TRIENTINE DR.REDDY'S trientine dihydrochloride 250 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trientine dihydrochloride, Quantity: 250 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: titanium dioxide; magnesium stearate; purified water; Gelatin; iron oxide yellow; macrogol 3350; colloidal anhydrous silica

Administration route:

Oral

Units in package:

100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Trientine dihydrochloride capsules are indicated for the treatment of patients with Wilson's disease who are intolerant of penicillamine.

Product summary:

Visual Identification: Yellow opaque, hard gelatin size 1 capsules imprinted with RDY on cap and 459 on body in black ink filled with white to pale yellow powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-03-29

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Summary of Product characteristics

_Version 29 March 2021 _
1
▼
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – TRIENTINE DR.REDDY’S
(TRIENTINE DIHYDROCHLORIDE) CAPSULES
1
NAME OF THE MEDICINE
Trientine dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules containing 250 mg of trientine dihydrochloride, equivalent to
167 mg trientine base .
Capsules also contain gelatin. For the full list of excipients, see
Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TRIENTINE DR.REDDY’S, trientine dihydrochloride capsules, 250 mg,
are yellow opaque, hard
gelatin size “1” capsules imprinted with “RDY” on cap and
“459” on body in black ink filled with
white to pale yellow powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Trientine dihydrochloride capsules are indicated for the treatment of
patients with Wilson's
disease who are intolerant of penicillamine.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Systematic evaluation of dose and/or interval between dose has not
been done. However, based
on clinical experience, the recommended initial doses of trientine
dihydrochloride capsules are
given below.
The doses are expressed in terms of trientine dihydrochloride and the
equivalent dose of
trientine free base. It should be noted that a dose of 250mg trientine
dihydrochloride
corresponds to a dose of 167mg trientine free base. This should be
considered if a patient is
transferred from one trientine formulation to another.
_CHILDREN > 5 YEARS _
_ _
500 to 750 mg trientine dihydrochloride /day (2 to 3 capsules) given
in divided doses two or
three times daily. This may be increased to a maximum of 1,500 mg/day
for children aged > 5
years. The paediatric dosage _in terms of trientine free base _is 333
to 500 mg/day to a maximum
of 1000mg/day.
The initial dose for children > 5 years can be expresse