Antazol Plus

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Antazol Plus

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Medically reviewed

Rosario Oropesa

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 Antazol Plus

Property Description
Active Ingredients Sodium Cromoglycate, Xylometazoline
Form Metered Dose Nasal Spray (Clear Aqueous Solution)
Pharmacological Class Mast Cell Stabilizer & Sympathomimetic Decongestant
Common Use Prophylaxis and relief of symptoms in allergic rhinitis
Origin Synthetic/Derived

Antazol Plus: Definition and Pharmacological Classification

Antazol Plus is a fixed-dose combination product designed for local nasal administration that uniquely combines an anti-allergic agent and a decongestant in a single preparation. Pharmacologically, it is classified as a co-formulation of a Mast Cell Stabilizer and a Sympathomimetic Nasal Decongestant. This combination is recognized for providing relief when both nasal congestion and allergic irritation are present, a common scenario in seasonal allergies.

The drug's structural basis relies on two distinct, synthetically derived active pharmaceutical ingredients (APIs): Sodium Cromoglycate and Xylometazoline. Sodium Cromoglycate functions as a mast cell stabilizer, aiming to inhibit the release of allergic mediators like histamine. Drugs in this class prevent the allergic response from initiating after exposure to an allergen. Xylometazoline is recognized as an alpha-adrenergic agonist, a type of decongestant that induces rapid localized vasoconstriction (narrowing of blood vessels).


Composition, Form, and General Purpose

The medication is supplied as a Clear Aqueous Solution in a Metered Dose Nasal Spray device, ensuring targeted delivery directly onto the nasal mucosa. The two key active components are dissolved within this Aqueous Vehicle base. Antazol Plus is specifically differentiated in the market by its ready-to-use combination for managing conditions such as hay fever, offering an advantage over purchasing and using two separate single-ingredient sprays.

The general purpose of Antazol Plus is the comprehensive management of nasal symptoms in allergic conditions. Its dual mechanism ensures that the medication both works prophylactically to reduce the tendency of the allergic reaction to escalate (via Sodium Cromoglycate) and provides immediate symptomatic relief by rapidly shrinking the swollen nasal tissues (via Xylometazoline).

What side effects are possible with Antazol Plus?

Possible Side Effects and Safety Information

The safety profile of this medicine is derived from the official regulatory classification of adverse reactions associated with the local nasal administration of a fixed combination of a mast cell stabilizer and a sympathomimetic decongestant.

Officially Classified Adverse Reactions

The majority of documented effects are localized to the nasal passage, while systemic effects, particularly affecting the cardiovascular and nervous systems, are generally classified as rare and are linked to the decongestant component.

Frequency Examples of Officially Listed Effects
Common Headache, Nasal Dryness, Nasal Discomfort, Burning Sensation, Nausea
Uncommon Epistaxis (Nosebleeds)
Rare/Very Rare Palpitations, Tachycardia, Hypertension, Transient Visual Impairment, Severe Hypersensitivity Reactions (e.g., Angioedema)

Safety Constraints and Time-Related Patterns

Adverse events are formally grouped by System-Organ Classes, including Respiratory, Nervous, and Cardiac Disorders. The official labeling documents that localized nasal irritation may occur during the initial use.

Prolonged or Excessive Use is specifically noted in regulatory texts as potentially leading to rebound congestion or drug-induced rhinitis. Caution is advised for individuals with known sensitivity to sympathomimetic agents and for patients with Long QT Syndrome due to the risk of serious Ventricular Arrhythmias.

Overdose and Emergency Response

Overdose and when to seek help

The following information on Antazol Plus overdose is derived strictly from authoritative government regulatory sources, such as the FDA Prescribing Information and the EMA Summary of Product Characteristics (SmPC). This section details the officially documented toxic effects and required emergency actions.


Documented Overdose Manifestations

Symptoms reported in regulatory documents following an acute overdose include a cluster of Central Nervous System (CNS) effects, such as altered consciousness (somnolence, confusion), and Gastrointestinal symptoms, including severe nausea and vomiting. Cardiovascular signs like hypotension and an increased heart rate (tachycardia) are also documented as potential manifestations of toxicity.

Life-Threatening Outcomes

Overdose with Antazol Plus is classified as potentially severe to life-threatening due to the reported risk of complications, including respiratory depression and profound, difficult-to-treat hypotension. Special consideration is noted for patients with pre-existing hepatic impairment, where the risk of severe toxicity is elevated.

Immediate Action Required

Seek immediate emergency medical attention (call emergency services or Poison Control Center) upon suspected overdose, regardless of whether any symptoms are currently present.

Official management procedures include immediate supportive care to maintain vital functions, measures to reduce absorption (e.g., activated charcoal, if appropriate), and continuous observation in a hospital setting. The regulatory information may specify that treatment is symptomatic and supportive in nature.

Therapeutic Uses of Antazol Plus

What Antazol Plus Treats: Main Uses and Benefits

Antazol Plus is used in situations involving certain distressing symptoms, particularly symptoms linked to organ-specific functional stress. It is commonly used across conditions presenting with acute episodes, and is considered relevant for managing conditions characterized by periods of heightened symptoms such as allergic rhinitis (hay fever) and nasal congestion. Its primary goal is to provide support that helps ease the overall burden of symptoms and helps patients cope more steadily with difficult episodes.


Easing Acute and Pronounced Symptoms

This medication is applied in clinical settings that involve acute or unstable symptom patterns, such as significant discomfort related to inflammatory or irritative states. It helps address symptom clusters that may become intense or disruptive. Antazol Plus is applied across domains where additional symptomatic support is needed, assisting with maintaining functional stability and providing supportive relief when symptoms interfere with routine activities.


Supporting Stability During Symptom Clusters

Antazol Plus is commonly used across conditions characterized by periods of heightened symptoms where short-term symptomatic assistance is needed. It is relevant for managing symptoms that interfere with daily comfort, such as recurrent or episodic manifestations. The medication helps address symptoms that create noticeable functional strain, and contributes to improved day-to-day comfort during periods of heightened symptoms, supporting the patient during difficult episodes by easing distress.

Quick Fact: Applied in contexts where short-term symptom management is appropriate.

Regulatory References

  1. MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Official Population Eligibility and Restrictions

The eligibility profile for Antazol Plus (Sodium Cromoglycate + Xylometazoline) is structured by absolute contraindications and mandatory restrictions defined in official regulatory labeling.

Eligibility Status Applicable Populations
Absolutely Contraindicated Patients with known hypersensitivity to any component. Use is prohibited in patients with closed-angle glaucoma, Rhinitis sicca, or Atrophic rhinitis. Use is also contraindicated in patients with a history of trans-sphenoidal hypophysectomy or surgery exposing the dura mater [Source 4.1].
Not Recommended The medicine is generally not recommended for use in children under 2 years of age [Source 2.5]. Use is not recommended during pregnancy (especially the first trimester) and while breastfeeding, as safety has not been established for the combination product [Source 4.1].
Conditional/Restricted Use The medicine should be used with caution in populations exhibiting a strong reaction to adrenergic substances. This includes patients with hypertension, cardiovascular disease (including Long QT syndrome), diabetes mellitus, hyperthyreosis, phaeochromocytoma, and prostatic hypertrophy [Source 4.1].

Age-Related Eligibility: Adults and older adults are included in the approved population [Source 1.2]. Specific age minimums vary by product concentration: the adult concentration (e.g., 0.1% Xylometazoline) is generally restricted to adolescents and adults (typically ge12 years), while a lower concentration may be indicated for children (e.g., 2 to 10 years) [Source 2.5]. The recommended dose must not be exceeded, particularly in the elderly [Source 4.1].

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes officially documented interactions involving the active ingredients of Antazol Plus, based strictly on information from authoritative governmental regulatory documents. It is essential to be aware of these combinations, as they may result in clinically significant effects.

Documented Interacting Medicinal Products

Official regulatory information identifies specific categories and products that interact with Antazol Plus, primarily due to the sympathomimetic component (Xylometazoline).

Product Category / Specific Medicine Documented Interaction Risk Regulatory Implication
Monoamine Oxidase Inhibitors (MAOIs) Potentially Fatal Hypertensive Crisis Avoid combination; use is prohibited
Sibutramine Increased heart rate or blood pressure (BP) Combination may require close monitoring or avoidance

Interaction Constraints

Concomitant use with medicines known as Monoamine Oxidase Inhibitors (MAOIs) is strictly restricted in official labeling due to the documented risk of a potentially fatal hypertensive crisis. This restriction is based on the official regulatory classification of the interaction severity. For other medicines that can increase heart rate or blood pressure, the official documentation notes the potential for additive effects, necessitating caution and, in some cases, avoidance of the combination. The official profile emphasizes severe risks associated with combining this product with drugs that affect monoamine metabolism.

Mechanism of Action

How Antazol Plus Works: Pharmacodynamics

Antazol Plus combines two components to modify distinct physiological processes within the nasal mucosa: local vascular tone and cellular immunological response.

Vascular Tone Modulation is mediated by Xylometazoline, which acts as an agonist by binding directly to the alpha1 -adrenergic receptors on vascular smooth muscle cells. This interaction triggers a cellular cascade leading to smooth muscle contraction and subsequent vasoconstriction. The narrowing of the nasal blood vessels physically reduces the volume of the engorged nasal turbinates, resulting in a functional decrease in air flow resistance.

Prophylactic Stabilization is mediated by Sodium Cromoglycate, a mast cell stabilizer. It functions by inhibiting the essential Calcium ion ( Ca^2+ ) influx necessary for mast cell degranulation. By blocking this molecular step, the drug inhibits the cellular release of inflammatory mediators, such as histamine, which functionally alters subsequent signaling cascades that govern vascular permeability and local sensory nerve activation.

Dosage and Administration Information

Official Administration Guide

Antazol Plus Nasal Spray is administered intranasally and is intended for use in adults and children.

Dosing and Frequency

Age Group Dose per Nostril Frequency
Adults and Children One metered spray Four times daily

Note: Do not exceed the recommended maximum dosage of one spray in each nostril, four times daily. The prolonged use or abuse of nasal decongestants, such as one component of this product, may lead to rebound nasal congestion (drug-induced rhinitis).

Preparation and Procedure

To ensure proper administration of the metered-dose spray, follow these official steps:

  1. Preparation: Gently shake the bottle and remove the dust cover. If the spray is being used for the first time, or if it has not been used for a week or more, the pump must be primed by pressing the nasal applicator down several times until a fine mist is released.
  2. Application: Gently clear the nose. Close one nostril and carefully insert the nasal applicator into the open nostril. Keep the spray bottle upright and the head slightly tilted forward.
  3. Dosing: While breathing in through the nose, firmly press the applicator down once to release the metered spray. Breathe out through the mouth.
  4. Repeat: Repeat steps 2 and 3 in the other nostril.
  5. Cleaning: The nasal spray should be cleaned at least once a week. Remove the dust cover and gently pull off the applicator. Wash the applicator and dust cover in warm water and allow them to air dry before reattaching them to the bottle. For hygienic reasons and to prevent cross-infection, each spray bottle should only be used by one person.

Recent Clinical Evidence

Research evidence / Overview of Studies for Antazol Plus

The research into this combination product was studied for conditions characterized by fluctuating or episodic manifestations in the nose, most commonly Allergic Rhinitis. Research examined the product's use in individuals experiencing both seasonal symptoms (like hay fever) and year-round perennial symptoms. The core evidence was studied for this use in clinical trials, including short-term Randomized Controlled Trials (RCTs) that involved methods designed to limit bias, including trials that involved placebo groups. These studies were evaluated in populations to assess outcomes linked to inflammatory or irritative states of the nose. Findings describe patterns observed in the studies related to symptom evolution over the defined trial period.

How Studies Measured Symptom Relief

Studies focused primarily on two main axes to describe how symptoms change. First, researchers describes how patient experiences were measured using patient-reported outcomes describing perceived discomfort related to the nose and sinuses. This score monitored symptoms, and is typically used in research exploring how symptoms change over time. Second, objective methods were observed in some studies to monitor physiological changes in nasal airflow and obstruction. These methods, such as Nasal Airway Resistance (NAR) measurements, provided an objective view of the physical state of the nasal passages. This research provides insight into short-term changes under the specific conditions of the trial.

Long-Term Data and Follow-up Duration

Research was observed in studies that explored symptom changes over defined time intervals, primarily focusing on short-term symptom changes. The data gathered mostly reflects the initial treatment period, often up to 10 to 14 days. While this research provides information on the early observed responses, the long-term effects for this combination product are not fully established. Existing studies provide limited insight into the patterns of symptoms or physiological change over periods exceeding the standard short follow-up durations.

Evidence in Specific Patient Groups

Research was observed in a variety of patient groups, including both Adults and Children (typically those aged 5 or 6 and older). The studies explored populations presenting with conditions involving periods of heightened symptoms, such as seasonal flare-ups and chronic perennial issues. The evidence contributes to the broader evidence landscape for these specific groups. Data for certain other specific patient subgroups, beyond the general inclusion criteria, remain insufficient.

Key Studies & References Sodium cromolyn nasal drug information (MedlinePlus)

Frequently Asked Questions (FAQ)

Common questions about Antazol Plus (FAQ)


Q: How quickly does Antazol Plus usually start to work?

Official information indicates that the decongestant ingredient, Xylometazoline, is known for its fast onset of action for nasal congestion relief. The quick onset of action described for the decongestant component indicates that its effects are generally perceived shortly after use.


Q: Is Antazol Plus considered a long-term medication?

Regulatory guidance advises against continuous use for more than 5 to 7 days due to the documented risk of rebound congestion. Prolonged use is specifically noted in official documentation as potentially leading to drug-induced rhinitis, a condition where nasal congestion worsens.


Q: Do many people experience stomach upset with Antazol Plus?

The majority of documented effects are localized to the nose. However, according to official adverse event reporting, Nausea (a feeling of sickness) is classified as a Common effect. This means it is among the more frequently observed reactions noted in the product's safety profile.


Q: Is Antazol Plus habit-forming or addictive?

The official documentation cautions against prolonged or excessive use due to the specific risk of developing rebound nasal congestion. The risk is described as a localized physical phenomenon where the nasal lining develops a tolerance, often resulting in worsening congestion when the medicine is stopped.


Q: How long does Antazol Plus stay in your system?

The anti-allergic ingredient, Sodium Cromoglycate, is poorly absorbed from the nose into the bloodstream. The small amount that is absorbed into the body is quickly eliminated, typically within a few hours. The therapeutic effects on the nasal lining are described as lasting approximately 6 hours.


Q: Is Antazol Plus the same as Antazol, or is it different?

Antazol Plus is described as a fixed-dose combination product, containing two active ingredients: Sodium Cromoglycate (an anti-allergic agent) and Xylometazoline (a decongestant). Single-ingredient products like Antazol typically contain only the decongestant, Xylometazoline.


Q: Is Antazol Plus known to cause drowsiness?

Safety information linked to this drug class sometimes lists drowsiness as a possible side effect of the decongestant component, Xylometazoline. While it is not always a common effect, it is a possibility noted in the official profile.


Q: Can Antazol Plus affect sleep?

Regulatory-linked information notes that the decongestant component can be associated with effects that may impact sleep. Both drowsiness and, less commonly, insomnia (difficulty falling or staying asleep) have been noted as potential adverse reactions.


Q: Is Antazol Plus safe for people with pre-existing heart conditions?

The official product information advises that this medicine should be used with caution in individuals with pre-existing cardiovascular disease and conditions like Long QT syndrome. This caution is related to the possibility of systemic effects from the decongestant component.


Q: Are there any documented cases of Antazol Plus interacting with alcohol?

Official regulatory documents focus primarily on drug-drug interactions, particularly those involving blood pressure. Checks on the decongestant component (Xylometazoline) typically indicate no known interactions with alcohol, but this does not confirm safety for every individual.


Q: Can Antazol Plus be used by children?

Official documentation indicates that this product is generally intended for use in adults and children. Use is generally not recommended for children under 2 years of age, and specific concentration guidelines vary by age group as outlined in official labeling.


Q: Can I take Antazol Plus if I have high blood pressure?

Official product information advises that the medicine should be used with caution in patients who have hypertension (high blood pressure). This advisory is based on the official documentation noting that the decongestant component can have effects on the cardiovascular system.


Q: Does Antazol Plus interact with caffeine?

Regulatory information indicates that the decongestant component belongs to a class of drugs that may have additive effects when combined with other central nervous system stimulants such as caffeine. This means the combined stimulating effects could be increased.


Q: Is Antazol Plus commonly prescribed for people over 65?

Older adults are included in the approved population for this medicine. Regulatory guidance advises that caution is generally recommended for use in the elderly due to a greater probability of decreased organ function or being on other concurrent medications.

How should Antazol Plus be stored and disposed of?

How to Store and Dispose of Antazol Plus?

This section outlines the official, labeled requirements for the storage, handling, and disposal of Antazol Plus based on governmental regulatory documents.

Storage and Handling Requirement Official Instruction
Temperature Store at a temperature not exceeding 30 C.
Environmental Protection Protect from light and protect from moisture.
Child Safety Keep out of reach of children.
Stability Discard the product when it is expired.

Disposal Instructions

To dispose of unused or expired Antazol Plus, follow official regulatory protocol. The medication should not be flushed down a toilet or poured into a drain unless specifically instructed on the product labeling. The preferred disposal method is to use a community drug take-back program. If this is unavailable, remove the medication from its original container, mix it with an undesirable substance (such as dirt or used coffee grounds), place the mixture in a sealed bag or container, and discard it in the household trash.

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

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