NU-MINOCYCLINE CAPSULE

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

Beschikbaar vanaf:

NU-PHARM INC

ATC-code:

J01AA08

INN (Algemene Internationale Benaming):

MINOCYCLINE

Dosering:

50MG

farmaceutische vorm:

CAPSULE

Samenstelling:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 50MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100/250/500/1000

Prescription-type:

Prescription

Therapeutisch gebied:

TETRACYCLINES

Product samenvatting:

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

Autorisatie-status:

CANCELLED (UNRETURNED ANNUAL)

Autorisatie datum:

2018-03-28

Productkenmerken

PRODUCT MONOGRAPH
NU-MINOCYCLINE
MINOCYCLINE HYDROCHLORIDE CAPSULES USP
50 MG AND 100 MG
ANTIBIOTIC
NU-PHARM INC. DATE OF PREPARATION:
50 MURAL ST., UNITS 1 & 2
October 7, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 133054
1
PRODUCT MONOGRAPH
NU-MINOCYCLINE
Minocycline Hydrochloride Capsules USP
50 mg and 100 mg
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTIONS
NU-MINOCYCLINE (minocycline hydrochloride) is a tetracycline with
antibacterial activity against some Gram-negative and Gram-positive
organisms. The action of NU-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 NU-MINOCYCLINE capsules was
measured and compared. The results are summarized as follows:
2
PERCENTAGE
NU-MINOCYCLINE
MINOCIN
OF MINOCIN
AUC
T
* (µg · hr/mL)
62.08 (22)
62.79 (16)
-1.1
AUC
I
* (µg · hr/mL)
66.56 (23)
66.99 (17)
-0.6
Cmax* (µg · mL)
3.52 (18)
3.49 (17)
+0.9
Tmax** (hr)
2.35 (0.71)
2.28 (0.83)
+3.1
t1/2** (hr)
18.62 (3.39)
18.11 (3.02)
+2.8
* Geometric means (CV)
**
Arithmetic means (SD)
INDICATION AND CLINICAL USES
NU-MINOCYCLINE (minocycline hydrochloride) may be indicated for the
treatment of the following infections due to susceptible strains of
the
designated organisms:
Gallbladder 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,
Staphy