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:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 attemp

Product summary:

Venlafaxine hydrochloride extended-release tablets are available as follows: 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. NDC: 70518-2933-00 PACKAGING: 90 in 1 BOTTLE PLASTIC 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride tablet, extended
release
REMEDYREPACK INC.
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\
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:
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 changes, in
mood, behaviors, thoughts, or feelings.
This is very important when an antidepressant medicine is started or
when the dose is changed.
· Call the healthcare pr

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
REMEDYREPACK INC.
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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 (5.18) 8/2021
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 tablets. Do not us