País: Canadà
Idioma: anglès
Font: Health Canada
FLUVOXAMINE MALEATE
TEVA CANADA LIMITED
N06AB08
FLUVOXAMINE
50MG
TABLET
FLUVOXAMINE MALEATE 50MG
ORAL
100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0122450002; AHFS:
CANCELLED POST MARKET
2018-05-18
PRODUCT MONOGRAPH RATIO-FLUVOXAMINE FLUVOXAMINE MALEATE 50 MG AND 100 MG FILM COATED, SCORED TABLETS ANTIDEPRESSANT ANTIOBSESSIONAL AGENT TEVA CANADA LIMITED DATE OF PREPARATION: 30 NOVOPHARM COURT MAY 31, 2013 TORONTO, ONTARIO CANADA, M1B 2K9 CONTROL #: 165097 2 PRODUCT MONOGRAPH ratio-FLUVOXAMINE (FLUVOXAMINE MALEATE) 50 MG AND 100 MG FILM COATED, SCORED TABLETS ANTIDEPRESSANT ANTIOBSESSIONAL AGENT ACTION The antidepressant and antiobsessional actions of RATIO-FLUVOXAMINE (fluvoxamine maleate) are believed to be related to its selective inhibition of presynaptic serotonin re- uptake in brain neurones. There is minimum interference with noradrenergic processes, and, in common with several other specific inhibitors of serotonin uptake, fluvoxamine maleate has very little _in vitro _affinity for Alpha 1 , Alpha 2 , Beta 1 , dopamine 2 , histamine 1 , serotonin 1 , serotonin 2 or muscarinic receptors. PHARMACOKINETICS In healthy volunteers, fluvoxamine maleate is well absorbed after oral administration. Following a single 100 mg oral dose, peak plasma levels of 31-87 ng/mL were attained 1.5 to 8 hours post-dose. Peak plasma levels and AUC's (0-72 hours) are directly proportionate to dose after single oral doses of 25, 50, and 100mg. Following single doses, the mean plasma half-life is 15 hours, and slightly longer (17-22 hours), during repeated dosing. Steady-state plasma levels are usually achieved within 10-14 days. The pharmacokinetic profile in the elderly is similar to that in younger patients. In a dose proportionality study involving fluvoxamine maleate at 100, 200 and 300 mg / day for 10 consecutive days in 30 normal volunteers, steady state was achieved after 3 about a week of dosing. Maximum plasma concentrations at steady state occurred within 3-8 hours of dosing and reached concentrations averaging 88, 283 and 546 ng/mL, respectively. Thus, fluvoxamine maleate had nonlinear pharmacokinetics over this dose range, i.e., higher doses of fluvoxamine maleate produced disproportionately higher concentrations Llegiu el document complet