Страна: Канада
Язык: английский
Источник: Health Canada
DOXYCYCLINE (DOXYCYCLINE HYCLATE)
PHARMEL INC
J01AA02
DOXYCYCLINE
100MG
CAPSULE
DOXYCYCLINE (DOXYCYCLINE HYCLATE) 100MG
ORAL
100
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0105569001; AHFS:
CANCELLED POST MARKET
2016-10-25
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 Прочитать полный документ