CEFACLOR capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Bryant Ranch Prepack

INN (국제 이름):

CEFACLOR

구성:

CEFACLOR ANHYDROUS 250 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

CEFACLOR- CEFACLOR CAPSULE
BRYANT RANCH PREPACK
----------
CEFACLOR CAPSULES, USP
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 is 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.
MOLECULAR FORMULA
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 those with complete abs