SANDOZ MINOCYCLINE CAPSULE

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

J01AA08

INN (Међународно име):

MINOCYCLINE

Дозирање:

50MG

Фармацеутски облик:

CAPSULE

Састав:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 50MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

TETRACYCLINES

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2019-08-01

Карактеристике производа

PRESCRIBING INFORMATION
PR
SANDOZ MINOCYCLINE
Minocycline Hydrochloride Capsules USP
50 mg and 100 mg minocycline
Antibiotic
USP
Sandoz Canada Inc.
110, de Lauzon Street
Boucherville, QC
J4B 1E6
Date of Revision
April 29, 2019
Submission Control Number: 226984
_Sandoz Minocycline _
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_Page 2 of 32_
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COMPLETE PRESCRIBING INFORMATION
Pr
Sandoz Minocycline
minocycline hydrochloride capsules USP
50 mg and 100 mg minocycline
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Sandoz Minocycline (minocycline hydrochloride) is a tetracycline with
antibacterial activity
against some Gram-negative and Gram-positive organisms. The action of
minocycline is
primarily bacteriostatic and is thought to exert its antimicrobial
effect by the inhibition of protein
synthesis.
COMPARATIVE BIOAVAILABILITY STUDIES
A comparative two-way cross-over bioavailability study between Sandoz
Minocycline 100 mg
capsules (Sandoz Canada Inc.) and Minocin 100 mg capsules
(GlaxoSmithKline Inc.) was
conducted, under fasting conditions, with eighteen (18) healthy male
subjects who completed the
study. The following results were obtained:
MINOCYCLINE
(2 X 100 MG) CAPSULES
FROM MEASURED DATA
ORAL ADMINISTRATION
GEOMETRIC MEAN
ARITHMETIC MEAN (CV %)
PARAMETER
TEST
*
REFERENCE
†
% RATIO OF
GEOMETRIC MEANS
CONFIDENCE INTERVALS (90%)
AUC
T
‡
(mcg·h/mL)
56.09
57.04 (-18.7)
55.54
56.88 (-20.1)
101.0
(91.9-111.0)
AUC
I
(mcg·h/mL)
59.89
61.00 (-19.3)
59.31
60.76 (-20)
101.0
(91.6-111.3)
C
MAX
(mcg·h/mL)
3.67
3.76
(-22.4)
3.75
3.88
(-25)
97.9
(88.1-108.7)
T
MAX
§
(h)
1.89
(0.58)
2.03
(-0.4)
T
½
2
(h)
15.8
(-3.24)
16.3
(-2.18)
*
Sandoz Minocycline, Sandoz Canada Inc.
†
Minocin, 100 mg capsules, GlaxoSmithKline Inc., formerly known as,
Lederle-Cyanamid Canada Inc.
§,2
For the T
max
and T
1/2el
parameters these are the arithmetic means with standard deviation in
parenthesis.
_Sandoz Minocycline _
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INDICATIONS AND CLINICAL USE
Sandoz Minocycline (minocycline hydrochloride) may be indicated for
the treatment