Land: Canada
Taal: Engels
Bron: Health Canada
DOXYCYCLINE (DOXYCYCLINE HYCLATE)
TEVA CANADA LIMITED
J01AA02
DOXYCYCLINE
100MG
TABLET
DOXYCYCLINE (DOXYCYCLINE HYCLATE) 100MG
ORAL
100
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0105569001; AHFS:
CANCELLED PRE MARKET
2015-08-06
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 Lees het volledige document