EFEXOR XR CAPSULE 75 mg

Valsts: Singapūra

Valoda: angļu

Klimata pārmaiņas: HSA (Health Sciences Authority)

Nopērc to tagad

Lejuplādēt Lietošanas instrukcija (PIL)
12-02-2014
Lejuplādēt Produkta apraksts (SPC)
31-07-2023

Aktīvā sastāvdaļa:

Venlafaxine hydrochloride 84.85mg eqv. venlafaxine

Pieejams no:

VIATRIS PRIVATE LIMITED

ATĶ kods:

N06AX16

Deva:

75 mg

Zāļu forma:

CAPSULE

Kompozīcija:

Venlafaxine hydrochloride 84.85mg eqv. venlafaxine 75 mg

Ievadīšanas:

ORAL

Receptes veids:

Prescription Only

Ražojis:

PFIZER IRELAND PHARMACEUTICALS

Autorizācija statuss:

ACTIVE

Autorizācija datums:

2000-12-19

Lietošanas instrukcija

                                 
 
EFEXOR*XR 
(venlafaxine hydrochloride) 
Extended-Release Capsules 
 
PHARMACOLOGICAL CLASSIFICATION 
_Antidepressant _
 
DESCRIPTION 
Venlafaxine hydrochloride is a
structurally novel antidepressant for oral administration. It is designated 
(R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl) 
ethyl] cyclohexanol hydrochloride or (±)-1-[
α-
[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula 
C
17
H
27
NO
2
HCl. Its molecular weight is 313.87. The structural formula
is shown below. 
 
Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water 
(adjusted to ionic strength of 0.2  M with
sodium chloride). Its octanol:water (0.2  M sodium chloride) 
partition coefficient is 0.43. 
 
Efexor XR is formulated as an extended-release capsule
for once-a-day oral administration. Drug release 
is controlled by diffusion through the coating membrane on
the spheroids and is not pH dependent. 
Capsules contain venlafaxine HCI equivalent to 75 mg or 150 mg
venlafaxine. 
 
CLINICAL PHARMACOLOGY 
PHARMACODYNAMICS 
The mechanism of the antidepressant action of venlafaxine in humans is believed to be associated with 
its potentiation of neurotransmitter activity in the central nervous system. Preclinical studies have shown 
that venlafaxine and its major metabolite, O-desmethylvenlafaxine
(ODV), are potent inhibitors of 
neuronal serotonin and norepinephrine
reuptake, and weak inhibitors of dopamine reuptake. Animal 
studies indicate that tricyclic antidepressants may reduce 
β-adrenergic receptor responsiveness following 
chronic administration. In contrast, venlafaxine and O-
desmethylvenlafaxine  reduce  β-adrenergic 
responsiveness after both acute (single dose) and
chronic administration. These results may predict a 
more
rapid onset of 
                                
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Produkta apraksts

                                Page 1 of 17
EFEXOR
 XR
(venlafaxine hydrochloride)
Extended-Release Capsules
PHARMACOLOGICAL CLASSIFICATION
_Antidepressant_
DESCRIPTION
Venlafaxine
hydrochloride
is
a
structurally
novel
antidepressant
for
oral
administration.
It
is
designated
(R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol
hydrochloride
or
(±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol
hydrochloride and has the empirical
formula C
17
H
27
NO
2
·HCl. Its molecular weight is 313.87. The structural formula is shown
below.
Venlafaxine hydrochloride is a white to off-white crystalline solid
with a solubility of 572 mg/mL in
water (adjusted to ionic strength of 0.2 M with sodium chloride). Its
octanol:water (0.2 M sodium
chloride) partition coefficient is 0.43.
Efexor XR is formulated as an extended-release capsule for once-a-day
oral administration. Drug
release is controlled by diffusion through the coating membrane on the
spheroids and is not pH
dependent. Capsules contain venlafaxine hydrochloride equivalent to 75
mg venlafaxine.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
The mechanism of the antidepressant action of venlafaxine in humans is
believed to be associated
with its potentiation of neurotransmitter activity in the central
nervous system (CNS). Preclinical
studies have shown that venlafaxine and its major metabolite,
O-desmethylvenlafaxine (ODV), are
potent inhibitors of neuronal serotonin and norepinephrine reuptake,
and weak inhibitors of dopamine
reuptake. Animal studies indicate that tricyclic antidepressants may
reduce β-adrenergic receptor
responsiveness
following
chronic
administration.
In
contrast,
venlafaxine
and
ODV
reduce
β-
adrenergic responsiveness after both acute (single dose) and chronic
administration. These results
may predict a more rapid onset of clinical activity for venlafaxine.
Venlafaxine and its major metabolite
appear to be equipotent with respect to their overall action on
neurotransmitter reuptake and receptor
binding.
Venlafaxine and ODV have virtually no affinity for rat b
                                
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