FLUOXETINE capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)

Dostupné s:

DIRECT RX

INN (Mezinárodní Name):

FLUOXETINE HYDROCHLORIDE

Složení:

FLUOXETINE 20 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax. 8.1 Pregnancy Teratogenic Effects Pregnancy Category C — Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. Treatment of Pregnant Women during the First Trimester — There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant women. Results of a number of published epidemiological studies assessing the risk of fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent results. More than 10 cohort studies and case-control studies failed to demonstrate an increased risk for congenital malformations overall. However, one prospective cohort study conducted by the European Network of Teratology Information Services reported

Přehled produktů:

Fluoxetine Capsules USP, 20 mg* are opaque green cap/opaque off white body, size ‘3’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘91’ on opaque off white body with black ink.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

FLUOXETINE- fluoxetine capsule
DIRECT RX
----------
Fluoxetine Capsules, USP
(floo ox' e teen)
for oral use
Read the Medication Guide that comes with fluoxetine capsules before
you start taking them 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 fluoxetine
capsules?
Fluoxetine capsules and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
Fluoxetine capsules 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 fluoxetine capsules 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
new or worse depression
new or worse anxiety or panic attacks
feeling agitated, restless, angry or irritable
trouble sleeping
an increase in activity or talking more than what is normal for you
other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
em

Charakteristika produktu

FLUOXETINE- FLUOXETINE CAPSULE
DIRECT RX
----------
FLUOXETINE
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children,
adolescents, and young adults in short-term studies. These studies did
not show
an increase in the risk of suicidal thoughts and behavior with
antidepressant use in
patients over age 24; there was a reduction in risk with
antidepressant use in
patients aged 65 and older [see WARNINGS AND PRECAUTIONS (5.1)].
In patients of all ages who are started on antidepressant therapy,
monitor closely
for worsening and for emergence of suicidal thoughts and behaviors.
Advise
families and caregivers of the need for close observation and
communication with
the prescriber [seeWARNINGS AND PRECAUTIONS (5.1)].
Fluoxetine is not approved for use in children less than 7 years of
age [see
WARNINGS AND PRECAUTIONS (5.1) and USE IN SPECIFIC POPULATIONS (8.4)].
When using fluoxetine and olanzapine in combination, also refer to
Boxed Warning
section of the package insert for Symbyax.
As with all drugs, the potential for interaction by a variety of
mechanisms (e.g.,
pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.)
is a possibility.
7.1 Monoamine Oxidase Inhibitors (MAOI)
[See DOSAGE AND ADMINISTRATION (2.9, 2.10), CONTRAINDICATIONS (4.1),
and
WARNINGS AND PRECAUTIONS (5.2)].
7.2 CNS Acting Drugs
Caution is advised if the concomitant administration of fluoxetine and
such drugs is
required. In evaluating individual cases, consideration should be
given to using lower
initial doses of the concomitantly administered drugs, using
conservative titration
schedules, and monitoring of clinical status [see CLINICAL
PHARMACOLOGY (12.3)].
7.3 Serotonergic Drugs
[See DOSAGE AND ADMINISTRATION (2.9, 2.10), CONTRAINDICATIONS (4.1),
and
WARNINGS AND PRECAUTIONS (5.2)].
7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin,
Warfarin)
Serotonin release by platelets plays an important role in hemostasis.
Epidemiological
studies of the case-cont