CEFADROXIL capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

CEFADROXIL (UNII: 280111G160) (CEFADROXIL ANHYDROUS - UNII:Q525PA8JJB)

Disponible depuis:

Bryant Ranch Prepack

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Cefadroxil Capsules USP are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli , P. mirabilis , and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil monohydrate for the prophylaxis of subsequent rheumatic fever are not available. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintai

Descriptif du produit:

Product: 63629-1358 NDC: 63629-1358-1 10 CAPSULE in a BOTTLE NDC: 63629-1358-2 20 CAPSULE in a BOTTLE NDC: 63629-1358-3 28 CAPSULE in a BOTTLE NDC: 63629-1358-4 30 CAPSULE in a BOTTLE NDC: 63629-1358-5 60 CAPSULE in a BOTTLE NDC: 63629-1358-6 4 CAPSULE in a BOTTLE NDC: 63629-1358-7 14 CAPSULE in a BOTTLE NDC: 63629-1358-8 40 CAPSULE in a BOTTLE NDC: 63629-1358-9 5 CAPSULE in a BOTTLE

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CEFADROXIL- CEFADROXIL CAPSULE
BRYANT RANCH PREPACK
----------
CEFADROXIL CAPSULES USP 500 MG
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefadroxil
capsules and other antibacterial drugs, cefadroxil capsules should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cefadroxil monohydrate 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:
Each capsule contains cefadroxil monohydrate USP equivalent to 500 mg
of cefadroxil. In addition,
each capsule also contains the following inactive ingredients:
crospovidone, D&C Red No. 28, FD&C
Blue No. 1, FD&C Red No. 40, ferric oxide black, gelatin, magnesium
stearate, microcrystalline
cellulose, potassium hydroxide, propylene glycol, shellac and titanium
dioxide.
CLINICAL PHARMACOLOGY
Cefadroxil monohydrate is rapidly absorbed after oral administration.
Following single doses of 500
mg and 1000 mg, average peak serum concentrations were approximately
16 and 28 mcg/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
mcg/mL during the period following a single 500-mg oral dose.
Increases in dosage generally produce
a proportionate increase in cefadroxil monohydrate urinary
concentration. The urine antibiotic
concentration, following a 1-g dose, was maintained well above the MIC
of susceptible urinary
pathogens for 20 to 22 hours.
MICROBIOLOGY
_In vitro _tests demonstrate that the cephalosporins are bact