CEFACLOR suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Cefaclor (UNII: 69K7K19H4L) (Cefaclor Anhydrous - UNII:3Z6FS3IK0K)

Available from:

Pack Pharmaceuticals, LLC

INN (International Name):

Cefaclor

Composition:

Cefaclor Anhydrous 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Cefac

Product summary:

Cefaclor Oral Suspension, USP are supplied in bottles with child-resistant caps as: 125 mg/5 mL strawberry flavor: 250 mg/5 mL strawberry flavor 375 mg/5 mL strawberry flavor 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFACLOR- CEFACLOR SUSPENSION
PACK PHARMACEUTICALS, LLC
----------
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 125 mg (0.34 mmol), 250 mg (0.68 mmol), or 375 mg (1 .0 mmol)
anhydrous cefaclor. The
suspensions also contain methylcellulose, sodium lauryl sulfate,
sucrose, and xanthan gum, FD&C Red
No. 40, strawbenry 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
s