DOXYCYCLINE-100 CAP 100MG USP CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DOXYCYCLINE (DOXYCYCLINE HYCLATE)

MAH:

PRO DOC LIMITEE

ATC_code:

J01AA02

INN:

DOXYCYCLINE

dosage:

100MG

pharmaceutical_form:

CAPSULE

composition:

DOXYCYCLINE (DOXYCYCLINE HYCLATE) 100MG

administration_route:

ORAL

units_in_package:

100/250

prescription_type:

Prescription

therapeutic_area:

TETRACYCLINES

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2010-07-13

SPC

0
PRESCRIBING INFORMATION
PR DOXYCYCLINE - 100
DOXYCYCLINE CAPSULES 100 MG (AS HYCLATE)
PR DOXYTAB
DOXYCYCLINE FILM COATED TABLETS 100 MG (AS HYCLATE)
ANTIBIOTIC
PRO DOC LTÉE
DATE OF REVISION:
2925, BOUL. INDUSTRIEL
July 16, 2009
LAVAL, QUEBEC
H7L 3W9
CONTROL NUMBER: 129731
1
NAME OF DRUGS
PR DOXYCYCLINE - 100
PR DOXYTAB
(DOXYCYCLINE HYCLATE)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
Doxycycline hyclate is a broad-spectrum antibiotic and is active
against a wide range of Gram-
negative and Gram-positive organisms. Doxycycline exerts its
bacteriostatic effect by the
inhibition of protein synthesis.
INDICATIONS AND CLINICAL USE
DOXYCYCLINE - 100 and DOXYTAB may be indicated for the treatment of:
Pneumonia
Single and multilobe pneumonia and bronchopneumonia due to susceptible
strains of
_Streptococcus_ _pneunomiae_ and other _Streptococcus _spp.,
_Staphylococcus _spp.,_ H. influenzae _
and_ Klebsiella pneumoniae_.
Other Respiratory Tract Infections
Pharyngitis, tonsillitis, sinusitis, otitis media, bronchitis caused
by susceptible strains of β-
hemolytic _Streptococcus_, _Staphylococcus spp.,_ _Streptococcus_
_pneunoniae_ and _H. influenzae_.
2
Genitourinary Tract Infections
Pyelonephritis, cystitis, urethritis, gonococcal urethritis caused by
susceptible strains of _Klebsiella_
spp., _Enterobacter aerogenes_, _E. coli_, _Enterococcus_ spp.,
_Staphylococcus_ spp., _Streptococcus_
spp. and_ Neisseria gonorrhoeae. _
In adult patients with urethrltis, cervicitis and vaginitis with a
positive test for _Chlamydia _
_trachomatis_ and/or _Ureaplasma urealyticum_, clinical resolution and
absence of detectable
organisms have been observed at completion of ORAL therapy with
doxycycline. Relapses or
reinfection can occur. In these cases, limited data suggest that some
patients may derive clinical
benefit from an alternative therapy. The effect on long term morbidity
has not been established.
Skin and Soft Tissue Infections
Impetigo, furunculosis, cellulitis, abscess, wound sepsis, paronychia,
caused by susceptible
strains