BRISDELLE- paroxetine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PAROXETINE MESYLATE (UNII: M711N184JE) (PAROXETINE - UNII:41VRH5220H)

Available from:

Sebela Pharmaceuticals Inc.

INN (International Name):

PAROXETINE MESYLATE

Composition:

PAROXETINE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitation of Use : BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE contains a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and efficacy of this lower dose of paroxetine in BRISDELLE have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing medication that is indicated for such use. Concomitant use of an MAOI with BRISDELLE or within 14 days of stopping treatment with BRISDELLE is contraindicated because of an increased risk of serotonin syndrome. The use of BRISDELLE within 14 days of stopping an MAOI is

Product summary:

BRISDELLE is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg” on each capsule. NDC 54766-907-53, blister packs of 30 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light and humidity.

Authorization status:

New Drug Application

Patient Information leaflet

BRISDELLE- PAROXETINE CAPSULE
Sebela Pharmaceuticals Inc.
----------
MEDICATION GUIDE
BRISDELLE ® (bris-del)
(Paroxetine)
Capsules
Read the Medication Guide that comes with BRISDELLE 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. BRISDELLE
contains a lower dose of
paroxetine, a medicine also used to treat a number of psychiatric
disorders. The lower dose of paroxetine in
BRISDELLE has not been studied in any psychiatric conditions and
BRISDELLE is not approved for any
psychiatric uses.
What is the most important information I should know about BRISDELLE?
BRISDELLE may cause serious side effects.
Call your healthcare provider right away if you have any of the
following symptoms, or go to the nearest
emergency room:
1. Suicidal thoughts or actions:
•
BRISDELLE, and related antidepressant medicines, may increase suicidal
thoughts or actions within
the first few months of treatment.
•
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 BRISDELLE is started.
•
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 or go to the nearest
emergency room if you have any of the
following symptoms, 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
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeli

Summary of Product characteristics

BRISDELLE- PAROXETINE CAPSULE
SEBELA PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRISDELLE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BRISDELLE.
BRISDELLE (PAROXETINE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
POTENTIAL FOR INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR ( 5.1)
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
( 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Sexual Dysfunction ( 5.12)
09/2021
INDICATIONS AND USAGE
BRISDELLE is a selective serotonin reuptake inhibitor (SSRI) indicated
for the treatment of moderate to
severe vasomotor symptoms associated with menopause (VMS) ( 1)
Limitation of Use: BRISDELLE is not indicated for the treatment of any
psychiatric condition ( 1)
DOSAGE AND ADMINISTRATION
The recommended dosage of BRISDELLE is 7.5 mg once daily, at bedtime (
2.1)
DOSAGE FORMS AND STRENGTHS
Capsules: 7.5 mg ( 3)
CONTRAINDICATIONS
Concurrent use with monoamine oxidase inhibitors (MAOI) or use within
14 days of MAOI use ( 2.2, 4.1,
5.2, 7.3)
Use with thioridazine ( 4.2, 7.1)
Use with pimozide ( 4.3, 7.1)
Hypersensitivity to any ingredient in BRISDELLE ( 4.4)
Pregnancy ( 4.5, 8.1)
WARNINGS AND PRECAUTIONS
_Suicidality_: Monitor for suicidality or unusual changes in behavior
( 5.1)
_Serotonin Syndrome_: Serotonin syndrome, which is potentially
life-threatening, has been reported with
SSRIs. Discontinue BRISDELLE and initiate supportive treatment ( 5.2,
7.3)
_Tamoxifen_: Efficacy of tamoxifen may be reduced when administered
concomitantly with BRISDELLE (
5.3, 7.1)
_Abnormal Bleeding_: Caution patients about the risk of bleeding
associated with the concomitant use of
BRISDELLE and non-steroidal anti-inflammatory drugs (NSAIDs), aspirin,
or other drugs that affect
coagulation ( 5.4, 7.1)
_Angle-Closure Glaucoma: _Angle closure glaucoma has occurre