TEVA-MINOCYCLINE CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

متاح من:

TEVA CANADA LIMITED

ATC رمز:

J01AA08

INN (الاسم الدولي):

MINOCYCLINE

جرعة:

100MG

الشكل الصيدلاني:

CAPSULE

تركيب:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

10/100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

TETRACYCLINES

ملخص المنتج:

Active ingredient group (AIG) number: 0131309002; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2020-09-25

خصائص المنتج

PRESCRIBING INFORMATION
Pr
TEVA-MINOCYCLINE
(Minocycline Hydrochloride)
50 mg and 100 mg Capsules
USP
Antibiotic
Teva Canada Limited
Date of Revision:
30 Novopharm Court
January 24, 2019
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control No.: 220692
– 1 –
PRESCRIBING INFORMATION
Pr
TEVA-MINOCYCLINE
(Minocycline Hydrochloride)
50 mg and 100 mg capsules
USP
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION & CLINICAL PHARMACOLOGY
TEVA-MINOCYCLINE (minocycline hydrochloride), a tetracycline
antibiotic, has
activity against some gram-negative and gram-positive organisms. The
antibacterial
effect of minocycline is primarily bacteriostatic and is thought to
act by inhibiting
protein synthesis.
Two comparative, two-way bioavailability studies were conducted in 13
normal
volunteers on two 50 mg minocycline capsule products, TEVA-MINOCYCLINE
50
mg capsules and MINOCIN 50 mg capsules and two 100 mg minocycline
capsule
products. The pharmacokinetic data calculated for the TEVA-MINOCYCLINE
and
MINOCIN capsule formulations is tabulated below.
50 mg Formulation:
Geometric Mean
Arithmetic Mean (C.V.)
TEVA-
MINOCYCLINE
4 x 50 mg
MINOCIN
®
4 x 50 mg
Percentage of
MINOCIN
®
AUC
T
(ng·h/mL)
48533
49008 (14)
54176
54762 (18)
90
– 2 –
AUC
I
(ng·h/mL)
51021
51552 (15)
56954
57848 (18)
90
Cmax
(ng/mL)
2697
2714 (14)
2835
2875 (17)
95
T
max
*
(h)
2.00 (0.79)
2.04 (0.75)
--
t
½
*
(h)
16.6 (1.5)
17.2 (1.8)
--
* These are arithmetic means (Standard Deviation)
100 mg Formulation:
Geometric Mean
Arithmetic Mean (C.V.)
TEVA-
MINOCYCLINE
2 x 100 mg
MINOCIN
®
2 x 100 mg
Percentage of
MINOCIN
®
AUC
T
(ng·h/mL)
49021
49931 (22)
51022
51955 (18)
96
AUC
I
(ng·h/mL)
52052
53145 (23)
54721
55479 (19)
95
Cmax
(ng/mL)
2697
2743 (22)
2752
2776 (16)
98
T
max
*
(h)
2.04 (0.75)
2.25 (0.69)
--
t
½
*
(h)
17.9 (2.9)
18.3 (2.4)
--
* These are arithmetic means (Standard Deviation)
INDICATIONS & CLINICAL USE
TEVA-MINOCYCLINE (minocycline hydrochloride) may be indicated for the
treatment of the following infections due to susceptib