SANDOZ MINOCYCLINE CAPSULE

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

Disponível em:

SANDOZ CANADA INCORPORATED

Código ATC:

J01AA08

DCI (Denominação Comum Internacional):

MINOCYCLINE

Dosagem:

100MG

Forma farmacêutica:

CAPSULE

Composição:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

TETRACYCLINES

Resumo do produto:

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

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2019-08-01

Características técnicas

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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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.
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INDICATIONS AND CLINICAL USE
Sandoz Minocycline (minocycline hydrochloride) may be indicated for
the treatment