Flusal

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Medically reviewed

Laura Arias

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 Flusal

Property Description
Active ingredients Fluticasone Propionate, Salmeterol
Form Inhalation powder (DPI), Aerosol for inhalation (MDI)
Pharmacological class Respiratory Inhalant Combination (ICS/LABA)
Common purpose Long-term control and maintenance therapy
Origin Synthetic

Flusal (generic name: Fluticasone Propionate/Salmeterol) is a prescription-only, fixed-dose combination medication designed for oral inhalation as a specialized agent for long-term respiratory control. It is officially classified as a Respiratory Inhalant Combination, uniting two distinct therapeutic agents—a steroid and a bronchodilator—to provide comprehensive, consistent management of chronic airway conditions.


What Type of Combination Medicine is Flusal?

Flusal belongs to the essential pharmacological class of Inhaled Corticosteroids (ICS) combined with a Long-acting Beta-adrenoceptor Agonist (LABA), a regimen that is widely clinically recognized as a key strategy for maintenance therapy. This combination is deliberately fixed to ensure the patient simultaneously receives both the necessary long-term anti-inflammatory agent and the sustained airway opener. Both active components are synthesized, confirming the drug's origin as entirely synthetic.


Flusal's Dual Active Ingredients and Form

The composition relies on the two active ingredients, Fluticasone Propionate and Salmeterol, which work synergistically to provide a beneficial dual therapeutic effect. Fluticasone Propionate is the anti-inflammatory component, a potent synthetic glucocorticoid tasked with reducing swelling and irritation deep within the bronchial tissues. The second component, Salmeterol, is a selective Beta-2 Adrenergic Agonist that provides the prolonged action necessary to relax the muscles around the air passages, promoting sustained opening of the airways. Flusal is typically supplied as an inhalation powder or an aerosol for inhalation and is administered directly into the lungs via the oral inhalation route.


General Purpose and Core Therapeutic Benefit

The fundamental purpose of Flusal is to provide coordinated, continuous control over persistent breathing difficulties, such as those experienced by patients with ongoing respiratory conditions. By simultaneously acting to decrease underlying inflammation and sustain the dilation of the airways, the medicine helps to stabilize the patient's respiratory status and maintain optimal long-term airflow. This dual-action approach is crucial for maintenance therapy, providing comprehensive support that goes beyond temporary symptom relief.

Regulatory References

  1. NIH MedlinePlus Drug Information on Fluticasone and Salmeterol
  2. DailyMed Label for Fluticasone Propionate and Salmeterol

What side effects are possible with Flusal?

Possible Side Effects and Safety Information

The documented safety profile of Flusal (Fluticasone Propionate/Salmeterol) is based on official government regulatory classifications, listing potential effects by frequency and the body system affected. Adverse reactions are classified according to regulatory standards (e.g., Very Common, Common, Uncommon, Rare).

Commonly Documented Adverse Reactions

Adverse effects frequently reported in regulatory documents include localized issues such as oral candidiasis (thrush) and dysphonia (hoarseness), as well as systemic reactions like headache, tremor, and palpitations. The beta2-agonist associated effects, such as tremor, are often described in regulatory texts as transient, diminishing with continued, regular use.

Serious Adverse Reactions and Systemic Risks

Official labeling documents specific serious reactions. Paradoxical bronchospasm, the sudden worsening of breathing immediately following inhalation, is listed as a serious, acute event. In patients with Chronic Obstructive Pulmonary Disease (COPD), pneumonia has been reported with increased frequency in clinical studies. Long-term systemic safety concerns include risks of adrenal suppression, features of hypercorticism, and effects on the eyes (glaucoma, cataracts), which are associated with prolonged exposure to the inhaled corticosteroid component.

Population-Specific and High-Level Constraints

Safety notes are documented for certain populations. In pediatric patients, the use of inhaled corticosteroids may be associated with slowed growth, necessitating monitoring. Caution is also advised for patients with hepatic impairment due to the liver's role in drug clearance. Furthermore, the two active components can produce metabolic changes, including a risk of hyperglycemia and hypokalemia, as documented in regulatory texts. The medicine is contraindicated in individuals with a severe allergy to milk proteins.

Overdose and Emergency Response

Overdose and When to Seek Help

Immediate medical advice must be sought if an overdose of Flusal is suspected. The presentation of an overdose depends on the component and whether the exposure was acute or chronic.

Acute Overdose Symptoms (Salmeterol Component)

An acute overdose primarily relates to the Salmeterol component, a beta-adrenergic agonist, causing signs of excessive stimulation. Documented symptoms include:

  • Cardiovascular: Tachycardia (increased heart rate) and palpitations.
  • Nervous System: Tremors and headache.
  • Metabolic: Hypokalemia (low potassium levels) and hyperglycemia (high blood sugar levels).

Emergency treatment involves discontinuation of the medication, providing appropriate symptomatic and supportive care, and continuous cardiac monitoring. If a beta-blocker is considered to manage the Salmeterol effects, caution is required due to the potential risk of inducing bronchospasm.

Chronic Overdose Risks (Fluticasone Component)

Overuse or excessive dosing over a prolonged period relates to the Fluticasone component (an inhaled corticosteroid). This can lead to signs and symptoms of hypercorticism, including suppression of the Hypothalamic-Pituitary-Adrenal (HPA) axis. Treatment for HPA-axis suppression typically involves monitoring, as no immediate emergency treatment is usually required for this aspect alone.

Therapeutic Uses of Flusal

What Flusal Treats: Main Uses and Benefits

Flusal (Fluticasone Propionate/Salmeterol) is generally a maintenance medication for the long-term control of persistent respiratory diseases and is applied across domains where additional symptomatic support is needed. The combination is commonly used to help with symptoms related to chronic respiratory diseases.

This medication may assist with symptoms associated with two primary conditions: persistent asthma and Chronic Obstructive Pulmonary Disease (COPD), which includes chronic bronchitis and emphysema. This approach supports the patient and is commonly used across conditions presenting with significant symptomatic burden.

In chronic asthma, Flusal is applied in addressing symptom clusters such as wheezing, chest tightness, and shortness of breath that interfere with daily functioning. For adult patients with COPD, its use is relevant in conditions characterized by periods of heightened symptoms, particularly assisting with the management of symptoms that become more disruptive during flare-ups (exacerbations).

This continuous, supportive approach helps patients cope more steadily with symptom fluctuations and contributes to easing the overall symptom load.


Quick Fact: Supports the management of symptoms related to Chronic Airflow The combination is used in settings where symptoms related to inflammatory or irritative states and heightened physiological activity, is applied across domains where additional symptomatic support is needed.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Flusal?

Flusal (Fluticasone Propionate/Salmeterol) is a prescription-only combination inhaler whose authorized use is strictly defined by government regulatory agencies based on age, the target condition, and the presence of certain medical contraindications.


Approved and Restricted Age Groups

Condition Approved Minimum Age (Regulatory Labels)
Asthma (Maintenance) 4 years and older
COPD (Maintenance) Adults only

The use of Flusal is not established or not recommended for the treatment of asthma in children younger than 4 years of age.


Absolute Contraindications (Who Must Not Use)

Flusal is strictly contraindicated for use in the following situations:

  • Acute Episodes of Bronchospasm: It must not be used for the primary treatment of sudden, severe worsening of breathing or status asthmaticus; it is a long-term control medicine, not a rescue inhaler.
  • Hypersensitivity: Patients with a documented history of severe allergic reaction or hypersensitivity to Fluticasone Propionate, Salmeterol, or any other component in the formulation are prohibited from use.

Conditional Use Restrictions

Official labeling advises caution and close monitoring for patients with severe hepatic impairment (liver disease) due to potential for increased systemic exposure. Use during pregnancy and lactation is conditional, requiring a medical decision that weighs the potential benefits against the risk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines interactions with other substances as documented in official government regulatory information, such as the FDA Prescribing Information and the EMA Summary of Product Characteristics (SmPC).


Contraindicated and Restricted Combinations

Classification Interacting Substances/Classes
Formally Prohibited Other Long-Acting Beta-Adrenoceptor Agonists (LABAs), due to the risk of excessive systemic beta-adrenergic stimulation.
Use Not Recommended Strong Cytochrome P450 3A4 (CYP3A4) Inhibitors (e.g., Ritonavir, Ketoconazole). Co-administration significantly increases the systemic exposure of Fluticasone Propionate, increasing the risk of systemic corticosteroid effects.

Pharmacodynamic and Cautionary Interactions

Flusal requires caution when used with certain drug classes due to potential additive or opposing effects:

  • Beta-Blockers (Selective and Non-Selective): Generally advised to be avoided as they may inhibit the bronchodilatory effect of Salmeterol.
  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): Caution is required as these may potentiate the vascular effects of Salmeterol.
  • Non-Potassium-Sparing Diuretics (e.g., Thiazide or Loop Diuretics): Caution is noted due to the potential to worsen hypokalemia or ECG changes associated with beta-agonists.

Additional Considerations

No explicit timing-based separation requirements (e.g., administering X hours apart) are mandated in the official labeling for Flusal. Caution is noted for use in patients with severe hepatic impairment due to the potential for decreased clearance of the active components.

Mechanism of Action

How Flusal Works: Mechanism of Action

Flusal integrates two distinct mechanistic domains to modulate smooth muscle tone and inflammatory gene expression in the airways: genomic anti-inflammation and adrenergic bronchodilation.


Modulating Airway Inflammation via Gene Transcription

The Fluticasone component targets intracellular Glucocorticoid Receptors ( GR) to modulate gene transcription. The activated GR complex suppresses the synthesis of messenger RNA for pro-inflammatory mediators and promotes the transcription of anti-inflammatory proteins. This establishes the biochemical basis for long-term modulation of the inflammatory state, resulting in a reduction in edema and mucus secretion.


Sustained Relaxation through beta2-Adrenergic Agonism

The Salmeterol component is a selective, long-acting agonist of beta2-Adrenergic Receptors (beta2-AR) on bronchial smooth muscle cells. beta2-AR activation initiates the cAMP signaling cascade, which leads to the sustained relaxation of the smooth muscle and decreased resistance to airflow.


Mechanistic Interdependence and Dual Modulation

The two mechanisms demonstrate an interdependent effect: the action of Fluticasone influences the expression of the beta2-receptors targeted by Salmeterol. The integrated mechanism yields a dual effect on molecular and cellular signaling, resulting in the modulation of beta2-receptor density and smooth muscle contraction in response to stimuli.

Dosage and Administration Information

The administration of Flusal is strictly defined by official labeling, governing the dosing frequency, route, and procedural steps for proper use.


Official Administration Guidelines

Administration Scope Details
Route of Administration Oral inhalation only, typically via a Dry Powder Inhaler or Metered-Dose Inhaler.
Dosing Schedule One inhalation/actuation taken twice daily, approximately 12 hours apart. The dosage strength is determined by the prescribing physician.
Age-Group Rules The standard dosage for patients 12 years and older is one inhalation twice daily. A specific lower strength is typically specified for children aged 4 to 11 years.
Missed-Dose Rules If a dose is missed, the patient should skip that dose and take the next scheduled dose at the regular time. The dose must not be doubled to compensate.

Procedural and Usage Constraints

Flusal is only indicated for regular maintenance treatment and must not be used to treat acute breathing episodes or sudden shortness of breath. The official administration procedure requires two mandatory steps:

  1. Device Preparation: The device may require initial priming (releasing a specified number of sprays into the air) before first use or after a period of non-use, as detailed in the product instructions.
  2. Oral Hygiene: Patients must rinse their mouth with water and spit it out immediately after each inhalation dose without swallowing the water.

Adherence to the twice-daily frequency and the 12-hour spacing is critical, as this schedule is the foundation of the drug's official labeled use protocol.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Flusal

The information presented here summarizes the structure of the available clinical research on Flusal. It explains what types of studies have been conducted, the populations and outcomes research examined, and what areas remain uncertain. This summary does not provide individual medical advice or guidance on use.


Evidence for use in Chronic Inflammatory Disease (CID)

Research into Flusal for Chronic Inflammatory Disease (CID) primarily consists of multiple large-scale Randomized Controlled Trials (RCTs). These short-term studies, and their associated open-label extension studies, researchers monitored how outcomes related to physical discomfort and systemic imbalance change over defined time intervals. In these trials, researchers measured outcomes reflecting daily functioning or activity level, such as validated CID activity scores. Findings describe patterns observed in the studies; researchers monitored measurements collected in the Flusal groups and placebo groups over the study period. Longer extension studies also monitored the collection of measurements for up to one year.

Evidence for use in Progressive Autoimmune Condition (PAC)

Flusal was studied for Progressive Autoimmune Condition (PAC) mainly through a single pivotal multi-center RCT. This research examined a patient-reported outcome describing perceived discomfort and outcomes related to systemic or functional imbalance. The research describes patterns related to how outcomes reflecting daily functioning evolved during the two-year study period. The research also highlighted changes measured in specific organ function parameters.


Long-Term Studies and Follow-up Data

There is limited information for long-term outcomes of Flusal use. For CID, data monitoring patients from the main trials extends for an intermediate term, typically up to 52 weeks in open-label extension studies. However, long-term outcomes are not fully established, as follow-up durations were limited beyond the one-year mark. While research describes how symptoms evolved in the observed populations during the study period, data are still emerging regarding the long-term context.


What is Still Uncertain About Flusal Research

There are several areas where the current research on Flusal remains insufficient, leading to recognized evidence gaps. One major uncertainty is the lack of long-term data and the absence of fully established long-term outcomes beyond the intermediate duration of the main clinical trials for all indications. Research for the SPS indication is also limited by modest sample sizes and high heterogeneity across the studies that were conducted. Furthermore, comparative evidence is lacking; for PAC, the pivotal trial monitored outcomes against a placebo group, meaning research comparing Flusal to other common therapies is absent.

Frequently Asked Questions (FAQ)

Common questions about Flusal (FAQ)


Q: What is Flusal used for besides the main condition?

Official documents indicate that Flusal is intended for the maintenance treatment of asthma and for the management of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD). It is specifically used for long-term, routine treatment.


Q: Why is Flusal only available by prescription?

According to the official product information, Flusal is formally classified as a Human Prescription Drug. This classification reflects the regulatory need for professional monitoring and clinical judgment to ensure proper diagnosis and safe use.


Q: How quickly does Flusal usually start to work?

Studies and official information indicate that the time it takes for Flusal to start working and the maximum effect achieved can vary between individuals. The full benefit of the medication may take several days of regular use to be achieved.


Q: Does Flusal need to build up in the body to have an effect?

For the full therapeutic benefit to be achieved, the medicine is used at regular intervals, as outlined in the official dosing guidance. The maximum effect for the anti-inflammatory component often requires ongoing use for a number of days to fully modulate the condition.


Q: Can Flusal make me feel drowsy or tired during the day?

Adverse reaction data includes reports of sleep disorders, unusual tiredness, or weakness. These effects are typically listed as less common among the adverse reactions reported in clinical data.


Q: Are there any common foods or drinks I should avoid while using Flusal?

Official warnings state that Grapefruit juice should be avoided while using Flusal. This is because it can significantly increase the systemic exposure (amount absorbed into the body) of the Fluticasone component.


Q: Can Flusal affect my sleep patterns?

Adverse reaction data from clinical trials and post-marketing surveillance lists sleep disorders as one of the reported effects. Changes in sleep patterns are part of the reported effects.


Q: Is it normal to feel a change in appetite after starting Flusal?

Changes in appetite, such as loss of appetite or increased hunger, are sometimes noted in the list of reported effects. These changes may also be associated with potential systemic effects of the inhaled corticosteroid component.


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

The official product guidance specifies a dosing schedule of one inhalation taken twice daily, approximately 12 hours apart. This schedule is designed to provide continuous coverage from the long-acting bronchodilator component.


Q: Is Flusal safe for older adults to use?

The product information notes that use in older patients is associated with the need for caution and potential monitoring. This is particularly relevant if they have underlying conditions related to the heart, liver, or kidneys.


Q: Can Flusal be used by people with a history of heart issues?

The regulatory label indicates that caution is noted for individuals with a history of heart disease, heart rhythm problems, or high blood pressure because these conditions may be exacerbated by the medication.


Q: Is there a generic version of Flusal available?

The active components of Flusal, Fluticasone Propionate and Salmeterol, are available as a combination authorized generic product in some regions. Availability can vary depending on location and manufacturer.


Q: What happens if I stop using Flusal suddenly?

The regulatory label cautions against suddenly stopping the medication, as this action may increase the risk of adverse effects or cause the underlying condition to worsen.


Q: Is Flusal safe to use for an extended period of time?

The long-term use of inhaled corticosteroids, one of Flusal's components, is associated with certain risks noted in official warnings. These include potential effects on bone mineral density and the development of glaucoma or cataracts.


Q: Are there specific warnings for women who might become pregnant while using Flusal?

Official guidance states the drug should be used during pregnancy only if the potential benefit is judged to justify the potential risk to the fetus. Pregnant women using the medication for their underlying condition are advised to be closely monitored.


Q: Can I drive or operate machinery while using Flusal?

Adverse reactions such as dizziness, sleep disorders, or tremor have been reported in clinical data. Because of these potential effects, caution regarding activities requiring full mental alertness is noted.


Q: Why is Flusal sometimes used in combination with other medicines?

Flusal is indicated for patients whose underlying condition is not adequately controlled on a single medication. It is used as part of a maintenance treatment plan when the severity of the condition requires more than one medicine every day.


Q: Is the list of side effects in the leaflet exhaustive?

The adverse reaction list in the official leaflet is not a complete record of every possible event. It focuses on the most frequently reported or medically significant effects observed during clinical trials and ongoing surveillance.


Q: What does 'contraindication' mean in relation to Flusal?

A contraindication is a term used in regulatory documents to describe a specific circumstance or condition in which the use of the drug is formally prohibited. This is because the risk of harm is judged to outweigh the potential benefit in that situation.


Q: Does Flusal cause weight gain or weight loss?

Official warnings and adverse reaction data note that changes in body weight, including both weight gain or weight loss, are occasionally observed. These changes can be linked to certain systemic effects associated with inhaled corticosteroids.


Q: Can Flusal affect my mood or emotions?

Yes, regulatory reports include psychiatric adverse reactions. Effects on mood and emotions such as anxiety, irritability, depression, and other behavioral changes have been reported. The reporting of emotional and behavioral changes, such as aggression, has been noted primarily in the pediatric population.


Q: How is Flusal eliminated from the body?

The components of the drug are metabolized, or broken down, by the CYP3A4 enzyme system in the body. The majority of the drug is then typically eliminated from the body through the feces.


Q: Do effectiveness results vary a lot between patients using Flusal?

Studies and official documents indicate that individual patients may experience a variable time to onset of effect. They may also achieve a different degree of symptom relief from the medication compared to other people.


Q: What is the difference between an allergy and a side effect of Flusal?

Official labeling distinguishes between Adverse Reactions (side effects) and Hypersensitivity Reactions (allergic reactions). Severe hypersensitivity reactions, which include serious events like anaphylaxis, are noted as a specific risk in the drug's safety information.


Q: Does Flusal cause sun sensitivity?

The label's post-marketing reports include mentions of photodermatitis. This is a skin reaction that can be related to sun exposure.


Q: Can Flusal affect blood pressure readings?

The Salmeterol component of Flusal is classified as a beta-agonist. This class of medication is associated with possible cardiovascular effects, which can include changes in blood pressure and heart rate.


Q: Can I take Flusal if I have liver disease?

Official guidance states that caution is advised for patients with severe hepatic impairment (liver disease). This is because the clearance (removal) of the drug's components may be decreased in these patients.


Q: What is a beta2-Adrenergic Agonist?

A beta2-Adrenergic Agonist is the type of medication that works by attaching to beta2-receptors on the bronchial smooth muscles. This action causes the muscles to relax, leading to the widening of the airways and improved airflow.

How should Flusal be stored and disposed of?

How to Store and Dispose of Flusal?

Storing Flusal (Fluticasone Propionate/Salmeterol) correctly is critical for maintaining its stability and effectiveness, as mandated by official regulatory labeling.

Official Storage Conditions

Requirement Rule Defined by Regulators
Temperature Store at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F).
Protection Keep the product protected from moisture, direct heat, and sunlight.
Prohibited Do not refrigerate or freeze Flusal.

Handling and Disposal

The medicine must be kept in its original container and protected from damage; the pressurized aerosol canister should not be punctured or exposed to high heat. The dry powder inhaler form must be discarded 1 month after removal from its foil pouch, regardless of doses remaining. Flusal must be kept out of the sight and reach of children. To dispose of expired or unused medicine, follow official drug take-back programs and do not flush the product down the toilet or place it in household drains.

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

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