MYLAN-MINOCYCLINE CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

Disponibil de la:

MYLAN PHARMACEUTICALS ULC

Codul ATC:

J01AA08

INN (nume internaţional):

MINOCYCLINE

Dozare:

50MG

Forma farmaceutică:

CAPSULE

Compoziție:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 50MG

Calea de administrare:

ORAL

Unități în pachet:

100/250

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

TETRACYCLINES

Rezumat produs:

Active ingredient group (AIG) number: 0131309001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2019-09-17

Caracteristicilor produsului

- 1 -
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-MINOCYCLINE
(Minocycline Hydrochloride Capsules USP)
50 MG & 100 MG
AS MINOCYCLINE BASE
Antibiotic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: December 14, 2018
Control#: 220688
- 2 -
PR
MYLAN-MINOCYCLINE
(Minocycline Hydrochloride Capsules, USP)
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION
MYLAN-MINOCYCLINE is a tetracycline with antibacterial activity
against some Gram-negative
and Gram-positive organisms. The action of MYLAN-MINOCYCLINE is
primarily bacteriostatic
and is thought to exert its antimicrobial effect by the inhibition of
protein synthesis.
COMPARATIVE BIOAVAILABILITY
The bioavailability study was performed on healthy volunteers using
MYLAN-MINOCYCLINE
100 mg capsules. The rate and extent of absorption of Minocycline
Hydrochloride after a single
dose of 100 mg MYLAN-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
MYLAN-MINOCYCLINE
100 MG CAPSULES
(MYLAN PHARMACEUTICALS
ULC)
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
MYLAN-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