International reference: 6 US FDA recalls for this ingredient

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. (reconstituted)

Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product (reconstituted)

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. (reconstituted)

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed. (reconstituted)

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. (reconstituted)

Failed Impurities/Degradation Specifications: Out-of-specification test results. (reconstituted)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Kenya.

amoxicillin reference
Reference image
(amoxicillin · DailyMed)
Registered Kenya · PPB

ACINET DRY SYRUP 457MG/5ML

EACH 5ML OF RECONSTITUTED SUSPENSION CONTAINS AMOXICILLIN TRIHYDRATE USP AND CLAVULANATE POTASSIUM USP

What it does

Amoxicillin is an antibiotic used to treat infections caused by bacteria.

Commonly used for: infections of the ear, nose, and throat, urinary tract infections, pneumonia, skin infections

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
H2018/CTD2536/621ER
Registration date
2019-02-21 00:00:00
Expiry date
2031 August 04
Status
Registered
Active ingredient
EACH 5ML OF RECONSTITUTED SUSPENSION CONTAINS AMOXICILLIN TRIHYDRATE USP AND CLAVULANATE POTASSIUM USP
Strength
-
Pack size
100ML AMBER COLOURED GLASS BOTTLE, SUCH BOTTLES PACKED IN A PREPRINTED MONO CARTON ALONG WITH PACK INSERT
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
A02BD - Combinations for eradication of Helicobacter pylori
RxNorm RxCUI
723
Manufacturer / MAH
Galaxy Pharmaceutical
Country of origin
FOREIGN
Manufacturer location
PRQC+GJ5, 3rd Parklands Ave, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:48:04 · updated 2026-09-25 02:10:01

Drug Interactions

7
Check interactions

Pharmacodynamic Warnings

Clavulanate appears in TABLE 1: Drugs that cause hepatotoxicity

Severe (1)

Penicillins - increases risk of adverse effects

Valproate increases the risk of adverse effects when given with penicillins (pivmecillinam). Avoid.

Severe Anecdotal

Unknown (6)

Amoxicillin - increases risk of skin rash

Allopurinol increases the risk of skin rash when given with penicillins (amoxicillin, ampicillin).

Unknown Study

Penicillins - increases risk of skin rash

Allopurinol increases the risk of skin rash when given with penicillins (amoxicillin, ampicillin).

Unknown Study

Penicillins - increases exposure

Leflunomide is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Theoretical

Penicillins - increases exposure

Nitisinone is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Study

Penicillins - increases exposure

Teriflunomide is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Study

Phenindione - increases risk of bleeding events

Penicillins are predicted to increase the risk of bleeding events when given with phenindione.

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About amoxicillin

Amoxicillin is an antibiotic used to treat infections caused by bacteria.

What it treats

  • infections of the ear, nose, and throat
  • urinary tract infections
  • pneumonia
  • skin infections

How it works

It kills bacteria or stops their growth, helping to clear up infections.

Who it's for

Amoxicillin is suitable for adults and children who have bacterial infections.

Drug class

Penicillins

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About clavulanate

Clavulanate is a medication that helps fight bacterial infections, often used alongside other antibiotics.

What it treats

  • bacterial infections
  • infections caused by certain bacteria

How it works

Clavulanate works by inhibiting the enzymes that bacteria use to resist antibiotics, making the antibiotics more effective.

Who it's for

It is for patients who have bacterial infections that require treatment, especially when other antibiotics may not work.

Cautions

  • • Avoid using with other drugs that can harm the liver.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About contains

This medicine contains a variety of active ingredients that work together to help treat certain health conditions.

How it works

The active ingredients in this medicine perform specific functions to help your body in various ways, depending on the condition being treated.

Who it's for

This medicine is meant for individuals with specific health issues as determined by a healthcare provider.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About reconstituted

Reconstituted medicines are those that have been mixed with a liquid to make them usable. They may be in powdered form and need to be prepared before use.

What it treats

  • various infections
  • certain medical conditions requiring injectable treatments

How it works

Reconstituted medicines contain active ingredients that work to treat or manage health conditions once they are properly mixed.

Who it's for

These medicines are usually for individuals who require specific treatments administered by a healthcare professional.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Amoxicillin

BNF-referenced

Amoxicillin is a broad-spectrum antibiotic belonging to the penicillin class, effective against a variety of bacterial infections. It is commonly used to treat conditions such as urinary tract infections, sinusitis, community-acquired pneumonia, and salmonellosis.

Indications

  • Bacterial infections
  • Urinary tract infections
  • Sinusitis
  • Uncomplicated community-acquired pneumonia
  • Salmonellosis
  • Oral infections
  • Lyme disease (under expert supervision)
  • Acute exacerbation of bronchiectasis
  • Anthrax (treatment and post-exposure prophylaxis)

Dosage

Children: 1 month–11 years: 30 mg/kg 3 times a day for 21 days; children 1–4 years: 250 mg 3 times a day; children 5–11 years: 500 mg 3 times a day.

Adults: 500 mg 3 times a day; increased if necessary up to 1 g 3 times a day in severe infections.

Mechanism of action

Amoxicillin works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, interfering with the transpeptidation process necessary for cell wall integrity.

Pharmacodynamics

Amoxicillin exhibits bactericidal activity against susceptible bacteria. Its action is time-dependent, meaning that its effectiveness is related to the duration of time that the drug concentration remains above the minimum inhibitory concentration (MIC) for the target pathogen.

Pharmacokinetics

Amoxicillin is well absorbed from the gastrointestinal tract, with peak plasma concentrations achieved within 1-2 hours after oral administration. It is widely distributed in body tissues and fluids, and it is excreted primarily via the kidneys. The elimination half-life is approximately 1 hour, and renal impairment may necessitate dosage adjustments.

Adverse effects

  • Skin rash
  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Allergic reactions (including anaphylaxis)
  • Superinfection (due to resistant organisms)

Interactions

  • Allopurinol (increases risk of skin rash)

Precautions

  • History of penicillin allergy
  • Renal impairment (reduce dose)
  • Use with caution in patients with mononucleosis

Pregnancy

Use only if clearly needed; no adequate studies in pregnant women.

Breast-feeding

Amoxicillin is excreted in breast milk; use with caution.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Phenoxymethylpenicillin 250mg/5ml oral solution
  • Phenoxymethylpenicillin 250 mg tablets
BNF for Children 2019-2020 p.373 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: clavulanate

BNF-referenced

Clavulanate is a beta-lactam compound that is primarily used as a beta-lactamase inhibitor. It is often combined with penicillin antibiotics, such as amoxicillin, to enhance their effectiveness against bacteria that produce beta-lactamase enzymes, which can render these antibiotics ineffective. Clavulanate itself has limited antibacterial activity but plays a crucial role in overcoming bacterial resistance mechanisms.

Indications

  • Bacterial infections caused by beta-lactamase producing organisms
  • Community-acquired pneumonia
  • Respiratory tract infections
  • Urinary tract infections
  • Skin and soft tissue infections

Dosage

Children: Paediatric dosing of clavulanate should be determined based on the specific indication and the formulation used. Refer to the BNF for

Adults: The usual adult dose of clavulanate varies depending on the specific antibiotic it is combined with, generally ranging from 125 mg to 250 mg, taken every 8 hours when combined with amoxicillin.

Mechanism of action

Clavulanate works by irreversibly binding to the active site of beta-lactamase enzymes. By inhibiting these enzymes, clavulanate protects beta-lactam antibiotics from degradation, allowing them to exert their antibacterial effects effectively. This mechanism enhances the spectrum of activity of the co-administered antibiotic, thereby improving clinical outcomes in infections caused by beta-lactamase producing organisms.

Pharmacodynamics

Clavulanate exhibits a time-dependent antibacterial effect, characterized by its ability to maintain effective concentrations against beta-lactamase producing bacteria. Its pharmacodynamic properties are mainly influenced by its interaction with beta-lactam antibiotics, enhancing their efficacy in treating infections. The overall effect is a synergistic relationship that increases the potency of the antibiotic treatment.

Pharmacokinetics

Clavulanate is usually administered orally or parenterally, and it is rapidly absorbed from the gastrointestinal tract. It reaches peak plasma concentrations within 1 to 2 hours after administration. The drug is widely distributed in body tissues, with a volume of distribution indicative of good tissue penetration. Clavulanate undergoes hepatic metabolism, primarily by conjugation, and is excreted largely in the urine as metabolites. The elimination half-life is approximately 1 hour, necessitating frequent dosing for optimal therapeutic effect.

Contra-indications

  • Hypersensitivity to clavulanate or any component of the formulation
  • History of jaundice or hepatic impairment related to previous use of beta-lactam antibiotics

Adverse effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Rash
  • Hepatic dysfunction
  • Allergic reactions

Interactions

  • Probenecid may increase concentrations of clavulanate
  • Anticoagulants may have altered effects due to changes in gut flora

Precautions

  • Monitor liver function during prolonged therapy
  • Use cautiously in patients with renal impairment
  • Assess for history of allergy to penicillins or cephalosporins

Pregnancy

Clavulanate is classified as category B. Animal studies have not shown teratogenic effects, but adequate and well-controlled studies in pregnant women are lacking.

Breast-feeding

Clavulanate is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct light. Keep out of reach of children.

Formulations

  • Clavulanate potassium 125 mg/5 mL
  • Clavulanate potassium 250 mg/5 mL

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: contains

Contains is a term generally used to refer to formulations that include one or more active pharmaceutical ingredients. The specific effects, uses, and formulations depend on the particular drug in question. It is often used in the context of drug labels to inform about the components of a medication.

Dosage

Children: Refer to specific drug information for detailed dosage recommendations.

Adults: Refer to specific drug information for detailed dosage recommendations.

Mechanism of action

The mechanism of action varies depending on the specific drug that 'contains' certain active ingredients. Each compound will have its own unique pharmacological pathway and target within the body, which can include receptor modulation, enzyme inhibition, or other biochemical interactions.

Pharmacodynamics

Pharmacodynamics will depend on the active ingredients in the formulation. It generally encompasses the biochemical and physiological effects of the drug and its mechanisms of action, including the relationship between drug concentration and effect.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of the specific active ingredients within the formulation. This can vary significantly based on the drug's chemical properties, route of administration, and individual patient factors.

Pregnancy

Consult with a healthcare provider before use, as safety during pregnancy has not been established.

Breast-feeding

Consult with a healthcare provider before use, as it is not known if this drug is excreted in human milk.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: reconstituted

Reconstituted drugs refer to powdered medications that need to be mixed with a specific diluent to create a liquid form suitable for administration. This process is commonly employed for antibiotics, vaccines, and certain biologics, which are unstable in liquid form but effective when reconstituted. The reconstitution process must be performed according to the manufacturer's instructions to ensure efficacy and safety.

Indications

  • Bacterial infections
  • Viral infections
  • Fungal infections
  • Vaccination
  • Rehydration therapy

Dosage

Children: Refer to the BNF for Children for appropriate dosing information based on the specific reconstituted medication and the child's age, weight, and clinical condition.

Adults: Refer to the specific product's prescribing information for detailed dosing guidelines. Doses vary depending on the drug being reconstituted and the condition being treated.

Mechanism of action

The mechanism of action for reconstituted drugs depends on the specific medication being reconstituted. For example, reconstituted antibiotics may work by inhibiting bacterial cell wall synthesis, disrupting protein synthesis, or interfering with nucleic acid metabolism. Each active ingredient will have its unique pathway that facilitates its therapeutic effect.

Pharmacodynamics

Pharmacodynamics refers to the study of the effects of drugs on biological systems. Reconstituted medications exhibit pharmacodynamic properties that are primarily dictated by their active ingredients. For antibiotics, this may involve bactericidal or bacteriostatic actions, determined by the drug's concentration and the susceptibility of the target bacteria. The onset of action, peak effect, and duration of action also vary based on the drug's formulation and the route of administration.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of drugs. Reconstituted medications are typically administered parenterally, which allows for rapid absorption into the bloodstream. The pharmacokinetics of the drug will depend on its specific formulation and the characteristics of the diluent used. Factors such as volume of reconstitution and the solubility of the active ingredient can influence the drug's bioavailability and clearance rates. Generally, reconstituted drugs follow first-order kinetics, where the rate of elimination is proportional to the drug concentration in the plasma.

Pregnancy

Consult relevant guidelines, as safety varies with specific drugs being reconstituted.

Breast-feeding

Consult relevant guidelines, as safety may vary based on the drug.

Storage

Store reconstituted solutions as per specific drug guidelines, typically in a cool, dry place, protected from light.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Amoxicillin

PubChem CID 33613

Molecular formula: C16H19N3O5S

Mechanism of action

Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin binding proteins. Penicillin bind proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action. The penicillins and their metabolites are potent immunogens because of their ability to combine with proteins and act as haptens for acute antibody-mediated reactions. The most frequent (about 95 percent) or "major" determinant of penicillin allergy is the penicilloyl determinant produced by opening the beta-lactam ring of the penicillin. This allows linkage of the penicillin to protein at the amide group. "Minor" determinants (less frequent) are the other metabolites formed, including native penicillin and penicilloic acids. /Penicillins/ Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.

Pharmacodynamics

Amoxicillin competitively inhibit penicillin binding proteins, leading to upregulation of autolytic enzymes and inhibition of cell wall synthesis. Amoxicillin has a long duration of action as it is usually given twice daily. Amoxicillin has a wide therapeutic range as mild overdoses are not associated with significant toxicity. Patients should be counselled regarding the risk of anaphylaxis, _Clostridium difficile_ infections, and bacterial resistance.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: clavulanate

PubChem CID 16204478

Molecular formula: C8H8NO5-

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.