Ampicillin Cloxacillin For Injection 250MG+250MG
COMPOSITION:
Sterile powder for preparing the equivalent of 250 mg ampicillin and 250 mg cloxacillin per vial.
PHARMACOLOGICAL ACTION:
AMPICLOX exhibits in vivo and in vitro bactericidal activity against Gram-positive and Gram-negative organisms.
Both ampicillin and cloxacillin are acid stable and well absorbed orally, giving peak serum levels about two hours after dosing. As there is a linear dose/response in peak serum level after oral administration of both components, doubling the dose virtually doubles the peak serum levels.
INDICATIONS:
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity resting should, therefore, be carried out wherever possible, to ensure the appropriateness of the therapy.
Infections caused by susceptible organisms where a mixed infection is present and includes penicillin-resistant staphylococci.
CONTRA-INDICATIONS:
Known allergy to penicillin or cephalosporins. Cases of cross sensitivity have been reported.
Babies born of hypersensitive mothers in the neonatal period.
The oral dosage forms are not recommended for chronic, severe, or deep-seated infections such as subacute bacterial endocarditis, meningitis or syphilis. AMPICLOX should not be administered by sub-conjunctival injection or used as an eye drop as it contains cloxacillin.
WARNINGS:
When administered to a patient with penicillin allergy anaphylactic shock may occur. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis. Use with caution in patients with a known history of allergy.
Because of the variability in intestinal absorption of cloxacillin containing products, oral administration is not a suitable substitute for the parenteral route in treatment of severe infections.
DOSAGE AND DIRECTIONS FOR USE:
| Adults and children over 10 | : | 500 mg –1 g intravenously or intramuscularly every 4 – 6 hours or as dictated by the severity of the infection. |
| Children 2 –10 years* | : | Half the adult dose. |
| Children up to 2 years* | : | Quarter the adult dose. |
| Neonates* | : | 75 mg (i.e. 1 neonatal vial) every 8 hours. |
Intramuscular injection:
| 500 mg vial | – | add 1,5 mL of Water for Injections B.P. and shake vigorously. |
Intravenous injection:
| 500 mg vial | – | dissolve in 10 mL of Water for Injections B.P. by first dissolving the contents of the vial in approximately 3 mL of the Water for Injections B.P. and then withdrawing the dissolved contents into a 10 mL syringe containing the remaining Water for Injections B.P. |
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
AMPICLOX may produce diarrhoea, nausea and heartburn. Allergic reactions which may include exfoliative dermatitis, other skin rashes, interstitial nephritis and vasculitis may occur. In this event, withdrawal of AMPICLOX and administration of an antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur.
A generalised sensitivity reaction with urticaria, fever, joint pains and eosinophilia can develop within a few hours to several weeks after starting treatment.
STORAGE INSTRUCTIONS:
Containers of AMPICLOX 500 should be kept tightly closed in a cool (below 25°C), dry place.
KEEP OUT OF REACH OF CHILDREN.
