DESVENLAFAXINE AMNEAL desvenlafaxine 50 mg modified release tablets bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
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Active ingredient:
desvenlafaxine, Quantity: 50 mg
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Desvenlafaxine
Pharmaceutical form:
Tablet, modified release
Composition:
Excipient Ingredients: alginic acid; purified talc; povidone; microcrystalline cellulose; hypromellose; magnesium stearate; citric acid monohydrate; titanium dioxide; macrogol 6000; iron oxide red
Administration route:
Oral
Units in package:
14, 28, 7
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the treatment of major depressive disorder, including the preventiton of relapse. Not indicated for paediatric use.
Product summary:
Visual Identification: Light pink colored, diamond shaped, biconvex tablets, debossed with 'Ll89' on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2014-11-26
Summary of Product characteristics
Desvenlafaxine Amneal Version 4 – Dec 19
1
AUSTRALIAN PRODUCT INFORMATION - DESVENLAFAXINE
AMNEAL (DESVENLAFAXINE)
1.
NAME OF THE MEDICINE
Desvenlafaxine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Two strengths of DESVENLAFAXINE AMNEAL tablets are available,
containing 50 mg and 100
mg of desvenlafaxine.
For the full list of excipients, see section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
DESVENLAFAXINE AMNEAL is formulated as a modified release tablet for
once-a-day oral
administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DESVENLAFAXINE AMNEAL is indicated for the treatment of major
depressive disorder,
including the prevention of relapse.
DESVENLAFAXINE AMNEAL is not indicated for paediatric use.
4.2
DOSE AND METHOD OF ADMINISTRATION
Desvenlafaxine should be taken at approximately the same time each
day. Tablets must be
swallowed whole with fluid and not divided, crushed, chewed, or
dissolved.
_INITIAL TREATMENT_
The recommended dose for desvenlafaxine is 50 mg once daily, with or
without food. In clinical
trials, no additional benefit was demonstrated at doses greater than
50 mg/day. Based on clinical
judgment, if dose increases are indicated for individual patients,
they should occur gradually and at
intervals of not less than 7 days. The maximum dose should not exceed
200 mg/day.
When discontinuing therapy, gradual dose reduction is recommended
whenever possible to minimise
discontinuation symptoms (see Section 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR
USE
and Section 4.8
ADVERSE EFFECTS (UNDESIRABLE EFFECTS))
.
_MAINTENANCE/CONTINUATION/EXTENDED TREATMENT_
It is generally agreed that acute episodes of major depressive
disorder require several months or
longer of sustained pharmacological therapy. Patients should continue
on the same dose at which
Desvenlafaxine Amneal Version 4 – Dec 19
2
they were stabilised. They should be periodically reassessed to
determine the need for continued
treatment.
CHILDREN AND ADOLESCENTS
Safety and efficacy in patients less than 18 years of age have n
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