CEFACLOR suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Azorian Pharma, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections , including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae , and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. 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. Cefaclo

Produktsammanfattning:

Cefaclor Oral Suspension, USP, is supplied in bottles with child-resistant caps as: 250 mg/5 mL strawberry flavor       NDC 81948-6250-1 (150 mL size) After mixing, store in a refrigerator. Shake well before using. Keep tightly closed. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days. Store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured by: Yung Shin Pharmaceutical Ind. Co., Ltd. Tachia, Taichung 43769, TAIWAN Manufactured for: Azorian Pharma, LLC Claymont, DE 19703 Revised: 10/22  KRP50e (Azorian) USA 2150153-001

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CEFACLOR- CEFACLOR SUSPENSION
AZORIAN PHARMA, LLC
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CEFACLOR SUSPENSION
CEFACLOR FOR ORAL SUSPENSION, USP
Rx Only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor
for Oral
Suspension, USP, should be used only to treat or prevent infections
that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Cefaclor, USP, 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 chemical formula for cefaclor is C
H
ClN O S•H O and the
molecular weight is 385.82.
After mixing, each 5 mL of Cefaclor for Oral Suspension will contain
cefaclor
monohydrate equivalent to 250 mg (0.68 mmol) anhydrous cefaclor. The
suspensions
also contain methylcellulose, sodium lauryl sulfate, sucrose, and
xanthan gum, FD&C
Red No. 40, strawberry flavor.
The color of drug powder in the dry powder state is white to
off-white. After
reconstitution, it turns to a red suspension.
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 h