|Ampicillin + Cloxacillin||Capsule||250mg + 250mg||1000.0820|
Ampicloxacillin Capsules 500mg
Ampicillin and Cloxacillin Capsules
Ampicillin trihydrate B.P. and Cloxacillin sodium B.P. available as:
Ampicillin/Cloxacillin 500: Gelatin capsules containing the equivalent of 250mg ampicillin and 250mg Cloxacillin.
Ampicillin/Cloxacillin exhibits in vivo and in vitro bactericidal activity against some Gram-positive and Gram-negative organisms, in vitro sensitivity does not necessarily imply in vivo efficacy.
Both ampicillin and Cloxacillin are acid stable and well absorbed orally, giving peak serum levels two hours after dosing. As there is a linear dose/response in peak serum levels after oral administration of both components, doubling the dose virtually doubles the peak serum levels.
Both components are excreted primarily by the kidneys by glomerular filtration and tubular secretion.
Bile: Bile concentrations of Ampicillin/Cloxacillin vary from 3 to 48 times the serum concentration, according to the condition of the biliary tract.
Higher Ampicillin/Cloxacillin serum levels can be achieved in patients with normal renal function by the concurrent administration of a renal blocking agent such as Probenecid. In adults, a dose of 500 mg of Probenecid four times daily will result in 1,5 – 2 fold increase in Ampicillin/Cloxacillin serum levels.
Infections caused by susceptible organisms where a mixed infection is present and includes penicillin-resistant staphylococci.
Allergy to penicillins is an absolute contra-indication to the use of Ampicillin/Cloxacillin. Ampicillin/Cloxacillin must not be used in the eye either subconjunctivally or locally.
DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for Ampicillin/Cloxacillin is 2 – 4 g per day. In severe infections, dosages may be safely increased.
Adults and children over 10 years: 500 mg – 1 g (1 – 2 x 500 mg capsules) every 6 hours.
Children 2 – 10 years: 250 – 500 mg (5 – 10 ml of 250 mg/5 ml syrup) every 6 hours.
Children up to 2 years: 250mg (5 ml of 250 mg/5 ml syrup) every 6 hours.
(1) Best results are obtained if dosages are administered half to one hour prior to meals.
(2) Patients with renal insufficiency may require a reduced dosage.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common adverse effects associated with penicillins are allergic reactions. Of these, skin rashes occur most frequently and are either urticarial or maculopapular. The incidence of this occurring is especially high in patients suffering from mononucleosis.
Patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may also be at increased risk of developing skin rashes. Administration of penicillins to a hypersensitive patient may occasionally result in anaphylactic shock with collapse and sometimes death. Angioedema or bronchospasm may also occur.
Gastro-intestinal adverse effects particularly diarrhea, nausea and vomiting occur quite frequently.
Pseudomembranous colitis has also been reported. Supra-infections with non-susceptible organisms may occur particularly with prolonged use. Renal and haematological systems should be monitored during prolonged high dose therapy. Jarisch-Herxheimer’[s reaction may occur when treating patients with syphilis.
Ampicillin may decrease the efficacy of oestrogen containing oral contraceptives and it may also affect the absorption of other drugs due to its effect on gastro-intestinal flora.
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity testing should therefore be carried out whenever possible, to ensure the appropriateness of the therapy.
As for ampicillin, see above.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms of overdosage.
As with all penicillins, oral administration of Ampicillin/Cloxacillin can cause gastro-intestinal symptoms such as transient diarrhea, nausea and colic which are dose related and a result of local irritation, not toxicity.