VENLAFAXINE HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trigen Laboratories, LLC

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 37.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) 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 Extended Release Tablets are indicated for the treatment of Social An

Product summary:

Venlafaxine Extended Release Tablets 37.5 mg are round, biconvex, white coated tablets with OS301 printed on one side. They are supplied as follows:         Unit of Use Bottles of 30 Tablets NDC 13811-712-30         Unit of Use Bottles of 90 Tablets NDC 13811-712-90 Venlafaxine Extended Release Tablets 75 mg are round, biconvex, white coated tablets with OS302 printed on one side. They are supplied as follows:         Unit of Use Bottles of 30 Tablets NDC 13811-713-30         Unit of Use Bottles of 90 Tablets NDC 13811-713-90 Venlafaxine Extended Release Tablets 150 mg are round, biconvex, white coated tablets with OS303 printed on one side. They are supplied as follows:         Unit of Use Bottles of 30 Tablets NDC 13811-714-30         Unit of Use Bottles of 90 Tablets NDC 13811-714-90 Venlafaxine Extended Release Tablets 225 mg are round, biconvex, white coated tablets with OS304 printed on one side. They are supplied as follows:         Unit of Use Bottles of 30 Tablets NDC 13811-715-30         Unit of Use Bottles of 90 Tablets NDC 13811-715-90 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Trigen Laboratories, LLC
----------
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 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 Extended
Release Tablets unless
directed to do so by your physician.
•
Do not start Venlafaxine 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 changes, in
mood, behaviors, thoughts, or
feelings. This i

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
TRIGEN LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE EXTENDED
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VENLAFAXINE
EXTENDED RELEASE TABLETS.
VENLAFAXINE 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 EXTENDED RELEASE TABLETS ARE NOT
APPROVED FOR USE
IN PEDIATRIC PATIENTS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.13)
08/2023
INDICATIONS AND USAGE
Venlafaxine 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 4-7 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 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, 75mg, 150 mg, and 225 mg tablets (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOI’s intended to treat
psychiatric disorders with
Venlafaxine Extended Release Tablets or within 7 days of stopping
treatment with Venlafaxine Extended
Release Tablets. Do not use Venlafaxine Extended Release Tablets
within 14 day