MYLAN-AMANTADINE CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

AMANTADINE HYDROCHLORIDE

Saadav alates:

MYLAN PHARMACEUTICALS ULC

ATC kood:

N04BB01

INN (Rahvusvaheline Nimetus):

AMANTADINE

Annus:

100MG

Ravimvorm:

CAPSULE

Koostis:

AMANTADINE HYDROCHLORIDE 100MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

ADAMANTANES

Toote kokkuvõte:

Active ingredient group (AIG) number: 0109101001; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2016-06-28

Toote omadused

PRODUCT MONOGRAPH
MYLAN-AMANTADINE
(Amantadine Hydrochloride Capsules, USP)
Capsules - 100 mg
Antiviral Agent
MYLAN PHARMACEUTICALS ULC
Date of Preparation:
85 Advance Road.
June 9, 2009
Etobicoke, ON
Date of Revision:
M8Z 2S6
Control#: 130467
1
PRODUCT MONOGRAPH
MYLAN-AMANTADINE
(Amantadine Hydrochloride Capsules, USP)
Capsules - 100 mg
THERAPEUTIC CLASSIFICATION
Antiviral Agent
ACTIONS AND CLINICAL PHARMACOLOGY
The antiviral activity of MYLAN-AMANTADINE (amantadine HCl) against
influenza A virus
in humans is not completely understood. The mode of action of
MYLAN-AMANTADINE
appears to be the prevention of the release of infectious viral
nucleic acid into the host cell.
In man, amantadine HCl is well absorbed, passes the blood-brain
barrier and appears in the
saliva and nasal secretions. Amantadine hydrochloride can be detected
in the blood and
cerebrospinal fluid at relatively low, but dose-related, levels. No
evidence of metabolites has
been found and 90% or more of the dose can be recovered in the urine
unchanged. Half-life
values have ranged from 9 to 37 hours, with an average of 24 hours.
A comparative bioavailability study was performed using normal human
volunteers. The rate
and extent of absorption after a single oral dose of MYLAN-AMANTADINE
100 mg or 100 mg
of a marketed Canadian brand product was measured and compared. The
results can be
summarized as follows:
2
Mean Pharmacokinetic Data
Geometric Mean
Arithmetic Mean (C.V.)
Ratio of
Parameter
Test
Reference
Means
AUC
T
4316
4359
0.99
(ng.h/mL)
4429 (23.3)
4436 (20.9)
AUC
I
4675
4722
0.99
(ng.h/mL)
4785 (23.5)
4819 (20.9)
C
max
224
226
0.99
(ng/mL)
226 (16.2)
229 (15.4)
T
max
*
(h)
2.29 (0.724)
2.63 (0.912)
--
T
½
*
(h)
14.6 (4.25)
14.6 (4.01)
--
*
For the T
max
and T
½
parameters these are the
arithmetic means (standard deviation).
INDICATIONS AND CLINICAL USE
INFLUENZA A VIRUS RESPIRATORY INFECTIONS
MYLAN-AMANTADINE (amantadine HCl) is indicated in the prevention
(prophylaxis) and
treatment of respiratory infections caused by influenza A virus
stra