Augmentin Retard

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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 Retard

Quick Facts

Property Description
Active Ingredients Amoxicillin, Clavulanic Acid
Form Modified-release tablet (Sustained-release)
Pharmacological Class \beta-lactam Antibacterial Agent, Antimicrobial Combination
Common Use Treating bacterial infections
Origin Semisynthetic (Penicillin derivative)

The Pharmacological Identity of Augmentin Retard

Augmentin Retard is a prescription-only medicine defined as a fixed-dose combination product belonging to the \beta-lactam antibacterial agent class, intended for systemic action against bacterial infections. The combination of Amoxicillin and Clavulanic Acid (co-amoxiclav) is categorized as an essential medicine, confirming its critical role in infection management.

This preparation is a potent broad-spectrum antimicrobial designed to treat various infectious diseases caused by susceptible pathogens. The combination is clinically recognized for its effectiveness against strains that demonstrate resistance to Amoxicillin when used alone.


Composition and Role of Amoxicillin and Clavulanic Acid

The preparation combines the semisynthetic penicillin Amoxicillin, the primary bactericidal agent, with Clavulanic Acid, which functions as a \beta-lactamase inhibitor. This pairing creates a synergistic effect essential for efficacy. Clavulanic Acid prevents Amoxicillin from being destroyed by certain bacterial enzymes, ensuring the antibiotic can effectively kill bacteria that would otherwise be resistant. The combined activity provides a robust mechanism for clearing complex infections.


Understanding the Modified-Release ("Retard") Formulation

The "Retard" designation signifies that this oral preparation is a modified-release tablet (sustained-release formulation). This specialized design controls the release of the active ingredients slowly and consistently after swallowing, unlike conventional immediate-release tablets. The unique extended-release dosage form is intended to maintain effective concentrations of Amoxicillin and Clavulanic Acid in the body over a longer duration, optimizing the medication's therapeutic power.

Regulatory References

  1. World Health Organization's Essential Medicines List
  2. WHO Essential Medicines List

What side effects are possible with Augmentin Retard?

Possible Side Effects and Safety Information

The safety profile for the combination of Amoxicillin and Clavulanic Acid (co-amoxiclav) is classified by regulatory authorities based on the frequency and system-organ class affected. The vast majority of reported effects are generally non-serious and affect the gastrointestinal system.


Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized based on incidence rates documented in official regulatory sources:

  • Common (may affect up to 1 in 10 people): Diarrhea, loose stools, nausea, vaginal mycosis, and skin rash are frequently reported.
  • Uncommon (may affect up to 1 in 100 people): Vomiting, indigestion, dizziness, headache, and reversible changes in liver enzyme levels (e.g., AST/ALT).
  • Rare and Very Rare classifications include more serious events affecting the blood and lymphatic system (e.g., reversible leukopenia) and rare severe skin reactions like Erythema Multiforme.

Serious Adverse Reactions and Safety Constraints

Official labeling highlights the potential for serious, low-incidence adverse reactions. These include severe hypersensitivity reactions (e.g., Anaphylaxis), severe cutaneous adverse reactions (e.g., Stevens-Johnson Syndrome), and serious hepatobiliary events such as cholestatic jaundice or hepatitis.

Regulatory documents contain specific safety constraints. The modified-release formulation is contraindicated in patients with a history of cholestatic jaundice associated with the combination and in those with severe renal impairment (creatinine clearance < 30 mL/min). Furthermore, hepatic events have been reported predominantly in males and elderly patients, and while these events usually occur during or shortly after treatment, they may not become apparent until several weeks after treatment has ceased.

Overdose and Emergency Response

Overdose with Augmentin Retard may result in severe clinical signs affecting the gastrointestinal system and the central nervous system. Documented manifestations include pronounced vomiting, diarrhea, and abdominal discomfort. More serious signs involve neurological effects such as seizures (convulsions), confusion, and excessive activity. Immediate medical attention must be sought if overexposure is suspected or if these severe symptoms occur.

Officially documented severe outcomes include the risk of renal failure, which may be secondary to crystalluria associated with high concentrations of the amoxicillin component. Hepatic dysfunction (liver injury) is also a known complication that can be severe, and regulatory reports have noted fatal outcomes. Patients with pre-existing impaired renal function are at a heightened risk for severe CNS effects. The official labeling indicates a higher incidence of hepatic issues in elderly individuals and males.

Treatment for overdose is specified as symptomatic and supportive. No specific antidote is known for the active substances. However, both Amoxicillin and Clavulanic Acid can be removed from the bloodstream using hemodialysis. Monitoring of fluid and electrolyte balance and renal function is required during management to address potential complications.

Therapeutic Uses of Augmentin Retard

What Augmentin Retard Treats: Main Uses and Benefits

Augmentin Retard is commonly used to help with conditions characterized by periods of heightened symptoms resulting from bacterial infections that may be difficult to manage. Its application is relevant for addressing the infectious cause and easing the associated systemic and localized discomfort.

This extended-release medication is relevant for use in certain severe bacterial infections, such as community-acquired pneumonia and acute bacterial sinusitis.

Therapeutic Scope and Patient Support

This medication is applied in contexts marked by increased discomfort or tension related to bacterial infection. It is commonly used to help with serious bacterial infections affecting the lungs and airways and potentially severe skin and soft tissue infections. It is relevant for managing symptoms that interfere with daily comfort, such as localized distress or difficulty breathing, and provides support that helps maintain a sense of stability when symptoms are more noticeable.

The core benefit is providing support that helps ease the overall symptom burden associated with acute systemic imbalance, such as fever, generalized discomfort, and fatigue. By being used for managing the infectious cause, it offers symptomatic relief that helps patients cope more steadily with difficult acute episodes and supports general well-being during symptomatic phases.

“This medication is considered relevant for use in clinical settings that involve acute or unstable symptom patterns related to specific severe bacterial infections.”

Quick Fact: Relief for Systemic Discomfort This medicine is applied in scenarios where symptoms create noticeable physiological strain, helping to ease the overall symptom load and support general comfort during periods of acute infection.

Eligibility and Restrictions for Use

Who Can and Cannot Use Augmentin Retard

The eligibility for using the modified-release formulation of Amoxicillin and Clavulanate (Augmentin Retard) is strictly defined by regulatory documents, focusing on patient history, organ function, and age.


Absolute Contraindications

The medicine must not be used by patients with a documented history of a serious hypersensitivity reaction to amoxicillin, clavulanate, or any other beta-lactam antibacterial drug (e.g., penicillins or cephalosporins). It is also contraindicated for individuals with a history of cholestatic jaundice or hepatic dysfunction associated with prior amoxicillin/clavulanate treatment.

Organ Function and Condition Restrictions

Augmentin Retard is contraindicated for patients with severe renal impairment (creatinine clearance < 30 mL/min) or those undergoing hemodialysis. Use in patients with hepatic impairment is permitted but requires caution and regular monitoring of liver function. Use should be avoided in patients with Infectious Mononucleosis.

Age and Special Population Rules

The extended-release tablet is primarily intended for adults. Its use is not recommended in pediatric patients weighing less than mathbf40 kg, as efficacy and safety have not been established for this group. During pregnancy, the medicine should only be used when clearly needed, and conditional restrictions apply regarding its use in women with PPROM. For nursing mothers, use is generally acceptable, but the infant must be monitored for potential adverse effects.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes documented interaction patterns for Augmentin Retard based on regulatory sources, focusing on how co-administered substances or conditions affect drug exposure and function.


Drug-Drug and Pharmacodynamic Interactions

Co-administration with Probenecid is not recommended due to a pharmacokinetic interaction where it inhibits the renal clearance of Amoxicillin, leading to prolonged and elevated plasma concentrations of the antibiotic component. When combined with oral anticoagulants, an effect on blood coagulation may occur, potentially increasing the prolongation of prothrombin time, which necessitates appropriate monitoring. Concurrent use with Allopurinol is associated with an increased incidence of rash. Furthermore, this medicine may reduce the efficacy of oral contraceptives.


Food, Timing, and Diagnostic Constraints

The extended-release tablet must be administered at the start of a standardized meal to optimize the absorption of its active ingredients. Conversely, consumption with a high-fat meal is not recommended, as this is documented to decrease the absorption of the Clavulanate component. Regarding laboratory procedures, the medicine may cause false positive results in non-enzymatic urine glucose tests and the Direct Antiglobulin Test (Coombs test). Due to critical clearance requirements, the modified-release formulation is also contraindicated in patients with severe renal impairment or those on hemodialysis.

Mechanism of Action

Augmentin Retard, a combination product, functions through the dual mechanistic actions of its two components: amoxicillin and clavulanic acid.

Amoxicillin is a beta-lactam derivative that acts as an irreversible inhibitor. It targets and binds covalently to penicillin-binding proteins (PBPs), which are bacterial transpeptidases essential for the final cross-linking stage of peptidoglycan synthesis. This inhibition prevents the formation of a structurally sound bacterial cell wall. The subsequent loss of cell wall integrity leads to osmotic instability and consequential cell lysis.

Clavulanic acid is a beta-lactamase inhibitor with minimal inherent activity on its own. Its mechanism involves acting as a suicide inhibitor by binding irreversibly to the active site of beta-lactamase enzymes produced by certain bacteria. beta-lactamase enzymes normally hydrolyze the beta-lactam ring of amoxicillin, rendering it pharmacologically inactive. By deactivating these enzymes, clavulanic acid ensures the preservation of amoxicillin's molecular structure, permitting its subsequent binding to PBPs and continuation of the cell wall synthesis inhibition cascade.

Dosage and Administration Information

How to Use Augmentin Retard

Augmentin Retard (amoxicillin and clavulanate potassium extended-release tablets) is a medicine for oral use only.

Administration Requirements

Instruction Domain General Guidelines
Route of Administration Oral use only.
Timing in Relation to Meals Must be administered at the start of a meal. This is required to optimize absorption of the clavulanate component and minimize potential gastrointestinal intolerance.
Tablet Integrity Tablets should be swallowed whole. They must not be crushed, chewed, or cut, as this would compromise the extended-release characteristics of the formulation.

Dosing and Schedule

Standard dosing for adults and children weighing 40 kg or more is typically a fixed schedule, such as one tablet taken three times a day, though the dose and frequency can vary based on the specific strength of the formulation prescribed.

  • Dosing Frequency: The medicine must be taken at the prescribed fixed time intervals to maintain appropriate levels in the body.
  • Course Duration: Treatment should not be extended beyond 14 days without clinical review.
  • Missed Dose: If a dose is missed, it should be taken as soon as the patient remembers, unless it is almost time for the next scheduled dose; the patient should not double the next dose.

Population-Specific Rules

Dose adjustments are required for patients with renal impairment (decreased kidney function). For example, a patient with a creatinine clearance below 30 ml/ min will need a modified dosage regimen. No dose adjustment is generally necessary for elderly patients.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Augmentin Retard


Evidence for Use in Acute Bacterial Sinusitis

The research evaluating the extended-release formulation for acute bacterial sinusitis (ABS) primarily involved randomized, double-blind trials where the product was studied against other approved formulations. These studies were applied in research contexts involving fluctuating or unstable symptoms typical of ABS in adult patients. Researchers monitored two primary types of measures: clinical outcome measures, which involved tracking how symptoms evolved in the observed populations, and bacteriological outcome measures, which focused on tracking the status of the causative pathogen.

However, existing evidence offers limited insight into the long-term patterns of symptom recurrence or the stability of the outcomes related to physical discomfort past the initial follow-up visit. Additionally, the research so far indicates that studies have focused mainly on adults, meaning data for certain groups, such as pediatric patients weighing less than 40 kg or adults with severe kidney conditions, remain insufficient.

Evidence for Use in Community-Acquired Pneumonia

Research exploring the extended-release formulation in community-acquired pneumonia (CAP) largely consists of large-scale Randomized Controlled Trials (RCTs). These studies were conducted during periods of increased symptom activity, focusing on adult patients, some of whom were stratified by mortality risk. Research examined outcomes related to systemic or functional imbalance, specifically tracking measures of clinical status and bacteriological status at defined time intervals.

Findings indicate that some studies reported patterns meeting the non-inferiority criteria when the product was studied alongside active treatment comparators, while others described variability in meeting those same research goals. A key research limitation is that the primary trial structure was designed to explore if the product was "not worse" than existing treatments, leaving the question of clear superior effect unaddressed in the main study results. Furthermore, the results apply only to the populations studied.


Evidence in Special Populations and Uncertainties

The research base primarily consists of studies involving healthy, non-pregnant adults. Specific dedicated studies for the extended-release formulation are unavailable for several important groups. Data for certain groups remain insufficient, particularly for pediatric patients who weigh less than 40 kg.

Research has also excluded individuals with severe renal impairment (significant kidney issues), and the evidence is lacking for how patterns observed in the studies would apply to individuals with this specific comorbidity. This highlights areas where more research is needed, such as the impact on highly resistant bacteria or the lack of studies designed to demonstrate superiority over existing treatments.

Key Studies & References

  1. World Health Organization (WHO) Model List of Essential Medicines (Amoxicillin + Clavulanic Acid)
  2. MedlinePlus Drug Information: Amoxicillin and Clavulanate

Frequently Asked Questions (FAQ)

Common questions about Augmentin Retard (FAQ)


Q: What is the proper dosage of Augmentin Retard for an adult?

Official administration guidelines indicate that standard dosing for adults is typically a fixed schedule, often involving one tablet taken three times a day. However, the exact dose and frequency can vary based on the specific strength of the formulation. A healthcare professional prescribes the precise schedule based on the patient's condition.

Q: Can I take Augmentin Retard if I am pregnant?

According to official regulatory sources, Augmentin Retard should only be used during pregnancy when it is clearly needed. Use in pregnant women with certain conditions may be subject to specific conditional restrictions. The decision to use this medication during pregnancy is made in consultation with a healthcare provider.

Q: What is the difference between this 'Retard' version and a regular Augmentin tablet?

The 'Retard' designation means this is a modified-release tablet (or sustained-release formulation). This specialized design releases the active ingredients, Amoxicillin and Clavulanic Acid, slowly and consistently after swallowing. This differs from a regular, immediate-release tablet, allowing the modified-release formulation to deliver ingredients over a longer duration.

Q: Does this antibiotic make my birth control pill less effective?

Regulatory documents indicate that this medicine may reduce the efficacy of oral contraceptives (birth control pills) due to a known interaction. Because the medicine can affect how well oral contraceptives may work, the official labeling suggests monitoring. Individuals concerned about this interaction often consult their healthcare provider to discuss whether alternative or additional contraceptive methods are needed.

Q: What should I avoid drinking (like alcohol or juice) when I take this medicine?

Official product information, such as the Summary of Product Characteristics (SmPC), does not typically list a specific contraindication or warning against the use of alcohol while taking this medicine. Similarly, the regulatory labeling does not provide specific dietary restrictions regarding common fruit juices or other beverages.

How should Augmentin Retard be stored and disposed of?

Storage and Disposal Requirements for Augmentin Retard

Official regulatory labeling outlines specific requirements to maintain the stability and integrity of Augmentin Retard (amoxicillin/clavulanate extended-release) tablets.

Storage Conditions

The medicine must be stored at room temperature, specifically below 25°C (77°F), and must be protected from both light and moisture. It is required that the product be kept out of the sight and reach of children to prevent accidental ingestion. The tablets must remain in the original container and must not be frozen.

Disposal Instructions

Unused or expired Augmentin Retard must not be disposed of via wastewater (such as flushing) or placed into household waste. For proper pharmaceutical waste handling, individuals must ask a pharmacist how to correctly discard any medicine that is no longer needed.

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

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