Apo-Cephalex 500mg tablets

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

cefalexin

MAH:

Apotex Inc.

ATC_code:

J01DB01

INN:

cefalexin

dosage:

500mg

pharmaceutical_form:

tablets

units_in_package:

(100) plastic container

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2015-04-16

SPC

APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page 1 of 11
1. NAME OF THE MEDICINAL PRODUCT
APO-CEPHALEX Tablets 250 mg and 500 mg
(Cephalexin Tablets USP)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
INGREDIENTS
FUNCTION
% W/W
QUANTITY (MG/TAB)
250 MG
500 MG
CORE
Cephalexin USP
Active
65.800
250.00
500.00
Microcrystalline Cellulose NF
(PH 102)
Diluent/binder
32.336
122.88
245.754
Stearic Acid NF
Lubricant
1.052
4.00
8.00
Sunset Yellow Aluminum Lake
40%
Coloring agent
0.337
1.28
2.56
Colloidal Silicon Dioxide NF
Glidant
0.211
0.80
1.60
Magnesium Stearate NF
Lubricant
0.264
1.00
2.00
TOTAL WEIGHT (CORE TABLETS)
100.00
380.00
760.00
COATING
Hydroxypropyl Cellulose NF
Type LF
Film-forming
polymer
3.00
1.50
3.00
Hydroxypropyl Methylcellulose
2910 USP E5
Film-forming
polymer
2.00
1.00
2.00
Polyethylene Glycol 8000 NF
Plasticizer
3.00
1.50
3.00
Titanium Dioxide USP
Opacifier/
pigment
4.76
2.38
4.76
Sunset Yellow Aluminum Lake
40%
Coloring agent
0.24
0.12
0.24
Purified Water USP*
Carrier vehicle
for coating
ingredients
87.00
43.50
87.00
TOTAL WEIGHT (COATING)
100.00
50.00
100.00
TOTAL WEIGHT (COATING- EXCLUDING WATER)
--
6.50
13.00
TOTAL WEIGHT (COATED TABLETS)
--
386.50
773.00
* Evaporates during coating process.
3. PHARMACEUTICAL FORM
Tablets
APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page 2 of 11
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-CEPHALEX (cephalexin) may be indicated for the treatment of
bacterial infections
of the respiratory tract including otitis media, genitourinary tract,
bones and joints, skin
and soft tissues when the infection is caused by susceptible
organisms. Culture and
susceptibility studies should be performed.
4.2
POSOLOGY
AND
METHOD
OF
ADMINISTRATION
(WHERE
APPROPRIATE
DOSAGE
ADJUSTMENTS IN SPECIFIC PATIENT GROUP SHOULD BE STATED)
APO-CEPHALEX (cephalexin) is administered orally.
Adults: The dosage ranges from 1 to 4 g daily in divided doses. The
usual adult dose is 1
g/day in divided doses every 6 hours. For more severe infections or