500mg/125mg Film-Coated Tablet
Each film-coated tablet contains:
Amoxicillin (as Trihydrate) ……… 500 mg
Clavulanic Acid (as Potassium Clavulanate) ……… 125 mg
The efficacy of Amoxicillin with Amoxicillin and 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.
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 experiments involving the administration of Clavulanic acid to animals suggests 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 the first 6 hour after oral administration of 500 + 125 mg of Amoxicillin 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 B-lactamase producing strains of haemophilus Influenzae and Moraxella (Branhamella) catarrhalis.
Otitis media & Sinusitis: caused by B-lactamase producing strains of haemophilus Influenzae and Moraxella (Branhamella)catarrhalis. Skin and Skin Structure Infections: caused by B-lactamase producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp. and Enterobacter spp.
DOSAGE AND ADMINISTRATIONS
Adult and children > 12 years old with mild to moderate infections: 250 mg/125 mg. More severe and Respiratory tract infections: 500 mg/125 mg every 8 hours. Or as prescribed by a physician.
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.
Amoxicillin with clavulanic acid is generally well tolerated. The majority of side effects observed in clinical trials were of a mild transient nature. The most frequently reported adverse effects were diarrhea/loose stools, nausea, skin rashes, urticaria, vomiting and vaginitis (1 %). The overall incidence of side effects and in particular diarrhea, 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.
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 and Clavulanic acid possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of long-term 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.
Most patients have been asymptomatic following overdosage or have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting and diarrhea. 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.
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.
Clavmoxwel -625 Tablet pack in Alu/Alu Blister foil of 10’s (Box of 10’s).
Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription.
Store at temperatures not exceeding 250C.
Protect from light, heat and moisture.
Keep all medicines out of the reach of children.
“For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph“.
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