Azutan Colutorio

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Azutan Colutorio

Method of action: Local Anesthetic, Stomatological

Treatment option: Bacterial Vaginosis

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 Azutan Colutorio

Quick Facts

Property Description
Active ingredient Benzydamine hydrochloride
Form Colutorio (Liquid Oral Rinse)
Pharmacological class Local NSAID and Local Anesthetic
General purpose Symptomatic relief of pain and swelling
Origin Synthetic Benzimidazole Derivative

Azutan Colutorio: Definition, Form, and Pharmacological Class

Azutan Colutorio is a medicinal preparation formulated as a colutorio, or liquid oral rinse, intended for topical application to the mucous membranes of the mouth and throat. Its active substance, Benzydamine hydrochloride, grants the drug a dual pharmacological classification: it functions as both a locally-acting Non-Steroidal Anti-inflammatory Drug (NSAID) and a local anesthetic.

The preparation is specifically engineered for oromucosal administration, concentrating its activity at the site of inflammation. Benzydamine is effective as a topical anti-inflammatory agent and pain reliever. The colutorio form is often positioned for ease of use in adults requiring comprehensive rinsing of the oropharyngeal area.

Composition and Origin of Benzydamine

The therapeutic efficacy of Azutan Colutorio relies on its sole active ingredient, Benzydamine hydrochloride. This compound is a synthetic substance belonging to the benzimidazole chemical group.

Benzydamine is structurally distinct from the majority of traditional NSAIDs. This unique indazole analogue structure allows it to accumulate selectively in inflamed tissues, a property that enhances localized anti-inflammatory effects. The colutorio consists of the dissolved active compound within an aqueous or hydro-alcoholic solution, serving as the necessary vehicle for effective local delivery.

General Therapeutic Purpose and Action

The general purpose of Azutan Colutorio is to provide effective symptomatic relief for pain and swelling associated with irritation. This action is driven by the dual mechanism of Benzydamine: anti-inflammatory activity that reduces tissue irritation and a swift local analgesic effect that alleviates discomfort. This combined approach targets the two primary components of mucosal distress simultaneously.

What side effects are possible with Azutan Colutorio?

Possible Side Effects and Safety Information

The safety profile of Azutan Colutorio (Benzydamine hydrochloride oral rinse) is officially documented by regulatory authorities, classifying possible adverse reactions by the frequency of their occurrence in clinical use and the body system affected.

Frequency and System-Organ Class

The most frequently documented side effects are localized sensory disturbances, which are classified as Uncommon (affecting up to 1 in 100 people). These typically involve a local sensation of numbness, stinging, or burning in the mouth and throat. Effects on other System-Organ Classes (SOCs) may include generalized symptoms such as headache, drowsiness, dry mouth, nausea, and vomiting.

Adverse reactions classified as Very Rare (affecting less than 1 in 10,000 people) include skin rash and itching. Severe systemic reactions are officially documented but have a Not Known frequency, meaning the occurrence rate cannot be estimated from available data.

Classification Example Reactions (SOC)
Uncommon Local numbness, stinging/burning sensation (Gastrointestinal/Nervous System)
Very Rare Skin rash, itching (Skin and Subcutaneous Tissue)
Not Known Severe allergic reaction (Anaphylaxis) (Immune System)

Serious Adverse Reactions and Safety Constraints

Official regulatory documents recognize the potential for a severe allergic reaction, such as anaphylaxis, as a serious adverse reaction. Signs of this condition include difficulty breathing and swelling of the throat, and it represents a critical safety restriction.

Safety statements require particular consideration for specific populations and conditions. Use is generally restricted in individuals with a known hypersensitivity to the active substance or excipients. Furthermore, official labels advise caution for patients with a history of bronchial asthma or known hypersensitivity to other NSAIDs, as well as during pregnancy and lactation.

Overdose and Emergency Response

The official regulatory documents state that systemic overdose of Azutan Colutorio (Benzydamine hydrochloride) is a risk primarily associated with the accidental ingestion of large quantities of the liquid oral rinse. Symptoms are not expected from normal topical use.

Documented Overdose Manifestations

Overdose manifestations are categorized into two main system effects:

  • Gastrointestinal (GI): Documented symptoms include nausea, vomiting, abdominal pain, and oesophageal irritation.
  • Central Nervous System (CNS): Clinical signs listed in labeling include dizziness, agitation, irritability, and hallucinations. Severe systemic exposure carries the potential for significant CNS toxicity, including the documented risk of seizures.

When to Seek Immediate Medical Help

If accidental ingestion of a large quantity is suspected, immediate medical assistance is required, even if symptoms have not yet appeared. The regulator mandates that individuals contact a healthcare practitioner, hospital emergency department, or a regional Poison Control Centre immediately.

Required Management and Observation

Management for overdose is strictly symptomatic and supportive, as no specific antidote is known for benzydamine hydrochloride. Patients must be kept under close medical observation, and supportive measures, such as maintaining adequate hydration, are officially described in the regulatory guidance.

Therapeutic Uses of Azutan Colutorio

What Azutan Colutorio Treats: Main Uses and Benefits

Azutan Colutorio is commonly used to address the symptomatic discomfort associated with acute inflammatory episodes in the throat and mouth, such as severe sore throat (pharyngitis) and painful oral mucosal conditions. The rinse is considered relevant for conditions presenting with symptomatic discomfort in the mouth and throat, including mouth ulcers (stomatitis), inflamed gums (gingivitis), and pain following dental surgery or tonsillectomy. It is commonly used when symptom clusters create noticeable physiological strain in the oropharyngeal area.

The medication offers symptomatic relief that helps patients cope more steadily with symptom fluctuations, contributing to improved comfort during symptomatic periods. It may also be part of symptomatic management in oncology, helping address symptoms related to oral mucositis that may occur during head and neck radiation therapy.


Quick Fact Relief for Localized Discomfort
Primary Domain Symptomatic management of pain and swelling in the mouth and throat.
Key Scenarios Acute sore throat, oral ulcers, post-dental procedures.

Regulatory References

  1. Public Assessment Report on Benzydamine Mouthwash

Eligibility and Restrictions for Use

Population Eligibility and Contraindications

Category Official Regulatory Classification
Populations for whom use is allowed Adults and adolescents aged 13 years and over.
Populations for whom use is contraindicated Patients with known hypersensitivity to benzydamine or any of the product's excipients.
Age-related eligibility rules The oral rinse formulation should not be used in children aged 12 years and under.
Eligibility-related restrictions Use is not advisable in patients with known hypersensitivity to acetylsalicylic acid or other NSAIDs.

Conditional Use and Special Populations

Category Official Regulatory Classification
Pregnancy and lactation eligibility Should not be used during pregnancy or lactation unless clearly deemed essential, as safety has not been established.
Condition-specific eligibility Caution must be exercised in patients with a history of bronchial asthma, due to the risk of precipitating bronchospasm.
Organ-function caution The possibility of systemic action must be considered in patients with renal impairment.

The official eligibility profile for Azutan Colutorio establishes clear non-eligibility for individuals with allergies to the active substance, and explicitly restricts use in children 12 years and under. Conditional use is required for populations like pregnant or breastfeeding individuals and those with asthma, where specific labeled warnings dictate caution.

What should I know about interactions with other medicines?

Azutan Colutorio, which contains the active ingredient Benzydamine hydrochloride, is formulated as a liquid oral rinse for strictly topical application. The official regulatory profile for this medicine is characterized by the absence of documented systemic interactions with other medicinal products.

Due to the localized route of administration and the resulting minimal systemic absorption, government regulatory bodies have concluded that no clinically relevant drug interactions have been reported for the locally administered rinse. Official prescribing information states that no specific interaction studies have been performed.

Official Interaction Profile

Classification Regulatory Status
Documented Drug-Drug Interactions None known.
Formal Contraindications for Interaction None documented.
Pharmacokinetic (Metabolic) Alterations Not documented (Minimal systemic exposure).
Required Timing Separation Rules None required.

The regulatory data confirms the absence of documented interactions that would significantly alter systemic exposure or involve specific metabolic pathways (e.g., CYP enzymes or transporters). Accordingly, the official product labeling does not impose mandatory timing rules for separation when co-administering other medicines.

Furthermore, no restrictions or prohibitions regarding interaction risks with food, alcohol, or herbal products are specified in the official regulatory documentation for Azutan Colutorio. The regulatory position is strictly based on the low systemic availability achieved through oromucosal application.

Mechanism of Action

How Azutan Colutorio Works

The action of Benzydamine hydrochloride involves a dual pharmacological mechanism—inhibition of inflammatory pathways and modulation of pain signal transmission—achieved at the site of application through two interrelated mechanistic domains.

Direct Inhibition of Signal Transmission

This domain involves the rapid modulation of sensory nerve activity achieved through direct molecular interaction with peripheral nociceptors. Benzydamine molecules intercede at the voltage-gated sodium channels ( Na v), causing a non-selective blockade that alters the nerve membrane potential, thereby preventing the necessary ion flux for generating an action potential. This mechanism arrests the electrical signal at its source, leading to the inhibition of electrical signal propagation in peripheral sensory nerve fibers.

Modulation of Upstream Inflammatory Cascades

This second domain involves modulating key inflammatory mediators and cellular structures. The drug inhibits the activation of the p38 MAPK pathway and reduces the synthesis and release of major pro-inflammatory cytokines, notably TNF-α and IL-1beta. Furthermore, it stabilizes lysosomal membranes in immune cells. This targeted interference with early molecular steps and cellular function limits the local accumulation of fluid and inflammatory compounds, resulting in decreased vascular exudation and tissue fluid accumulation.

Dosage and Administration Information

Official Administration Guidelines for Azutan Colutorio

Azutan Colutorio, which contains Benzydamine hydrochloride 0.15% w/v, is intended for oromucosal administration only. The instructions for its use define the route, volume, frequency, and time limits for administration.

Dosing and Technique

  • Route of Administration: Topical application to the mouth and throat mucosa via gargle or rinse.
  • Standard Dose: 15 mL of the solution should be used for each single dose. This volume is typically measured using the cup provided with the product.
  • Frequency: The dose may be repeated every 1.5 to 3 hours as required for symptomatic relief. The minimum interval between doses must be respected.
  • Preparation: The solution should generally be used undiluted. However, if the user experiences a local stinging sensation or irritation, the rinse may be diluted by adding an equal amount of lukewarm water (1:1 dilution) before use.

Procedural Requirements and Constraints

  • Duration of Contact: The liquid must be kept in contact with the inflamed mucosal area for 20 to 30 seconds during the rinse or gargle.
  • Do Not Swallow: The solution must be expelled from the mouth immediately after the rinse; it is not for internal consumption.
  • Treatment Duration: Uninterrupted use should not exceed seven days. If discomfort persists or worsens after seven days, or after three days when treating mouth ulcers, use must be discontinued unless explicitly advised otherwise by a healthcare professional.
  • Age Restriction: The standard adult dosing regimen applies to adolescents aged 13 years and over. The 0.15% w/v mouthwash is not recommended for children aged 12 years or under.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Azutan Colutorio


Evidence for Use in Acute Sore Throat

Research into the use of Azutan Colutorio (Benzydamine Oral Rinse) for acute throat discomfort has primarily been conducted through Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies monitored adults with symptoms from conditions characterized by episodic or acute manifestations, such as pharyngitis. The research explored how symptoms change over time by focusing on patient-reported outcomes describing perceived discomfort, specifically through the measurement of pain severity and the assessment of symptoms like difficulty swallowing.

In these studies, data show patterns related to short-term symptom changes following administration. Findings describe patterns observed in the studies regarding the time taken for patients to report a measurement change in symptom severity. Some older clinical reports were cited within systematic reviews to contribute to the broader evidence landscape.

Evidence for Preventing Symptoms of Radiation-Induced Oral Mucositis

The research structure for this indication is established, including consensus guidelines. Research was evaluated in settings where symptoms may vary in intensity, specifically for patients undergoing moderate-dose radiation therapy. The studies conducted during periods of increased symptom activity were often placebo-controlled and have informed major international oncology Consensus Guidelines.

Research examined outcomes capturing phases of heightened symptom activity, primarily to evaluate findings related to the incidence and severity of oral mucositis, which are outcomes linked to inflammatory or irritative states. Studies also explored the time to onset for severe grades of mucosal injury.

Evidence for Symptomatic Pain after Procedures

Research has explored the use of the oral rinse in conditions involving temporary discomfort in the oropharyngeal area following various procedures, including postoperative sore throat after intubation and pain from minor oral surgeries. The evidence is derived from settings with varying symptom burdens, relying on Randomized Controlled Trials (RCTs) and Meta-analyses that combined information from these trials.

Studies monitored outcomes related to physical discomfort in the immediate aftermath of a procedure, such as assessing the incidence and severity of throat soreness. However, findings were mixed when aggregating data across trials, particularly for evaluating discomfort after intubation. Some trials described certain observed patterns, while others reported an absence of measurable difference when compared to the control group.

What is Still Uncertain About the Research Base

Research exploring long-term use is not the primary focus of the existing evidence base; follow-up durations were limited, meaning the data available is often restricted to short-term time intervals. The evidence also highlights uncertainties regarding certain groups: data for older adults are not well-characterized, and research is limited regarding application in patients receiving accelerated or high-dose radiation therapy regimens.

Key Studies & References

  1. Public Assessment Report, Decentralised Procedure, Benzydamine Hydrochloride 0.15% w/v Mouthwash (MHRA)

Frequently Asked Questions (FAQ)

Common questions about Azutan Colutorio (FAQ)


Q: Is Azutan Colutorio considered a prescription medicine or is it over-the-counter?

Official information indicates that the Benzydamine 0.15% w/v rinse may be available to purchase from a pharmacy (over-the-counter) or may be available on prescription. The specific classification depends on the country's regulations or the indication for which it is being used.


Q: Does Azutan Colutorio contain alcohol?

Official product information for some formulations of Benzydamine 0.15% w/v mouthwash does list Ethyl Alcohol as a non-medicinal ingredient. It is noted that alcohol-free versions of the rinse may also be available in certain regions.


Q: Is it common to feel a slight tingling sensation after using Azutan Colutorio?

Some users have reported a feeling of stinging or numbness in the mouth and throat after using the product. Regulatory documents describe this local sensory change as a known, though uncommon, side effect. This sensation is generally temporary and expected to fade within a few minutes.


Q: How quickly does Azutan Colutorio start to feel like it's working?

Evidence indicates that symptoms will usually start to improve within a few minutes after the product is used. The effect is generally maintained for a period of a few hours, based on the required dosing interval.


Q: Is there any information about using Azutan Colutorio during pregnancy or breastfeeding?

Official documents advise that the product should not be used during pregnancy or lactation unless it is determined to be clearly essential, as the safety profile for use in these specific populations has not been established.


Q: What should I do if I miss a usage of Azutan Colutorio?

If a usage is missed, official instructions advise using the rinse as soon as it is remembered. The instructions indicate that use should continue at the required interval, but users are advised against taking an extra dose to compensate.


Q: Is there a specific age limit for who can use Azutan Colutorio?

Official regulatory labels state that the 0.15% w/v mouthwash is intended for use by adults and adolescents aged 13 years and over. It is explicitly not recommended for children aged 12 years and under.


Q: Does the efficacy of Azutan Colutorio change if I dilute it with water?

Regulatory warnings state that the mouthwash should ideally be used undiluted. Dilution (adding an equal amount of lukewarm water) is specifically permitted only if the user experiences local irritation or stinging. The label does not provide specific data quantifying the impact of dilution on symptom relief.


Q: Does Azutan Colutorio contain sugar or artificial sweeteners?

The list of non-medicinal ingredients for some Benzydamine oral rinse products includes a sweetener. This is typically Sorbitol Solution, which is added alongside flavoring agents.


Q: How long does the effect of Azutan Colutorio last in the mouth?

Official instructions indicate the duration of effect by setting the minimum interval between doses at every 1.5 to 3 hours. This is the interval determined by regulatory authorities for maintaining the symptomatic effect.


Q: What happens if I forget to spit out the mouthwash completely?

Official documents strictly state that the product must be expelled from the mouth immediately after rinsing, as it is not for internal consumption. Official guidance indicates that if a user, including a child, swallows significantly more than the recommended dose, contact with a Poison Control Center or medical attention may be necessary.


Q: Are there different formulations or flavors of Azutan Colutorio available?

Regulatory labels indicate that various versions may exist, often differentiated by non-medicinal ingredients. These may include a standard formula and an alcohol-free formula, which can be identified by checking the ingredients list.


Q: Are there different strengths of Azutan Colutorio available?

Regulatory documents for Benzydamine rinses typically define the standard strength as 0.15% w/v. The active ingredient may also be available in other forms and strengths, such as sprays or lozenges.


Q: Is Azutan Colutorio different from generic mouth rinses?

Official regulatory information classifies this product as a Local Non-Steroidal Anti-inflammatory Drug (NSAID) and a Local Anesthetic. This classification defines its difference from non-medicinal mouthwashes or simple antiseptic rinses.


Q: Is staining of the teeth or tongue a possible side effect of Azutan Colutorio use?

The regulatory data for Benzydamine mouthwash does not list tooth or tongue staining as a known or commonly reported side effect. The most frequently documented side effects are local sensory changes, such as stinging or numbness.


Q: Is it safe to use Azutan Colutorio while undergoing dental procedures or treatments?

Official data confirms that the local route of administration results in minimal systemic absorption, meaning no clinically relevant drug-drug interactions are reported with other medicines. This addresses the main safety concern with systemic interference.


Q: Can Azutan Colutorio be used long-term, or is it only for short-term use?

The official regulatory limit states that uninterrupted use should not exceed seven days. If the discomfort persists or worsens after this period, use must be stopped unless otherwise advised by a healthcare professional.


Q: What is the purpose of the main ingredient in the overall treatment?

The main ingredient, Benzydamine hydrochloride, is officially defined as having a dual mechanism of action. Its purpose is to provide both local anti-inflammatory activity to reduce irritation and a swift local analgesic effect to alleviate discomfort.


Q: Are there common user misunderstandings about the 'How it works' section of Azutan Colutorio?

The mechanism is officially described as involving two actions at the site of application: the inhibition of electrical pain signals in sensory nerves, and the modulation of inflammatory cascades to reduce swelling and irritation. This dual action is key to its intended use.


Q: Does Azutan Colutorio affect the way food or drinks taste afterward?

While direct taste alteration is not explicitly listed, the official profile reports local sensory changes like numbness and a stinging/burning sensation as uncommon side effects. These temporary sensory changes could affect perception immediately after use.


Q: Is it necessary to rinse with water after using Azutan Colutorio?

Official instructions specify that the solution must be expelled from the mouth immediately after rinsing. The procedure does not require or mention an additional rinse with water afterward.


Q: Are there any limitations on what kind of research supports Azutan Colutorio?

Regulatory summaries indicate that the existing research primarily focuses on short-term use, meaning studies exploring long-term effects have limited follow-up periods. Additionally, data for certain groups like older adults are described as not being well-characterized.


Q: Is it possible to use Azutan Colutorio too frequently?

The regulatory label defines the minimum interval between uses as every 1.5 to 3 hours. Using the product more frequently than this minimum interval is inconsistent with the official dosing guidelines.

How should Azutan Colutorio be stored and disposed of?

How to Store and Dispose of Azutan Colutorio

Azutan Colutorio (Benzydamine mouthwash) must be stored and disposed of according to official regulatory requirements to maintain its stability and ensure environmental safety.


Official Storage and Stability Rules

Requirement Type Constraint Defined in Regulatory Labeling
Temperature Limit Do not store above 25 C
Protection Keep the product in its original outer carton to protect from light.
Child Safety Must be kept out of the sight and reach of children.
In-Use Stability Once opened, do not keep for more than 6 months.
Visual Check Do not use if there are visible signs of deterioration.

Disposal Instructions

Unused or expired Azutan Colutorio must not be thrown away via wastewater or standard household waste. Disposal must be carried out in accordance with local requirements, typically through a pharmacy take-back scheme, to prevent environmental contamination.

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

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