Amoclavisol 625 Tablet
16 Nnobi Street, By Kilo B/stop, Surulere lagos.
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Tel: 08023102841, 08099931251, 07054679238.
Sunstone Star (Zhangjiakou) Pharmaceutical Company 24 Jianguo Road, Zhangjiakou, China
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: A4-7050 ); Amoxicillin 500 mg, Clavulanic acid 125 mg.
Pack Size: 2 x 8 tablets.
AMOCLAVISOL is a combination of amoxicillin and clavulanic acid. Amoxicillin is a broad spectrum bactericidal antibiotic, which is active against both Gram-positive and Gram-negative organisms.
Clavulanic acid itself has only a minimal antibacterial action. However, by binding irreversibly to the beta-lactamases produced by many strains of organisms usually resistant to penicillins, the clavulanic acid protects the amoxicillin from hydrolysis.
Clavulanic acid has been shown in vitro, to be an irreversible inhibitor of beta-lactamases produced by many bacteria including: Escherichia coli; Haemophilus influenzae; Klebsiella pneumoniae; Bacteroides fragilis; Staphylococcus aureus as well as Proteus vulgaris; Proteus mirabilis and Neisseria gonorrhoeae.).
The pharmacokinetics of amoxicillin are very similar to that of clavulanic acid. Food has no affect on the absorption of either amoxicillin or clavulanic acid. Peak serum levels are reached between one to two hours. There is very little effect on the excretion rate of clavulanic acid when probenecid is concomitantly administered.
AMOCLAVISOL is indicated for the treatment of infections caused by all organisms sensitive to amoxicillin, as well as those organisms which produce beta-lactamases that are sensitive to clavulanic acid. This includes:
- Infections of the upper respiratory tract (otitis media)
- Infections of the lower respiratory tract (bronchitis)
- Infections of the genito-urinary tract
- Infections of the skin and soft tissues
AMOCLAVISOL is contra-indicated in patients with:
- a history of allergic reactions to either penicillins and/or cephalosporins
- a previous history of jaundice and/or hepatic dysfunction associated with amoxicillin and clavulanic acid
When administered to a patient with a penicillin allergy, serious and occasionally fatal hypersensitivity (anaphylactoid) reactions may occur and although this occurs more frequently after intravenous administration, oral therapy has been known to elicit the same response.
When considering starting therapy with AMOCLAVISOL, previous history of hypersensitivity to penicillins cephalosporins or other allergens must therefore be excluded.
If an allergic reaction occurs, AMOCLAVISOL should be discontinued. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis.
Reversible hepatitis and cholestatic jaundice has been reported with amoxicillin and clavulanic combination so that Amoclavisol should be used with caution in patients with evidence of hepatic dysfunction.
Probenecid prolongs the half-life of benzylpenicillin. An increased frequency of skin rashes has been reported in patients receiving amoxicillin together with allopurinol.
The most common adverse effects are hypersensitivity reactions; especially skin rashes; anaphylaxis occasionally occurs and has sometimes been fatal. Hepatitis and cholestatic jaundice have been reported with the combination amoxycillin with clavulanic acid; the clavulanic acid component has been implicated.
Erythema multiforme (including the Stevens-Johnson syndrome), toxic epidermal necrolysis, and exfoliative dermatitis have also been attributed occasionally to amoxycillin with clavulanic acid.
Skin rashes are however the most common side-effects and are generally either urticarial or maculopapular; the urticarial reactions are typical of penicillin hypersensitivity. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis. Haemolytic anaemia and neutropenia have been reported.
Dosage & Administration
The presence of food does not affect the absorption of AMOCLAVISOL, so that AMOCLAVISOL may be taken on a full or empty stomach. In that the incidence of any possible gastrointestinal side-effects is reduced in the presence of food, it is recommended that AMOCLAVISOL be taken at the beginning of a meal.
Excretion takes place through the kidneys so that patients with renal function impairment should have their dose reduced to the dosing interval extended.
The following guideline may be used for dose adjustments: Generally, depending on the severity of infection, Amoclavisol 625 is given either every 12 hours or every 8 hours.
Nausea, vomiting and diarrhoea may occur with overdosing. Treatment is symptomatic and supportive.
Keep out of reach of children.
Store in a cool, dry place below 25°C in tightly closed containers.
Protect from moisture - do not remove desiccant.