MINOCYCLINE CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

זמין מ:

AA PHARMA INC

קוד ATC:

J01AA08

INN (שם בינלאומי):

MINOCYCLINE

כמות:

50MG

טופס פרצבטיות:

CAPSULE

הרכב:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 50MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/250

סוג מרשם:

Prescription

איזור תרפויטי:

TETRACYCLINES

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2019-09-27

מאפייני מוצר

Page 1 of 30
PRESCRIBING INFORMATION
PR
MINOCYCLINE
MINOCYCLINE HYDROCHLORIDE CAPSULES USP
50 MG AND 100 MG
ANTIBIOTIC
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1,
VAUGHAN, ONTARIO
L4K 4N7
CONTROL NUMBER: 230823
DATE OF REVISION:
September 27, 2019
Page 2 of 30
COMPLETE PRESCRIBING INFORMATION
Pr
MINOCYCLINE
Minocycline Hydrochloride
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTIONS
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
A single-dose, standard two-way crossover bioavailability study was
performed using normal
human volunteers. The rate and extent of absorption of minocycline
after a single oral dose of
200 mg given as either two 100 mg MINOCIN capsules or as two 100 mg
MINOCYCLINE
capsules was measured and compared. The results are summarized as
follows:
MINOCYCLINE
MINOCIN
PERCENTAGE
OF MINOCIN
AUC
r
*
(mcg•hr/ml}
62.08 (22)
62.79 (16)
-1.1
AUC
r
* (mcg •
hr/ml)
66.56 (23)
66.99 (17)
-0.6
C
max
* {mcg/ml}
3.52 (18)
3.49 (17)
+0.9
T
max
** (hr}
2.35 (0.71)
2.28 (0.83)
+3.1
t
1/2
** {hr}
18.62 (3.39)
18.11 (3.02)
+2.8
INDICATION AND CLINICAL USES
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
gonorrhoeae_.
When penicillin is contraindicated, minocycline may be employed as an
alternative drug in the
treatment of anal and pharyngeal gonorrhea and syphilis.
Skin and soft tissue infections: abscess, cellulitis, furunculosis,
impetigo and pyoderma caused
by: _Staphylococcus epidermidis_. _Staphylococcus aureus,
Streptoco