Augmentin BIS

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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 Augmentin BIS

Property Description
Active Ingredients Amoxicillin and Clavulanic acid (Co-amoxiclav)
Form Powder for oral suspension
Pharmacological Class beta-Lactam antibiotic / beta-Lactamase inhibitor
Common Use Treating bacterial infections
Origin Semi-synthetic and Synthetic

What is Co-amoxiclav (Augmentin BIS) and Its Class?

Augmentin BIS is a combination product generically known as Co-amoxiclav (Amoxicillin/Clavulanate potassium). It is officially classified as a systemic antibacterial agent belonging to the beta-Lactam antibiotic class, potentiated by the inclusion of a beta-Lactamase inhibitor. Its primary function is to counter microbial resistance.

This medicine has been clinically recognized for its ability to overcome common microbial resistance mechanisms. Amoxicillin/Clavulanic acid is included on the List of Essential Medicines, confirming its importance in human therapy. This classification confirms the drug's established efficacy and reliability in addressing global bacterial threats.

Composition and Formulation: The Enhanced Oral Suspension

The medicine contains two distinct active ingredients: the semi-synthetic penicillin compound Amoxicillin and the enzyme inhibitor Clavulanic acid. Amoxicillin handles the direct antibacterial action, while Clavulanic acid's role is strictly protective, safeguarding the antibiotic from deactivation by bacterial enzymes.

The specific Augmentin BIS designation refers to its Dosage form: a Powder for oral suspension intended for the Oral route of administration. This form must be prepared with an aqueous suspension base. The Clavulanate component ensures the Amoxicillin is effective against bacteria that would otherwise be resistant to Amoxicillin alone. The 'BIS' variant typically signifies a higher-concentration presentation, which facilitates proper therapeutic dosing, often for pediatric patients who require reliable and easily administered liquid medication.

Regulatory References

  1. U.S. National Library of Medicine
  2. MedlinePlus Drug Information

What side effects are possible with Augmentin BIS?

Possible side effects and safety information

The official safety profile for Co-amoxiclav (Amoxicillin/Clavulanate) organizes potential adverse reactions according to frequency and affected body systems, as documented by government regulatory agencies.

Frequency Classification

The most frequently reported adverse event, classified as Very Common (may affect more than 1 in 10 people), is diarrhea in adults. Reactions classified as Common (up to 1 in 10) include nausea, vomiting, and mucocutaneous candidiasis.

System-Organ Class Effects

Adverse effects are categorized by the systems they involve. Gastrointestinal disorders (e.g., indigestion, diarrhea) are prominent. Effects on the Hepatobiliary Disorders system, such as hepatitis and cholestatic jaundice, are documented. These hepatic events are rare, often reversible, but can rarely be severe; they may manifest during treatment or several weeks after discontinuation. Skin and Subcutaneous Tissue Disorders include rash and urticaria.

Serious Adverse Reactions and Restrictions

Official labeling documents the risk of Serious Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, and potentially fatal immediate hypersensitivity reactions (anaphylaxis). The medicine is strictly contraindicated in individuals with a history of severe immediate hypersensitivity to any penicillin or a history of cholestatic jaundice associated with prior use of Co-amoxiclav. Population-specific considerations include an increased risk of rash in patients with infectious mononucleosis and a higher reported incidence of Drug-Induced Enterocolitis Syndrome (DIES) in pediatric patients.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation states that any suspected overexposure to Co-amoxiclav requires the user to seek immediate medical attention. The most common manifestations of an overdose state are documented as gastrointestinal symptoms, including upset stomach, vomiting, and diarrhoea.

Overdose has the potential to cause more serious clinical presentations, particularly convulsions (seizures), which are documented as being more likely in patients with pre-existing renal impairment or those who have received very high doses. If symptoms escalate to include seizures or severe clinical distress, regulatory agencies mandate that emergency services must be contacted immediately.

A significant physiological complication associated with high amoxicillin concentrations is the formation of amoxicillin crystalluria, which can lead to acute kidney injury (AKI) and decreased urine output. Management of overdose is symptomatic and supportive, as no specific chemical antidote is known.

Procedurally, official labeling describes that haemodialysis is an effective measure for removing both the amoxicillin and clavulanic acid components from the circulation. To minimize complications like crystalluria, measures such as ensuring adequate fluid intake are officially advised.

Therapeutic Uses of Augmentin BIS

Co-amoxiclav is considered relevant across domains where additional symptomatic support is needed, and is commonly used in clinical settings that involve acute or unstable symptom patterns.

The medication is applicable within clinical settings that involve acute or disruptive symptom patterns, including infections of the sinuses, middle ear, lower respiratory tract, skin and soft tissues, urinary tract, and odontogenic areas. It is used to address symptom clusters that may become intense or disruptive, such as fever, purulent discharge, and localized pain that interfere with daily comfort. The therapy generally supports the patient during difficult episodes by easing distress and contributing to better day-to-day comfort.

“The treatment is relevant in contexts involving heightened systemic burden and disruptive symptom patterns.”

Quick Fact: Support for Systemic Discomfort and Pain Management

Co-amoxiclav is commonly used across conditions presenting with acute episodes in situations involving bacterial strains requiring specific management. This approach assists with maintaining functional stability and helps ease the impact of symptoms in challenging phases.

Regulatory References

  1. NIH StatPearls overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Augmentin BIS?

Eligibility for Co-amoxiclav (Augmentin BIS) is strictly determined by official regulatory documents, focusing on patient history and existing health conditions.

Contraindicated Populations

Use is absolutely prohibited for patients with a documented history of serious hypersensitivity reactions to Amoxicillin, Clavulanate, or any other penicillin or beta-lactam agent. It is also contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with previous Co-amoxiclav use.

Age and Physiological Restrictions

Population Group Eligibility Status (Regulatory Basis)
Infants (< 3 months) Use not established (Limited clinical data).
Children (≥ 3 months) Use established; dosing must be weight-based.
Hepatic Impairment Use with caution; hepatic function must be monitored.
Severe Renal Impairment (CrCl < 30 mL/min) Not recommended for certain high-ratio formulations.
Pregnancy Use should be avoided during the first trimester unless deemed essential.
Infectious Mononucleosis Use should be avoided due to high risk of generalized rash.

Older adults with normal renal function generally require no dose adjustment. The oral suspension contains phenylalanine and requires caution in patients with Phenylketonuria.

What should I know about interactions with other medicines?

Augmentin BIS (amoxicillin/clavulanate) has documented interactions with several other medicines and specific laboratory tests.

Interacting Medicinal Products

Product Category Interaction Summary
Oral Anticoagulants (e.g., warfarin) May prolong prothrombin time (increase INR). Monitoring of blood clotting parameters is necessary when co-administered.
Oral Contraceptives May reduce the effectiveness of combined oral contraceptives. This is a potential risk that patients should be aware of.
Probenecid (Uricosuric agent) Concomitant use is not recommended as it increases and prolongs the blood concentration of amoxicillin by delaying its kidney excretion.
Allopurinol (Xanthine oxidase inhibitor) The concurrent use of Allopurinol with amoxicillin/clavulanate has been associated with an increased incidence of skin rashes.
Methotrexate Co-administration can increase the concentration of Methotrexate, potentially increasing its side effects. Monitoring is required.

Other Important Interaction Information

  • Mononucleosis: Use of this product should be avoided in patients with mononucleosis due to a significantly increased risk of developing a skin rash.
  • Laboratory Tests: High concentrations of amoxicillin in the urine may cause false-positive results when testing for glucose using non-enzymatic methods (e.g., Benedict's solution, Fehling's solution). Enzymatic glucose oxidase tests are recommended instead.
  • Phenylketonuria (PKU): Certain liquid suspension forms of Augmentin BIS contain aspartame (a source of phenylalanine) and are therefore not suitable for individuals with PKU.

Mechanism of Action

Augmentin BIS is a fixed-dose combination containing amoxicillin and clavulanic acid. The two components execute distinct, synergistic pharmacodynamic mechanisms primarily targeting bacterial cell wall synthesis.

Amoxicillin, a beta-lactam antibiotic, acts as an inhibitor by covalently binding to penicillin-binding proteins (PBPs) located on the inner membrane of susceptible bacterial cell walls. PBPs are DD-transpeptidases, essential for the final cross-linking of peptidoglycan monomers. The binding of amoxicillin inhibits this transpeptidation process, interrupting cell wall biosynthesis. This structural compromise triggers the activation of bacterial autolytic enzymes, leading to osmotic instability, subsequent cellular lysis, and irreversible intracellular consequences.

Clavulanic acid functions as a suicide inhibitor of beta-lactamase enzymes, which are produced by resistant bacteria and hydrolyze the beta-lactam ring of amoxicillin. Clavulanic acid irreversibly binds to the beta-lactamase active site, neutralizing its enzymatic function. This protective mechanism maintains the structural integrity of amoxicillin, allowing it to successfully engage and inhibit the PBPs. The systemic physiological consequence is a broader modulation of bacterial proliferation due to the preservation of amoxicillin's bactericidal activity against organisms that produce beta-lactamases.

Dosage and Administration Information

How to Use Augmentin (Amoxicillin and Clavulanate Potassium) — Administration Guidelines

This section describes the administration protocol for Augmentin oral formulations.


Administration Protocol

Attribute Instruction
Route of Administration Oral.
Timing in Relation to Meals Must be taken at the start of a meal to minimize gastrointestinal intolerance.
Frequency and Schedule Doses are administered at evenly spaced times, typically twice daily (every 12 hours) or three times daily (every 8 hours), depending on the specific regimen prescribed.

Preparation and Dosing Requirements

Dosing: The amount is calculated based on the amoxicillin component and is adjusted according to the patient’s age, weight, and renal function. The two 250 mg tablets are not interchangeable with the 500 mg tablet due to differing clavulanic acid amounts.

Preparation Steps:

  • Oral Suspension: The powder must be reconstituted by adding the labeled amount of water in two portions, shaking vigorously after each addition. The bottle must be shaken well before each measured dose.
  • Chewable Tablets: Must be chewed completely before swallowing.
  • Measuring: Doses must be measured using the accurate dosing device supplied, not a household spoon.

Special Conditions:

  • Renal Impairment: Dose reduction and/or extended intervals are required for adult patients with reduced kidney function (GFR < 30 mL/min). The 875 mg formulation is generally not recommended for these patients.
  • Duration: Treatment should not be extended beyond 14 days without medical review. Missed doses should be taken as soon as remembered, unless it is near the time for the next scheduled dose, in which case the missed dose is skipped.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Augmentin BIS (amoxicillin/clavulanate) is a combination antibiotic used to treat bacterial infections. Clinical studies and regulatory-reviewed data for this formulation focus on its role in addressing bacteria that may be resistant to amoxicillin alone due to the production of beta-lactamase enzymes. The addition of clavulanic acid inhibits these enzymes, allowing amoxicillin to remain active.


Efficacy Studies

Clinical trials, including randomized controlled trials (RCTs), have evaluated the use of amoxicillin/clavulanate in treating various infections, such as acute otitis media (AOM), respiratory tract infections, and complicated dental infections.

  • Pediatric AOM: High-dose amoxicillin/clavulanate formulations have been studied in children with bacterial AOM, particularly in cases where antibiotic resistance is suspected or when initial amoxicillin therapy was unsuccessful. One investigator-blinded, multicenter RCT reported that a high-dose amoxicillin/clavulanate regimen was associated with better clinical and bacteriological outcomes compared to azithromycin in children with bacterial AOM.
  • Combination Coverage: The formulation is often selected when infections are caused by a mixed population of bacteria (polymicrobial) or when the infecting bacteria are known to produce beta-lactamase.

Safety and Tolerability

The safety profile of amoxicillin/clavulanate has been extensively monitored in post-marketing surveillance and clinical trials.

Area of Monitoring Research Findings
Gastrointestinal Effects Diarrhea and nausea are the most frequently reported side effects, typically mild. Gastrointestinal symptoms may be more common with the clavulanate component.
Hepatic Events Hepatic dysfunction, including cholestatic jaundice, has been reported. These events are generally reversible and occur more often in males and the elderly, though they are rare in all populations.
Hypersensitivity As with all penicillins, the drug is associated with a risk of serious hypersensitivity reactions, which requires careful patient screening prior to administration.

Long-term studies confirm that the overall adverse event profile is generally consistent with that of the penicillin class of antibiotics, with a greater emphasis placed on monitoring potential gastrointestinal and hepatic effects.

Key Studies & References

  1. Amoxicillin/Clavulanate for Acute Otitis Media in Children: A Systematic Review and Meta-analysis
  2. NICE Guideline NG19: Antimicrobial prescribing for acute otitis media

Frequently Asked Questions (FAQ)

Common questions about Augmentin BIS (FAQ)


Q: Why does my prescription say 'BIS' on it?

A: The 'BIS' designation typically indicates a higher-concentration formulation of the Augmentin oral suspension. According to official product information, this concentration is used because it allows for a smaller total volume of medicine to be administered for each dose. This formulation is frequently used for pediatric patients.


Q: Is it normal to feel tired or dizzy after taking this medicine?

A: Official labeling reports that dizziness and a temporary increase in physical activity (reversible hyperactivity) have been reported as rare side effects. Other central nervous system effects, such as agitation or confusion, are also included in the reported list of possible reactions. Unexpected effects should be discussed with a healthcare provider.


Q: What foods or supplements should I avoid while taking Augmentin BIS?

A: Regulatory instructions emphasize that the medicine must be taken at the start of a meal. This is done to help minimize the potential for common stomach or intestinal side effects. The official labeling does not specify restrictions on particular foods or supplements.


Q: Can I take Augmentin BIS if I have mononucleosis?

A: Official warnings state that the use of this medicine should be avoided in patients diagnosed with infectious mononucleosis. The reason for this restriction is a significantly increased risk of developing a widespread skin rash when Augmentin BIS is administered in this patient population.


Q: Can a pregnant woman or breastfeeding mother take Augmentin BIS?

A: According to official product information, use of this medicine should be avoided during the first trimester of pregnancy unless a healthcare professional deems it essential. For breastfeeding, the active components of the medicine may pass into breast milk, and official documents advise that use should proceed with caution.


Q: Is the liquid form of Augmentin BIS different from the tablets?

A: Yes, there are differences, particularly in the ratio of the two active ingredients (amoxicillin and clavulanic acid). Regulatory documents state that different formulations, such as the two 250 mg tablets versus one 500 mg tablet, are not interchangeable because the clavulanic acid amounts vary. Liquid forms are often high-concentration ratios. This is often done to suit specific dosing needs.


Q: Can Augmentin BIS be used for ear infections?

A: Yes. According to official indications, Augmentin BIS is used to treat certain bacterial infections, including Acute Otitis Media (AOM), which is a type of ear infection. This is supported by regulatory-reviewed clinical trials, especially in cases where antibiotic resistance may be suspected.


Q: What is the significance of the mg/mL concentration in the liquid form?

A: The concentration is critical for ensuring accurate administration. All dosing instructions are calculated based on the amount of the amoxicillin component. The specific concentration directly determines the volume of liquid that must be measured and taken to achieve the prescribed dose.


Q: Can I take Augmentin BIS if I have Phenylketonuria (PKU)?

A: Official warnings state that certain liquid suspension forms of Augmentin BIS contain aspartame, which is a source of phenylalanine. For this reason, the use of these specific formulations requires caution or may be unsuitable for individuals with the inherited metabolic disorder Phenylketonuria (PKU).


Q: Does Augmentin BIS work for viral infections like the common cold?

A: No. Official labeling consistently states that Augmentin BIS is an antibiotic designed to treat infections caused by bacteria. Like other antibiotics, it is not effective and should not be used to treat infections caused by viruses, such as the common cold or the flu.


Q: Is it safe to take Augmentin BIS with ibuprofen or Tylenol (acetaminophen)?

A: The official product labeling does not specify an interaction with non-prescription pain relievers like ibuprofen or acetaminophen. The key interaction warnings focus on prescription medicines such as blood thinners (anticoagulants), probenecid, and allopurinol.


Q: What are the age restrictions for taking Augmentin BIS?

A: Official information establishes use for children aged 3 months and older, with dosing calculated based on weight. The drug labeling does not specify a general upper age restriction, noting that older adults with normal kidney function typically do not require a dose adjustment.


Q: Are there any long-term effects of taking Augmentin BIS?

A: The official recommended duration of treatment should not be extended beyond 14 days without medical review. Safety data confirms the drug's adverse event profile is consistent with the penicillin class, with potential side effects largely focusing on reversible gastrointestinal or hepatic events.


Q: Does Augmentin BIS interact with alcohol?

A: While the official drug labels do not list a direct chemical interaction with alcohol, general healthcare guidance often suggests limiting or avoiding alcohol during antibiotic treatment. Guidance often suggests limiting consumption due to the potential for intensified side effects such as dizziness and nausea.


Q: Are there research studies showing the effectiveness of Augmentin BIS for sinusitis?

A: Yes. The medicine is officially indicated for the treatment of certain bacterial infections, including Acute Bacterial Sinusitis (ABS). Regulatory-reviewed clinical studies have evaluated its effectiveness and proper dosing regimens for this specific respiratory tract infection.


Q: Is there a generic version of Augmentin BIS available?

A: Yes. Augmentin BIS is a brand name for the combination of active ingredients generically known as amoxicillin and clavulanate potassium. Approved generic versions containing the same active ingredients are widely available.


Q: Does taking Augmentin BIS cause yeast infections?

A: Yes. Official labeling lists mucocutaneous candidiasis, which is a type of yeast infection, as a Common side effect. This means it may affect up to 1 in 10 people taking the medicine.


Q: Can Augmentin BIS affect my ability to drive?

A: Official documents contain general warnings that the medicine may cause side effects such as dizziness or, in rare cases, convulsions. Any side effect that affects alertness or motor function may impact the ability to drive or operate machinery.


Q: Does Augmentin BIS interact with antacids?

A: The official product labeling does not list a known direct interaction with most common antacids. The key interaction warnings are for drugs that affect how the body eliminates the antibiotic, such as probenecid, or drugs that increase the risk of skin rash, such as allopurinol.


Q: Does Augmentin BIS affect blood sugar levels?

A: Official information does not note a direct systemic effect on blood sugar levels. However, high concentrations of amoxicillin in the urine have been reported to cause false-positive results when certain non-enzymatic methods are used for glucose testing.


Q: Can older adults safely use Augmentin BIS?

A: Use is generally established in older adults. However, official warnings note a higher reported incidence of hepatic dysfunction (liver issues) in the elderly. Therefore, monitoring of liver function may be advised by a healthcare professional during treatment.


Q: How does the BIS formulation compare to other amoxicillin-clavulanate products?

A: The BIS formulation is a higher-concentration oral suspension. Official labels stress that different products, including various suspensions and tablet strengths, are not always interchangeable because they contain different ratios of the two active ingredients.


Q: Is there research on the resistance patterns to Augmentin BIS?

A: Yes. The medicine is specifically used to combat resistance mechanisms caused by beta-lactamase-producing bacteria. Its clinical use is often reserved for infections where this type of resistance is known or suspected to ensure the antibiotic remains effective.


Q: Can Augmentin BIS be used for urinary tract infections (UTIs)?

A: Yes. The medicine is officially indicated for the treatment of various bacterial infections, which includes Urinary Tract Infections (UTIs). Its use is based on regulatory-reviewed clinical data for susceptible organisms.


Q: Are there alternatives to Augmentin BIS for people with a severe penicillin allergy?

A: Yes. Because Augmentin BIS contains a penicillin component, it is strictly contraindicated for patients with a severe penicillin allergy. Official drug information and clinical guidance discuss the use of alternative antibiotic agents for these patients, where appropriate.


Q: What is the main purpose of using an antibiotic combination like this?

A: The main purpose is to counter microbial resistance. The combination ensures that the clavulanic acid protects the amoxicillin from deactivation by bacterial enzymes, which allows the amoxicillin to successfully kill bacteria that would otherwise be resistant to amoxicillin alone.


Q: Does Augmentin BIS cause lightheadedness?

A: Official labeling reports that side effects such as dizziness are reported rarely. Lightheadedness is considered part of the central nervous system (CNS) effects that have been reported by patients using the medicine.

How should Augmentin BIS be stored and disposed of?

Storage and Disposal Requirements

Official regulatory guidelines define distinct storage conditions for the dry powder and the reconstituted liquid suspension of Augmentin BIS.


Storage

Product Form Required Conditions Stability/Shelf-Life
Dry Powder Store in the original container at or below 25°C (77°F), protected from moisture. Indefinite until expiration date.
Liquid Suspension Store under refrigeration (2 C to 8 C). Do not freeze. Discard any unused portion after 7 to 10 days of refrigeration.

Storage rules also require that the medicine be kept out of the sight and reach of children.

Disposal

Unused or expired medicine must be disposed of according to official procedures. Regulatory documents strictly mandate that Augmentin BIS must not be thrown away with household waste or poured into wastewater (sinks or toilets). Patients must consult a pharmacist or local authority for instruction on pharmaceutical return programs.

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

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