WARNINGS
Serious and occasionally fatal hypersensitivity (anaphylactic
shock with collapse) reactions have occurred in patients receiving penicillin.
The incidence of anaphylactic shock in all penicillin-treated patients is
between 0.015% and 0.04%. Anaphylactic shock resulting in death has occurred in
approximately 0.002% of the patients treated. Although anaphylaxis is more
frequent following a parenteral administration, it has occurred in patients
receiving oral penicillins.
When penicillin therapy is indicated, it should be initiated only after a
comprehensive patient drug and allergy history has been obtained. If an allergic
reaction occurs, the drug should be discontinued and the patient should receive
supportive treatment, e.g., artificial maintenance of ventilation, pressor
amines, antihistamines and corticosteroids. Individuals with a history of
penicillin hypersensitivity may also experience allergic reactions when treated
with a cephalosporin.
PRECAUTIONS
General
Prescribing dicloxacillin sodium capsules USP in the absence of a
proven or strongly suspected bacterial infection or a prophylactic indication is
unlikely to provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.
Dicloxacillin should generally not be administered to patients with a history
of sensitivity to any penicillin.
Penicillin should be used with caution in individuals with histories of
significant allergies and/or asthma. Whenever allergic reactions occur,
penicillin should be withdrawn unless, in the opinion of the physician, the
condition being treated is life-threatening and amenable only to penicillin
therapy.
The oral route of administration should not be relied upon in patients with
severe illness, or with nausea, vomiting, gastric dilatation, cardiospasm or
intestinal hypermotility. Occasionally, patients will not absorb therapeutic
amounts of orally administered penicillin.
The use of antibiotics may result in overgrowth of nonsusceptible organisms.
If new infections due to bacteria or fungi occur, the drug should be
discontinued and appropriate measures taken.
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