CEFACLOR- cefaclor capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

CEFACLOR (UNII: 69K7K19H4L) (CEFACLOR ANHYDROUS - UNII:3Z6FS3IK0K)

Commercializzato da:

A-S Medication Solutions

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae , Haemophilus influenzae , staphylococci, and Streptococcus pyogenes   Lower respiratory tract infections , including pneumonia caused by Streptococcus pneumoniae , Haemophilus influenzae, and Streptococcus pyogenes   Pharyngitis and Tonsillitis , caused by Streptococcus pyogenes   Note : Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections , including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphy

Dettagli prodotto:

Product: 50090-0518 NDC: 50090-0518-2 21 CAPSULE in a BOTTLE NDC: 50090-0518-0 30 CAPSULE in a BOTTLE

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CEFACLOR- CEFACLOR CAPSULE
A-S MEDICATION SOLUTIONS
----------
CEFACLOR
CEFACLOR CAPSULES, USP
Rev. 09/15
Rx Only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefaclor and
other antibacterial drugs, cefaclor should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Cefaclor Capsules, USP are a semisynthetic cephalosporin antibiotic
for oral administration. It is
chemically designated as
3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid
monohydrate. The molecular formula for cefaclor is C
H ClN O S•H O and the molecular weight is
385.82.
Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68
mmol) or 500 mg (1.36 mmol)
anhydrous cefaclor. The capsules also contain black iron oxide,
croscarmellose sodium, FD & C Red
No.3, FD & C Blue No.2, gelatin, magnesium stearate, corn starch, and
titanium dioxide.
The color of the capsule powder is white to off white.
CLINICAL PHARMACOLOGY
Cefaclor is well absorbed after oral administration to fasting
subjects. Total absorption is the same
whether the drug is given with or without food; however, when it is
taken with food, the peak
concentration achieved is 50% to 75% of that observed when the drug is
administered to fasting
subjects and generally appears from three fourths to 1 hour later.
Following administration of 250-mg,
500-mg, and 1-g doses to fasting subjects, average peak serum levels
of approximately 7, 13, and 23
mcg/mL respectively were obtained within 30 to 60 minutes.
Approximately 60% to 85% of the drug is
excreted unchanged in the urine within 8 hours, the greater portion
being excreted within the first 2
hours. During this 8-hour period, peak urine concentrations following
the 250-mg, 500-mg, and 1-g
doses were approximately 600, 900, and 1,900 mcg/mL, respectively. The
serum half-life in normal
subjects is 0.6 to 0.9 hour. In patients with reduced renal function,
the serum half-life of cefaclor is
slightly prolonged. In t