ENTRIP amitriptyline hydrochloride 25 mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amitriptyline hydrochloride, Quantity: 25 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

amitriptyline hydrochloride

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 6000; hypromellose; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

50's, 250's, 1000's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of major depression. Nocturnal enuresis where organic pathology has been excluded.

Product summary:

Visual Identification: Round yellow coloured biconvex tablets debossed AM on one side and 25 on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-11-27

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ENTRIP (AMITRIPTYLINE
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Amitriptyline hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ENTRIP tablets contain 10 mg, 25 mg or 50mg of amitriptyline
hydrochloride.
Excipients with known effect: lactose monohydrate. For the full list
of excipients, see SECTION 6.1
LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ENTRIP 10 mg tablet: Round blue coloured biconvex tablets debossed AM
on one side and 10 on the
other side.
ENTRIP 25 mg tablet: Round yellow coloured biconvex tablets debossed
AM on one side and 25 on
the other side.
ENTRIP 50 mg tablet: Round brown coloured biconvex tablets debossed AM
on one side and 50 on
the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of major depression. ENTRIP 50 mg tablets are
indicated only for the maintenance
treatment of major depression (see SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
Nocturnal enuresis where organic pathology has been excluded.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DEPRESSION
_Dosage considerations _
2
Dosage should be initiated at a low level and increased gradually,
noting carefully the clinical
response and any evidence of intolerance.
_Initial dosage for outpatient adults _
75 mg a day in divided doses is usually satisfactory. If necessary,
this may be increased to a total of
150 mg a day. Increases are made preferably in the late afternoon
and/or bedtime doses. The
sedative effect is usually rapidly apparent. The antidepressant
activity may be evident within three
or four days or may take up to 30 days to develop adequately.
Alternative methods for initiating therapy in outpatients are: begin
therapy with 50 to 100 mg
preferably in the evening or at bedtime; this may be increased by 25
to 50 mg as necessary to a total
of 150 mg per day.
_Dosage for hospitalised patients _
100 mg a day may be required initially. This can be increased
gradually to 200 mg a day if necessary.
A small number of hospitalised patients may need as mu