amoxicillin + clavulanic acid


Indchemie Health Specialities


Full Prescribing Info
Co-amoxiclav: Amoxicillin, clavulanate acid.
Each film-coated tablet contains: Amoxicillin Trihydrate USP eq. to Amoxicillin 500 mg; Clavulanate potassium USP eq. to Clavulanic acid 125 mg.
Pharmacology: The efficacy of Amoxicillin with Clavulanic acid is the result of bactericidal activity of Amoxicillin combined with the inhibitory activity of Clavulanic acid on B-lactamase produced by different bacterial strains. Like other B-lactams, Clavulanic acid penetrates through the bacterial cell wall but it generally possesses poor intrinsic antimicrobial activity and is generally a more potent inhibitor of cell free B-lactamases. The binding of B-lactamases with Clavulanic acid is a complex physiochemical process which rapidly leads to lysis of the cell.
Pharmacokinetics: Amoxicillin with Clavulanic acid are well absorbed from the gastrointestinal tract after oral administration of Amoxicillin with Clavulanic acid. The safety and efficacy of Amoxicillin with Clavulanic acid have been established in clinical trials where Amoxicillin with Clavulanic acid was taken without regard to meals. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the bread and spinal fluid. The results of expirements involving the administration of Clavulanic acid to animals suggest that this compound, like Amoxicillin, is well distributed in body tissues. Approximately 50% to 70% of the Amoxicillin and approximately 25% to 40% of the Clavulanic acid are excreted unchanged in urine during the first 6 hour after oral administration of 500 + 125mg of Amoxcillin with Clavulanic acid Tablet. Concurrent administration of probenecid delays renal excretion of Amoxicillin but does not delay renal excretion of Clavulanic acid.
Amoxicillin with Clavulanic acid is indicated in the treatment of infections caused by susceptible strains listed: Lower Respiratory Tract Infections: Caused by β-lactamase producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
Otitis media & Sinusitis: Caused by β-lactamase producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
Skin and Skin Structure Infections: caused by β-lactamase producing strains of Staphylococcus aureus, Echerichia coli and Klebsiella spp. and Enterobacter spp.
Dosage/Direction for Use
Adult & Children > 12 year Mild to moderate infection: 250 mg/125 mg, more severe & respiratory tract infection: 500 mg/125 mg every 8 hours. Or as prescribed by the physician.
Most patients have been asymptomatic following overdosage or have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting and diarrhoea. Rash, hyperactivity or drowsiness has also been observed in a small number of patients. In case of overdosage, discontinue Amoxicillin with Clavulanic acid, treat symptomatically and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed.
Amoxicillin with Clavulanic acid is contraindicated in patients with allergic reactions to any penicillin.
It is also contraindicated in patients with a previous history of Amoxicillin with Clavulanic acid associated cholestatic jaundice/hepatic dysfunction.
Special Precautions
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy.
If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted. While Amoxicillin with Clavulanic acid possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of long therapy. A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin class antibiotics should not be administered to patients with mononucleosis.
Adverse Reactions
Amoxicillin with Clavulanic acid is generally well tolerated. The majority of side effects observed in clinical trials were of a mild and transient nature. The most frequently reported adverse effects were diarrhoea/loose stools, nausea, skin rashes, urticaria, vomiting and vaginitis (1%). The overall incidence of side effects and in particular diarrhoea, increased with the higher recommended dose. Other less frequently reported reactions include abdominal discomfort, flatulence and headache. Erythema multiforme, Stevens-Johnson Syndrome and toxic epidermal necrolysis.
Drug Interactions
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of Amoxicillin with Clavulanic acid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin with Clavulanic acid may reduce the efficacy of oral contraceptives. The possibilities of prolonged bleeding time in individuals receiving anti-coagulants concurrently should be borne in mind.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Tab 20's, 50's.
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