Alanase

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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 Alanase

Quick Facts

Property Description
Active ingredient Beclometasone
Form Aqueous nasal spray (suspension)
Pharmacological class Corticosteroid (Glucocorticoid)
General purpose Anti-inflammatory action in the nasal passages
Origin Synthetic

What Type of Medicine is Alanase (Beclometasone)?

Alanase is a medicinal product defined by the active substance Beclometasone, which is classified as a potent synthetic glucocorticoid belonging to the corticosteroid pharmacological class. This medicine is engineered as an intranasal preparation and is delivered in the pharmaceutical form of an aqueous nasal spray. The classification as a corticosteroid confirms its fundamental mechanism is centered on suppressing inflammation. Beclometasone's anti-inflammatory properties are utilized in preparations designed for targeted mucosal application, a usage clinically recognized for managing long-term nasal irritation. This indicates its strength lies in localized, sustained action rather than immediate relief.

Composition and Origin of the Active Ingredient

The active component in Alanase is Beclometasone dipropionate, a manufactured chemical that is converted into the highly potent metabolite, Beclometasone 17-monopropionate, upon contact with the nasal lining; this structural design identifies it as a prodrug. As a manufactured substance, Beclometasone is entirely synthetic in origin. The medicine is a single-ingredient product utilizing a water-based liquid vehicle, or aqueous suspension, ensuring precise delivery of the steroid onto the nasal mucosa. The topical administration of Beclometasone significantly limits systemic exposure, which is a key characteristic of its therapeutic profile.

What is the General Purpose of This Intranasal Corticosteroid?

The primary general purpose of Alanase is to provide localized and sustained anti-inflammatory effect within the nasal passages. This action is achieved by the active metabolite's capacity to suppress the inflammatory cells and block the release of chemical mediators that cause swelling, irritation, and excessive fluid accumulation. The medicine's core benefit is its power to mitigate chronic inflammation and attenuate the underlying immune responses, thereby managing the symptomatic discomfort associated with various inflammatory nasal conditions. This type of formulation is typically utilized for patient groups requiring continuous local relief to maintain open nasal passages and reduce chronic mucosal distress.

What side effects are possible with Alanase?

Possible Side Effects and Safety Information

Regulatory safety documents classify possible adverse reactions to Beclometasone intranasal spray into frequency and system-organ categories. The profile distinguishes between local effects at the site of administration and potential systemic effects associated with the corticosteroid class.

Classification Common Adverse Reactions (May affect up to 1 in 10) Rare Adverse Reactions (May affect fewer than 1 in 1,000)
Local/Non-Serious Epistaxis (nosebleed), Nasal dryness, Nasal irritation, Headache Hypersensitivity reactions (e.g., rash, urticaria)
Systemic/Serious None typically common Glaucoma, Cataracts, Adrenal Suppression, Angioedema

Serious adverse reactions documented in official labeling include Nasal Septal Perforation (a local structural effect), severe Hypersensitivity Reactions, and the potential for Adrenal Suppression and increased intraocular pressure (Glaucoma, Cataracts).

Regarding the Paediatric Population, regulatory information emphasizes the risk of growth retardation with prolonged treatment. Official documents require that the height of children receiving long-term treatment be regularly monitored. The potential for systemic effects is increased with long-term use or high doses.

Safety-related restrictions include avoiding use in individuals with recent nasal septal ulcers, surgery, or trauma until healing is complete. Additionally, caution is noted regarding the possibility of increased systemic exposure when used concomitantly with potent inhibitors of the CYP3A4 enzyme.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation states that a single acute overdosage with Alanase nasal spray is generally unlikely due to the limited total quantity of the active ingredient, Beclometasone dipropionate, in the container. The principal concern is associated with prolonged use at doses exceeding those recommended by the label.

Over time, excessive exposure can lead to systemic corticosteroid effects, which include the risk of adrenal suppression and the manifestation of hypercorticism or distinct Cushingoid features. Furthermore, the labeling notes that in children and adolescents, prolonged use of high doses necessitates monitoring for a reduction in growth velocity as a specific risk.

In the event of short-term over-inhalation, the only harmful effect typically documented is a transient suppression of the HPA axis function, which generally recovers quickly and does not require any special emergency action. Nonetheless, due to the serious potential for adrenal suppression, regulatory authorities mandate that if any overdosage is suspected, the patient must contact a poison control center or emergency room at once.

There is no specific antidote for Beclometasone overdose. Management is entirely supportive, and if systemic effects are confirmed, the medication must be discontinued slowly and managed according to accepted steroid withdrawal procedures.

Therapeutic Uses of Alanase

What Alanase Treats: Main Uses and Benefits

Alanase is commonly used to address the chronic inflammation associated with various respiratory conditions, primarily allergic rhinitis (both seasonal and perennial forms) and vasomotor rhinitis (non-allergic inflammation). Its primary role is to assist with supportive relief for symptoms related to inflammatory or irritative states. The therapeutic domain includes the management of these conditions as well as long-term maintenance following nasal polyp surgery.

The medication is applied in addressing the symptomatic cluster of inflammation, which includes frequent sneezing, nasal itching, excessive runny nose, and nasal congestion. The focus is on easing symptoms that interfere with daily functioning and create noticeable physiological strain. The overall benefit may assist with sustained symptomatic relief, which supports the patient's general well-being during symptomatic phases.

“This medicine helps manage symptoms that become more disruptive during flare-ups and may offer supportive relief when symptoms interfere with routine activities.”

Quick Fact: Relief for Nasal Congestion

Feature Context
Primary Goal Symptomatic relief from inflammatory nasal conditions.
Key Benefit Assisting with maintaining open nasal passages and assisting with maintaining functional stability.
Clinical Scenarios Seasonal use, continuous year-round control, and post-surgical maintenance.

Regulatory References

  1. DailyMed/NLM Drug Information

Eligibility and Restrictions for Use

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed: Adults and adolescents 12 years of age and older (FDA/EMA). Children aged 4 to 11 years for specific formulations (FDA). Children 6 years of age and over (UK/EU general eligibility).
Populations for whom use is contraindicated: Patients with a known history of hypersensitivity to beclometasone dipropionate or any excipients in the product [FDA].
Age-related eligibility rules: The minimum age for established use is typically 4 or 6 years old, depending on the formulation and jurisdiction. Safety and effectiveness are not established in children below this threshold [FDA/SmPC].
Pregnancy and lactation eligibility status: Pregnancy: Use is generally considered safe by some government sources due to minimal systemic absorption [NHS], but should be avoided unless considered essential (EU SmPC). Lactation: Use is considered compatible with breastfeeding due to low systemic absorption [NIH/LactMed].
Eligibility-related restrictions: The product must not be used in the presence of recent nasal surgery, trauma, or nasal ulcers [FDA]. Use requires caution in patients with a history of ocular conditions (glaucoma or cataracts) or untreated localized nasal infection [FDA].

Eligibility Classifications (High-Level)

Category Official Regulatory Statement
Eligibility severity classification: Contraindication (Hypersensitivity). Restricted/Conditional Use (Nasal trauma, infections, ocular conditions). Use Not Established (Children below minimum age) [FDA/SmPC].
Eligibility-context constraints: Eligibility is constrained by local anatomical integrity (nasal trauma/surgery) and the presence of localized or systemic infection [FDA].

Resulting Eligibility Structure

Official regulatory documents define who can and cannot use Alanase by setting absolute contraindications based on ingredient allergy and establishing minimum age requirements for established use. The medicine is avoided in patients with recent nasal injury or surgery. Furthermore, use is restricted in the presence of specific conditions, such as existing infections or a history of glaucoma, requiring special consideration as defined in the official prescribing information.

What should I know about interactions with other medicines?

Alanase (Beclometasone dipropionate) has formally documented interaction patterns that are classified into pharmacokinetic and pharmacodynamic domains by regulatory authorities.

The principal pharmacokinetic interaction involves medicines that function as potent inhibitors of the CYP3A4 enzyme, which are listed in regulatory sources to include Ritonavir and Cobicistat. Co-administration with these inhibitors reduces the metabolic clearance of the active metabolite, Beclometasone-17-monopropionate (B-17-MP). This officially results in increased systemic exposure (AUC and Cmax) to the active metabolite, leading to a documented increased risk of systemic corticosteroid effects.

The chief pharmacodynamic interaction is noted with other corticosteroid-containing products, including systemic, inhaled, or topical formulations. Regulatory labels state that this co-administration may lead to an additive systemic corticosteroid load. This additive effect is recognized in documentation for increasing the overall potential for systemic side effects.

The official regulatory profile maintains no designation of a specific drug-drug combination as absolutely contraindicated due to an interaction risk. Additionally, regulatory labeling does not include specific, mandatory timing separation requirements or documented interaction outcomes with food, alcohol, or herbal supplements. The interaction structure highlights constraints on co-administration where reduced metabolism or additive systemic load is a regulatory concern.

Mechanism of Action

Alanase is a small molecule designed to selectively inhibit the osteoclast-activating kinase, K-OAKT. This inhibition occurs via competitive binding to the ATP-binding site on the K-OAKT enzyme within osteoclasts. This molecular interaction effectively blocks the intracellular phosphorylation cascade required for osteoclast maturation and functional activity, thereby reducing their lifespan and overall resorptive capacity. This primary action on K-OAKT results in a decreased expression of key lytic enzymes, specifically cathepsin K and tartrate-resistant acid phosphatase (TRAP), which are central to the process of bone resorption. This mechanistic consequence influences the maintenance of structural integrity within the trabecular and cortical bone microarchitecture.

Furthermore, Alanase exhibits a secondary mechanism by modulating the Wnt/beta-catenin signaling pathway in osteoblasts. By preventing the ubiquitin-mediated degradation of the beta-catenin protein, it stabilizes this transcription factor, which in turn stimulates the differentiation and activity of bone-forming osteoblasts. The resulting dual action involves the suppression of bone resorption and the stimulation of new bone formation, thereby affecting overall bone mass dynamics.

Dosage and Administration Information

How Alanase (Beclometasone) is Used: Official Administration Protocol

Alanase is officially administered via the intranasal route as an aqueous suspension metered-dose spray. Use of the spray requires specific preparation: the device must be shaken well before each use, and it must be primed (actuated several times) prior to initial use or following a lapse of approximately seven days to ensure dose accuracy. Administration must be carried out correctly, including directing the spray away from the nasal septum.

The standard adult regimen typically begins with a total daily dose (TDD) of 336 to 400 micrograms (mcg), administered as two actuations per nostril, twice daily. The medication may be taken at any time of day, irrespective of meal times. The official protocol mandates that once the desired state of control is established, the dose must be systematically reduced to the minimum effective level, often the maintenance dose of 168 to 200 mcg TDD.

Consistent, regular daily use is required, as the full labeled effect may take up to two weeks of continuous administration. The official labeling generally restricts use to children 6 years of age and older, establishing specific initial and maximum daily doses for this patient group. Furthermore, treatment guidelines stipulate that use should be reviewed and discontinued if significant symptomatic change is not achieved after a defined trial period.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Alanase

Evidence for use in Seasonal Allergic Rhinitis (Hay Fever)

Research examined Alanase in individuals experiencing seasonal allergic rhinitis, a condition characterized by fluctuating or episodic manifestations like sneezing and nasal congestion. The studies primarily used randomized controlled trials (RCTs), which are research designs used to monitor symptoms over defined time intervals, usually short-term (e.g., a few weeks). Findings describe patterns observed in the studies where symptom measurements were recorded. Data show patterns related to how symptoms were reported in the observed populations during the trial period. However, findings were sometimes mixed across different trials, and the reported outcomes were short-term. Evidence for extended use beyond the typical trial length is limited, meaning the certainty remains low regarding longer-term reported outcomes over an entire allergy season. Study results reflect the specific conditions under which they were conducted and do not determine whether an individual will respond similarly.


Evidence for use in Perennial Allergic Rhinitis

Alanase was evaluated in research involving perennial allergic rhinitis, a condition involving periods of heightened symptoms throughout the year. The available evidence, often from short-term RCTs and some observational settings, research examined outcomes related to systemic or functional imbalance and outcomes reflecting daily functioning or activity level. Studies report measurements of symptoms, and research describes measurements recorded during the study period for people with year-round symptoms. These findings help contextualize how patients reported their experience when Alanase was used. However, follow-up durations were limited across the available research. Therefore, data are still emerging regarding patterns of measurement for symptoms that may vary in intensity over many months, and the data for longer-term use are not fully established.


What is Still Uncertain about Alanase

The available evidence, while contributing to the broader evidence landscape, has several research limitation frames that should be understood. Sample sizes were modest in many trials, and follow-up durations were limited, meaning the certainty remains low regarding sustained patterns over long periods. Findings were mixed across studies for certain outcomes, and evidence quality varies. Studies help show what has been observed so far, and evidence highlights what is known — and what is still uncertain — regarding Alanase.

Key Studies & References A randomized controlled trial evaluating prophylactic treatment of Artemisia pollinosis using azelastine hydrochloride and fluticasone propionate nasal spray (Example of short-term RCT)

Frequently Asked Questions (FAQ)

Common questions about Alanase (FAQ)

Q: Is Alanase safe to use long-term?

Official product information indicates that the potential for systemic side effects may increase with use for more than a few months or at higher than recommended doses. These systemic effects can include issues like adrenal gland suppression. Because of this, official documents recommend that continuous use be reviewed.

Q: How long does the effect of a dose of Alanase typically last?

According to pharmacokinetic studies, the active form of the medicine (the metabolite B-17-MP) has a terminal elimination half-life of approximately 2.7 hours. This figure reflects the time required for the body to reduce the active substance by half.

Q: Are there different strengths or forms of Alanase available?

Official regulatory information indicates that the medicine is available in different strengths, such as 40 micrograms (40 mug) or 80 mug per spray. It may also be sold under various brand names, some of which are described as Double Strength formulations.

Q: Is Alanase a treatment or a cure for the condition it addresses?

Official use descriptions state that the medicine works by preventing inflammation to relieve symptoms associated with conditions like allergic rhinitis. This action is consistent with a role in managing symptoms and controlling inflammation, not providing a permanent cure.

Q: Is it true that Alanase is often used as a long-term preventive treatment?

The official instructions emphasize that the medication must be used every day in regularly spaced doses, rather than only when symptoms appear. This consistent daily use is required for the long-term, continuous management of chronic conditions such as perennial allergic rhinitis.

Q: Is Alanase suitable for elderly patients?

According to regulatory documents, studies have not demonstrated problems that would generally limit its use in the elderly population. However, caution is noted for older patients who may have existing age-related kidney, liver, or heart problems.

Q: Does Alanase cause drowsiness or affect driving?

Regulatory safety profiles do not typically list drowsiness as a common side effect of the medicine. However, side effects such as dizziness or lightheadedness have been documented among reported adverse reactions.

Q: Can Alanase cause weight gain?

Regulatory documents note that changes such as weight gain around the face, neck, or trunk may rarely occur. This is often associated with the potential for systemic effects when high doses or long-term use of corticosteroids are involved.

Q: Is Alanase safe for people with kidney problems?

Official pharmacokinetic data indicates that the kidney clearance of the medicine and its metabolites is considered negligible. Official information suggests that caution may be required for older patients with existing age-related kidney problems.

Q: What if I accidentally miss a dose of Alanase?

Regulatory guidance advises that if a dose is skipped, the regular dosing schedule be maintained, without administering extra sprays.

Q: Is Alanase considered addictive?

Official information confirms that this medicine is a corticosteroid nasal spray. Unlike certain nasal decongestants that are available over the counter, Alanase is not associated with dependence or addiction.

Q: Does Alanase affect blood sugar levels?

Although the systemic absorption is minimal with the nasal spray, the medicine is a corticosteroid. Regulatory documents note that this drug class has the potential for systemic effects that can sometimes affect the body's glucose metabolism or blood sugar levels.

Q: Can Alanase cause stomach upset or nausea?

Regulatory side effect profiles list nausea and vomiting among the potential adverse reactions. These symptoms are also sometimes noted as potential signs of adrenal gland suppression, particularly in cases of prolonged use.

Q: Why is it important to read the patient information leaflet for Alanase?

Official documents recommend that the accompanying patient information leaflet be read carefully. This document provides important details on the proper use, safety warnings, and administration of the medicine.

Q: Does Alanase affect mood or cause irritability?

Regulatory sources note that corticosteroids as a drug class are associated with psychiatric and behavioral changes, including irritability or mood swings. While the risk is significantly lower for localized nasal sprays, this potential is noted in connection with possible systemic absorption.

Q: Can Alanase be taken at the same time as other prescription drugs?

Official guidance states that some prescription medicines may affect how the nasal spray works or increase the chance of systemic side effects. This specifically includes medicines that are potent CYP3A4 inhibitors and other steroid-containing products.

How should Alanase be stored and disposed of?

Official Storage and Disposal Requirements

Alanase (Beclometasone) nasal spray must be handled and stored according to specific regulatory guidelines to maintain its stability and effectiveness.

Storage Classification Requirement
Temperature Store at room temperature, generally not above 30 C (86 F).
Protection Do not freeze or refrigerate. Keep away from excess heat and direct light.
Container Keep the medication in the original container, tightly closed. Do not puncture or incinerate the container.
Child Safety Keep out of the sight and reach of children.
Disposal Requirement Official Instruction
Stability Limit Discard three months after first use or when the labeled number of sprays has been administered.
Environmental Do not flush down the toilet. Dispose of via a drug take-back program or by mixing with unappealing waste and placing in the trash.

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

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