DURICEF cefadroxil powder for suspension

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

cefadroxil (UNII: 280111G160) (cefadroxil - UNII:280111G160)

Disponible depuis:

Warner Chilcott, Inc.

DCI (Dénomination commune internationale):

cefadroxil

Composition:

250 mg in 5 mL

Type d'ordonnance:

PRESCRIPTION DRUG

Résumé des caractéristiques du produit

DURICEF- CEFADROXIL POWDER, FOR SUSPENSION
DURICEF- CEFADROXIL TABLET
DURICEF- CEFADROXIL CAPSULE
WARNER CHILCOTT, INC.
----------
DURICEF
(CEFADROXIL MONOHYDRATE, USP)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of DURICEF and
other antibacterial drugs, DURICEF should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
DURICEF is a semisynthetic cephalosporin antibiotic intended for oral
administration. It is a white to
yellowish-white crystalline powder. It is soluble in water and it is
acid-stable. It is chemically
designated as 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,
7-[[amino(4-
hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-,
monohydrate[6R-[6α,7β(R*)]]-. It has the formula
C
H N O S • H O and the molecular weight of 381.40. It has the
following structural formula:
DURICEF film-coated tablets, 1 g, contain the following inactive
ingredients: microcrystalline
cellulose, hydroxypropyl methylcellulose, magnesium stearate,
polyethylene glycol, polysorbate 80,
simethicone emulsion, and titanium dioxide.
DURICEF for Oral Suspension contains the following inactive
ingredients: FD&C Yellow No. 6,
flavors (natural and artificial), polysorbate 80, sodium benzoate,
sucrose, and xanthan gum.
DURICEF capsules contain the following inactive ingredients: D&C Red
No. 28, FD&C Blue No. 1,
FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide.
CLINICAL PHARMACOLOGY
DURICEF is rapidly absorbed after oral administration. Following
single doses of 500 mg and 1000
mg, average peak serum concentrations were approximately 16 and 28
μg/mL, respectively. Measurable
levels were present 12 hours after administration. Over 90% of the
drug is excreted unchanged in the
urine within 24 hours. Peak urine concentrations are approximately
1800 μg/mL during the period
following a single 500 mg oral dose. Increases in dosage generally
produce a proportionate increase in
DURICEF (cefadroxil monohydrate, USP)