DESVENLAFAXINE AMNEAL desvenlafaxine 50mg modified release tablets blister
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
desvenlafaxine
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Desvenlafaxine
Authorization status:
Registered
Patient Information leaflet
Desvenlafaxine Amneal Version 3 – Jul 18
1
AUSTRALIAN PRODUCT INFORMATION - DESVENLAFAXINE
AMNEAL DESVENLAFAXINE
1.
NAME OF THE MEDICINE
DESVENLAFAXINE AMNEAL desvenlafaxine 50 mg and 100 mg modified release
tablets.
DESVENLAFAXINE AMNEAL contains the active ingredient desvenlafaxine as
the base drug.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Two strengths of DESVENLAFAXINE AMNEAL tablets are available,
containing 50 mg and 100
mg of desvenlafaxine.
Desvenlafaxine is a white to off-white crystalline powder that is
practically insoluble in water and
slightly soluble in ethanol and acetone. The solubility of
desvenlafaxine is pH dependent.
Inactive ingredients are alginic acid, citric acid monohydrate,
microcrystalline cellulose, povidone,
purified talc, magnesium stearate and hypromellose. The
50 mg tablets are film coated with
OPADRY film coating system 03F84770 PINK (ARTG No. 109228) and the 100
mg tablets are
coated with OPADRY film coating system 03F86990 BROWN (ARTG No.
109232).
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.
Desvenlafaxine Amneal Version 3 – Jul 18
2
When discontinuing therapy, gradual dose reducti
Read the complete document
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
Read the complete document
