APOTEX-CEPHALEXIN cefalexin (as monohydrate) 250 mg capsules blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

cefalexin

Tillgänglig från:

Lupin Australia Pty Limited

INN (International namn):

cefalexin

Bemyndigande status:

Registered

Produktens egenskaper

PRODUCT INFORMATION
APOTEX-CEPHALEXIN
CEPHALEXIN (AS CEPHALEXIN MONOHYDRATE)
NAME OF THE MEDICINE
APOTEX-CEPHALEXIN (cephalexin monohydrate) is a semisynthetic
cephalosporin antibiotic for oral
administration. It is 7-(D-
α
-amino-
α
-phenyl-acetamido)-3-methyl-3-cephem-4-carboxylic acid,
monohydrate Cephalexin monohydrate has the following structural
formula.
O
H
NH
2
NH
O
N
S
H
H
CH
3
CO
2
H
H
2
O
Molecular formula: C
16
H
17
N
3
O
4
S. H
2
O
Molecular weight: 365.4
CAS number: [23325-78-2]
DESCRIPTION
The nucleus of cephalexin is related to that of other cephalosporin
antibiotics. The compound is a
zwitterion; ie. 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;
1or 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.
Product Information
Apotex-Cephalexin capsules
Lupin Australia Pty Ltd
Version 3 22 March 2011
Page 2 of 13
Apotex Cephalexin capsules contains cephalexin monohydrate equivalent
to 250 mg or 500 mg of
anhydrous cephalexin. They also contain microcrystalline cellulose and
magnesium stearate. The
capsules are of gelatin, sodium lauryl sulphate, and are coloured with
sunset yellow (E110),
quinoline yellow (E104), titanium dioxide (E171), patent blue (E131)
and black ink (SW 9008).
PHARMACOLOGY
PHARMACOKINETICS
The following mean pharmacokinetic parameters have been reported for
the oral administration of
cephalexin capsules. Pharmacokinetic parameters obtained for
Apotex-Cephalexin capsules (250 mg
and 500 mg) have shown a linear relationship to known values for both
strengths.
_ _
Drug