RAN-MINOCYCLINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

Available from:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC code:

J01AA08

INN (International Name):

MINOCYCLINE

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG

Administration route:

ORAL

Units in package:

10/500

Prescription type:

Prescription

Therapeutic area:

TETRACYCLINES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2012-07-27

Summary of Product characteristics

_RAN-MINOCYCLINE (minocycline hydrochloride) Product Monograph Page 1
of 35_
PRESCRIBING INFORMATION
PR
RAN™-MINOCYCLINE
(MINOCYCLINE HYDROCHLORIDE)
CAPSULES 50 MG AND 100 MG MINOCYCLINE (AS MINOCYCLINE HYDROCHLORIDE)
USP
ANTIBIOTIC
Ranbaxy Pharmaceuticals Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
November 7, 2018
Submission Control Number: 220690
_ _
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
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_RAN-MINOCYCLINE (minocycline hydrochloride) Product Monograph Page 2
of 35_
COMPLETE PRESCRIBING INFORMATION
Pr
RAN™-MINOCYCLINE
(minocycline hydrochloride)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTIONS
Minocycline hydrochloride is a tetracycline with antibacterial
activity against some Gram-negative
and Gram-positive organisms. The action of RAN-MINOCYCLINE is
primarily bacteriostatic and
is thought to exert its antimicrobial effect by the inhibition of
protein synthesis.
INDICATION AND CLINICAL USES
RAN-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 gonorrhea. _
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, Streptococcus
pyogenes, Proteus species,_
_Escherichia coli_
. Although tetracyclines are not the drugs of choice in any
staphylococcal or
streptococcal infection minocycline could be useful in circumstances
where these organisms are
shown to be resistant to other agents but sensitive to minocycline.
Bacterial evaluation of clinical
cases involving proteus suggests