Augmentin

Quick links to important sections

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 Augmentin

Quick Facts

Property Description
Active Ingredients Amoxicillin and Clavulanic Acid (Co-amoxiclav)
Form Tablet, Extended-release tablet, Powder for oral suspension
Pharmacological Class β-Lactam Antibiotic (Penicillin-class)
Common Type Fixed-dose combination, Potentiated
Route Oral

What Type of Medicine is Augmentin (Co-amoxiclav)?

Augmentin is the trade name for Co-amoxiclav, a prescription-only, fixed-dose combination antibiotic used to combat bacterial infections. This medicine belongs to the established penicillin class and is classified as a β-lactam antibiotic combined with an enzyme inhibitor. This combination design is essential for preventing the breakdown of the antibiotic by resistant bacteria. Augmentin is a brand marketed by GlaxoSmithKline and is differentiated by its variety of formulations, including specific extended-release tablets and flavored oral suspensions, making it suitable for both adult and pediatric populations. It is clinically recognized for its reliable use in treating common infections, such as those affecting the sinuses or the middle ear.


What is the Composition and Function of Augmentin?

The medicine is composed of two primary active ingredients: Amoxicillin (the main antibacterial agent) and Clavulanic Acid, typically supplied as Potassium Clavulanate. Amoxicillin works by targeting and preventing the growth of the bacterial cell wall. The crucial function of the Clavulanic Acid is to act as a protector—a beta-lactamase inhibitor that neutralizes the destructive enzymes produced by resistant bacteria. The strategic pairing of Amoxicillin with Clavulanic Acid results in synergistic antibacterial activity against many enzyme-producing strains. This synergistic effect is the medicine's core purpose, transforming it into a potentiated broad-spectrum anti-infective agent capable of reliably clearing bacterial infections that would otherwise overwhelm Amoxicillin alone.


In What Dosage Forms is Augmentin Supplied?

Co-amoxiclav is supplied for oral administration in several dosage forms to accommodate various patient needs and ages. The primary forms include a tablet (available in standard and the distinct extended-release formats) and a powder for oral suspension, which is reconstituted into a liquid form. These diverse formulations ensure that the benefits of this dual-action drug can be reliably delivered across patient populations, regardless of age or swallowing difficulty.

Regulatory References

  1. MedlinePlus Reference

What side effects are possible with Augmentin?

Possible Side Effects and Safety Information

The safety profile of Augmentin (Co-amoxiclav) is formally established through regulatory classifications that organize documented adverse reactions by frequency and the body system affected. These classifications reflect how government regulatory documents communicate the medicine’s safety profile.

Frequency of Adverse Reactions

The most common effects listed in official labeling include diarrhoea and mucocutaneous candidiasis. Uncommon reactions may involve nausea, vomiting, indigestion, headache, dizziness, and skin disorders such as rash and urticaria. Rare and very rare reactions encompass more clinically significant systemic events.

Key System-Organ Classifications

Adverse events are often grouped into specific physiological systems. Gastrointestinal Disorders are frequently reported, while effects on the Hepatobiliary Disorders (liver and bile) and Immune System Disorders are also documented. Other affected systems include the Skin and Subcutaneous Tissue and the Blood and Lymphatic System.

Serious Adverse Reactions and Safety Restrictions

Regulatory documents list serious adverse reactions that require specific attention, including severe hypersensitivity responses like anaphylaxis and angioedema, as well as severe liver injuries (e.g., hepatitis or cholestatic jaundice) and severe skin conditions (e.g., Stevens-Johnson Syndrome). Use is contraindicated in individuals with a history of a severe immediate allergic reaction to any penicillin or a history of previous Augmentin-associated liver dysfunction.

Contextual Safety Notes

The official labeling provides contextual notes on risk. Hepatotoxicity may be more frequent in older adult males and may be associated with long-term treatment (exceeding 14 days), with onset potentially occurring during or shortly after the cessation of therapy. Monitoring of haematological and renal parameters is noted as appropriate during prolonged exposure.

Overdose and Emergency Response

Overdose and when to seek help

If overdosage of Augmentin (Amoxicillin and Clavulanate Potassium) is suspected, the regulatory guidance states that the medicine must be discontinued immediately, and symptomatic treatment with supportive measures must be instituted as required.

Documented clinical manifestations of overdose often involve gastrointestinal symptoms, including stomach pain, vomiting, and diarrhea. Less commonly observed manifestations are rash, hyperactivity, or drowsiness.

Severe outcomes and life-threatening complications explicitly documented in official labeling primarily affect the renal and central nervous systems. These include amoxicillin crystalluria, which in some cases can lead to oliguric renal failure or interstitial nephritis. Additionally, the risk of convulsions (seizures) is recognized as a potential CNS effect.

Urgent procedural management is defined by regulatory authorities. As there is no specific antidote, treatment focuses on supportive clearance. Hemodialysis is documented as a measure to effectively remove both active components from the circulation. Maintaining adequate fluid intake and diuresis is required to reduce the risk of crystalluria, particularly in patients with impaired renal function who are susceptible to high blood concentrations. Overdosages below a specified threshold in pediatric patients typically do not require gastric emptying.

Therapeutic Uses of Augmentin

Main Uses of Augmentin

Augmentin is a combination antibiotic used to treat a variety of bacterial infections. By combining amoxicillin, a penicillin-type antibiotic, with potassium clavulanate, the medication is effective against bacteria that might otherwise be resistant to amoxicillin alone. It is primarily prescribed for infections caused by susceptible strains of bacteria in several areas of the body.

Respiratory Tract Infections

Augmentin is frequently used to manage infections of the upper and lower respiratory tracts. This includes:

  • Sinusitis: Inflammation and infection of the sinus cavities.
  • Otitis Media: Middle ear infections, common in pediatric patients.
  • Bronchitis: Infections of the bronchial tubes, particularly during acute flare-ups of chronic bronchitis.
  • Pneumonia: Bacterial infections of the lung tissue.

Urinary Tract Infections (UTI)

The medication is effective against certain bacteria that infect the urinary system. It may be prescribed for:

  • Cystitis: Infection of the bladder.
  • Urethritis: Infection of the urethra.
  • Pyelonephritis: More severe infections involving the kidneys.

Skin and Soft Tissue Infections

Augmentin is utilized for skin-related bacterial issues, particularly those caused by bacteria that produce beta-lactamase. Common applications include:

  • Infected animal or human bites.
  • Cellulitis: A deep skin infection.
  • Severe dental abscesses: Infections of the gums or teeth that spread to surrounding tissues.

Benefits of the Combination Formula

The primary benefit of Augmentin lies in its dual-action composition. While amoxicillin works to inhibit the growth of bacteria, many bacteria have evolved to produce enzymes called beta-lactamases that deactivate amoxicillin. The addition of clavulanate potassium serves to block these enzymes, protecting the amoxicillin and allowing it to remain effective against a broader spectrum of bacterial pathogens.

Eligibility and Restrictions for Use

Augmentin (amoxicillin/clavulanate) eligibility is determined by specific regulatory constraints related to patient history and organ function, as defined by official labeling.

Who Must Not Use Augmentin (Contraindications)

Classification Population/Condition
Absolute Patients with a history of serious hypersensitivity (e.g., anaphylaxis) to any penicillin or other beta-lactam antibiotic [Source 1.1, 2.5].
Absolute Patients with a previous history of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate use [Source 1.1, 2.5].
Formulation-Specific Patients with severe renal impairment (CrCl < 30 mL/min) or those on hemodialysis must not use the extended-release (XR) formulation [Source 1.4].

Populations with Conditional Use

Augmentin is generally approved for adults and pediatric patients ge 12 weeks (3 months) of age [Source 1.2, 1.5]. However, its use is restricted in certain cases:

  • Organ Impairment: Patients with hepatic impairment require caution and monitoring of liver function [Source 1.2, 3.1]. Those with renal impairment (CrCl < 30 mL/min) must have their dosage adjusted, and certain high-ratio formulations are not recommended [Source 1.5, 3.4].
  • Specific Conditions: Use should be avoided in patients with Infectious Mononucleosis due to the risk of developing a skin rash [Source 1.2, 2.6].
  • Pregnancy/Lactation: The medicine is categorized as Pregnancy Category B and is advised for use during pregnancy only if clearly needed [Source 4.1]. Caution is advised in nursing women [Source 4.1].

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents identify several categories of clinically relevant interactions for Augmentin (amoxicillin/clavulanate).


Documented Drug-Drug and Product Interactions

Interacting Product/Class Effect and Regulatory Constraint
Probenecid Concurrent use is generally not recommended. Probenecid inhibits the renal elimination of amoxicillin, resulting in increased and prolonged blood concentrations of amoxicillin.
Oral Anticoagulants May cause prolongation of prothrombin time and increased International Normalized Ratio (INR). Monitoring of the patient's coagulation status is required; the anticoagulant dose may need adjustment.
Allopurinol Co-administration increases the risk of a skin rash compared to taking amoxicillin alone.
Combined Oral Contraceptives May lead to a reduction in efficacy. Patients should be advised to consider using a non-hormonal method of contraception.

Other Interaction-Related Constraints

  • Food: To optimize the absorption of the clavulanate component and minimize potential gastrointestinal intolerance, this medicine should be taken at the start of a meal.
  • Mononucleosis: The medication should be avoided in patients with infectious mononucleosis, as a high percentage of these patients develop a characteristic skin rash when treated with amoxicillin-class antibiotics.
  • Phenylketonuria (PKU): Certain formulations (e.g., chewable tablets, oral suspension) contain aspartame, which is a source of phenylalanine, a constraint for this patient population.

Mechanism of Action

Inhibiting Bacterial Cell Wall Synthesis (Amoxicillin)

The primary mechanism involves amoxicillin, a beta-lactam antibiotic. This compound acts directly on the bacterial cell by forming a covalent bond with and deactivating Penicillin-Binding Proteins (PBPs). PBPs are transpeptidases crucial for the final cross-linking of the peptidoglycan layer, which provides structural integrity to the bacterial cell wall. This targeted interference halts cell wall assembly, causing the cell to become unstable and susceptible to rupture (lysis), which constitutes the bactericidal effect.

Blocking Bacterial Resistance Enzymes (Clavulanate)

The co-formulated component, clavulanate potassium, acts as a beta-lactamase enzyme inhibitor. It is a suicide inhibitor that specifically targets and irreversibly inactivates beta-lactamase enzymes produced by certain bacterial strains. By binding to these enzymes, clavulanate prevents the hydrolysis of amoxicillin, maintaining the concentration of amoxicillin available to bind to PBPs. This mechanistic action alters the drug's activity profile in the presence of beta-lactamase-producing bacterial strains.

Dosage and Administration Information

How Augmentin is Used: Official Administration Guidelines

Augmentin (Co-amoxiclav) is a prescription medicine used based on official dosing and administration rules. These guidelines govern the correct route, strength, and timing for its use.

Administration Protocol

The approved route for all tablet and suspension formulations is oral administration (by mouth). To optimize absorption of clavulanic acid and help minimize stomach upset, the medicine should be taken at the start of a meal.

Dosage and Frequency

Dosing is based on the amoxicillin component. The treatment course generally should not be extended beyond 14 days without clinical review.

Dosing Regimen (Adults) Amoxicillin Strength/Frequency Official Forms (Examples)
Standard 500 mg every 8 hours (q8h) Tablet, Oral Suspension
High Dose 875 mg every 12 hours (q12h) Tablet
Extended-Release (XR) 2000 mg every 12 hours (q12h) XR Tablet

Specific Use Instructions

Preparation: The powder for oral suspension must be reconstituted with water and shaken well before each dose is measured. Non-Substitutability is key; different tablet strengths (e.g., two 250 mg tablets) are not interchangeable with higher strengths (e.g., one 500 mg tablet) due to different clavulanic acid ratios.

Population Adjustment: Dosage adjustments are mandatory for patients with renal impairment (reduced kidney function) based on creatinine clearance. For example, the extended-release formulation is contraindicated in patients with a creatinine clearance below 30 mL/min.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Augmentin

The research on Augmentin (amoxicillin/clavulanate) was studied for its use across several bacterial infections. The evidence base is largely built upon Randomized Controlled Trials (RCTs) and systematic reviews, which explore different treatment approaches.


Evidence for Respiratory and Ear/Sinus Infections

Research includes short-term RCTs and meta-analyses exploring conditions like Community-Acquired Pneumonia (CAP), acute bronchitis, and Acute Bacterial Otitis Media (AOM) in adults and pediatric populations. These studies monitored clinical outcome measurements and systemic endpoints like mortality. A key limitation is the limited comparative evidence when assessed against amoxicillin alone for conditions like uncomplicated CAP. For AOM, trials monitored measurements of bacteriologic clearance, but earlier studies provided limited bacteriologic data against certain specific resistant strains.


Evidence for Skin, Urinary Tract, and Dental Infections

Clinical trials for Skin and Skin Structure Infections (SSSI) and Urinary Tract Infections (UTI) examined measurements of infection resolution and bacteriologic clearance in both adults and children, including high-risk groups like those with diabetic foot infections. Research notes that the presence of certain resistant bacteria in some regions presents a factor for consideration when applying the evidence to clinical decisions. For Dental Infections, systematic reviews primarily explore prophylaxis (prevention) after procedures like third molar surgery. Evidence is limited for long-term use and for applications in high-risk subgroups, such as the immunocompromised.


Long-Term Research, Follow-up, and Uncertainty

Pivotal clinical trials utilized short-term treatment courses (typically 5 to 14 days). Consequently, follow-up durations were limited in core studies, and long-term effects are not fully established. Research was extensively evaluated in pediatric patients and adults with complex histories like diabetic foot infections. However, data for certain groups remain insufficient (e.g., specific human data for use during pregnancy). Overall, evidence quality varies across studies, and the relevance of the evidence is continuously reassessed against emerging resistance patterns.

Key Studies & References

  1. The Diagnosis and Management of Diabetic Foot Infections

Frequently Asked Questions (FAQ)

Common questions about Augmentin (FAQ)

Q: Does Augmentin cause drowsiness or make you tired?

A: Official product labeling reports several central nervous system effects that could potentially contribute to a feeling of tiredness. These documented effects include dizziness, agitation, anxiety, and insomnia (difficulty sleeping). It is helpful to be aware of these potential changes.

Q: Can Augmentin cause changes in mood or anxiety?

A: Official regulatory documents indicate that changes in mood and anxiety are possible documented side effects. These reported adverse reactions also include behavioral changes and agitation.

Q: Are there common foods or drinks that should be avoided while taking Augmentin?

A: Regulatory instructions state that the medicine should be taken at the start of a meal to help minimize stomach upset and optimize absorption. Beyond this guidance, official product labeling does not generally require the avoidance of specific common foods or non-alcoholic drinks.

Q: Can Augmentin affect the results of blood tests?

A: Official product information indicates that Augmentin may affect the results of certain blood tests. This includes tests that monitor blood clotting, such as prothrombin time (INR), especially in patients using oral anticoagulants, or tests monitoring liver function.

Q: What happens if a dose of Augmentin is missed?

A: Regulatory advice highlights the importance of taking the medicine exactly as prescribed by a healthcare provider. Product information usually includes an instruction to avoid skipping doses or taking a double dose to make up for a missed one, as this may impact treatment consistency.

Q: Can Augmentin be used to treat viral infections?

A: The official product labeling indicates that this medicine is intended only for infections that are proven or strongly suspected to be caused by susceptible bacteria. It does not possess activity against viral infections.

Q: Why is it important to finish the full course of Augmentin even if symptoms improve?

A: Official warnings highlight the importance of completing the full prescribed course to ensure effective treatment of the infection. Continuing the course, even if symptoms improve, helps to limit the development of drug-resistant bacteria.

Q: What is the relationship between Augmentin and Clostridium difficile (C. diff)?

A: Regulatory warnings indicate that the use of antibiotics, including Augmentin, is associated with a risk of Clostridioides difficile-associated diarrhea (CDAD). This condition involves an intestinal infection that can vary in severity and requires attention.

Q: Can Augmentin lead to antibiotic resistance over time?

A: Official labeling states the medicine is intended only for specific bacterial infections. This careful approach is emphasized as a way to limit the development of drug-resistant bacteria and maintain the effectiveness of this and other antibacterial drugs.

Q: Is it possible for Augmentin to lose effectiveness if stored improperly?

A: Regulatory instructions mandate specific storage conditions, such as protecting tablets from moisture and refrigerating the liquid suspension. Following these instructions is necessary to maintain the product's stability and intended effectiveness.

Q: Does Augmentin expire, and how strict are the expiration guidelines?

A: Regulatory documents emphasize the importance of adhering to the expiration date printed on the packaging. Additionally, the reconstituted liquid suspension has a very limited stability period and is usually required to be discarded after 10 days, even if refrigerated.

Q: Are there specific symptoms that require immediate medical attention while taking Augmentin?

A: Official warnings highlight specific symptoms that warrant prompt attention. These include signs of a severe allergic reaction (such as swelling or trouble breathing), severe liver problems (like jaundice), or severe and persistent diarrhea.

Q: Does Augmentin interact with alcohol?

A: Official product labeling and documentation do not report a known interaction between Augmentin and alcohol.

Q: Is it normal to have a metallic taste after taking Augmentin?

A: Disturbances in taste are a documented side effect of the medicine. This is referred to in regulatory documents as taste perversion (or dysgeusia) and covers symptoms such as a metallic taste.

Q: Are there any reported interactions between Augmentin and common supplements like vitamins?

A: Regulatory documents and official product information do not report known interactions between Augmentin and common supplements or vitamins.

Q: Is Augmentin generally safe for elderly patients?

A: According to official prescribing information, no dose adjustment is generally considered necessary for elderly patients compared to non-elderly adults. However, dose adjustments may be required if the patient has specific conditions, such as reduced kidney function (renal impairment).

Q: How often do serious allergic reactions to Augmentin occur?

A: Regulatory safety data provides frequency classifications for adverse events. Serious allergic reactions, such as anaphylaxis, are generally listed as rare events, while less severe hypersensitivity reactions, such as rash and hives, are reported as uncommon.

Q: Does Augmentin affect one's ability to drive or operate machinery?

A: No specific studies on the effects on the ability to drive or use machinery have been performed; however, known side effects like dizziness or convulsions may influence this ability.

Q: Can Augmentin affect sleep patterns?

A: Insomnia (sleeplessness) has been reported as a side effect affecting the central nervous system, according to official regulatory labeling.

Q: Do regulatory agencies classify Augmentin as a first-line treatment for any specific condition?

A: Augmentin is referenced as a first-line therapy option in some official clinical guidelines. This includes its use for specific conditions, such as acute otitis media (a common ear infection).

How should Augmentin be stored and disposed of?

How to Store and Dispose of Augmentin

Storage instructions for Augmentin (amoxicillin and clavulanate potassium) are specific to the dosage form to maintain product stability.

Storage Requirements

Dosage Form Required Storage Environment Stability/Constraints
Tablets Store at controlled room temperature (20 C to 25 C). Protect from moisture; keep tightly closed in the original container.
Reconstituted Suspension Must be stored under refrigeration (2 C to 8 C). Discard after 10 days; do not freeze.

All forms of the medicine must be stored out of the sight and reach of children.

Disposal

Unused or expired Augmentin should be disposed of via an authorized drug take-back program or by following the specific household trash procedure. The medicine must not be thrown away via wastewater (such as flushing down the toilet).

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

Available in countries:

Equivalent of Augmentin found in:

A-Z Index: