Clavoxilin Plus

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Medically reviewed

Rosario Oropesa

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 Clavoxilin Plus

Property Description
Active ingredients Amoxicillin, Clavulanic acid
Form Tablet, Oral Suspension
Pharmacological class Penicillin Antibiotic, beta-Lactamase Inhibitor Combination
General Purpose Elimination of infectious bacteria
Origin Semi-synthetic (Amoxicillin derivative)

Clavoxilin Plus is a combination antibiotic classified pharmacologically as a beta-lactam antibacterial agent and beta-lactamase inhibitor preparation, belonging to the penicillin antibiotic class. The medicine is recognized by its generic international nonproprietary name (INN), Amoxicillin/Clavulanate Potassium. It is a fixed-dose combination product intended for oral administration. The strategic pairing of these two components is clinically recognized for its ability to overcome common bacterial resistance mechanisms.


What is the Composition and Type of Clavoxilin Plus?

The core composition of Clavoxilin Plus consists of two distinct active ingredients: Amoxicillin and Clavulanic acid. Amoxicillin, a semi-synthetic derivative of penicillin, acts as the primary antibacterial agent. Clavulanic acid is a protective agent that inhibits bacterial enzymes, typically supplied as Clavulanate Potassium. The combination is used to combat bacterial infections, particularly where the presence of beta-lactamase-producing bacteria is suspected. This preparation is manufactured in several dosage form(s), most commonly as a tablet and as a powder for oral suspension, allowing for accurate dosing across different patient groups.


What is the General Purpose of this Combination?

The general purpose of Clavoxilin Plus is to act as an effective antibacterial tool for the elimination of infectious bacteria, such as those causing typical respiratory or skin infections. This efficacy is achieved through synergistic action: Amoxicillin targets the bacterial cell wall, while Clavulanic acid neutralizes the beta-lactamase enzymes. This strategy grants the medicine broad-spectrum activity and is fundamentally intended to restore and extend the capability of the antibiotic to reliably suppress microbial threats.

Regulatory References

  1. Amoxicillin and Clavulanic Acid: MedlinePlus Drug Information
  2. Amoxicillin Clavulanate - StatPearls - NCBI Bookshelf

What side effects are possible with Clavoxilin Plus?

Possible Side Effects and Safety Information

Clavoxilin Plus (Amoxicillin/Clavulanate Potassium) is associated with adverse reactions classified according to their frequency and the body system affected, as documented in official regulatory labeling.


Frequency-Classified Adverse Reactions

The most frequently reported adverse events are generally related to the gastrointestinal system.

  • Very Common: Diarrhea (primarily observed in adults).
  • Common: Nausea, vomiting, diarrhea (in children), and mucocutaneous candidiasis (vaginitis).
  • Uncommon: Skin rash, urticaria, headache, dizziness, and reversible increases in certain liver enzymes.
  • Rare/Not Known: Serious reactions like severe hypersensitivity and hepatic events are classified as rare or of unknown frequency.

Serious Adverse Reactions and Safety Constraints

Official documents define several clinically significant adverse reactions. These include potentially fatal Severe Hypersensitivity Reactions (such as anaphylaxis) and severe Hepatic Dysfunction (including hepatitis and cholestatic jaundice). Other critical documented effects are Severe Cutaneous Adverse Reactions (SCAR) and Clostridioides difficile-associated diarrhea (CDAD).

Certain constraints are noted in labeling. The medicine is contraindicated in patients with a history of serious hypersensitivity to any penicillin or other beta-lactam drugs. It is also contraindicated in those with a prior history of cholestatic jaundice or hepatic dysfunction linked to its previous use. Dosage adjustment is required for patients with severe renal impairment.

Safety notes indicate that hepatic events may occur during or shortly after treatment but may be delayed for several weeks after cessation. CDAD has been reported to occur up to two months after the completion of therapy.

Overdose and Emergency Response

Overdose and When to Seek Help

The information below summarizes the officially documented overdose profile for Clavoxilin Plus (Amoxicillin/Clavulanate Potassium), based strictly on government regulatory documents.

Mandated Immediate Action

In the event of an overdose, it is officially required to seek emergency medical attention and to discontinue the drug immediately.

Documented Overdose Manifestations

Overdosage may initially lead to mild or moderate symptoms, primarily involving the digestive system. Officially documented presentations include:

  • Gastrointestinal Effects: Vomiting, diarrhea, stomach pain, and abdominal pain.
  • Neurological Effects: Drowsiness, hyperactivity, and rash.

Serious Outcomes and Complications

Regulatory sources identify the potential for more serious outcomes, including amoxicillin crystalluria and, in rare instances, oliguric renal failure due to interstitial nephritis. Convulsions may also occur, particularly in patients with impaired renal function or following the administration of high doses.

Officially Described Management

There is no specific antidote documented in the official prescribing information. Management focuses on treating symptoms and instituting supportive measures. Procedures for recent ingestion may include attempting to remove the drug from the stomach. Both active components can be efficiently removed from circulation by hemodialysis.

Therapeutic Uses of Clavoxilin Plus

The therapeutic application of Clavoxilin Plus (Amoxicillin/Clavulanate Potassium) is centered on helping address specific bacterial infections, particularly those where bacterial resistance may be involved, offering symptomatic relief and is applied in addressing conditions where progression is a concern.

The combination of amoxicillin and clavulanic acid is commonly used to manage infections of the ears, lungs, sinus, skin, and urinary tract caused by bacteria. The medication is relevant for managing conditions that present with acute or disruptive symptom manifestations, such as Community-Acquired Pneumonia, rhinosinusitis, otitis media, cellulitis, and certain urinary tract infections.

“Clavoxilin Plus is relevant when supportive symptom management is appropriate in contexts involving heightened systemic burden.”

It helps manage symptom clusters like fever, pain, localized swelling, and persistent cough, providing symptomatic relief that contributes to easing the overall symptom load and supports general well-being during symptomatic periods. The drug is often applied in clinical settings that involve acute or unstable symptom patterns, such as step-down oral treatment or managing infections resulting from animal bites.

Quick Fact: Relevant for Symptoms related to Inflammatory States

Regulatory References

  1. Amoxicillin and Clavulanic Acid: MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Clavoxilin Plus?

Eligibility for Clavoxilin Plus (Amoxicillin/Clavulanate Potassium) is strictly determined by official regulatory labeling, focusing on a patient's medical history and physiological state.


Absolute Contraindications (Must Not Use)

Use is contraindicated for patients with a known history of hypersensitivity to penicillins or other beta-lactam antibiotics. It is also prohibited for individuals with a prior history of cholestatic jaundice or hepatic dysfunction associated with the use of Amoxicillin/Clavulanate.


Age and Organ Function Eligibility

Population Group Eligibility Status
Adults Eligible for use under standard conditions.
Pediatric Patients Established for those aged 3 months and older.
Severe Renal Impairment Requires mandatory dosage adjustment, and certain high-dose formulations are contraindicated.
Hepatic Impairment Requires use with caution and regular monitoring of liver function.

Specific Restrictions

Use is generally avoided in patients with Infectious Mononucleosis due to the high risk of a non-allergic rash. For pregnancy and lactation, use is only permitted if clearly needed, and caution is advised during breastfeeding due to the excretion of Amoxicillin in human milk.

What should I know about interactions with other medicines?

This section outlines officially documented interactions for Clavoxilin Plus (Amoxicillin/Clavulanate Potassium) as specified in government regulatory prescribing information.


Documented Drug Interactions

Interacting Substance Official Regulatory Description of Interaction Interaction Classification
Probenecid Decreases the renal tubular secretion of the Amoxicillin component, resulting in increased and prolonged blood concentrations of Amoxicillin. Co-administration is generally not recommended. Pharmacokinetic
Oral Anticoagulants (e.g., Warfarin) May increase the prolongation of prothrombin time, requiring appropriate monitoring of coagulation status. Pharmacodynamic
Methotrexate Co-administration is associated with increased systemic exposure to Methotrexate. Pharmacokinetic
Allopurinol Concurrent use increases the incidence of rashes compared to Amoxicillin alone. Pharmacodynamic
Oral Contraceptives The efficacy of combined hormonal contraceptives may be reduced due to effects on intestinal flora. Pharmacodynamic

Administration and Lab Test Interactions

Regulatory documents specify that to enhance the absorption of the Clavulanate Potassium component and minimize gastrointestinal intolerance, the medicine is typically administered at the start of a meal.

Furthermore, the Amoxicillin component may cause false-positive reactions in urine glucose tests that utilize non-enzymatic methods, such as the CLINITEST® system. The use of enzymatic glucose oxidase tests is required for accurate results. These interaction points establish the formal constraints and monitoring requirements for the product’s use.

Mechanism of Action

How Clavoxilin Plus Works

Molecular Target: RANKL Receptor Binding

Clavoxilin Plus is an inhibitor of the Osteoclast Differentiation Factor (ODF) pathway. The active compound, Compound-A, directly and competitively binds to the RANKL receptor located on pre-osteoclast cells.


Intracellular Signaling Cascade Inhibition

This interaction prevents the downstream activation of key intracellular regulators, specifically the NF-kappa B and MAPK signaling cascades. This action subsequently inhibits cellular fusion and maturation, leading to a decreased formation of multinucleated osteoclasts.


Modulation of Bone Resorption

This mechanism modulates the ratio of osteoblast-to-osteoclast activity. The net effect is a resulting reduction in osteoclast-mediated bone resorption at the system level.

Dosage and Administration Information

Clavoxilin Plus is intended for oral administration and is available in formulations such as a tablet and a powder for oral suspension. The medicine must be administered at the start of a meal to enhance the absorption of the clavulanate component and help minimize potential gastrointestinal discomfort.

Standardized dosing regimens for adults are determined by the severity of the clinical scenario, with official schedules calling for administration every 8 hours or every 12 hours. The highest commonly prescribed single dose is the 875 mg amoxicillin component strength, which is typically taken on the twice-daily (every 12 hours) schedule. The standard course of treatment is generally 7 to 10 days and should not exceed 14 days without clinical reassessment.

Administration requires adherence to specific label instructions. Pediatric patients weighing less than 40 kg must receive a dose calculated based on body weight (mg/kg/day). Furthermore, mandatory dose adjustments are required for patients with renal impairment, specifically when creatinine clearance is le 30 mL/min. The 875 mg strength is restricted from use in this renal-impaired population. For the suspension form, the powder must be reconstituted with water and shaken well before dispensing each dose. A key procedural restriction is the non-substitutability of certain tablet strengths due to differences in the clavulanate ratio.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Clavoxilin Plus

The research evidence for Amoxicillin/Clavulanate Potassium (Clavoxilin Plus) comes from official sources, including clinical trials and systematic scientific reviews. These studies help show what has been observed so far about the medicine’s studied role in the context of specific bacterial infections. Research provides context but not individual predictions.


Evidence for use in Community-Acquired Pneumonia (CAP)

The studied role of Clavoxilin Plus in the context of CAP, a condition characterized by fluctuating or episodic manifestations of lung infection, was studied for both adults and specific pediatric groups. The research includes Randomized Controlled Trials (RCTs) and systematic reviews that research examined how symptoms change over time. These studies monitored outcomes related to systemic or functional imbalance, such as observed changes in fever, along with rates of microbiological findings.


Evidence for use in Acute Bacterial Otitis Media (AOM) and Sinusitis

Clavoxilin Plus was evaluated in studies for its studied role in the context of Acute Bacterial Otitis Media (AOM), an ear infection, particularly in children. Studies explored short-term symptom changes and monitored patient-reported outcomes describing perceived discomfort and clinical endpoints. For Sinusitis, the combination was studied for adults and children presenting with prolonged or worsening symptoms. Research examined how symptoms change over time, using scoring systems to measure outcomes related to physical discomfort. Research suggests that The research provides insight into short-term changes in these specific conditions associated with acute or disruptive episodes.


What is Still Uncertain About Clavoxilin Plus

Research primarily focuses on acute infection phases, and long-term effects are not fully established. Comparative evidence is lacking for its studied role against every current antimicrobial option in all clinical contexts. Evidence quality varies across studies depending on the specific infection being examined. The research available often applies only to the specific populations and conditions studied, meaning that findings reflect the specific conditions under which they were conducted.

Key Studies & References

  1. Antibiotics for acute otitis media: a meta-analysis with individual patient data (Cochrane Review Summary)

Frequently Asked Questions (FAQ)

Common questions about Clavoxilin Plus (FAQ)

Q: What is Clavoxilin Plus used for?

A: Clavoxilin Plus is a combination antibiotic prescribed to treat a variety of bacterial infections. According to official product information, it is indicated for infections in the ears, sinuses, urinary tract, skin, and lower respiratory tract, among others. Its two ingredients work together to fight bacteria, including some that are resistant to penicillin alone.

Q: Can I take Clavoxilin Plus with milk or food?

A: Regulatory documents state that taking Clavoxilin Plus at the start of a meal is generally recommended. This approach is often recommended to help improve tolerability and absorption of the medication. Taking the medicine with a meal, as directed, is part of the established guidelines found in the official product information.

Q: What should I do if I miss a dose of Clavoxilin Plus?

A: The official product information typically outlines a procedure where a missed dose should be taken if remembered shortly after the scheduled time. However, if the time is close to the next scheduled dose, the label usually indicates skipping the missed dose. The general instruction is to continue with the regular schedule and not take a double dose to make up for the one that was missed.

Q: Does Clavoxilin Plus affect birth control pills?

A: Studies and official information indicate that Clavoxilin Plus may potentially reduce the effectiveness of oral contraceptives (birth control pills). This interaction means that additional, non-hormonal birth control methods may be necessary while the antibiotic is being used. Regulatory documents suggest that individuals using oral contraceptives should review the potential interaction risk with a healthcare provider.

Q: Is it safe to drink alcohol while taking Clavoxilin Plus?

A: According to official prescribing information, there is no specific contraindication (reason to avoid) for moderate alcohol consumption while taking Clavoxilin Plus. However, general wellness guidance suggests limiting alcohol intake when taking any medication. Specific questions regarding alcohol consumption while using Clavoxilin Plus are best addressed by a prescribing healthcare provider.

Q: How long does it takes for Clavoxilin Plus to start working?

A: The time it takes to see improvement can vary greatly depending on the individual and the infection being treated. Official instructions consistently emphasize that the full prescribed course of treatment must be completed. This is the case even if an individual feels better before the course is finished.

Q: What happens if I stop taking Clavoxilin Plus early?

A: Official regulatory documents consistently emphasize the importance of completing the entire prescribed course of Clavoxilin Plus. Incomplete treatment may lead to the failure of the antibiotic to fully clear the infection. Finishing the course as prescribed is also essential to help minimize the risk of developing antibiotic resistance.

How should Clavoxilin Plus be stored and disposed of?

How to Store and Dispose of Clavoxilin Plus

Official storage and disposal instructions ensure the stability and safety of this medication, which must be stored differently depending on its form.


Storage Requirements

  • Dry Powder/Tablets: Store the dry product in its original, tightly closed container at controlled room temperature, 20 C to 25 C (68 F to 77 F). Protect from moisture and excessive heat.
  • Reconstituted Suspension: The mixed liquid suspension must be refrigerated at 2 C to 8 C (36 F to 46 F). Do not freeze.
  • Child Safety: Keep the medication out of the sight and reach of children in all forms.

Stability and Disposal

The refrigerated oral suspension is stable for 10 days. Any unused portion of the reconstituted liquid must be discarded after 10 days. Disposal of all unused or expired product must be carried out according to local regulations for pharmaceutical waste.

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

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