PAROXETINE- paroxetine hydrochloride tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

State of Florida DOH Central Pharmacy

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Paroxetine is indicated for the treatment of major depressive disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY—Clinical Trials). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine in maintaining a response

Produkt oversigt:

Paroxetine tablets USP are supplied as white to off-white, oval, film-coated tablets as follows: 10 mg scored tablets imprinted “APO” with a partial bisect on one side and “097” on the other side. 20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side. 30 mg unscored tablets imprinted “APO” on one side and “084” on the other side. 40 mg unscored tablets imprinted “APO” on one side and “101” on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. PAROXETINE TABLETS USP 10 mg, 20 mg, 30 mg and 40 mg Manufactured by:                                     Manufactured for: Apotex Inc.                                              Apotex Corp. Toronto, Ontario                                       Weston, Florida Canada M9L 1T9                                     33326 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

PAROXETINE - PAROXETINE HYDROCHLORIDE TABLET
State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
ANTIDEPRESSANT MEDICINES, DEPRESSION AND OTHER SERIOUS MENTAL
ILLNESSES, AND SUICIDAL THOUGHTS OR ACTIONS
Read the Medication Guide that comes with you or your family member's
antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member's, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults when the medicine is first started.
2.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts
and actions. Some people may have a particularly high risk of having
suicidal thoughts or
actions. These include people who have (or have a family history of)
bipolar illness (also called
manic-depressive illness) or suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
first started or when the dose
is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new, worse, or worry

Produktets egenskaber

PAROXETINE - PAROXETINE HYDROCHLORIDE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
PAROXETINE TABLETS USP
10 MG, 20 MG, 30 MG AND 40 MG
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 TABLETS USP 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 TABLETS
USP ARE 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 is an orally administered psychotropic drug.
It is the hydrochloride salt of a
phenylpiperidine compound identified chemically as
(-)-_trans_-4_R_-(4'-fluorophenyl)-3_S_-[(3',4'-
methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and
has the empirical formula of
C
H FNO •HCl. The molecular weight is 365.8 (anhydrous) (329.4 as free
base). The structural
formula of paroxetine hydrochloride is:
Paroxetine hydrochloride is an odorless, off-white powder, having a
melting point range of 116° to
120°C and a solubility of 5.4 mg/mL in water.
Each film-coat