PMS-DOXYCYCLINE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

DOXYCYCLINE (DOXYCYCLINE HYCLATE)

Доступна з:

PHARMASCIENCE INC

Код атс:

J01AA02

ІПН (Міжнародна Ім'я):

DOXYCYCLINE

Дозування:

100MG

Фармацевтична форма:

TABLET

Склад:

DOXYCYCLINE (DOXYCYCLINE HYCLATE) 100MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

TETRACYCLINES

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2019-07-04

Характеристики продукта

1
PRESCRIBING INFORMATION
PR
PMS-DOXYCYCLINE
Doxycycline Hyclate Capsules, USP
100 mg doxycycline (as hyclate)
Doxycycline Hyclate Tablets, USP
100 mg doxycycline (as hyclate)
Antibiotic
Pharmascience Inc.
Date of Revision:
6111, Royalmount Ave, Suite #100
September 14, 2009
Montréal, Quebec H4P 2T4
Control #
129474
2
NAME OF DRUG
Pr
pms-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.
INDICATIONS AND CLINICAL USE
pms-DOXYCYCLINE Capsules and Tablets may be indicated for the
treatment of:
PNEUMONIA
: Single and multilobe pneumonia and bronchopneumonia due to
susceptible strains of
_Streptococcus pneumoniae_
and other
_Streptococcus_
spp.,
_Staphylococcus _
spp.,
_H. influenzae _
and
_Klebsiella pneumoniae_
.
3
OTHER RESPIRATORY TRACT INFECTIONS
: Pharyngitis, tonsillitis, sinusitis, otitis media, bronchitis
caused by susceptible strains of beta-hemolytic
_Streptococcus_
,
_Staphylococcus spp_
.,
_Streptococcus_
_pneumoniae_
and
_H. influenzae_
.
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 urethritis, cervicitis and vaginitis and with a
positive test for
_Chlamydia_
t
_rachomatis_
and/or
_Ureaplasma urealyticum_
, clinical resolution and absence of detectable organisms
have only been observed at the completion of oral doxycycline hyclate
therapy. 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 SO