NTP-DOXYCYCLINE TABLETS

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DOXYCYCLINE (DOXYCYCLINE HYCLATE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

J01AA02

INN (International Adı):

DOXYCYCLINE

Doz:

100MG

Farmasötik formu:

TABLET

Kompozisyon:

DOXYCYCLINE (DOXYCYCLINE HYCLATE) 100MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

TETRACYCLINES

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2015-08-06

Ürün özellikleri

1
_ _
_PRESCRIBING INFORMATION _
PR
NTP-DOXYCYCLINE CAPSULES
Doxycycline Hyclate Capsules, USP
_100 mg doxycycline (as hyclate) _
PR NTP-DOXYCYCLINE_ _TABLETS_ _
Doxycycline Hyclate Tablets, USP
_100 mg doxycycline (as hyclate) _
_Antibiotic _
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165998
Date of Preparation:
July 17, 2013
2
NAME OF DRUGS
PR
NTP-DOXYCYCLINE CAPSULES
Doxycycline Hyclate Capsules, USP
_100 mg doxycycline (as hyclate) _
PR NTP-DOXYCYCLINE_ _TABLETS_ _
Doxycycline Hyclate Tablets, USP
_100 mg doxycycline (as 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
NTP-Doxycycline Capsules / NTP-Doxycycline Tablets 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 pneumoniae_ and _H. influenzae_.
Genitourinary Tract
Infections:
Pyelonephritis, cystitis, urethritis, gonococcal urethritis caused by
3
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 with a
positive test for _Chlamydia trachomatis _ and/or _Ureaplasma _
_urealyticum_, clinical resolution and absence of detectable
organisms have only been observed at completion of ORAL
therapy with doxycycline hyclate. Relapses or reinfection can
occur. In these cases, li