APO-AMITRIPTYLINE 10 amitriptyline hydrochloride 10mg tablet bottle pack

Summary of Product characteristics

                                Product Information – Australia
APO-Amitriptyline Tablets
Page 1
APO-AMITRIPTYLINE 10 TABLETS
APO-AMITRIPTYLINE 25 TABLETS
APO-AMITRIPTYLINE 50 TABLETS
NAME OF THE MEDICINE
Amitriptyline hydrochloride
ACTIVE INGREDIENT
Chemical Name:
3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-
dimethylpropylamine hydrochloride
Structural Formula:
Molecular Formula:
C
20
H
23
N.HCl
Molecular Weight:
313.9
CAS Registry Number:
549-18-8
DESCRIPTION
Amitriptyline hydrochloride occurs as colourless crystals or a white
or almost white powder; odourless
or almost odourless; taste, bitter and burning, followed by a
sensation of numbness. It is soluble in 1
part of water, in 1.5 parts of ethanol (96%), in 1.2 parts of
chloroform and in 1 part of methanol. It is
practically insoluble in ether. pKa of amitriptyline hydrochloride is
9.4.
Each tablet contains amitriptyline hydrochloride as the active
ingredient. In addition, each tablet
contains the following inactive ingredients: lactose, microcrystalline
cellulose, crospovidone, maize
starch, colloidalanhydrous silica, purified talc, magnesium stearate,
hypromellose, titanium dioxide,
macrogol 6000, brilliant blue FCF aluminium lake (10mg only),
quinoline yellow aluminium lake (25mg
only), sunset yellow FCF aluminium lake and indigo carmine aluminium
lake (50mg only).
PHARMACOLOGY
Amitriptyline is a tricyclic antidepressant with sedative properties.
MECHANISM OF ACTION
The mechanism of action of amitriptyline in man is not known. It is
not a monoamine oxidase inhibitor
and it does not act primarily by stimulation of the central nervous
system. In broad clinical use,
amitriptyline has been found to be well tolerated.
Amitriptyline inhibits the membrane pump mechanism responsible for
uptake of noradrenaline and
serotonin in adrenergic and serotonergic neurons. Pharmacologically,
this action may potentiate or
prolong neuronal activity since reuptake of these biogenic amines is
important physiologically in
terminating its transmitting activity. This interference with the
uptak
                                
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