CEFADROXIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Jazeera Pharmaceutical

INN (International Name):

CEFADROXIL

Composition:

CEFADROXIL ANHYDROUS 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefadroxil Tablets, 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 is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil 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 maintain the effectiveness of 

Product summary:

Cefadroxil Tablets USP, 1 g are available as white to off-white capsule shaped, bisected film coated tablets, imprinted “WW” on the left side of the break-line and “948” on the right side. Cefadroxil Tablets USP, are supplied as follows: Bottle of 50 Bottle of 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFADROXIL- CEFADROXIL TABLET, FILM COATED
JAZEERA PHARMACEUTICAL
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CEFADROXIL TABLETS
CEFADROXIL TABLETS, USP
Rev. 01/16
Rx Only
To reduce the development of drug resistant bacteria and maintain the
effectiveness of cefadroxil
tablets and other antibacterial drugs, cefadroxil tablets should be
used only to treat or prevent infections
that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Cefadroxil Tablets, USP is a semisynthetic cephalosporin antibiotic
intended for oral administration. It
is a white to off-white crystalline powder. It is soluble in water and
it is acid-stable. It is chemically
designated as (6
_R_,7_R_)-7-[(_R_)-2-amino-2-(_p_-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. It has the
following structural formula:
C
H N O S·H O M.W.381.40
Cefadroxil oral tablets available in 1 g strength contain the
following inactive ingredients: colloidal
silicon dioxide, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, and
titanium dioxide.
CLINICAL PHARMACOLOGY
Cefadroxil 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 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 bactericidal
because of their inhibition of cell-wall
synthesis. Cefadroxil has been shown to be active against the
following organisms