort during periods of heightened symptoms.

Quick Fact: Relief for Obstructive Symptoms
Target Symptoms Wheezing, Chronic Coughing, Chest Tightness, Shortness of Breath
Use Scenario Foundational, long-term maintenance of chronic respiratory function

Eligibility and Restrictions for Use

The eligibility for using Maizar (Fluticasone Propionate/Salmeterol) is strictly defined by regulatory authorities for its use as a long-term maintenance therapy. It is not indicated for the relief of acute bronchospasm or for the primary treatment of status asthmaticus or acute COPD episodes.

Contraindicated Populations

Use is contraindicated in patients with a known hypersensitivity to Fluticasone Propionate, Salmeterol, or any product excipient, including those with a severe allergy to milk proteins.

Age-Related Eligibility

Indication Eligible Age Group
Asthma Maintenance Adults, Adolescents (ge 12 years), and Children (ge 4 years)
COPD Maintenance Adults only (ge 18 years)

Safety and effectiveness are not established in children younger than 4 years of age for asthma treatment, and its use is not recommended in this group.

Conditions Requiring Caution

Use requires caution and close monitoring in populations with pre-existing conditions, including severe hepatic (liver) impairment, cardiac arrhythmias, hypertension, thyrotoxicosis, or diabetes mellitus. For pregnancy and lactation, official regulatory documents indicate that use is conditional upon a risk-benefit assessment.

What should I know about interactions with other medicines?

Maizar’s official interaction profile is defined by restrictions on co-administration based on documented effects on drug clearance and pharmacodynamics. The regulatory labels emphasize that the medicine must not be used concurrently with other Long-Acting Beta₂-Agonists (LABAs), a restriction put in place due to the risk of overdose and excessive systemic exposure.

A key class of interacting agents are the Strong Cytochrome P450 3A4 (CYP3A4) Inhibitors, such as ritonavir and ketoconazole. Co-administration with these substances is officially not recommended because they inhibit the metabolism of both active components. This can lead to significantly increased plasma concentrations and potential systemic effects, as documented by regulatory authorities.

The profile also includes several documented pharmacodynamic interactions. Non-selective beta-adrenergic receptor blocking agents may antagonize, or counteract, the bronchodilatory action of the Salmeterol component, risking severe bronchospasm. Additionally, co-use with Monoamine Oxidase Inhibitors (MAOIs), Tricyclic Antidepressants (TCAs), or Non-Potassium-Sparing Diuretics carries a heightened risk for additive effects, including vascular potentiation or the worsening of hypokalemia. Patients with documented hepatic impairment may also experience increased effects due to the slowed clearance of the medicine from the body. The ingestion of grapefruit juice is noted as an interaction risk due to its role as a CYP3A4 inhibitor.

Mechanism of Action

The mechanism of Maizar relies on two co-acting pharmacological domains that modulate physiological processes within the airways, leading to sustained modulation of both inflammatory signals and muscle tone.

u1f52c Dual Action: Anti-Inflammatory Gene Modulation

The Fluticasone Propionate component activates the Glucocorticoid Receptor (GR) inside cells, which directly alters the genetic programming of airway tissue. This genomic action initiates a cascade that suppresses the creation of pro-inflammatory factors (like cytokines and chemokines) while promoting the synthesis of anti-inflammatory proteins. This mechanism is associated with reduced cellular infiltration and decreased mucosal edema, thereby modulating the physiological sensitivity of airway tissue.

️ Sustained Bronchodilation via β₂-Adrenergic Agonism

The Salmeterol component is a selective partial agonist that binds to the mathbfBeta-2 Adrenergic Receptor (β₂ -AR) on bronchial smooth muscle. This interaction triggers the Adenylyl Cyclase / cAMP signaling cascade, resulting in a crucial decrease in intracellular calcium ions. The physiological consequence of this is the sustained relaxation of the bronchial smooth muscle. The sustained relaxation physically widens the bronchial lumen. The high lipophilicity of Salmeterol supports this prolonged action at the receptor site.

Mechanistic Synergy and Reciprocal Enhancement

The fixed-dose combination exhibits an enhanced functional consequence through a unique reciprocal enhancement at the molecular level. Fluticasone Propionate (the corticosteroid) functionally upregulates and increases the sensitivity of the beta2-ARs, thereby strengthening Salmeterol's ability to facilitate smooth muscle relaxation. This combined mechanism leads to targeted, simultaneous intervention against two core physiological mechanisms in the pulmonary system.

Dosage and Administration Information

Maizar (Fluticasone Propionate/Salmeterol) is intended exclusively for oral inhalation as a scheduled maintenance treatment, delivered via a specific dry powder inhaler (DPI) or metered-dose inhaler (MDI) device. The medicine is administered twice daily, with doses taken approximately 12 hours apart to ensure a consistent presence of the active ingredients within the airways throughout the day. It is essential to use the medicine every day as a controller, even during periods when symptoms are well-controlled, as it is not intended for as-needed use.

The official dosage regimen is based on the condition and age. For adults and adolescents (12 years or older) with asthma, the dose is 1 or 2 inhalations twice daily, with the strength selected based on the required Fluticasone component. The dose must be titrated to the lowest dose that maintains effective control. For the maintenance treatment of COPD in adults, the standard regimen for the DPI formulation is typically 1 inhalation of the 250 mcg/50 mcg strength twice daily.

Administration Requirements

Procedural Instruction Contextual Rule
Timing Doses must be taken 12 hours apart, and the total dose must never exceed twice daily.
Post-Dose Rinse A mouth rinse with water (without swallowing) is required immediately following each administration.
Acute Restriction The medicine must not be used for the immediate relief of acute or sudden breathing difficulties.

If a regularly scheduled dose is missed, that dose should be skipped, and the next dose should be taken at the usual time; extra inhalations must not be taken to compensate for the missed administration.

Recent Clinical Evidence

⌒ Research evidence / Overview of studies for Maizar

This section describes the types of official research that have explored the fixed-dose combination of Fluticasone Propionate and Salmeterol, what outcomes those studies measured, and the areas where evidence remains limited or uncertain. This information is based on findings from clinical trials and scientific literature and does not contain any medical advice or treatment recommendations.


Evidence for Use in Persistent Asthma

The primary evidence foundation consists of Randomized Controlled Trials (RCTs), many of which were designed to compare the combination against the use of the inhaled corticosteroid (ICS) component alone, or against a placebo. Research examined outcomes related to pulmonary function measures, such as FEV1 (Forced Expiratory Volume in 1 second), and patient-reported outcomes describing perceived discomfort related to symptoms.

The studies describe patterns observed in patient populations who received the fixed combination, where measurements of FEV1 and PEF (Peak Expiratory Flow) values were taken and compared to those observed in patient groups who received only the ICS component. Findings describe observed symptom patterns and contribute to the broader evidence landscape for the management of this condition. Research does not determine whether an individual will respond similarly to the group patterns observed in these studies.


Evidence for Use in Chronic Obstructive Pulmonary Disease (COPD)

The evidence base for this combination in Chronic Obstructive Pulmonary Disease (COPD) was examined in large-scale Randomized Controlled Trials (RCTs) over extended periods. Studies focused mainly on adults with moderate-to-severe COPD who had a history of acute or disruptive episodes (exacerbations). Research examined outcomes related to episodic or acute changes, specifically the annual rate of moderate or severe COPD exacerbations, and outcomes reflecting daily functioning.

Clinical trials documented observations of the annualized rates of moderate-to-severe exacerbations in patients receiving the combination, which were then compared to groups receiving only the long-acting beta agonist (LABA) component, over typical follow-up periods of one year or more. These findings help contextualize the fixed combination in research settings for maintenance therapy for conditions involving periods of heightened symptoms.

However, certainty remains low for the evidence regarding which specific patient group within the overall COPD population may benefit most from the inhaled corticosteroid component. While studies were conducted during periods of increased symptom activity, the effect on all-cause mortality specifically attributable to the combination across the general COPD population remains limited or inconclusive across major trials.


Understanding the Research Gaps and Uncertainty

One key limitation in the research is that comparative evidence is lacking in some areas, particularly in direct head-to-head trials against the wide array of newer therapies that have been developed. Furthermore, while the evidence contributes to understanding symptom patterns, subgroup findings are uncertain regarding the optimal use of the inhaled corticosteroid component in patients with COPD who are at lower risk for exacerbations.

Finally, many follow-up durations were limited in earlier studies, meaning there is limited information for long-term outcomes on the rate of disease progression or life-long functional decline compared to the wealth of data on short-term symptom changes. Research is ongoing to help clarify these factors.

Frequently Asked Questions (FAQ)

Common questions about Maizar (FAQ)

Q: Why does my doctor call Maizar by another name?

Maizar is a brand name for a medicine containing the active ingredients Fluticasone Propionate and Salmeterol. Official documents indicate that this combination may be marketed under different brand names depending on the country or region, such as Advair, Wixela Inhub, or Seretide. The key active components are consistent across these various authorized products.

Q: Is it necessary to avoid caffeine while using Maizar?

The Salmeterol component in Maizar is classified as a sympathomimetic agent, which can stimulate the body's cardiovascular system. Official warnings describe that combining this medicine with other substances that also affect the heart and blood pressure, such as caffeine, may increase the potential for heart rate or blood pressure changes. This information is provided to increase awareness during treatment.

Q: What happens if I accidentally take Maizar with a Long-Acting Beta₂-Agonist (LABA)?

Regulatory documents strictly advise against using Maizar concurrently with any other medicine containing a Long-Acting Beta₂-Agonist (LABA). This restriction is in place because using two LABAs can increase the risk of an overdose. An excessive amount of LABA can increase the risk of serious cardiovascular adverse effects, such as changes in heart rhythm.

Q: Are there any known issues with taking Maizar while pregnant or breastfeeding?

Official documents describe that using this medicine during pregnancy should only be considered if the potential benefit is determined to outweigh the potential risk. Similarly, for breastfeeding, use is conditional upon a risk-benefit assessment. Official information states it is unknown if the components are excreted into human milk.

Q: What official documents describe the proper disposal of unused Maizar?

Patient information instructions generally state that unused or expired medication should be discarded in accordance with guidance provided by a healthcare professional. Patients are generally advised to return the medicine to a pharmacist for appropriate disposal, which is the procedure consistent with official patient information leaflets.

Q: Is it possible for a side effect of Maizar to start happening after months of use?

Official product information indicates that certain serious adverse reactions are associated with the long-term, continued use of the inhaled corticosteroid component. These long-term effects, such as reduced bone mineral density or certain eye problems, are associated with long-term use and may develop over months or years of treatment.

Q: Does Maizar carry a boxed warning (Black Box Warning) in the US?

The US Food and Drug Administration (FDA) previously required a Boxed Warning regarding the increased risk of asthma-related death associated with Long-Acting Beta₂-Agonists (LABAs). The FDA has since removed this Boxed Warning for fixed-dose combinations that contain both an inhaled corticosteroid (ICS) and a LABA, such as Maizar.

Q: What kind of monitoring (e.g., blood work) is sometimes needed when taking Maizar?

Regulatory documents advise on monitoring for certain systemic effects, particularly with long-term use. This may include monitoring the growth velocity of pediatric patients, checking bone mineral density, and conducting eye examinations to screen for issues like glaucoma or cataracts. Healthcare providers are also advised to be alert to certain metabolic effects.

Q: What are the specific signs of an allergic reaction to Maizar?

The official label describes that signs of a severe allergic reaction, which is classified as a rare event, may include difficulties with breathing, the appearance of hives, or swelling of the face, lips, tongue, or throat. If these signs occur, professional medical attention is advised.

Q: What is the history of Maizar's approval—when did it get approved?

The fixed-dose combination of Fluticasone Propionate and Salmeterol was first approved for medical use in the United States by the FDA in the year 2000. Its approval was based on data supporting its use as a maintenance therapy for chronic respiratory conditions.

Q: How is Maizar packaged (e.g., blister pack, bottle)?

The medicine is supplied as an inhalation powder within a specific dry powder inhaler device. Each individual dose is contained within a foil strip of blisters found inside the device, which is initially sealed within a protective foil pouch.

Q: Does taking Maizar affect blood test results?

Official documents note the potential for metabolic effects associated with this medicine. These effects include the possibility of high blood sugar (hyperglycemia) or low potassium levels (hypokalemia), both of which are common measurements taken during routine blood tests.

How should Maizar be stored and disposed of?

How to Store and Dispose of Maizar

The storage and handling of Maizar (Fluticasone Propionate/Salmeterol Inhalation Powder) must strictly adhere to regulatory requirements to maintain product integrity and stability.

Storage Conditions and Stability

Maizar must be stored at Controlled Room Temperature, which is between 20°C and 25°C (68°F and 77°F). It is mandatory to store the device in a dry place, protected from direct heat and sunlight. The device must be kept in its foil pouch until first use to prevent moisture exposure, and it should never be frozen or washed.

Shelf-Life and Disposal

The medicine must be kept out of the sight and reach of children. The device has a defined shelf-life after opening and must be discarded 1 month after removal from the foil pouch or when the dose counter reads “0”, whichever occurs sooner. Unused or expired medication should be disposed of in accordance with the guidance provided by a healthcare professional.

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

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