CEPHATRUST 250 cefalexin monohydrate 250 mg capsules blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

cefalexin

Tersedia dari:

Lupin Australia Pty Limited

INN (Nama Internasional):

cefalexin

Status otorisasi:

Registered

Karakteristik produk

PRODUCT INFORMATION
CEPHATRUST
CEPHALEXIN (AS CEPHALEXIN MONOHYDRATE)
NAME OF THE MEDICINE
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
Cephatrust capsules
Lupin Australia Pty Ltd
Version 322 March 2011
Page 2 of 13
Cephatrust 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
Cephatrust capsules (250 mg and 500
mg) have shown a linear relationship to known values for both
strengths.
_ _
Drug
Bioavailability
(%)
Half-life (h)
T