Flosal

Quick links to important sections

Flosal

Treatment option:

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 Flosal

Property Description
Active Ingredients Fluticasone Propionate and Salmeterol Xinafoate
Form Dry Powder Inhaler (DPI) or Metered-Dose Inhaler (MDI)
Pharmacological Class Inhaled Corticosteroid (ICS) / Long-Acting Beta2-Agonist (LABA) Combination
Route of Administration Inhalation (Pulmonary delivery)
Origin Synthetic

Flosal is a fixed-dose combination (FDC) respiratory medicine that pairs two distinct synthetic active ingredients: the corticosteroid Fluticasone Propionate and the bronchodilator Salmeterol Xinafoate. This pairing ensures that both anti-inflammatory and airway-opening actions are delivered simultaneously in a single device, such as a DPI or MDI, via inhalation. The medicine belongs to the ICS/LABA Combination class, a formulation clinically recognized for providing more comprehensive respiratory management than either monotherapy alone. While Flosal is a specific brand name, the same foundational combination of Fluticasone and Salmeterol is globally available under other recognized brand names, illustrating its widespread clinical acceptance.


The Dual Composition and Its Purpose

The composition ensures that two foundational elements of chronic respiratory support are addressed. Fluticasone Propionate functions as a potent anti-inflammatory agent, reducing sensitivity and swelling in the airways. Concurrently, Salmeterol Xinafoate provides sustained bronchodilation by relaxing the smooth muscles surrounding the air passages. The general therapeutic purpose of this dual composition is to ensure consistent, foundational support by simultaneously addressing both chronic irritation and muscle constriction, a key aspect of maintenance therapy. The combination yields a synergistic benefit, enhancing the overall stability and openness of the lungs beyond what either component could achieve alone, positioning this FDC as an essential tool for providing consistent, everyday respiratory support.

What side effects are possible with Flosal?

Possible Side Effects and Safety Information

The official safety profile for Flosal (Fluticasone Propionate/Salmeterol Xinafoate) is defined by government regulatory documents, which classify potential adverse reactions based on their frequency and the body system affected.


Adverse Reaction Scope

Classification Examples of Documented Adverse Reactions
Common Headache, oral candidiasis (thrush), dysphonia (hoarseness/voice changes), pharyngitis, and upper respiratory tract infections.
Uncommon Tremor, palpitations, anxiety, tachycardia, and muscle cramps.

Serious adverse reactions are specifically documented in regulatory labels. These include the potential for paradoxical bronchospasm—an immediate, severe tightening of the airways—and severe immediate hypersensitivity reactions (e.g., swelling, rash). The risk of pneumonia is also noted, particularly in certain patient populations. Systemic effects of the corticosteroid component may lead to adrenal suppression or signs of hypercorticism with prolonged exposure.


Safety Considerations

Category Regulatory Safety Note
Exposure-Related Long-term use is associated with risks such as the development of glaucoma and cataracts.
Population-Specific Pediatric patients require monitoring for possible effects on growth. Hepatic impairment may increase the risk of systemic side effects due to slower clearance.
Restrictions Contraindicated in individuals with a known hypersensitivity to any component. Concomitant use with strong CYP3A4 inhibitors is generally not recommended due to increased systemic exposure.

This structured safety information ensures that all officially documented risks, from common local effects to serious systemic and long-term consequences, are communicated clearly and neutrally, without providing clinical advice or therapeutic claims.

Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Flosal, a combination of Fluticasone Propionate and Salmeterol Xinafoate, is defined by the acute and chronic risks associated with its two components, as documented in regulatory sources.

Acute overdose is primarily associated with beta-adrenergic overstimulation from the Salmeterol component. Documented manifestations include tachycardia (fast heart rate), palpitations, tremor, nervousness, and chest pain. Regulator-listed physiological findings include hypokalemia (low potassium) and hyperglycemia (high blood sugar). Chronic overdose, resulting from prolonged high-dose exposure, may lead to official manifestations of hypercorticism or adrenal suppression.

Severe outcomes documented in regulatory sources include cardiac arrhythmias, seizures, and paradoxical bronchospasm. Due to the potential for these life-threatening events, immediate medical attention or contact with a poison control center is required for any suspected overdose. Emergency services must be contacted at once if the person is collapsed, has trouble breathing, or cannot be awakened.

No specific antidote is known for this overdose. Management consists of symptomatic and supportive treatment, with required clinical actions focusing on cardiac monitoring and electrolyte monitoring to manage documented complications. Individuals with hepatic impairment should be monitored closely due to the drug's metabolism.

Therapeutic Uses of Flosal

What Flosal Treats: Main Uses and Benefits

This product is commonly used to address active, localized bleeding that occurs during a surgical procedure. The primary therapeutic domain is supporting hemostasis in situations involving certain distressing symptoms (blood loss). Flosal may be part of symptomatic management when additional support is needed alongside standard surgical methods.

Flosal may assist with achieving control over the blood loss in scenarios involving various types of surgery, including cardiovascular, abdominal, and gynecological procedures. This is relevant for managing symptoms that create noticeable physiological strain during surgical procedures, which are conditions characterized by periods of heightened physiological stress.

In practical terms, its use supports the management of the surgical site and provides supportive relief during these acute episodes.


Quick Fact: Relief for Active Bleeding

This product is relevant when short-term symptomatic assistance is needed to control localized blood flow during an operation.

Regulatory References

  1. FDA Instructions for Use

Eligibility and Restrictions for Use

Who Can and Cannot Use Flosal?

The eligibility for using Flosal (Fluticasone Propionate and Salmeterol combination for inhalation) is determined by strict official regulatory criteria, focusing only on population suitability and absolute exclusions.

Contraindicated Populations

Flosal is contraindicated and must not be used by patients with a known hypersensitivity to any component, including Fluticasone, Salmeterol, or potential milk protein allergy in dry powder formulations. Use is also contraindicated during acute episodes of bronchospasm (such as status asthmaticus) and in patients currently receiving another Long-Acting Beta2-Agonist (LABA).

Age and Comorbidity Restrictions

The medicine is generally allowed for asthma treatment in adults and adolescents aged 12 years and older, and in children 4 years and older. Safety and efficacy are not established in children under 4 years of age.

Caution is advised for populations with pre-existing conditions, including severe cardiovascular disease, certain infectious diseases (e.g., active tuberculosis), thyrotoxicosis, or diabetes mellitus.

Special Eligibility Status

Use during pregnancy and lactation is conditional; it is only considered if the potential benefit outweighs the potential risk. No dosage adjustment is typically required for patients with renal impairment, though caution is advised for those with hepatic impairment.

What should I know about interactions with other medicines?

Flosal Interactions with other medicines and products

The official interaction profile for Flosal (Fluticasone Propionate/Salmeterol Xinafoate) is defined by constraints related to drug metabolism and additive pharmacological effects, as documented in government regulatory sources.

Metabolic Pathway Restriction A significant pharmacokinetic interaction involves the Cytochrome P450 3A4 (CYP3A4) enzyme. Potent inhibitors of this pathway, such as Ritonavir and Ketoconazole, are strongly restricted or prohibited for co-administration. These substances inhibit the clearance of Fluticasone Propionate and, to a lesser extent, Salmeterol, resulting in a substantial and officially documented increase in the plasma concentration and systemic exposure of both active ingredients. Caution is also noted for patients with severe liver dysfunction as decreased clearance from the disease itself may similarly increase exposure.

Pharmacodynamic Restrictions Co-administration with other Long-Acting Beta2-Agonists (LABAs) is formally prohibited in labeling due to the risk of additive bronchodilatory effects. Furthermore, caution is mandated when using Non-selective Beta-Blockers, as they may counteract the intended effects of Salmeterol. Caution is also required with medications that affect the cardiovascular system or electrolytes, including Monoamine Oxidase Inhibitors (MAOIs), Tricyclic Antidepressants (TCAs), and Non-Potassium-Sparing Diuretics, due to documented risks of vascular system potentiation or hypokalemia. Certain food substances, like Grapefruit Juice, are noted as potentially interacting through the same CYP3A4 pathway.

Mechanism of Action

Flosal exerts its effects via two primary domains: mechanical stabilization and acceleration of the coagulation sequence.


Direct Surface Tamponade

This mechanistic domain involves the physical properties of the gelatin matrix. The spherical gelatin granules quickly swell upon contact with blood or other fluids at the application site. This swelling forms a mechanically stable matrix that restricts fluid flow and physically exerts a localized compressive force. This action initiates a physical impedance to vessel outflow.


Coagulation Cascade Engagement

This domain focuses on the biochemical signaling sequence necessary for fibrin polymerization. The Flosal product contains a high concentration of Thrombin, a key serine protease in the final stages of the common coagulation pathway. This high concentration of Thrombin is rapidly available to interact with the patient's circulating fibrinogen in the blood. This enzyme-substrate interaction catalyzes the cleavage of fibrinogen, leading to the prompt formation of a mechanically stable fibrin clot directly at the site of application.

Dosage and Administration Information

How to Use Flosal: Official Administration Guidelines

Flosal (Fluticasone Propionate/Salmeterol) is administered exclusively via Oral Inhalation for pulmonary delivery, as specified in prescribing information. It is designated for long-term maintenance treatment and is strictly prohibited for use in providing immediate relief for acute breathing difficulties or bronchospasm.


Dosing and Schedule

Administration is required twice daily (BID), with doses taken approximately 12 hours apart. The dosage strength varies based on the indication and device used (Dry Powder Inhaler or Metered-Dose Inhaler). For adult Chronic Obstructive Pulmonary Disease (COPD), the standardized dose is one inhalation of the 250/50 mcg strength DPI twice daily.

Population & Indication Standard Regimen (Twice Daily)
Adult COPD One inhalation of 250/50 mcg DPI
Pediatric Asthma (4–11 yrs) One inhalation of 100/50 mcg DPI

Procedural Requirements

After each administration, the user must rinse their mouth with water and spit it out; swallowing the water is not advised. If using a Metered-Dose Inhaler, the device requires priming (test sprays) before initial use. Guidance specifies that if a dose is missed, the user should skip the missed dose and take the next scheduled dose at the usual time; doubling the dose is explicitly forbidden. The prescribed dose should not be exceeded under any circumstances.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Flosal

This summary outlines the types of official research conducted on Flosal (a gelatin/thrombin matrix) as an adjunctive agent studied in contexts of localized bleeding during surgery. The findings describe group patterns observed in studies and do not provide individual predictions or medical advice.


Evidence for Adjunctive Hemostasis in Cardiovascular Surgery

Research examined the use of Flosal in adult patients undergoing complex operations, such as elective heart and major vascular surgery. The primary evidence for this application comes from Randomized Controlled Trials (RCTs). These trials were studied for acute outcomes related to bleeding control, such as the rate of achieving hemostasis and the precise time-to-hemostasis within a few minutes of application. Research also monitored outcomes related to blood loss, such as the need for blood transfusions.

Evidence for Adjunctive Hemostasis in Spine and Joint Surgery

Research exploring the use of Flosal during spinal procedures mainly relies on Retrospective Observational Studies, which reviewed records to examine blood loss and operative times. For total joint replacement (like knee arthroplasty), the evidence includes RCTs and systematic reviews that monitored the total calculated blood loss and the rate of allogeneic blood transfusion.

Durability and Research Gaps

Clinical trials typically monitored patient outcomes for a short duration, primarily focusing on the immediate postoperative period. Data show patterns related to resource utilization, but long-term effects are not fully established because the primary efficacy endpoints are achieved and measured during the acute surgical phase. The evidence quality varies across surgical areas, and data for certain groups, such as children, remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Flosal (FAQ)

Q: Are the common side effects of Flosal serious?

Official regulatory documents list common side effects, such as headache or upper respiratory infections, which are generally manageable. However, the official warnings also document serious adverse effects, including fast or irregular heartbeat, chest pain, and severe allergic reactions. If a patient experiences any of the documented serious symptoms, it is advised to seek medical attention immediately.

Q: How does the way Flosal works differ from older treatments?

Flosal is a combination medication that addresses two key aspects of chronic respiratory conditions simultaneously. It combines a corticosteroid component to reduce airway swelling and inflammation, and a long-acting beta-agonist to help relax and open the air passages. This dual approach provides foundational support for consistent maintenance treatment.

Q: Does Flosal require a special diet?

Official drug information indicates that patients should generally continue their normal diet while taking Flosal, unless they have been given specific instructions. The product label notes a potential interaction with Grapefruit Juice, but does not mandate a special diet.

Q: How long can someone safely take Flosal?

Flosal is officially designated for twice-daily maintenance treatment of asthma and COPD. Official guidance indicates that for asthma, treatment duration is often adjusted to the shortest period necessary to maintain control. Continuation of maintenance treatment is generally managed in consultation with a healthcare provider.

Q: Do many people experience allergic reactions to Flosal?

Official regulatory information documents the possibility of immediate hypersensitivity reactions, such as severe rash or swelling, which would require the medication to be discontinued. This medication is formally contraindicated for use in patients with a known hypersensitivity to any of its components. If such a reaction occurs, it is advised to seek medical attention immediately.

Q: Is Flosal considered safe for long-term use?

Flosal is prescribed for long-term maintenance treatment of chronic respiratory conditions. However, the official labels for all inhaled corticosteroids, like the one in Flosal, note that prolonged use may be associated with systemic side effects. These risks include a potential decrease in bone mineral density or the development of cataracts or glaucoma.

Q: What happens if I take Flosal near the time I take my blood pressure medicine?

The label indicates a potential for interaction with certain cardiovascular medications. The medication can interact with non-potassium-sparing diuretics (water pills) and non-selective beta-blockers, which are commonly used for blood pressure, due to the potential for additive effects on the cardiovascular system or electrolyte levels.

Q: What should I do if a specific side effect listed for Flosal occurs?

Official regulatory documents identify specific symptoms that are classified as serious, such as sudden breathing difficulty, chest pain, or a severe allergic reaction. Official regulatory documents advise consulting a healthcare provider immediately if serious symptoms occur.

Q: How is the effectiveness of Flosal usually measured in clinical trials?

Official documentation of clinical trials indicates that the effectiveness of Flosal is typically measured by observed improvements in lung function, such as FEV1 (forced expiratory volume in one second). Researchers also monitor for a reduction in the number of asthma or COPD exacerbations (worsening of symptoms).

Q: Are there any specific lifestyle changes that are often recommended while taking Flosal?

The most critical procedural requirement noted in the product information is that patients are instructed to rinse their mouth with water and spit it out after each use. This step is recommended to help reduce the risk of a local infection in the mouth or throat (thrush) caused by the corticosteroid component.

Q: How quickly does Flosal start working?

Official product information notes that some patients may observe an improvement in asthma control within 30 minutes of starting treatment. However, it is also noted that the maximum therapeutic benefit may take one week or longer to be fully achieved.

Q: What kind of stomach issues are linked to taking Flosal?

Official drug information lists specific gastrointestinal complaints as reported side effects. These include the occurrence of nausea and heartburn.

Q: Is it common to feel tired when starting Flosal?

While fatigue or tiredness is not typically listed as a common side effect in the official adverse reaction table, symptoms of hormonal suppression related to the corticosteroid component may occasionally be associated with low energy. This is not a frequently reported adverse reaction.

Q: Can Flosal cause changes in weight?

Weight changes are generally not noted as a common side effect for the inhaled combination drug. However, the systemic effects of the corticosteroid component, especially with very high doses or prolonged exposure, can rarely lead to symptoms that may include weight gain.

Q: Can I take Flosal if I also take a vitamin supplement?

Official regulatory guidance emphasizes informing a healthcare provider about all substances being taken. This includes all prescription and non-prescription medicines, as well as any vitamins, nutritional supplements, and herbal products.

Q: What happens if Flosal is taken with alcohol?

Flosal does not have a formal interaction noted with alcohol in its official label. However, as with many medications, consuming alcohol may enhance or worsen potential common side effects such as headache, nausea, or dizziness.

Q: Is it okay to drive after taking Flosal?

The official warnings indicate that Flosal can cause side effects such as dizziness, lightheadedness, and tremors. It is recommended that individuals understand how they react to this medication before performing tasks like driving or operating heavy machinery.

Q: Can Flosal be used by older adults?

Flosal is indicated for the treatment of asthma and COPD in adults, which includes older adults. Official labels advise that all adults with risk factors should be monitored for potential long-term effects, such as decreases in bone mineral density.

Q: Is Flosal known to cause interactions with caffeine?

Regulatory-sourced interaction databases indicate a moderate potential for interaction with caffeine. This is because both caffeine and the salmeterol component of Flosal can increase blood pressure and heart rate, which may enhance these effects.

Q: Can I stop taking Flosal suddenly?

Official product information cautions against stopping the medication abruptly without consultation. Abrupt discontinuation, particularly for patients with COPD, may be associated with a sudden or symptomatic worsening of their condition.

Q: Can Flosal affect my ability to sleep?

Official regulatory documents list the occurrence of difficulty falling asleep or staying asleep, generally described as a sleep disorder, as a less common reported side effect of the medication.

Q: Is Flosal a controlled substance?

Official classification sources indicate that Flosal (Fluticasone Propionate/Salmeterol) is not classified as a controlled substance by regulatory authorities.

Q: Is it possible for Flosal to stop working over time?

Official warnings advise that if a patient experiences a sudden or progressive loss of control over their respiratory condition, it may signal that their current treatment is no longer adequate. If this deterioration occurs, it is advised to seek prompt consultation with a physician.

Q: Are there any common reasons why Flosal might be discontinued by a patient?

Regulatory documentation indicates that the medication may be discontinued and alternative therapy instituted if a patient experiences paradoxical bronchospasm, which is a severe and immediate tightening of the airways immediately following use. Severe allergic reactions are another official reason for immediate cessation.

Q: Does Flosal have any known effects on mood?

Systemic effects of inhaled corticosteroids may be associated with behavioral changes, including irritability, particularly in children. The salmeterol component may also cause nervousness. Changes in mood should be monitored and discussed with a healthcare provider.

Q: Can I take Flosal with herbal products like St. John's Wort?

Official regulatory guidance emphasizes informing a healthcare provider about all products being used, including herbal products and nutritional supplements. This allows for proper evaluation of the risk of potential interactions.

Q: What is the purpose of the black box warning on Flosal (if applicable)?

The combination product previously carried a Boxed Warning concerning an increased risk of asthma-related death associated with the long-acting beta-agonist component, Salmeterol. However, the FDA has since removed this warning for the combination product after studies indicated that the risk was not increased when Salmeterol was used in fixed combination with an inhaled corticosteroid.

Q: Does Flosal cause dizziness or lightheadedness?

Yes, official drug information lists dizziness as a potential common side effect of the medication. The possibility of experiencing this side effect should be kept in mind when engaging in activities requiring concentration.

Q: How long before an operation should Flosal generally be stopped?

Official product information emphasizes informing the treating doctor or dentist about current or recent corticosteroid use before having surgery. The official product information does not specify a fixed pre-operative stopping time for the inhaled corticosteroid component.

Q: Is Flosal a habit-forming drug?

No, official classification sources indicate that Flosal (Fluticasone Propionate/Salmeterol) is not classified as a controlled medication and is not considered a habit-forming drug by regulatory bodies.

How should Flosal be stored and disposed of?

How to Store and Dispose of Flosal?

Flosal (Fluticasone Propionate/Salmeterol Inhaler) must be stored according to specific regulatory requirements to maintain product stability and safety. The product should be kept at Controlled Room Temperature, typically between 20 C and 25 C (68 F and 77 F), and must be protected from freezing and excessive heat.

Storage Constraint Requirement
Environmental Protect from moisture and excessive heat; do not freeze.
Packaging Keep in the original container and close the device tightly when not in use.
Stability For the Dry Powder Inhaler (DPI), discard 1 month after removing from the foil pouch.
Child Safety Keep out of the reach and sight of children.

Expired or unused medicine must not be thrown into the household trash or down the drain. Disposal must follow local regulations or drug take-back programs. The Metered-Dose Inhaler (MDI) canister should not be punctured or incinerated due to pressurized contents.

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

Equivalent of Flosal found in:

A-Z Index: