Amoxicillin + Clavulanic Acid Tablet
Each film coated tablet contains amoxicillin trihydrate equivalent to 500mg amoxicillin and potassium clavulanate equivalent to 125mg clavulanic acid.
The formulation of amoxicillin, a bactericidal β-lactam penicillin antibiotic, and clavulanic acid, an irreversible β-lactamase inhibitor, is a bactericidal antibiotic, with a broad spectrum of bactericidal activity against Gram-positive and Gram-negative aerobic and anaerobic bacteria. The presence of clavulanic acid in the formulation extends the spectrum of activity of amoxicillin to include many β-lactamase-producing bacteria normally resistant to amoxicillin and other
The combination of amoxicillin and clavulanic acid is indicated for the treatment of:
– Upper respiratory tract infections (sinusitis, tonsillitis, otitis media).
– Lower respiratory tract infections (pneumonia, empyema, lung abscess, bronchitis).
– Genito-urinary tract and abdominal infections (cystitis, pyelonephritis, urethritis, pelvic infections, gonorrhoea and intra-abdominal sepsis).
– Soft tissue and dermal infections (wound infections, animal bites and severe dental abscess with spreading cellulitis).
Administer at the start of a meal.
NOTE: All doses expressed as amoxicillin.
1-6 years: 125mg every 8 hours.
6-12 years: 250mg every 8 hours.
Adults and children over 12 years: 250 mg every 8 hours, doubled in severe infections.
Severe denial infections: Adult: 250mg every 8 hours for 5 days.
Pregnancy and breast-feeding
Use should be avoided in pregnancy, especially during first trimester. Amoxicillin + clavulanic acid should be considered appropriate when the potential benefits outweigh the potential risks associated with treatment. Amoxicillin + clavulanic acid may be given with caution during lactation.
Contra-indications and warnings
Amoxicillin + clavulanic acid should be used for infections likely, or known, to be caused by amoxicillin-resistant β-lactamase-producing strains. Do not use in case of hypersensitivity to penicillins. Cross allergy to other β-lactams such as cephalosporins should be taken into account. Contra-indicated in previous history of amoxicillin/ clavulanic acid or penicillin-associated jaundice or hepatic dysfunction. Use with caution in patients with evidence of hepatic dysfunction.
Avoid in infectious mononucleosis, because of the risk of skin rashes; patients with lymphatic leukaemia or possibly HIV infection may also be at increased risk. Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin. Reduce dose if creatinine clearance is less than 30 ml/min. Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Amoxicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
Side-effects are uncommon and mainly of mild and transitory nature. Gastro-intestinal reactions e.g. nausea, diarrhoea, vomiting and mucocutaneous candidiasis have been reported. Superficial tooth discolouration has been reported rarely; it can usually be removed by brushing. Genito-urinary effects e.g. vaginal itching, soreness and discharge may occur. Hepatitis and jaundice have been reported rarely with the combination amoxicillin + clavulanic acid; the clavulanic acid component has been implicated. The risk increases with duration of treatment longer than 14 days. Signs and symptoms may not become apparent for several weeks after treatment has ceased.
Rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, interstitial nephritis and exfoliative dermatitis have been reported. As with other β-lactams transient leucopenia (including neutropenia and agranulocytosis), thrombocytopenia and haemolytic anaemia have been reported rarely. Convulsions may occur with impaired renal function or in those receiving high doses. During the administration of high doses of amoxicillin, maintain adequate fluid intake and urinary output to reduce the possibility of amoxicillin crystalluria.
Overdosage is not likely to occur, but if encountered it should be treated symptomatically.
Store in a dry place below 25°C, protected from light.
NAFDAC REG. No. A4-6558
Micro Labs Limited, India.
1030 AB Amsterdam,