Amirol

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Amitriptyline hydrochloride 25mg;  ; Amitriptyline hydrochloride 25mg

Tillgänglig från:

AFT Pharmaceuticals Ltd

INN (International namn):

Amitriptyline hydrochloride 25 mg

Dos:

25 mg

Läkemedelsform:

Film coated tablet

Sammansättning:

Active: Amitriptyline hydrochloride 25mg   Excipient: Colloidal silicon dioxide Hypromellose Lactose Macrogol 400 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified talc   Quinoline yellow Sodium starch glycolate Titanium dioxide Active: Amitriptyline hydrochloride 25mg Excipient: Colloidal silicon dioxide Hypromellose Lactose Macrogol 400 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified talc   Quinoline yellow Sodium starch glycolate Titanium dioxide

Enheter i paketet:

Blister pack, PVC/Al, 50 tablets, 50 tablets

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

R.L. Fine Chem

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC - 50 tablets - 5 years from date of manufacture stored at or below 25°C

Tillstånd datum:

2008-04-01

Produktens egenskaper

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