Amirol
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
18-09-2022
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Active ingredient:
Amitriptyline hydrochloride 10mg;
Available from:
AFT Pharmaceuticals Ltd
INN (International Name):
Amitriptyline hydrochloride 10 mg
Dosage:
10 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Amitriptyline hydrochloride 10mg Excipient: Colloidal silicon dioxide Hypromellose Brilliant Blue E133 Lactose Macrogol 400 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified talc Sodium starch glycolate Titanium dioxide
Units in package:
Blister pack, PVC/Al, 50 tablets, 50 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
R.L. Fine Chem
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/Al, 50 tablets - 50 tablets - 5 years from date of manufacture stored at or below 25°C
Authorization date:
2008-04-01
Summary of Product characteristics
NEW ZEALAND DATA SHEET
Page 1 of 11
1
AMIROL
Amitriptyline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amirol 10 - Film coated tablets 10mg
Amirol 25 - Film coated tablets 25mg
3
PHARMACEUTICAL FORM
Film coated tablets
AMIROL 10mg tablets are blue, film coated biconvex tablets, 9/32"
diameter. Each tablet contains
10mg amitriptyline hydrochloride.
AMIROL 25mg tablets are yellow, film coated biconvex tablets, 9/32"
diameter. Each tablet contains
25mg amitriptyline hydrochloride.
For both strengths do not halve tablet, dose equivalent when the
tablet is divided has not been
established.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
AMIROL is recommended for the treatment of depression.
4.2
Dose and method of administration
DEPRESSION
DOSAGE CONSIDERATIONS
Dosage should be initiated at a low level and increased gradually,
noting carefully the clinical response
and any evidence of intolerance.
Oral Dosage.
Do not halve tablet, dose equivalent when the tablet is divided has
not been established.
INITIAL ADULT DOSAGE FOR OUTPATIENTS
75mg of amitriptyline a day in divided doses is usually satisfactory.
If necessary, this may be increased
to a total of 150mg 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 3 or
4 days or may take up to 30 days to develop adequately.
Alternate methods
of
initiating
therapy
in outpatients
are
to
begin
therapy
with 50
to
100mg
amitriptyline preferably in the evening or at bedtime; this may be
increased by 25 to 50mg as
necessary to a total of 150mg per day. Initiate therapy with one 75mg
capsule or tablet preferably in
the evening or at bedtime and increase, if necessary, to two, or one
in the morning and one in the
evening.
NEW ZEALAND DATA SHEET
Page 2 of 11
DOSAGE FOR HOSPITALISED PATIENTS
100mg a day may be required initially. This can be increased gradually
to 200mg a day if necessary. A
small number of hospitalised patients may need as mu
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