VENLAFAXINE HYDROCHLORIDE tablet, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Sun Pharmaceutical Industries, Inc.

Designació comuna internacional (DCI):

VENLAFAXINE HYDROCHLORIDE

Composición:

VENLAFAXINE 37.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Venlafaxine hydrochloride extended-release tablets are available as follows: 37.5 mg, round, pink and white colored biconvex bilayer coated tablet imprinted with "760" with black ink on one side and plain on other side. Bottles of 30 with Child Resistant Cap………..….........................................NDC 47335-760 -83 Bottles of 90 with Child Resistant Cap………...............................................NDC 47335-760-81 Bottles of 100 with Child Resistant Cap…………..........................................NDC 47335-760-88 Bottles of 100 …......................................…....NDC 47335-760-08 Bottles of 1000 …….........................................NDC 47335-760-18 Unit-Dose blister pack of 100 (10 × 10) tablets....................................................NDC 47335-760-61  75 mg, round, pink and white colored biconvex bilayer coated tablet imprinted with "759" with black ink on one side and plain on other side. Bottles of 30 with Child Resistant Cap………….............................................NDC 47335-759-83 Bottles of 90 with Child Resistant Cap………...........................................…..NDC 47335-759-81 Bottles of 100 with Child Resistant Cap............................................................NDC 47335-759-88 Bottles of 100 …................................................NDC 47335-759-08 Bottles of 1000 ..................................................NDC 47335-759-18 Unit-Dose blister pack of 100 (10 × 10) tablets....................................................NDC 47335-759-61  150 mg, oval, pink and white colored biconvex bilayer coated tablet imprinted with "758" with black ink on one side and plain on other side. Bottles of 30 with Child Resistant Cap………..........................................…......NDC 47335-758-83 Bottles of 90 with Child Resistant Cap………..........................................….......NDC 47335-758-81 Bottles of 100 with Child Resistant Cap...............................................................NDC 47335-758-88 Bottles of 100 .......................................................NDC 47335-758-08 Bottles of 1000 …..................................................NDC 47335-758-18 Unit-Dose blister pack of 20 (2 × 10) tablets………..........................................…..NDC 47335-758-99 225 mg, oval, pink and white colored biconvex bilayer coated tablet imprinted with "794" with black ink on one side and plain on other side. Bottles of 30 with Child Resistant Cap................................................................... NDC 47335-794-83 Bottles of 90 with Child Resistant Cap................................................................. ..NDC 47335-794-81 Bottles of 100 with Child Resistant Cap................................................................. NDC 47335-794-88 Bottles of 100 ..........................................................NDC 47335-794-08 Bottles of 500 ..........................................................NDC 47335-794-13 Unit-Dose blister pack of 50 (5 × 10) tablets.............................................................NDC 47335-794-99 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]. Protect from moisture and humidity.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Sun Pharmaceutical Industries, Inc.
----------
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
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

Fitxa tècnica

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
SUN PHARMACEUTICAL INDUSTRIES, 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)
RECENT MAJOR CHANGES
Warning and Precautions (5.2, 5.13) 8/2023
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)
INDICATION
STARTING DOSE
DOSE INCREASE
MAXIMUM DOSE
Major Depressive
Disorder
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 Disorder
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
37.5 mg, 75 mg, 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 ta