CEFADROXIL capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

RedPharm Drug, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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. Bottles of 50                NDC 57237-096-50 Bottles of 100              NDC 57237-096-01 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]. Distributed by: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/78/1996 Revised: 09/2018

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CEFADROXIL- CEFADROXIL CAPSULE
REDPHARM DRUG, INC.
----------
CEFADROXIL 500MG
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.
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 U