PENTA-CEPHALEXIN - 500MG TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE)

Διαθέσιμο από:

PENTAPHARM LTD.

Φαρμακολογική κατηγορία (ATC):

J01DB01

INN (Διεθνής Όνομα):

CEFALEXIN

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE) 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

FIRST GENERATION CEPHALOSPORINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0105911003; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2004-07-30

Αρχείο Π.Χ.Π.

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PRODUCT MONOGRAPH
PR
CEPHALEXIN - 500
CEPHALEXIN TABLETS USP
500 MG
ANTIBIOTIC
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
May 28, 2021
Laval, Quebec
H7L 3W9
CONTROL NUMBER: 251955
4
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PRODUCT MONOGRAPH
PR
CEPHALEXIN - 500
Cephalexin Tablets USP
500 mg
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
Cephalexin is bactericidal against many gram-positive and
gram-negative organisms. _In _
_vitro _tests demonstrate that the cephalosporins are bactericidal
through their inhibition of
cell-wall synthesis
(15)
.
Comparative Bioavailability
A bioavailability study was performed using normal human volunteers.
The rate and
extent of absorption and urinary excretion after a single oral dose of
500 mg of
cephalexin, following an overnight fast was measured and compared
[Administration was
in the form of either 2 x 250 mg CEPHALEXIN tablets, or 2 x 250 mg
Keflex tablets]. The
results can be summarized as follows:
_Serum Data _
Parameter
Mean* ± SD
Relative Mean**
(%)
90% Confidence
Interval (%)
CEPHALEXIN
Keflex†
AUC
T
(mcg•hr/mL)
34.9 ± 8.9
36.9 ± 12.0
96.1
91.6 - 100.8
C
max
(mcg/mL)
22.1 ± 5.8
23.4 ± 9.3
97.4
85.0 - 111.6
AUC
I
(mcg•hr/mL)
36.7 ± 9.5
36.8 ± 12.2
96.3
92.3 - 100.4
t
max
(hr)
1.00 ± 0.26
1.00 ± 0.27
87.5
λ (hr
-1
)
0.703 ± 0.111
0.728 ± 0.165
96.5
t
½
(hr)
1.01 ± 0.19
1.00 ± 0.24
101.2
*for raw data.
**based on geometric means for AUC
T,
AUC
I
and C
max
and arithmetic means for t
max,
λ and t
½.
_ _
_ _
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_Urine Data _
Parameter
Mean* ± SD
Relative Mean**
(%)
90% Confidence
Interval (%)
CEPHALEXIN
Keflex†
CUMEX (mg)
359 ± 113
324 ± 113
110.0
97.4 - 124.2
EXRMAX (mg/hr)
175 ± 77
143 ± 69
124.6
EXTMAX (hr)
1.50 ± 0.59
1.50 ± 0.86
96.1
*for raw data. For EXTMAX these are the medians.
**based on geometric means for AUC
T,
AUC
I
and C
max
and arithmetic means for t
max,
λ and t
½..
† Keflex is manufactured by Eli Lilly Canada Inc. and was purchased
in Canada.
INDICATIONS
CEPHALEXIN - 500 (cephalexin) may be indicated for the treat