CEFADROXIL powder, for suspension

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Aurobindo Pharma Limited

ІПН (Міжнародна Ім'я):

CEFADROXIL

Склад:

CEFADROXIL ANHYDROUS 250 mg in 5 mL

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 function studies should be performed when indicated.   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 susceptible bacteria.  When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  In the absence of such data, local epidemology and susceptibility patterns may contribute to the empiric selection of therapy. Cefadroxil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Огляд продуктів:

Cefadroxil for Oral Suspension, USP  is an off white to light orange colored granular powder which after reconstitution is orange colored and is orange-pineapple flavored, and is supplied as follows: 250 mg/5 mL 50 mL Bottle                NDC 65862-083-50 100 mL Bottle              NDC 65862-083-01 500 mg/5 mL   50 mL Bottle                NDC 65862-084-50 75 mL Bottle                NDC 65862-084-75 100 mL Bottle              NDC 65862-084-01 Prior to reconstitution: 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: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 09/2021

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

CEFADROXIL - CEFADROXIL POWDER, FOR SUSPENSION
AUROBINDO PHARMA LIMITED
----------
CEFADROXIL FOR ORAL SUSPENSION, 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 monohydrate, 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 for oral suspension USP, after reconstitution, contains
cefadroxil
monohydrate equivalent to 250 mg or 500 mg cefadroxil base per 5 mL.
In addition,
cefadroxil for oral suspension also contains the following inactive
ingredients: FD&C
Yellow No. 6 Aluminum lake, polysorbate 80, sodium benzoate, sucrose,
xanthan gum,
orange flavor and pineapple flavor. The orange flavor and pineapple
flavor contains
sulfur 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
16
17
3
5
2
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.
MIC