CEPHALEXIN capsule

Summary of Product characteristics

                                CEPHALEXIN- CEPHALEXIN CAPSULE
DISPENSING SOLUTIONS, INC.
----------
CEPHALEXIN CAPSULES, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin and
other antibacterial drugs, cephalexin should be used only to treat or
prevent infections that are proven
or strongly suspected to be caused by bacteria.
DESCRIPTION
Cephalexin capsules, USP is a semisynthetic cephalosporin antibiotic
intended for oral administration. It
is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic
acid monohydrate. Cephalexin
has the molecular formula C
H N O S•H O and the molecular weight is 365.41.
Cephalexin has the following structural formula:
The nucleus of cephalexin is related to that of other cephalosporin
antibiotics. The compound is a
zwitterion; i.e., the molecule contains both a basic and an acidic
group. The isoelectric point of
cephalexin in water is approximately 4.5 to 5.
The crystalline form of cephalexin which is available is a
monohydrate. It is a white crystalline solid
having a bitter taste. Solubility in water is low at room temperature;
1 or 2 mg/mL may be dissolved
readily, but higher concentrations are obtained with increasing
difficulty.
The cephalosporins differ from penicillins in the structure of the
bicyclic ring system. Cephalexin has a
_D_-phenylglycyl group as substituent at the 7-amino position and an
unsubstituted methyl group at the 3-
position.
Each capsule contains cephalexin monohydrate equivalent to 250 mg (720
µmol) or 500 mg (1439 µmol)
of cephalexin. The capsules also contain the following inactive
ingredients: microcrystalline cellulose,
croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow
No. 6, gelatin,
magnesium stearate, titanium dioxide, and sodium lauryl sulfate.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin is acid stable and may be given without regard to meals. It
is rapidly absorbed after oral
administration. Following doses of 250 mg, 500 mg, and 1 g, average
peak serum levels of
16
17
3
4
2
approxi
                                
                                Read the complete document