AMOXICILLIN

The dosage depends on the susceptibility of the pathogens and the severity of the disease.

Standard dosage:

Adults and adolescents (> 40 kg body weight): The usual dosage covers a range from 750 mg to 3g amoxicillin daily in three divided doses. In some areas 1500 mg amoxicillin daily in three divided doses is recommended as the upper usual dose.

Short course treatment:

Uncomplicated urinary tract infections: two 3 g doses with 10-12 hours between the doses are recommended in some areas. Children (under 12 years) For infants and children oral suspensions containing amoxicillin are recommended.

Dosage for the prevention of endocarditis:

For the prevention of endocarditis, in patients not having a general anaesthetic, 3 g amoxicillin are given in the hour preceding the surgical procedure, followed by (6 hours later) a further 3 g dose, if considered necessary.

Dosage in impaired renal function:

The dose should be reduced in patients with severe renal impairment. 4). Short course treatments with a single dose of 3 g cannot be given in patients with renal failure.

Duration of therapv:

In general the therapy should be continued for 2 to 3 days following the disappearance of symptoms. In β-haemolytic streptococcal infections the duration of therapy should be at least 10 days in order to achieve eradication of the organism.

Method of administration:

The preparations are administered orally. g. a glass of water). The absorption of amoxicillin is not reduced by food intake. 2). *PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.

Children weighing more than 40 kg should be given the usual adult dosage. Special dosage recommendation Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media:

The most commonly reported adverse drug reactions are hypersensitivity reactions:

Common (≥1 % but < 10%) • Cutaneous reactions such as exanthema, pruritus, urticaria; the typical morbilliform exanthema occurs 5 - 11 days after start of therapy. Immediate appearance of urticaria indicates an allergic reaction to amoxicillin and therapy should therefore be discontinued.

4) • Angioneurotic oedema (Quincke's oedema) • Erythema multiforme exsudativum • Stevens-Johnson syndrome • Eosinophilia • Drug fever • Laryngeal oedema • Serum sickness • Haemolytic anaemia • Allergic vasculitis • Interstitial nephritis • Anaphylactic shock Blood disorders: There have been isolated reports of leucopenia, granulocytopenia, thrombocytopenia, pancytopenia, anaemia, myelosuppression, agranulocytosis, prolongation of bleeding time, and prolongation of prothrombin time.

However, these changes were reversible on discontinuation of therapy.

Gastrointestinal disorders:

Common (≥1% but < 10%): Gastric complaints, nausea, loss of appetite, vomiting, flatulence, soft stools, diarrhoea, enanthemas (particularly in the region of the mouth), dry mouth, taste disturbances. These effects on the gastrointestinal system are mostly mild and frequently disappear either during the treatment or very soon after completion of therapy.

The occurrence of these side-effects can generally be reduced by taking Amoxicillin 500mg Capsules during meals or with some food. If severe and persistent diarrhoea occurs, the very rare possibility of pseudomembranous colitis should be considered.

The administration of anti-peristaltic drug is contraindicated. 01%): Development of a black tongue. 1% but < 1%) Moderate and transient increase of liver enzymes. Rare reports of hepatitis and cholestatic jaundice. 1%): Acute interstitial nephritis may occur in rare cases.

Patients suffering from severe gastrointestinal disturbances with diarrhoea and vomiting should not be treated with Amoxicillin 500mg Capsules, due to the risk of reduced absorption. In these cases parenteral treatment with amoxicillin is advisable.

Amoxicillin 500mg Capsules should be used with caution in patients with allergic diathesis and asthma. ). The prolonged use of amoxicillin may occasionally result in an overgrowth of non- susceptible organisms or yeasts. Patients should therefore be watched carefully for superinfections.

The occurrence of anaphylactic shock and other severe allergic reactions is rare following the oral administration of amoxicillin. v. administration of epinephrine, followed by antihistaminic drugs, volume substitution and administration of glucocorticoids.

Patients should be kept under close observation, and further therapeutic measures (artificial respiration, oxygen) should be administered as required. The presence of high urinary concentrations of amoxicillin can cause precipitation of the product in urinary catheters.

Therefore, catheters should be visually inspected at intervals. At high doses, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria. Amoxicillin 500mg Capsules contains sunset yellow.

This may cause allergic reactions. Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.

Amoxicillin 500mg Capsules is contraindicated in patients with a previous history of hypersensitivity to amoxicillin or to any of the excipients. g. penicillins, cephalosporins, carbapenems, monobactams). Consequently a careful history should be taken in regard to any allergic reactions before commencing treatment.

Amoxicillin 500mg Capsules is also contraindicated in viral infections, acute lymphatic leukaemia, or infectious mononucleosis (due to an increased risk of erythematous skin rashes).