DURICEF CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CEFADROXIL

Dostępny od:

BRISTOL-MYERS SQUIBB CANADA

Kod ATC:

J01DB05

INN (International Nazwa):

CEFADROXIL

Dawkowanie:

500MG

Forma farmaceutyczna:

CAPSULE

Skład:

CEFADROXIL 500MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

FIRST GENERATION CEPHALOSPORINS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0115958005; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2009-02-05

Charakterystyka produktu

PRODUCT MONOGRAPH
PR DURICEF*
(CEFADROXIL)
CAPSULES, 500 MG
ANTIBIOTIC
Bristol-Myers Squibb Canada
Date of Preparation:
2365 Cote de Liesse
October 25, 2004
St. Laurent PQ
H4N 2M7
Control#: 094706
*
TM of Bristol-Myers Squibb Company used
under licence by Bristol-Myers Squibb Canada
1
PRODUCT MONOGRAPH
DURICEF*
(CEFADROXIL)
Capsules, 500 mg
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION AND CLINICAL PHARMACOLOGY
DURICEF (cefadroxil) is a cephalosporin with bactericidal activity.
_In vitro_ studies have shown
that the antibacterial activity of the cephalosporins results from
their ability to inhibit
mucopeptide synthesis in the bacterial cell wall.
INDICATIONS AND CLINICAL USE
DURICEF (cefadroxil) may be indicated for the treatment of the
following infections when
caused by susceptible strains of the organisms indicated:
-
Acute uncomplicated urinary tract infections when caused by _E. coli_,
Klebsiella species and
some strains of _Proteus mirabilis_.
-
Skin and skin structure infections caused by _Staphylococcus aureus_
and/or group A beta-
hemolytic streptococci.
-
Acute pharyngitis-tonsillitis, when caused by group A beta-hemolytic
streptococci.
-
Lower respiratory tract infections, including pneumonia, caused by _S.
pneumoniae (D._
_pneumoniae), S. Pyogenes_ (Group A-beta hemolytic streptococci), _K.
pneumoniae_ and _S._
_aureus_.
Appropriate bacteriological studies should be performed prior to and
during therapy in order to
identify and determine the susceptibility of the causative
organism(s).
CONTRAINDICATIONS
DURICEF (cefadroxil) is contraindicated in patients with a known
hypersensitivity to the
cephalosporin group of antibiotics or to any component of the
formulation.
WARNINGS
Before therapy with DURICEF is instituted, careful inquiry should be
made to determine whether
the patient has had previous hypersensitivity reactions to DURICEF,
other cephalosporins,
penicillins, or other drugs. If this product is to be given to
penicillin-sensitive patients, caution
should be exercised because cross-sensitivity am