Nazione: Canada
Lingua: inglese
Fonte: Health Canada
AMITRIPTYLINE HYDROCHLORIDE
SIVEM PHARMACEUTICALS ULC
N06AA09
AMITRIPTYLINE
50MG
TABLET
AMITRIPTYLINE HYDROCHLORIDE 50MG
ORAL
100/1000
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0101524003; AHFS:
CANCELLED POST MARKET
2018-11-01
_Pr_ _AMITRIPTYLINE _ _1 of 10 _ PRODUCT MONOGRAPH Pr AMITRIPTYLINE (Amitriptyline Hydrochloride, USP) 10mg, 25mg, and 50mg tablets Antidepressant Sivem Parmaceuticals ULC 4705 Dobrin Street Saint-Laurent, Quebec Canada H4R 2P7 www.sivem.ca Date of Preparation: February 03, 2016 Control Number: 191591 _Pr_ _AMITRIPTYLINE _ _ 2 of 10 _ ACTION Amitriptyline hydrochloride is a tricyclic antidepressant with sedative properties. Its mechanism of action in man is not known. Amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain. Amitriptyline has pronounced anticholinergic properties and produces EKG changes and quinidine-like effects on the heart (See ADVERSE REACTIONS). It also lowers the convulsive threshold and causes alterations in EEG and sleep patterns. Orally administered amitriptyline is readily absorbed and rapidly metabolized. Steady-state plasma concentrations vary widely and this variation may be genetically determined. Amitriptyline is primarily excreted in the urine, mostly in the form of metabolites, with some excretion also occurring in the feces. INDICATIONS AMITRIPTYLINE (amitriptyline hydrochloride USP) is indicated for the relief of symptoms of depressive illness. CONTRAINDICATIONS Known hypersensitivity. Amitriptyline should not be given concomitantly with or within at least 14 days following the discontinuance of a MAO inhibitor. Then initiate dosage of amitriptyline cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline is not recommended during the acute recovery phase following myocardial infarction, and in the presence of acute congestive heart failure. WARNINGS Arrhythmias, sinus tachycardia, and prolongation of the conduction time have been reported, particularly with high doses of amitriptyline. A few instances of unexpected death have been reported in patients with cardiovascular disorders. M Leggi il documento completo