VENLAFAXINE HYDROCHLORIDE ER- venlafaxine hydrochloride capsule, extended release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)

Saadav alates:

Advanced Rx Pharmacy of Tennessee, LLC

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: Major Depressive Disorder (MDD) [see CLINICAL STUDIES (14.1)] Generalized Anxiety Disorder (GAD) [see CLINICAL STUDIES (14.2)] Social Anxiety Disorder (SAD) [see CLINICAL STUDIES (14.3)] Panic Disorder (PD) [see CLINICAL STUDIES (14.4)] Venlafaxine hydrochloride extended-release capsules are contraindicated in patients: with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see ADVERSE REACTIONS (6.2)]. taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see DOSAGE AND ADMINISTRATION (2.11), WARNINGS AND PRECAUTIONS (5.2), and DRUG INTERACTIONS (7.1)]. 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochlor

Toote kokkuvõte:

Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘1’) of opaque peach color cap and opaque peach color body imprinted with “E” on cap and “74” on the body with edible black ink. Bottles of 30 Capsules NDC: 80425-0296-01 Bottles of 60 Capsules NDC: 80425-0296-02 Bottles of 90 Capsules NDC: 80425-0296-03 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Venlafaxine Hydrochloride Extended-Release Capsules USP
(ven'' la fax' een hye'' droe klor' ide)
What is the most important information I should know about venlafaxine
hydrochloride extended-release
capsules?
Venlafaxine hydrochloride extended-release capsules may cause serious
side effects, including:
•
Increased risk of suicidal thoughts and actions. Venlafaxine
hydrochloride extended-release
capsules and other antidepressant medicines may increase suicidal
thoughts and actions in some
children, adolescents, and young adults, especially within the first
few months of treatment or
when the dose is changed. Venlafaxine hydrochloride extended-release
capsules are not for use in
children.
•
Depression or other serious mental illnesses are the most important
causes of suicidal
thoughts or actions.
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
started or when the dose is
changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call your healthcare provider or get emergency help right away if you
or a family member have any of
the following symptoms, especially if they are new, worse, or worry
you:
•
attempts to commit suicide
•
acting aggressive, being angry, or violent
•
new or worse depression
•
panic attacks
•
new or worse irritability
•
an extreme increase in activity or talking (mania)
•
thoughts about suicide or dying
•
acting on dangerous impulses
•
new or worse anxiety
•
feeling very agitated or restless
•
trouble sleeping
•
other unusual

Toote omadused

VENLAFAXINE HYDROCHLORIDE ER- VENLAFAXINE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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VENLAFAXINE HCL ER 75MG CAPSULE
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in pediatric
and young adult patients in short-term studies. Closely monitor all
antidepressant-
treated patients for clinical worsening, and emergence of suicidal
thoughts and
behaviors [see WARNINGS AND PRECAUTIONS (5.1)]. Venlafaxine
hydrochloride
extended-release capsules are not approved for use in pediatric
patients [see USE
IN SPECIFIC POPULATIONS (8.4)].
1. INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are indicated in
adults for the
treatment of:
Major Depressive Disorder (MDD) [see CLINICAL STUDIES (14.1)]
Generalized Anxiety Disorder (GAD) [see CLINICAL STUDIES (14.2)]
Social Anxiety Disorder (SAD) [see CLINICAL STUDIES (14.3)]
Panic Disorder (PD) [see CLINICAL STUDIES (14.4)]
2. DOSAGE AND ADMINISTRATION
2.1 General Administration Information
Administer venlafaxine hydrochloride extended-release capsules as a
single dose with
food, either in the morning or in the evening at approximately the
same time each day
[see CLINICAL PHARMACOLOGY (12.3)]. Swallow capsules whole with fluid.
Do not
divide, crush, chew, or place in water.
The capsule may also be administered by carefully opening the capsule
and sprinkling
the entire contents on a spoonful of applesauce. This drug/food
mixture should be
swallowed immediately without chewing and followed with a glass of
water to ensure
complete swallowing of the pellets (spheroids).
2.2 Major Depressive Disorder
For most patients, the recommended starting dose for venlafaxine
hydrochloride
extended-release capsules is 75 mg per day, administered in a single
dose. For some
patients, it may be desirable to start at 37.5 mg per day for 4 to 7
days to allow new
patients to adjust to the medication before increasing to 75 mg per
day. Patients not
responding to the initial 75