PAROXETINE HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PAROXETINE HYDROCHLORIDE (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)

Available from:

Physicians Total Care, Inc.

INN (International Name):

PAROXETINE HYDROCHLORIDE

Composition:

PAROXETINE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Paroxetine hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder. The efficacy of paroxetine hydrochloride extended-release tablets in the treatment of a major depressive episode was established in two 12 week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning and includes the presence of at least 5 of the following 9 symptoms during the same 2 week period: Depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impai

Product summary:

Paroxetine Hydrochloride Extended-release Tablets are available containing paroxetine hydrochloride (hemihydrate) USP, equivalent to 12.5 mg, 25 mg paroxetine. The 12.5 mg tablet is a white enteric film-coated, round, unscored tablet with M over P3 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: The 25 mg tablet is a lavender enteric film-coated, round, unscored tablet with M over P4 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: Store at 20° to 25 °C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PAROXETINE HYDROCHLORIDE - PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
PAROXETINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
(pa rox′ e teen hye″ droe klor′ ide)
12.5 mg, 25 mg and 37.5 mg
Read the Medication Guide that comes with paroxetine hydrochloride
extended-release tablets before you
start taking it and each time you get a refill. There may be new
information. This Medication Guide does
not take the place of talking to your healthcare provider about your
medical condition or treatment. Talk
with your healthcare provider if there is something you do not
understand or want to learn more about.
What is the most important information I should know about paroxetine
hydrochloride extended-release
tablets?
Paroxetine hydrochloride extended-release tablets and other
antidepressant medicines may cause serious
side effects, including:
1.
Suicidal thoughts or actions:
•
Paroxetine hydrochloride extended-release tablets and other
antidepressant medicines may
increase suicidal thoughts or actions in some children, teenagers or
young adults within the
first few months of treatment or when the dose is changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal
thoughts or actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts or
feelings, especially
if severe.
•
Pay particular attention to such changes when paroxetine hydrochloride
extended-
release tablets are started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried
about symptoms.
Call your healthcare provider right away if you have any of the
following symptoms or call 911 if
an emergency, especially if they are new, worse or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
�

Summary of Product characteristics

PAROXETINE HYDROCHLORIDE - PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS IN SHORT-TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
PAROXETINE OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT OR YOUNG
ADULT MUST BALANCE
THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN
INCREASE IN THE RISK OF
SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND
AGE 24; THERE WAS A
REDUCTION IN RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS
AGED 65 AND OLDER.
DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES
ASSOCIATED WITH
INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED
ON ANTIDEPRESSANT
THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR
CLINICAL WORSENING,
SUICIDALITY OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS
SHOULD BE ADVISED OF THE
NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER.
PAROXETINE IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL
WORSENING AND SUICIDE
RISK, PRECAUTIONS: INFORMATION FOR PATIENTS AND PRECAUTIONS: PEDIATRIC
USE.)
DESCRIPTION
Paroxetine hydrochloride extended-release tablets are an orally
administered psychotropic drug with a
chemical structure unrelated to other selective serotonin reuptake
inhibitors or to tricyclic, tetracyclic
or other available antidepressant or antipanic agents. It is the
hydrochloride salt of a phenylpiperidine
compound identified chemically as
(3S-trans)-3-[(1,3-benzodioxol-5-yloxy)methyl)]4-(4-fluorophenyl)-
piperidine hydrochloride hemihydrate and has the molecular formula of
C
H FNO • HCl • ½ H O.
The molecular weight is 374.8 (329.4 as free base). The structural
formula of paroxetine
hydrochloride is:
Paroxetine hydrochloride