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Назарел

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Назарел

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Treatment option: Fever, Rhinitis, Hay Fever

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.

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Overview of Назарел

Property Description
Active ingredient Fluticasone Propionate
Form Aqueous Suspension Nasal Spray
Pharmacological class Synthetic Glucocorticosteroid (GCS)
Common use Relief of allergic and nonallergic rhinitis symptoms
Origin Synthetic (Fluorinated steroid derivative)

Definition and Pharmacological Classification

Назарел is a specialized medication intended for local use via the nasal passages, categorized as a potent, synthetic glucocorticosteroid preparation, a classification widely recognized in clinical practice. The single active ingredient is Fluticasone Propionate, which is structurally a fluorinated steroid derivative, confirming its synthetic origin. This core chemical identity places the drug within a class of agents designed for powerful, targeted anti-inflammatory activity. The Назарел brand is generally positioned for both adults and children from a specific age group, underscoring its broad application for patients needing topically focused inflammation control.

Composition, Form, and General Therapeutic Purpose

The medication is supplied as an aqueous suspension nasal spray, a dosage form carefully engineered to ensure the Fluticasone Propionate is evenly dispersed and delivered directly to the nasal mucosa via the intranasal route of administration. Intranasal fluticasone propionate exhibits low systemic absorption and high topical potency. This characteristic is crucial, as it allows the medication to concentrate its anti-inflammatory effects where they are needed most, aligning with its general therapeutic purpose: to provide substantial relief from symptoms caused by chronic inflammation and allergic processes. This class of medication works by blocking the release of multiple natural substances that cause allergy symptoms.

Core Mechanism Summary

The primary mechanism principle of the active ingredient is to exert a powerful local anti-inflammatory effect directly on the cells lining the nasal passages. This local action involves targeted immunosuppression that stabilizes the nasal tissues and suppresses the entire biochemical cascade that fuels the inflammatory cycle. Fluticasone Propionate is specifically noted for its high receptor affinity, a characteristic that supports its clinical recognition for consistent efficacy in dampening the chronic irritation and swelling that drives patient discomfort.

Regulatory References

  1. Allergic reactions: MedlinePlus
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What side effects are possible with Назарел?

Possible side effects and safety information

The safety profile for Fluticasone Propionate nasal spray is documented in regulatory sources based on observed adverse reactions categorized by frequency and system-organ class. Most documented effects are local and generally expected given the route of administration, while systemic effects associated with glucocorticosteroids are classified as rare or very rare.

Adverse Reactions by Frequency

Official regulatory documents classify adverse reactions based on how often they have been reported:

  • Very Common: Epistaxis (nosebleeds).
  • Common: Headache, nasal dryness, nasal irritation, throat dryness, throat irritation, and alterations in taste or smell (dysgeusia/parosmia).
  • Very Rare: Hypersensitivity reactions, including bronchospasm, anaphylactic reactions, and angioedema. Very rare effects also include ocular concerns such as glaucoma and cataracts, and systemic effects like adrenal suppression or Cushing's syndrome.

Clinically Significant Safety Considerations

Serious adverse reactions documented in regulatory documents include nasal septal perforation and the development of cataracts or glaucoma, primarily identified from post-marketing reports following prolonged treatment. Systemic effects such as adrenal suppression and growth retardation in children are also categorized as very rare but known risks.

Usage restrictions are also documented. For instance, use should be deferred until healing is complete in individuals with recent nasal trauma, nasal surgery, or nasal ulcers. Caution is necessary when co-administering the medication with strong inhibitors of Cytochrome P450 3A4, as this may increase systemic exposure and the potential for corticosteroid adverse effects.

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Overdose and Emergency Response

Overdose and When to Seek Help

Назарел (which contains fluticasone propionate) is a nasal corticosteroid with a very low amount of the medication absorbed into the body when used correctly. Consequently, a single, acute overdose following accidental ingestion or excessive use of the nasal spray is generally not expected to cause life-threatening symptoms.

However, the primary concern is the potential for systemic corticosteroid effects resulting from chronic use at doses higher than recommended or prolonged use over many months. This overuse can lead to a condition known as hypercorticism or, less commonly, adrenal suppression, where the body's natural production of cortisol is affected.

Seek immediate medical attention for the following serious symptoms, as they may indicate a severe reaction or require emergency management:

Symptom Category Manifestations Requiring Urgent Help
Allergic/Systemic Swelling of the face, tongue, or throat; difficulty breathing; severe rash or hives.
Severe Local Effects Severe or frequent nosebleeds; persistent or worsening thick nasal discharge; a whistling sound from the nose (which may indicate a septal perforation).
Hormonal/Vision Symptoms of hormonal change (e.g., unusual fatigue, weakness, dizziness, or vomiting) if using high doses for a prolonged period; changes in vision, eye pain, or seeing halos around lights.

If a person swallows a large amount of the nasal spray, or if symptoms of acute distress or the above-mentioned complications are observed, emergency medical services should be contacted immediately. It is critical to inform medical personnel about the exact amount of medication used and the duration of use.

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Therapeutic Uses of Назарел

What Назарел Treats: Main Uses and Benefits

Fluticasone Propionate nasal spray is commonly used for managing symptoms related to inflammatory or irritative states of the nasal passages. This is applied across domains where additional symptomatic support is needed, primarily addressing conditions such as allergic rhinitis (seasonal and perennial), nonallergic rhinitis, chronic rhinosinusitis, and symptoms linked to nasal polyps. The medication helps address symptom clusters that may become intense or disruptive, including persistent nasal congestion, sneezing, runny nose (rhinorrhea), and itching of the nose and eyes.

“The goal is supportive symptomatic relief for persistent and bothersome nasal and ocular symptoms, supporting the management of symptoms that interfere with daily comfort.”

Used in areas where short-term symptom management is appropriate, this treatment contributes to easing the overall symptom load, which may assist with maintaining functional stability during symptomatic periods.

Quick Fact: Support for Persistent Nasal and Ocular Symptoms.

Regulatory References

  1. NIH MedlinePlus overview
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Eligibility and Restrictions for Use

The eligibility profile for Назарел (Fluticasone Propionate nasal spray) is determined by official regulatory documents, defining who may or may not use the medicine.

Populations Excluded from Use

Classification Eligibility Statement (Regulatory Basis)
Contraindicated Use is strictly prohibited in patients with a known hypersensitivity or allergy to fluticasone propionate or any of the formulation's ingredients.
Use Not Established The medicine is not recommended for children under 4 years of age, as safety and efficacy have not been sufficiently established in this young pediatric group.

Populations Requiring Caution or Restriction

Classification Eligibility Statement (Regulatory Basis)
Restricted Use Avoid use in patients with recent nasal trauma, surgery, or unhealed ulcers in the nasal mucosa due to the potential for delayed wound healing.
Conditional Use Caution is advised, or use may be restricted, in patients with concurrent systemic infections (especially tuberculosis, fungal, bacterial, or viral infections, or ocular herpes simplex).
Special Monitoring Patients with pre-existing conditions like glaucoma or cataracts should be closely monitored during treatment. Caution is also advised in cases of severe liver impairment due to the risk of increased systemic exposure.

Summary of Eligibility

Official labeling allows use for adults, adolescents, and children aged 4 and older, provided no contraindications are present. The primary constraints are absolute exclusion due to allergy and mandatory caution/restriction for individuals with certain severe infections, recent nasal injury, or other specific comorbidities where the drug may pose an increased risk.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Fluticasone Propionate is based on its primary metabolic pathway. The active ingredient undergoes extensive clearance predominantly mediated by the Cytochrome P450 3A4 (CYP3A4) enzyme. Inhibition of this pathway is the established basis for all clinically significant interactions documented in regulatory labeling.

Category Official Regulatory Documentation Statement
Medicinal Product Categories Strong CYP3A4 Inhibitors
Specific Interacting Medicines Ritonavir (formal avoidance), Ketoconazole, Cobicistat-containing products
Mechanistic Basis Pharmacokinetic interaction leading to reduced clearance and subsequent systemic exposure.
Interaction Restriction Co-administration with Ritonavir is officially not recommended due to high risk.

The most significant constraint is the formal avoidance of highly potent CYP3A4 inhibitors, particularly Ritonavir. Co-administration with Ritonavir is documented to cause a marked increase in plasma concentrations of Fluticasone Propionate, with studies showing an increase in systemic exposure by up to 350-fold. This pharmacokinetic change introduces the documented risk of developing systemic corticosteroid effects, which may include features of Cushing's syndrome and adrenal suppression. This finding leads to the classification of the combination as a Major interaction risk in official documents. Caution is also advised for other strong CYP3A4 inhibitors. Furthermore, a specific caution is noted for patients with severe hepatic impairment, as reduced liver function may inherently increase systemic exposure and the risk of adverse events.

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Mechanism of Action

How Назарел works

The mechanism of action for Fluticasone Propionate involves the modulation of gene expression pathways that regulate cellular inflammatory responses, resulting in altered tissue function.

Molecular Control via the Glucocorticoid Receptor

The drug's activity begins by acting as an agonist of the intracellular Glucocorticoid Receptor ( GR), its primary biological target. This molecular interaction initiates two key processes: transcriptional repression (blocking pro-inflammatory gene transcription by inhibiting factors like NF-kappa B) and transcriptional activation (upregulating the synthesis of anti-inflammatory proteins). This gene control mechanism defines the scope of the drug's anti-inflammatory activity.

Cascade Suppression and Tissue Function Alteration

The molecular action leads to the suppression of a broad range of events within the inflammatory cascade. By reducing the production of inflammatory mediators (e.g., cytokines and eicosanoids) and lowering the presence of inflammatory cells (e.g., eosinophils) in the tissue, the drug alters key physiological functions. This results in the core physiological change of reducing microvascular permeability and diminishing tissue fluid accumulation (edema).

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Dosage and Administration Information

Administration Guidelines for Назарел (Nasal Spray)

This section outlines the usage instructions for the metered-dose nasal spray.


Administration Scope and Dosing

Feature Labeled Instruction
Route of Administration Intranasal use only.
Adults (12 years and over) Starting dose: Two sprays in each nostril once daily. Maintenance dose: Typically one spray in each nostril once daily.
Children (6 to 11 years) One spray actuation in each nostril once daily. The dose may be increased to two sprays per nostril once daily if necessary.
Frequency Pattern Once daily administration, preferably at a consistent time each day.

Preparation and Procedure

Device Preparation: Before the first use or after a specified period of non-use (e.g., 7 to 30 days), the device must be primed. This involves gently shaking the bottle and pressing the pump until a fine mist is observed. The bottle should be gently shaken before each administration.

Administration Technique: To administer the drug, gently clear the nostrils, insert the spray tip, and aim away from the nasal septum (the central wall) while simultaneously pressing the pump firmly and gently inhaling through the nose. The spray tip must be wiped clean after use, and harsh cleaning objects must not be used. Safety and efficacy are generally not established for children under 6 years of age.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Назарел (Fluticasone Propionate)

The evidence base for Fluticasone Propionate nasal spray focuses on the clinical evaluation for conditions in the nasal passages. The research primarily consists of Randomized Controlled Trials (RCTs), alongside systematic reviews and meta-analyses. Studies contribute to understanding how symptoms change over time in observed populations.


Evidence for Use in Allergic Rhinitis (Seasonal and Perennial)

Research explored whether the nasal spray was associated with patterns in populations with conditions characterized by fluctuating or episodic manifestations linked to seasonal (SAR) and perennial (PAR) allergies. RCTs were widely used, comparing the nasal spray to a placebo or to other active treatments, and involved Adults, Adolescents, and Children (aged 4 years and older). Researchers measured outcomes related to physical discomfort using standardized rating systems, such as the Total Nasal Symptom Scores (TNSS) and Total Ocular Symptom Scores (TOSS).

Comparing Study Designs: Placebo and Active Treatments

Studies explored short-term symptom changes, and data show patterns related to symptom measurements in the active group compared to the placebo groups. Comparative evidence is lacking between the nasal spray and many other active nasal steroid treatments. For the few comparisons that exist against other nasal steroids, studies report how symptoms evolved, with findings sometimes mixed across specific symptoms.


Evidence for Use in Chronic Rhinosinusitis with Nasal Polyps

Research was conducted using the spray in patients with conditions marked by functional limitations due to nasal polyps. The evidence base for this indication was evaluated in intermediate-term, placebo-controlled trials. Researchers used both objective measures, such as endoscopically assessing the size of the polyps (Nasal Polyp Grade/Score), and patient-reported outcomes to describe perceived discomfort related to congestion. Studies monitored patients with bilateral nasal polyps, including those who had undergone prior sinus surgery.


Research Gaps and Areas of Uncertainty

While the research describes symptom patterns, limited information is available for long-term outcomes for continuous use beyond one year. Evidence quality varies across studies, particularly for nonallergic rhinitis, where certainty remains low due to small sample sizes. Research does not determine whether an individual will respond similarly; study results reflect the specific conditions under which they were conducted.

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Frequently Asked Questions (FAQ)

Common questions about Назарел (FAQ)

Q: How long does it usually take to feel the effects of Назарел?

Studies and official product information indicate that the onset of a therapeutic effect may begin within 12 hours after the first administration. For some individuals, symptom relief may start in as little as 2 to 4 hours. However, the full anti-inflammatory benefits of the medicine may be achieved after several days of consistent use.

Q: Can Назарел be used for symptoms that are not related to seasonal allergies?

Yes. The active ingredient in this medication is indicated in official documents for the management of perennial nonallergic rhinitis, which refers to persistent nasal symptoms not caused by an allergic reaction. This indication is included in the official labeling alongside use in adults and adolescents.

Q: Does Назарел help with both nasal congestion and sneezing?

The active ingredient is described in official documents as being used to address multiple common symptoms of allergic rhinitis. This includes addressing stuffy nose (congestion) and runny nose, as well as symptoms like itching and sneezing.

Q: Is there a risk of rebound congestion with a medication like Назарел?

Rebound congestion, sometimes called Rhinitis Medicamentosa, is a phenomenon known to be associated with the overuse of topical decongestant nasal sprays. Regulatory and safety documents for this medicine do not list this specific risk; rebound congestion is a risk primarily associated with topical decongestant sprays, which belong to a different drug class.

Q: Do official documents mention any effects of Назарел on growth in children?

Regulatory agencies advise that the growth of pediatric patients receiving intranasal corticosteroids should be monitored. While some studies showed no significant effect on growth rate, this monitoring is required due to the potential for systemic effects associated with corticosteroids, as noted in the safety information.

Q: Is the medication absorbed into the bloodstream after using Назарел?

Yes, a small amount of the medicine is absorbed into the bloodstream after intranasal use. However, the active ingredient has very low systemic bioavailability. This low systemic absorption contributes to minimizing the potential for effects on the rest of the body.

Q: Are there different strengths or versions of Назарел available?

The medicine is a nasal spray suspension. Official documentation confirms that each actuation (spray) is designed to deliver a specific, fixed amount of the active ingredient, Fluticasone Propionate.

Q: Is it normal to not feel the full effect of Назарел immediately?

Yes, it is normal. This medication works over time by reducing underlying inflammation, and official information indicates that the full therapeutic effect relies on regular, consistent use. Symptom improvement may begin within hours, and the full benefits of the medication may become apparent after several days of consistent use.

Q: Is there a maximum number of days or weeks that Назарел is approved for continuous use?

Regulatory labeling does not specify a single maximum time limit for duration when used at recommended doses. However, monitoring is generally noted in official information for continuous, long-term use.

Q: What happens if I miss a scheduled application of Назарел?

According to official drug guidance, if an application is missed, it should be used as soon as the patient remembers, unless it is nearly time for the next scheduled dose. If so, official guidance describes skipping the missed application and continuing with the regular schedule. It is specified that two doses should not be used together.

Q: Do you need a prescription to buy Назарел in all countries?

No. The regulatory classification for the active ingredient varies globally. While it is classified for prescription use in some regions, other countries permit it to be sold over the counter (OTC) or as a Pharmacy Medicine.

Q: Does Назарел cause drowsiness or affect ability to drive?

Drowsiness or dizziness are not listed among the commonly reported side effects of this nasal spray. Regulatory safety information indicates these symptoms are typically only associated very rarely, potentially as a manifestation of a severe allergic reaction (hypersensitivity).

Q: What kind of nasal symptoms is Назарел specifically designed to address?

The product is designed to address the nasal symptoms of allergic and non-allergic rhinitis. This includes a comprehensive range of symptoms such as a stuffy nose, runny nose, and sneezing.

Q: Can Назарел be used for short periods during a cold or flu?

Official regulatory guidance advises that this medicine is not indicated and should not be used to address nasal symptoms that are caused by the common cold.

Q: Is Назарел considered a preventative treatment or a symptom reliever?

The active ingredient functions as an anti-inflammatory agent that works to control and reduce the allergic or inflammatory reaction at the source. Due to this mechanism, it is considered a controller or preventative treatment that also provides symptom relief.

Q: Can pregnant or breastfeeding people use Назарел, based on official information?

Regulatory information advises that use during pregnancy is not recommended unless a healthcare provider determines that the potential benefit to the patient outweighs the potential risk to the fetus. For breastfeeding, the potential risk to the infant is considered low due to the drug's low systemic absorption.

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How should Назарел be stored and disposed of?

How to Store and Dispose of Назарел (Fluticasone Propionate Nasal Spray)

The storage and disposal requirements for Fluticasone Propionate Nasal Spray are defined by regulatory labeling to maintain stability and ensure safety.

Storage Conditions

The medication must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). It is strictly required not to freeze or refrigerate the product, as this can affect the aqueous suspension's integrity. The container should be kept tightly closed and stored upright, away from excess heat, light, and moisture.

Stability and Child Safety

To ensure efficacy, the product has a fixed in-use period (e.g., 120 sprays or 6 months after first use), after which it must be discarded. The nasal spray must always be stored out of the sight and reach of children.

Disposal

Unused or expired medicine must not be thrown away via wastewater or household waste. Disposal must follow approved procedures in accordance with local requirements.

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

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