PMS-MINOCYCLINE CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

Предлага се от:

PHARMASCIENCE INC

АТС код:

J01AA08

INN (Международно Name):

MINOCYCLINE

дозиране:

100MG

Лекарствена форма:

CAPSULE

Композиция:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

TETRACYCLINES

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2019-10-23

Данни за продукта

PRODUCT MONOGRAPH
PR
PMS-MINOCYCLINE
(Minocycline Hydrochloride Capsules USP)
50 MG & 100 MG
AS MINOCYCLINE BASE
Antibiotic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite #100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision: September 04, 2018
Control#: 219639
- 2 -
COMPLETE PRESCRIBING INFORMATION
PRODUCT MONOGRAPH
PR
PMS-MINOCYCLINE
(Minocycline Hydrochloride Capsules, USP)
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION
pms-MINOCYCLINE is a tetracycline with antibacterial activity against
some Gram-
negative and Gram-positive organisms. The action of pms-MINOCYCLINE is
primarily
bacteriostatic and it is thought to exert its antimicrobial effect by
the inhibition of protein
synthesis.
The
bioavailability
study
was
performed
on
healthy
volunteers
using
pms-MINOCYCLINE 100 mg capsules. The rate and extent of absorption of
Minocycline
Hydrochloride after a single dose of 100 mg pms-MINOCYCLINE and the
marketed brand
was measured and compared. The pharmacokinetic data are presented in
the table below:
Geometric Mean
Arithmetic Mean (C.V. %)
PARAMETER
PMS-MINOCYCLINE
100 MG CAPSULES
(PHARMASCIENCE INC.)
MINOCIN®
100 MG CAPSULES
(LEDERLE CYANAMID, CANADA)
RATIO OF
MEANS
%
AUC
0-t
(ng hr/mL)
10013.46
10290.9 (22. 4%)
10274.29
10541.2 (23.0 %)
97.5 % (97.6%)**
97.6 %
AUC
inf
(ng hr/mL)
12050.56
12292.1 (19.9 %)
10274.29
10541.2 (23.0 %)
97.6 % (97.7
%)**
97.6 %
C
max
(ng/mL)
698.06
711.66 (19.6 %)
737.61
745.30 (14.6 %)
94.6% (94.7%)**
95.5 %
T
max
* (h)
1.729 (47.5%)
1.901 (43.4 %)
N/A
T
½
* (h)
14.70 (19.8 %)
15.00 (17.4 %)
N/A
* for Tmax and T½ arithmetic mean (C.V. %) are presented.
**the potency corrected ratio of means of the test product
INDICATIONS AND CLINICAL USE
pms-MINOCYCLINE (minocycline hydrochloride) may be indicated for the
treatment of
the following infections due to susceptible strains of the designated
organisms:
- 3 -
Gall bladder infections caused by Escherichia coli.
Urinary tract infections: cystitis, gonorrhea, pyelonephritis caused
by
_Escherichia coli, _
_Proteus species, Kl