VENLAFAXINE HYDROCHLORIDE tablet, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Nostrum Laboratories, Inc.

INN (nemzetközi neve):

VENLAFAXINE HYDROCHLORIDE

Összetétel:

VENLAFAXINE 150 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Venlafaxine hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies (14.1) ]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-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 impaired concentration, a suicide attempt or suicidal ideation. Venlafaxine hydrochloride extended-release tablets are indicated for the treatment of Social An

Termék összefoglaló:

Venlafaxine Hydrochloride Extended-Release Tablets 150 mg are white to off-white ,film-coated, round, debossed with "NV3" on one side. Venlafaxine Extended-Release Tablets 225 mg are white to off-white, film-coated, round, debossed with "NV4" on one side. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride tablet, extended
release
Nostrum Laboratories, Inc.
----------
FDA-approved Medication Guide
Antidepressant Medicines, Depression and Other Serious Mental
Illnesses, and Suicidal Thoughts or Actions
Read the Medication Guide that comes with your 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
Who should not take Venlafaxine Hydrochloride Extended-Release
Tablets?
•
take a monoamine oxidase inhibitor (MAOI). Ask your healthcare
provider or pharmacist if you are
not sure if you take an MAOI, including the antibiotic linezolid.
•
Do not take an MAOI within 7 days of stopping Venlafaxine
Hydrochloride Extended-Release
Tablets unless directed to do so by your physician.
•
Do not start Venlafaxine Hydrochloride Extended-Release Tablets if you
stopped taking an MAOI in
the last 2 weeks unless directed to do so by your physician.
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 within the first few months of treatment.
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 chang

Termékjellemzők

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
NOSTRUM LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VENLAFAXINE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
WARNING: SUICIDALITY AND ANTIDEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS. VENLAFAXINE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE NOT APPROVED FOR USE IN
PEDIATRIC PATIENTS. (5.1)
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release tablets are a selective
serotonin and norepinephrine reuptake inhibitor
(SNRI) indicated for:
Major Depressive Disorder (MDD) (1.1)
Social Anxiety Disorder (SAD) (1.2)
DOSAGE AND ADMINISTRATION
Initial Treatment (2.1)
INDIC ATIO N
STARTING DOSE
DOSE INCREASE
MAXIMUM
DO SE
Major Depressive
Disorde r
75 mg/day (in some patients 37.5 mg/day
for 4 to 7 days)
75 mg/day increments at intervals of 4
days or longer
225 mg/day
Social Anxiety
Disorde r
75 mg/day
No benefit at higher doses
75 mg/day
Venlafaxine hydrochloride extended-release tablets should be taken as
a single daily dose with food in either the
morning or evening at the same time each day. (2)
Discontinuation: Gradual; individualized as necessary. (2.4)
DOSAGE FORMS AND STRENGTHS
150 mg, and 225 mg tablets (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOI’s intended to treat
psychiatric disorders with Venlafaxine
hydrochloride extended-release tablets or within 7 days of stopping
treatment with Venlafaxine hydrochloride
extended-release tablets. Do not use Venlafaxine hydrochloride
extended-release tablets within 14 days o