CEFIXIME 400 MG UD- cefixime capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)

Available from:

Health Department, Oklahoma State

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFIXIME 400 MG UD- CEFIXIME CAPSULE
HEALTH DEPARTMENT, OKLAHOMA STATE
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CEFIXIME 400 MG UD
WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Anaphylactic/anaphylactoid reactions (including shock and fatalities)
have been reported
with the use of cefixime.
Before therapy with cefixime is instituted, careful inquiry should be
made to determine
whether the patient has had previous hypersensitivity reactions to
cephalosporins,
penicillins, or other drugs. If this product is to be given to
penicillin-sensitive patients,
caution should be exercised because cross hypersensitivity among
beta-lactam
antibiotics has been clearly documented and may occur in up to 10% of
patients with a
history of penicillin allergy. If an allergic reaction to cefixime
occurs, discontinue the
drug.
5.2 Clostridium difficile-Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported
with use of nearly all
antibacterial agents, including cefixime, and may range in severity
from mild diarrhea to
fatal colitis. Treatment with antibacterial agents alters the normal
flora of the colon
leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the
development of CDAD.
Hypertoxin producing isolates of C. difficile cause increased
morbidity and mortality, as
these infections can be refractory to antimicrobial therapy and may
require colectomy.
CDAD must be considered in all patients who present with diarrhea
following antibacterial
use. Careful medical history is necessary since CDAD has been reported
to occur over
two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not
directed against C.
difficile may need to be discontinued. Appropriate fluid and
electrolyte management,
protein supplementation, antibacterial treatment of C. difficile, and
surgical evaluation
should be instituted as clinically indicated.
5.3 Dose Adjustment in Renal Impairment
The dose of cefixime should be adjusted in patients with