APO-PAROXETINE 20 mg Tablets

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

PAROXETINE HYDROCHLORIDE

제공처:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (International Name):

PAROXETINE HYDROCHLORIDE

패키지 단위:

30Tablet Tablets

Manufactured by:

APOTEX INC

환자 정보 전단

APO-PAROXETINE TABLETS
Paroxetine hydrochloride (20mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Apo-Paroxetine is used for
2.
How Apo-Paroxetine works
3.
Before you use Apo-Paroxetine
4.
How to use Apo-Paroxetine
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Paroxetine
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-PAROXETINE_ _IS USED FOR
Apo-Paroxetine has been prescribed to
you by your doctor to relieve your
symptoms of the following conditions:
-
depression
-
panic disorder, with or without
agoraphobia (fear of public or open
spaces)
-
obsessive-compulsive disorder (OCD)
(persistent, obsessive thoughts that
make you carry out repetitive
behaviour)
HOW APO-PAROXETINE WORKS
Apo-Paroxetine contains the active
ingredient paroxetine. It belongs to a
family of medicines called Selective
Serotonin Reuptake Inhibitors (SSRIs).
Apo-Paroxetine is believed to work by
enhancing the availability of serotonin,
one of the chemical substances in the
brain. Depression and OCD have been
associated with a decrease in the flow of
serotonin between certain brain cells.
BEFORE YOU USE APO-PAROXETINE_ _
-
_When you must not use it _
Do not use Apo-Paroxetine if you are
allergic to
_ _
paroxetine hydrochloride or
any other ingredients in this
medication (See section
PRODUCT
DESCRIPTION
).
Do not take Apo-Paroxetine if you are
taking or have recently taken
medicines called monoamine oxidase
inhibitors (MAOIs) within the last 14
days.
_ _
Check with your doctor or pharmacist
if you are unsure as to whether or not
you are taking a MAOI. Your doctor
will know when it is safe to start Apo-
Paroxetine after the MAOI has been
stopped, or to start another MAOI after
discontinuing Apo-Paroxetine
treatment.
Do not take Apo-Paroxetine if you are
taking thioridazine or pimozide
(medicines used for mental disorder)
-
_Before you start to use it _
Before taking Apo-Paroxetine, your
doctor needs to know any other
medical con

제품 특성 요약

APO-PAROXETINE
PAROXETINE HCL EQUIVALENT TO PAROXETINE 20MG
Antidepressant
PHARMACOLOGY
Paroxetine is a potent and selective serotonin (5-hydroxytryptamine),
5-
HT reuptake inhibitor (SSRI). This activity of the drug on brain
neurons is thought to be responsible for its antidepressant and
anxiolytic action in the treatment of depression, obsessive-compulsive
disorder (OCD), panic disorder, social phobia (social anxiety
disorder),
generalized anxiety disorder (GAD) and posttraumatic stress disorder
(PTSD). Paroxetine is a phenylpiperidine derivative which is
chemically unrelated to the tricyclic or tetracyclic antidepressants.
Pharmacokinetics: APO-PAROXETINE is well absorbed after oral
administration. Paroxetine is subject to a biphasic process of
metabolic
elimination which involves presystemic (first-pass) and systemic
pathways. First-pass metabolism is extensive, but may be partially
saturable, accounting for the increased bioavailability observed with
multiple dosing. Approximately 64% of an administered dose of
paroxetine is eliminated by the kidneys and 36% in the faeces. Less
than 2% of the dose is recovered in the form of the parent compound.
The mean elimination half-life value for healthy subjects appears to
be
about 24 hours, although a range of 3 to 65 hours has been reported.
Both the rate of absorption and the terminal elimination half-life
appear
to be independent of dose. Steady-state plasma concentrations of
paroxetine are generally achieved in 7 to 14 days.
INDICATIONS
Depression including reactive and severe depression, depression with
anxiety. Symptomatic treatment of Obsessive Compulsive Disorder
(OCD) and Panic Disorder, with or without agoraphobia.
RECOMMENDED DOSE
Depression
Usual adult dose: The administration of APO-PAROXETINE
(paroxetine) should be initiated at 20 mg daily. For most patients, 20
mg daily will also be the optimum dose. The therapeutic response may
be delayed until the third or fourth week of treatment.
Dose range: For those patients who do not respond adequately to the 2