CEFADROXIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

CEFADROXIL

Composition:

CEFADROXIL ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 th

Product summary:

Cefadroxil Capsules USP, 500 mg-maroon cap and white body, imprinted with LU on cap and with F11 supplied as follows: NDC 66267-045-10 Bottle of 10 NDC 66267-045-14 Bottle of 14 NDC 66267-045-20 Bottle of 20 NDC 66267-045-30 Bottle of 30

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFADROXIL- CEFADROXIL CAPSULE
NUCARE PHARMACEUTICALS, INC.
----------
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