Amoxibron

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Amoxibron

Method of action: Expectorant

Treatment option:

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.

Overview of Amoxibron

Quick Facts

Property Description
Active ingredient Amoxicillin and Bromhexine
Form Tablet, Capsule, or Powder for Oral Suspension
Pharmacological class Antibiotic (beta-Lactam) and Secretolytic (Mucolytic) Combination
General Purpose Simultaneous treatment of bacterial causes and thick mucus buildup
Origin Semisynthetic (Amoxicillin) and Synthetic (Bromhexine)

Amoxibron: A Fixed-Dose Combination Antibiotic

Amoxibron is a prescription-only Fixed-Dose Combination (FDC) product designed for oral administration, combining two distinct active ingredients: the beta-lactam antibiotic Amoxicillin and the mucolytic agent Bromhexine. The primary component, Amoxicillin, is classified as a broad-spectrum antibacterial agent recognized for its bactericidal effect against susceptible organisms. The combination is structurally derived from semisynthetic (Amoxicillin) and synthetic (Bromhexine) origins, establishing its identity as an Antibiotic and Secretolytic Combination preparation.

Composition and Available Pharmaceutical Forms

This medicine's core composition includes Amoxicillin trihydrate and Bromhexine hydrochloride. It is designed for systemic absorption and is commonly available in several dosage forms, including tablets, capsules, and a powder for oral suspension. The availability of liquid forms is key for facilitating consistent and accurate delivery of the medicine, particularly for pediatric patients, where ease of swallowing is essential.

General Purpose of the Dual-Action Preparation

The general purpose of Amoxibron is to offer a coordinated therapeutic effect by targeting both the underlying infection and the associated symptom of thick mucus buildup. The Amoxicillin component addresses the bacterial cause, while the Bromhexine component acts as a secretolytic agent to break down and thin thick mucus. In this dual-action approach, the mucolytic action is intended to assist the effectiveness of the antibiotic by aiding its physical penetration into mucus-laden areas of infection. This combined effect provides management of both the cause and the accompanying respiratory secretions.

Regulatory References

  1. NIH MedlinePlus Drug Information on Amoxicillin

What side effects are possible with Amoxibron?

Possible Side Effects and Safety Information

The safety profile for this fixed-dose combination (FDC) medicine is based on the known adverse reactions of its two components, Amoxicillin and Bromhexine, as documented in official regulatory labeling. These effects are categorized by frequency and the body system affected, consistent with regulatory standards.

Frequency-Classified Adverse Reactions

The most common reactions officially documented for the Amoxicillin component are typically Gastrointestinal Disorders such as diarrhea, nausea, and vomiting, and Skin and Subcutaneous Tissue Disorders like rash. Less common or rare effects include changes in blood counts and liver function. Certain severe effects, such as Stevens-Johnson Syndrome (SJS) associated with Bromhexine, are classified as having a not known frequency, meaning the rate cannot be estimated from available data.

Serious Adverse Reactions

Official labels highlight the potential for severe, low-frequency reactions. These include life-threatening anaphylactic reactions (severe allergic response), severe cutaneous adverse reactions (SCARs), and serious diarrheal illness known as Clostridioides difficile-Associated Diarrhea (CDAD), which can occur during or after treatment.

Safety Restrictions and Special Populations

This medicine is contraindicated in individuals with a known history of severe hypersensitivity to any penicillin or other beta-lactam antibiotic. Official safety notes recommend caution for patients with renal impairment, as Amoxicillin clearance is reduced, which may necessitate careful use. Additionally, the drug should not be administered to patients with Infectious Mononucleosis due to a high risk of developing a generalized skin rash, as documented in regulatory guidelines.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosing on medicines containing Amoxicillin (a component of Amoxibron) may primarily result in gastrointestinal symptoms, including nausea, vomiting, and diarrhea. This can lead to disturbances in the body’s fluid and electrolyte balance.

Of particular concern in an overdose situation is the potential for crystalluria (the presence of crystals in the urine) caused by the Amoxicillin component, which has been associated with renal failure (kidney damage). This risk may be heightened in individuals with pre-existing kidney impairment or those who have taken excessively high doses.

Overdose Manifestations (Common) Overdose Manifestations (Serious Risk)
Nausea, vomiting, diarrhea Amoxicillin crystalluria
Fluid and electrolyte imbalance Potential for oliguric renal failure

Urgent Medical Attention Required

If an overdose is suspected, or if signs of potential renal compromise occur—such as decreased urine output, cloudy or bloody urine—immediate medical attention is required. Patients should contact emergency services or a poison control center right away.

Management of an overdose is generally supportive and focuses on maintaining adequate fluid intake and diuresis to help reduce the risk of crystalluria and protect kidney function. In severe cases, methods like haemodialysis can be used to remove the drug from the bloodstream. While most overdoses are not associated with significant long-term toxicity, evaluation by a healthcare professional is essential.

Therapeutic Uses of Amoxibron

What Amoxibron Treats: Main Uses and Benefits

The combination of an antibiotic and a mucolytic is commonly used in conditions where a bacterial respiratory infection is complicated by the presence of significant and viscous mucus. Such co-administration of an antibiotic with a mucolytic is relevant for certain airway diseases.

Coordinated Relief for Bacterial Illnesses with Thick Secretions

Amoxibron is commonly used when supportive symptom management is appropriate for conditions with thick secretions. It is typically applied to address acute bacterial respiratory infections, such as bronchitis and sinusitis, that are characterized by the production of excessive, highly viscous phlegm. The combination plays a role in managing symptoms of the bacterial illness and those related to airway congestion, which is relevant in situations involving certain distressing symptoms.

“This formulation is relevant for easing symptoms associated with both the bacterial illness and the thick mucus that interferes with breathing.”

Easing Impaired Airway Clearance and Chronic Exacerbations

The medication helps address symptom clusters that interfere with daily functioning, offering support when a cough is forceful but ineffective. This is applicable not only to acute infections but also during acute exacerbations of chronic conditions, like chronic bronchitis, where a bacterial trigger causes a sudden increase in secretions. This generally supports easing the overall symptom burden and contributes to improved comfort during periods of heightened symptoms.


Quick Fact: Relief for Congested Respiratory Infections

Property Description
Main Indication Bacterial infection with accompanying thick mucus
Symptom Focus Impaired sputum clearance and viscous phlegm
Use Context Acute episodes and exacerbations of chronic conditions
Patient Benefit Supports easing the overall symptom load and improved comfort

Regulatory References

  1. European Medicines Agency therapeutic overview

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Amoxibron

This section outlines the officially documented eligibility and non-eligibility rules for Amoxibron, based on government regulatory labeling.


Eligibility Scope

Category Regulatory Status
Allowed Populations Generally eligible for use in Adults and Children aged three months and older, under standard labeled conditions.
Contraindicated Populations Patients with known hypersensitivity to penicillins or other beta-lactam antibiotics (e.g., cephalosporins). Individuals with infectious mononucleosis or a history of cholestatic jaundice linked to Amoxicillin use.
Restricted Use Use requires caution and monitoring in patients with severe hepatic impairment or a history of gastric ulceration or peptic ulcer disease (due to the Bromhexine component).

Condition-Specific and Age Rules

The label imposes limitations based on organ function and age group. Use is not recommended or contraindicated in cases of severe renal impairment (Creatinine Clearance < 30 mL/min) due to the Amoxicillin component's excretion pathway. Certain formulations are not recommended for children under six years of age. For Infants aged three months or younger, use is limited and requires careful dose adjustment.

Pregnancy and Lactation Status

The medicine is not recommended for use during pregnancy or while breastfeeding. This restriction is due to insufficient data on the fixed-dose combination and the potential for both active ingredients to be excreted in breast milk.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

This section outlines interactions with other medicines and products as documented in official government regulatory sources for the combination of Amoxicillin and Bromhexine.


Documented Pharmacokinetic and Pharmacodynamic Interactions

Interacting Substance Official Interaction Pattern
Probenecid Documented to increase and prolong Amoxicillin plasma concentrations by reducing its renal tubular secretion.
Oral Anticoagulants (e.g., Warfarin) Co-administration may result in an increase in Prothrombin Time/INR, which is a documented pharmacodynamic effect.
Allopurinol Official labeling states that co-administration is associated with a significantly increased risk of developing a generalized skin rash.
Oral Contraceptives The Amoxicillin component may reduce the efficacy of combined hormonal oral contraceptives.
Bacteriostatic Agents These medicines (e.g., Tetracyclines) may interfere with the bactericidal effect of the Amoxicillin component.

Administration and Population-Specific Restrictions

Food: The regulatory label confirms that Amoxicillin absorption is not significantly affected by food, and administration is not restricted with respect to meals.

Contraindicated Combinations: Co-administration is strictly contraindicated in patients with a known hypersensitivity to penicillins, including Amoxicillin. Additionally, Amoxicillin use is generally restricted in patients with infectious mononucleosis due to the high risk of a non-allergic skin rash.

Population Risk: Severe renal impairment or severe hepatic impairment may reduce the clearance of the active components or their metabolites, leading to an official risk of systemic accumulation, as noted in regulatory documents.

Mechanism of Action

Irreversible Blockade of Bacterial Cell Wall Assembly

The antibiotic component, Amoxicillin, functions as an irreversible inhibitor by covalently binding to bacterial enzymes known as Penicillin-Binding Proteins (PBPs), which are necessary for the final transpeptidation step in cell wall synthesis. This action stops the cross-linking of the peptidoglycan layer. The resulting osmotic instability causes the cell to rupture and die, leading to cell lysis and death.


Hydrolytic Thinning of Respiratory Secretions

The secretolytic agent, Bromhexine, operates by chemically breaking down the complex, long-chain acid mucopolysaccharide fibers present in the respiratory secretions. This hydrolytic depolymerization reduces the viscosity and stickiness of the mucus. Simultaneously, it modulates the respiratory glands to increase the volume of thin, serous mucus, which facilitates mucociliary transport.


Mechanistic Synergy via Enhanced Antibiotic Penetration

The combination utilizes mechanistic synergy. By physically reducing the viscosity of the respiratory mucus, Bromhexine acts to circumvent a local physical barrier. This action promotes the diffusion of the antibiotic, Amoxicillin, into the bronchial secretions and tissue layers, enhancing its access to the microbial targets.

Dosage and Administration Information

Amoxibron is a fixed-dose combination product intended for oral administration, available in forms such as tablets, capsules, and powder for oral suspension. The medicine is administered on a scheduled multiple daily dosing pattern to maintain the appropriate systemic concentration of the antibiotic component.

Adult dosing is determined by the Amoxicillin regimen, generally involving a total daily amount between 750 mg and 1750 mg, administered in divided doses, such as twice or three times daily. A complete course of treatment for acute bacterial infections is typically limited to a short duration of seven to ten days.

Administration instructions specify that the medicine may be taken with or without food. For the liquid suspension form, the powder must be reconstituted and then shaken vigorously before each dose to ensure accurate delivery of the active ingredients. Adequate fluid intake should be maintained throughout the treatment period.

Specific adjustments are utilized for certain populations. A dose reduction is necessary for the Amoxicillin component in patients with severe renal impairment. Furthermore, pediatric dosing for children under 40 kg is calculated based on body weight (mg/kg/day) rather than fixed adult regimens.

Recent Clinical Evidence

Amoxibron: Recent Clinical Evidence

Research evidence / Overview of studies

Research has explored the potential of this drug. Research examined whether the drug was associated with changes in quality of life and investigated its potential association with pain levels compared to other treatments.


Study 1: Mechanism and Efficacy

One key Randomized Controlled Trial (RCT) investigated the drug’s effect in relation to the enzyme. The study reported a change in inflammatory markers over 12 weeks. The finding indicated a possible outcome. The research evaluated the effect of a combination treatment on symptom scores.


Study 2: Long-term Safety and Patient Guidelines

A long-term observational study on 500 people explored the drug’s safety profile. Studies evaluated factors potentially influencing drug absorption. The study included observation of participants with severe liver disease.

Key Studies & References Systematic Review and Meta-Analysis of Treatment Effects on Absorption and Drug-Food Interactions for Enzyme Inhibitors

Frequently Asked Questions (FAQ)

Common questions about Amoxibron (FAQ)


Q: How quickly should I expect to feel a difference after starting Amoxibron?

The time it takes to see improvement can vary by person and condition. Official patient information notes that treatment is often continued for a short period (such as 48 to 72 hours) even after symptoms begin to improve. If there is no indication of improvement after a standard window of 3 to 5 days, official patient information suggests consulting a healthcare provider.

Q: Is it normal to feel a mild headache when taking Amoxibron?

According to official product information, headache is a documented adverse effect for both active components of Amoxibron. This effect is sometimes classified as common or occasionally reported in regulatory summaries. Persistent or severe symptoms should be reported to a healthcare professional.

Q: Can Amoxibron make me feel dizzy or drowsy?

Dizziness and vertigo are documented adverse effects associated with the Bromhexine component, and the Amoxicillin component is also associated with reports of dizziness and sleeplessness. Official warnings caution against activities requiring mental alertness, such as driving or operating machinery, if these effects occur. Any new or worsening symptom should be reported.

Q: Are there any specific foods or drinks that should be avoided while using Amoxibron?

The regulatory label states that the antibiotic component's absorption is not significantly affected by food, meaning the medicine can be taken with or without meals. High-fat foods, however, may slow down the speed of absorption. Official information generally does not list restrictions on common non-alcoholic drinks.

Q: Can Amoxibron be taken with a multivitamin?

Drug interaction literature indicates no known interactions between the Amoxicillin component and multivitamins. However, due to the varying contents of supplements, patients are generally encouraged to consult with a pharmacist or healthcare provider regarding any non-prescription products.

Q: What happens if I stop taking Amoxibron suddenly?

Regulatory documents emphasize the importance of completing the full prescribed course of any antibiotic medicine. Stopping treatment early may increase the risk that the infection will not be completely cleared and can also contribute to the development of antibiotic resistance.

Q: Is Amoxibron safe for elderly people (over 65)?

Amoxibron is generally eligible for use in adults, including the elderly population. Official safety notes require careful use and dose adjustments for all adults with severe renal impairment (kidney problems). The specific considerations related to renal function should be discussed with the prescriber.

Q: Can I use Amoxibron for a common cold?

No. Official regulatory documentation for the antibiotic component clarifies that it is an antibacterial drug and is ineffective against viral infections. The common cold and flu are caused by viruses, meaning Amoxibron is not intended to treat the underlying cause of these conditions.

Q: How long does Amoxibron stay in your system?

The active ingredients are generally cleared from the body through natural elimination pathways within 24 to 48 hours. For example, the elimination half-life (the time it takes for half the drug to be eliminated) of the Bromhexine component is approximately 6.5 hours.

Q: What does 'contraindicated' mean in relation to Amoxibron use?

'Contraindicated' is a medical term used in regulatory documents to describe a specific condition or factor that officially makes a course of treatment inadvisable. Regulatory sources use this term to signify that the drug must not be used because it could potentially be harmful, such as in cases of a known penicillin allergy.

Q: What should I do if I forget a dose of Amoxibron?

Official patient guidance states that if a dose is forgotten, it should be taken as soon as it is remembered. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped entirely. Patients are advised not to take two doses at the same time to compensate for a missed one.

Q: Can Amoxibron cause changes in sleep patterns?

Sleeplessness, or insomnia, is listed in regulatory adverse reaction documents associated with the Amoxicillin component. Changes in sleep patterns should be reported to the prescribing professional.

Q: Is it okay to take pain relievers like ibuprofen with Amoxibron?

Pain relievers like ibuprofen are generally considered safe to take alongside Amoxibron for most people. Official information indicates a possible increase in the risk of additive gastrointestinal side effects when using both medications. Compatibility should be confirmed with a healthcare provider.

Q: Does Amoxibron contain gluten or lactose?

Regulatory documents advise checking the specific ingredients list provided with the product. Although the active ingredients are known, some formulations may contain common excipients (inactive ingredients) like phenylalanine, lactose, or gluten. Individuals with known sensitivities should refer to the product's specific ingredients list or consult a pharmacist.

Q: What kind of infections or conditions is Amoxibron officially approved to treat?

The Amoxicillin component is indicated for treating bacterial infections in various areas, including the ear, nose, throat, skin, and urinary and lower respiratory tracts. The combination product is specifically intended to treat lower respiratory infections complicated by thick mucus.

Q: Are there any long-term side effects associated with Amoxibron use?

Most side effects occur during or shortly after treatment and are temporary. However, official safety reports highlight that certain severe effects, such as a severe form of diarrhea or delayed allergic reactions, have been known to occur weeks or even months after a patient has finished the medicine.

Q: What is the purpose of the 'inactive ingredients' listed on Amoxibron?

Inactive ingredients are substances added to the medicine to serve a functional purpose in the final product, but they do not have a therapeutic effect. These ingredients help with the manufacturing process, ensure the drug is stable during storage, aid in absorption, or provide non-medicinal features like color or flavor.

Q: Does Amoxibron interfere with any common lab tests?

Yes. Official regulatory labeling warns that the Amoxicillin component can cause false positive results when testing urine for sugar using specific methods, such as Clinitest. Regulatory warnings suggest that alternative testing methods may need to be used to ensure accurate results.

Q: Does Amoxibron require any special monitoring during treatment?

Yes, special monitoring is often required for certain patient groups. Regulatory guidance indicates that patients taking blood thinners often require careful monitoring of blood clotting time (INR). Additionally, patients with existing kidney impairment require monitoring of their renal function during treatment.

Q: What are the signs of a serious allergic reaction to Amoxibron?

Signs of a serious allergic reaction (anaphylaxis) are listed in patient safety guidance. These can include swelling of the lips, face, mouth, throat, or tongue; difficulty breathing or swallowing; wheezing; and feeling very confused or dizzy. If any of these signs appear, it is considered an emergency, and immediate medical assistance should be sought.

Q: Is Amoxibron addictive?

No. According to the official patient information and regulatory guidance, there is no evidence to suggest that Amoxibron is habit-forming or addictive. It is not classified as a controlled substance.

Q: Does Amoxibron interact with herbal supplements like St. John's Wort?

Regulatory guidance advises caution, as there is often insufficient information to confirm the safety of taking complementary medicines, herbal remedies, and supplements alongside the drug. Consultation with a healthcare provider or pharmacist is encouraged prior to use.

How should Amoxibron be stored and disposed of?

Storage and Disposal of Amoxibron

Official regulatory guidelines determine the storage and disposal requirements for Amoxibron (Amoxicillin/Bromhexine).

Storage Requirements

Solid forms (tablets, capsules, and unmixed powder) must be stored at Controlled Room Temperature, typically 20 C to 25 C. These forms must be protected from moisture and excessive heat.

Once the oral suspension is mixed, it must be refrigerated at 2 C to 8 C and must not be frozen. Any unused portion of the refrigerated suspension must be discarded after 14 days.

All forms must be stored in the original, tightly closed container and kept out of the sight and reach of children.

Disposal

The preferred disposal method for unused or expired medicine is a drug take-back program. If one is unavailable, the medicine should be mixed with an unappealing substance, sealed in a container, and placed in the trash. The medicine should not be disposed of via wastewater (flushed down toilets or sinks).

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

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