MINOCYCLINE CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

Dostępny od:

SANIS HEALTH INC

Kod ATC:

J01AA08

INN (International Nazwa):

MINOCYCLINE

Dawkowanie:

100MG

Forma farmaceutyczna:

CAPSULE

Skład:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/250

Typ recepty:

Prescription

Dziedzina terapeutyczna:

TETRACYCLINES

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2018-07-16

Charakterystyka produktu

- 1 -
PRODUCT MONOGRAPH
PR
MINOCYCLINE
(Minocycline Hydrochloride Capsules USP)
50 MG & 100 MG
AS MINOCYCLINE BASE
Antibiotic
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
May 10, 2018
Control#: 215156
- 2 -
COMPLETE PRESCRIBING INFORMATION
PRODUCT MONOGRAPH
PR
MINOCYCLINE
(Minocycline Hydrochloride Capsules, USP)
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION
MINOCYCLINE is a tetracycline with antibacterial activity against some
Gram-negative
and Gram-positive organisms. The action of 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
MINOCYCLINE 100
mg capsules. The rate and extent of absorption of Minocycline
Hydrochloride after a single
dose of 100 mg 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
MINOCYCLINE
100 MG CAPSULES
(SANIS HEALTH 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
- 3 -
INDICATIONS AND CLINICAL USE
MINOCYCLINE (minocycline hydrochloride) may be indicated for the
treatment of the
following infections due to susceptible strains of the designated
organisms:
Gall bladder infections caused by Escherichia coli.
Urinary tract infections: cystitis, gonorrhea, pyelonephritis caused
by
_Escherichia coli, _
_Proteus species, Klebsiella species, Enterobacter aerogenes,
Neisseria gonorrhea_