CEFADROXIL- cefadroxil capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

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 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 Capsules USP, 500 mg are available as opaque chocolate brown and white hard gelatin capsules, imprinted with “WEST-WARD 947”. 49999-021-20 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 CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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CEFADROXIL CAPSULES AND TABLETS - MFD BY JAZEERA
CEFADROXIL CAPSULES, USP
Rev. 01/16
Rx Only
To reduce the development of drug resistant bacteria and maintain the
effectiveness of cefadroxil
capsule and other antibacterial drugs, cefadroxil capsule should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cefadroxil is a semisynthetic cephalosporin antibiotic intended for
oral administration. It is a white to
yellowish-white crystalline powder. It is chemically designated as (6
R,7R)-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 Capsules, USP contain the following inactive ingredients:
black iron oxide, colloidal silicon
dioxide, croscarmellose sodium, gelatin, lactose monohydrate,
magnesium stearate, red iron oxide, 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 both _in vitro_ and in
clinical infections (see INDICATIONS AND USAGE