CEFADROXIL capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals,Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Cefadroxil is 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 fu

Produkt oversigt:

Cefadroxil Capsules, USP 500 mg are maroon/white colored, size “0” hard gelatin capsules filled with white to off-white granular free flowing powder and imprinted with “C” on maroon opaque cap and “97” on white opaque body with black ink. NDC 68071-2752-1 BOTTLES OF 10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Aurobindo Pharma Limited Chitkul (V)-502 307, India M.L.No.: 78/MD/AP/96/F/B/R Revised: 09/2018

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CEFADROXIL- CEFADROXIL CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
CEFADROXIL CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
cefadroxil and other antibacterial drugs, cefadroxil should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Cefadroxil, USP 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:
Cefadroxil capsules contain the following inactive ingredients:
Lactose monohydrate,
magnesium stearate, FD&C Blue No.1, D&C Red No.28, FD&C Red No. 40,
titanium
dioxide, gelatin, sodium lauryl sulphate, and edible black ink (black
iron oxide).
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.
16
17
3
5
2
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 clinic