PHL-DOXYCYCLINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOXYCYCLINE (DOXYCYCLINE HYCLATE)

Available from:

PHARMEL INC

ATC code:

J01AA02

INN (International Name):

DOXYCYCLINE

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

DOXYCYCLINE (DOXYCYCLINE HYCLATE) 100MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

TETRACYCLINES

Product summary:

Active ingredient group (AIG) number: 0105569001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-10-25

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
phl
-
DOXYCYCLINE
(Doxycycline Hyclate Tablets, USP)
100 mg tablets
(Doxycycline Hyclate Capsules, USP)
100 mg capsules
Antibiotic
Pharmel Inc.
Date of Preparation:
6111, Royalmount Ave, Suite #100
December 12, 2006
Montréal, Quebec H4P 2T4
Control # 110390
2
NAME OF DRUG
phl-DOXYCYCLINE
(Doxycycline Hyclate Tablets, USP)
(Doxycycline Hyclate Capsules, USP)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
Doxycycline hyclate is a broad-spectrum antibiotic, which is active
against a wide range of
Gram-negative and Gram-positive organisms. Doxycycline hyclate exerts
its bacteriostatic effect by
inhibition of protein synthesis
5
.
INDICATIONS AND CLINICAL USE
phl-DOXYCYCLINE (doxycycline hyclate) may be indicated for the
treatment of:
PNEUMONIA
: Single and multilobe pneumonia and bronchopneumonia due to
susceptible strains of
Streptococcus
pneumoniae
(formerly
Diplococcus
pneumoniae)
and
other
Streptococci,
Staphylococcus, H. influenzae and Klebsiella pneumoniae.
OTHER RESPIRATORY TRACT INFECTIONS
: Pharyngitis, tonsillitis, sinusitis, otitis media, bronchitis
caused by susceptible strains of beta-hemolytic Streptococcus,
Staphylococcus, Streptococcus
pneumoniae (formerly Diplococcus pneumoniae) and H. influenzae.
3
GENITOURINARY TRACT INFECTIONS
: Pyelonephritis, cystitis, urethritis, gonococcal urethritis caused
by
susceptible
strains
of
Klebsiella
species,
Enterobacter
aerogenes,
E.
coli,
Enterococcus,
Staphylococcus, Streptococcus and Neisseria gonorrhoeae.
Clinical resolution and absence of detectable organisms have been
observed at the
completion of oral doxycycline hyclate therapy in adult patients with
urethritis, cervicitis and
vaginitis and having positive tests for Chlamydia trachomatis and/or
Ureaplasma urealyticum.
Relapses or reinfection can occur. In these cases, limited data
suggest that some patients may derive
clinical benefit from oral administration of doxycycline hyclate or an
alternative therapy. The effect
on long-term morbidity has not been established.
SKIN AND SOFT TISS