Amoxicillin / Clavulanic acid

Brands available in Kenya

Acinet, Cachet Pharma Pvt
Amciclav, PSM Pharmaceuticals Ltd
Amclamed , Medisel Kenya Limited
Amocin-cla , Beijing Holley-Cotec Pharmaceuticals Co Ltd
Amoklav, Scott Edil
Amoklavin , Pharmaco Healthcare Limited
Amoxiclav-Denk ,Denk Pharma GmbH & Co KG Prinzregentenstr
Augmin, Laborate Pharmaceuticals India Limited
Augmentin, GSK
Augyclav , Salama Pharmaceuticals Limited
Bactoclav , Micro Labs Ltd
Beeclav , Krishna Chemists Ltd
Cinclav, Cintana Healthcare Ltd.
Clamoxin ,Bliss GVS Pharma Ltd.
Claneksi , PT Sanbe Farma
Clanoxy , Galpha Laboratories Ltd
Clav , Shambhuprasad and Sons
Clavall , Questa Care Inc
Clavam, Alkem Laboratories
Clavimox , Clarion India
Clavulin , GSK
Claxy, Theon Pharmaceuticals Ltd
Cledomox, Medopharm Pvt Ltd
Corclav , Signature Healthcare Ltd
Cosil , Cosmos Limited
Curam , Sandoz GmbH Kundl
Dioclav , National Pharmaceutical Industries Co. (SAOG)
Dumoclav , Mylan Pharmaceuticals Private Limited
Enhancin, Sun Pharmaceutical Industries Limited
Famoxiclav, Pharmsmart Ltd
Finemox CV , Finecure Pharmaceuticals Ltd
Forcid Solutab , Astellas Pharma (Pty) Ltd
Gamok , Guilin Pharmaceutical (Shanghai) Co. Ltd.
Indclav , Indchemie Health specialities PVT Ltd
Injmentin ,Inject Care Parenterals Pvt. Ltd
Koact , Aurobindo Pharma Ltd Unit XII
Labclav, Laboratory & Allied Ltd
Lasoclav, Laso Healthcare Pvt. Ltd.
Moxikind-CV ,Mankind Pharma Ltd
Myclav ,Unichem Laboratories Ltd.
Neoclav, Neopharma L.L.C.
Numolav ,Europa Healthcare Limited
Rapiclav , Ipca Laboratories Limited
Redamox , Sakar Healthcare Ltd.
Winclav , Daima Dispensing Chemists Ltd
Zyclave , National Pharmacy Ltd


 Amoxicillin clavulanic acid
Amoxicillin clavulanic acid Chemical Structures

MODE OF ACTION

Amoxicillin

Amoxicillin is in the class of beta-lactam antimicrobials. Beta-lactams act by binding to penicillin-binding proteins that inhibit a process called transpeptidation (cross-linking process in cell wall synthesis), leading to activation of autolytic enzymes in the bacterial cell wall.

Clavulanic acid

Clavulanic acid contains a beta-lactam ring and binds strongly to beta-lactamase at or near its active site, thereby hindering enzymatic activity. This protects other beta-lactam antibiotics from beta-lactamase catalysis, thereby enhancing their antibacterial effects.

INDICATIONS

Augmentin is indicated for the treatment of the following infections in adults and children

Acute bacterial sinusitis (adequately diagnosed)

Acute otitis media

Acute exacerbations of chronic bronchitis (adequately diagnosed)

Community acquired pneumonia

Cystitis

Pyelonephritis

Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.

Bone and joint infections, in particular osteomyelitis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

CONTRAINDICATIONS

Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.

History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid

DRUG INTERACTIONS

Oral anticoagulants:

If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary

Methotrexate

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

Probenecid

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.

Mycophenolate mofetil

A change in the dose of mycophenolate mofetil should not normally be necessary in the absence of clinical evidence of graft dysfunction. However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.

Allopurinol
The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

Oral Contraceptives
Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Effects on Laboratory Tests
High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin and clavulanate potassium, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

ADVERSE EFFECTS

Gastrointestinal: Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Hypersensitivity Reactions: Pruritus, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported.

Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported.

Renal: Interstitial nephritis, hematuria, and crystalluria have been reported.

Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Thrombocytosis was noted in less than 1% of the patients treated with amoxicillin and clavulanate potassium. There have been reports of increased prothrombin time in patients receiving amoxicillin and clavulanate potassium and anticoagulant therapy concomitantly.

Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.

Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Clinical | Pharmacokinetic data


Pregnancy Category:
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Protein Binding:
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Legal Status | Dosage forms & Strengths


Prescription Category:
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:


Drug Indentifiers:

CAS Number
PubChem CID
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UNII
KEGG
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Drug Images

References/ Citation:

  1. Todd, Peter A., and Paul Benfield. “Amoxicillin/clavulanic acid.” Drugs 39.2 (1990): 264-307.
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